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Key Points: Question: Can an antistigma campaign and a mobile technology–based electronic decision support system result in reduced stigma and improved mental health for adults at high risk of common mental disorders at the primary health care level? Findings: This cluster randomized clinical trial included 44 primary health center clusters with 9928 eligible participants (3365 in the high-risk cohort). There was a significant difference in mean depression scores between intervention vs control groups at 12 months, with lower scores in high-risk cohort. Meaning: A multifaceted primary health center intervention with high implementation fidelity may be effective in reducing depression risk. This cluster randomized clinical trial evaluates the use of a digital mental health intervention and community-based antistigma campaign in reducing risk of depression and mental health–related stigma. Importance: More than 150 million people in India need mental health care but few have access to affordable care, especially in rural areas. Objective: To determine whether a multifaceted intervention involving a digital health care model along with a community-based antistigma campaign leads to reduced depression risk and lower mental health–related stigma among adults residing in rural India. Design, Setting, and Participants: This parallel, cluster randomized, usual care–controlled trial was conducted from September 2020 to December 2021 with blinded follow-up assessments at 3, 6, and 12 months at 44 rural primary health centers across 3 districts in Haryana and Andhra Pradesh states in India. Adults aged 18 years and older at high risk of depression or self-harm defined by either a Patient Health Questionnaire–9 item (PHQ-9) score of 10 or greater, a Generalized Anxiety Disorder–7 item (GAD-7) score of 10 or greater, or a score of 2 or greater on the self-harm/suicide risk question on the PHQ-9. A second cohort of adults not at high risk were selected randomly from the remaining screened population. Data were cleaned and analyzed from April 2022 to February 2023. Interventions: The 12-month intervention included a community-based antistigma campaign involving all participants and a digital mental health intervention involving only participants at high risk. Primary health care workers were trained to identify and manage participants at high risk using the Mental Health Gap Action Programme guidelines from the World Health Organization. Main Outcomes and Measures: The 2 coprimary outcomes assessed at 12 months were mean PHQ-9 scores in the high-risk cohort and mean behavior scores in the combined high-risk and non–high-risk cohorts using the Mental Health Knowledge, Attitude, and Behavior scale. Results: Altogether, 9928 participants were recruited (3365 at high risk and 6563 not at high risk; 5638 [57%] female and 4290 [43%] male; mean [SD] age, 43 [16] years) with 9057 (91.2%) followed up at 12 months. Mean PHQ-9 scores at 12 months for the high-risk cohort were lower in the intervention vs control groups (2.77 vs 4.48; mean difference, −1.71; 95% CI, −2.53 to −0.89; P <.001). The remission rate in the high-risk cohort (PHQ-9 and GAD-7 scores <5 and no risk of self-harm) was higher in the intervention vs control group (74.7% vs 50.6%; odds ratio [OR], 2.88; 95% CI, 1.53 to 5.42; P =.001). Across both cohorts, there was no difference in 12-month behavior scores in the intervention vs control group (17.39 vs 17.74; mean difference, −0.35; 95% CI, −1.11 to 0.41; P =.36). Conclusions and Relevance: A multifaceted intervention was effective in reducing depression risk but did not improve intended help-seeking behaviors for mental illness. Trial Registration: Clinical Trial Registry India: CTRI/2018/08/015355. [ABSTRACT FROM AUTHOR]

Background: In supporting primary healthcare in delivering high-quality care for individuals with type 2 diabetes mellitus (T2DM), previous research emphasized strategies to facilitate communication and collaboration between primary healthcare providers and hospitals. This study aims to evaluate the effectiveness of case discussion conferences between specialists from hospitals and primary healthcare providers in China on the optimization of diabetes management and the improvement of patient health outcomes. Methods: This study will be a parallel cluster randomized controlled trial in which primary healthcare institutions in Shouguang city and Shangsi County will be randomly allocated to the intervention and control groups. The intervention will involve regular case discussion conferences where attendants will meet to discuss complex cases with patients diagnosed with type 2 diabetes mellitus, exchange experiences, and seek and provide expert advice. Family doctor teams from primary healthcare institutions and specialists from secondary or tertiary hospitals will engage in these conferences. Data will be collected at baseline and at the 6- and 12-month follow-ups. The primary clinical outcome measures will focus on the changes in the HbA1c and FBG levels of patients under management. The secondary outcomes will include other physiological indicators, such as blood pressure, BMI, and cholesterol. The evaluation will extend to changes in the capabilities and behaviors of primary healthcare providers. Furthermore, the feasibility and adherence of this intervention will be thoroughly assessed. Discussion: This study is designed to generate robust evidence on the effectiveness of case discussion conferences, an interprofessional collaboration strategy, in enhancing diabetes care delivery in primary healthcare, with the ultimate goal of improving patient health outcomes. Trial registration: Chinese Clinical Trial Registry ChiCTR2300078829. Registered on December 19, 2023. https://www.chictr.org.cn/showproj.html?proj=210293 [ABSTRACT FROM AUTHOR]

Background: We previously performed a pragmatic cluster randomized controlled trial (RCT) in general practices and older adult care organizations in Poland, the Netherlands, Norway, and Sweden. We found that a multifaceted antibiotic stewardship intervention (ASI) substantially reduced antibiotic use for suspected urinary tract infections (UTIs) in frail older adults compared with usual care. We aimed to evaluate the implementation process of the ASI to provide recommendations for clinical practice. Methods: We conducted a process evaluation alongside the cluster RCT. The ASI consisted of a decision-tool and a toolbox, which were implemented using a participatory-action-research (PAR) approach with sessions for education and evaluation. We documented the implementation process of the intervention and administered a questionnaire to health care professionals (HCPs) from participating organizations in the intervention and usual care clusters. We evaluated the multiple components of the intervention and its implementation following a structured framework. Results: The questionnaire was completed by 254 HCPs from the 38 participating clusters. All components were largely delivered according to plan and evaluated as useful. The decision-tool and toolbox materials were reported to facilitate decision-making on UTIs. Regarding the PAR approach, educational sessions focusing on the distinction between UTIs and asymptomatic bacteriuria were held in all 19 intervention clusters. In 17 out of these 19 clusters, evaluation sessions took place, which were reported to help remind HCPs to implement the ASI. During both sessions, HCPs valued the reflection that took place and the resulting awareness of their behavior. It allowed them to explore implementation barriers and to tailor their local implementation process to overcome these. For example, HCPs organized extra educational sessions or revised local policies to incorporate the use of the decision-tool. Various HCPs took key roles in implementation. Staff changes and the COVID-19 pandemic were important contextual barriers. Conclusions: We found each component of the multifaceted ASI and its implementation to have added value in the process to improve antibiotic prescribing for suspected UTIs in a heterogeneous older adult care setting. We recommend using a multifaceted, multidisciplinary approach that enables HCPs to reflect on their current practice and accordingly tailor local implementation. Trial registration: ClinicalTrials.gov NCT03970356. Registered on May 31, 2019. [ABSTRACT FROM AUTHOR]

Background: Management of rheumatoid arthritis (RA) relies on symptoms reported by patients during infrequent outpatient clinic visits. These reports are often incomplete and inaccurate due to poor recall, leading to suboptimal treatment decisions and outcomes. Asking people to track symptoms in-between visits and integrating the data into clinical pathways may improve this. However, knowledge on how to implement this into practice and its impact on services and outcomes remains scarce in RA. Therefore, we evaluate the comparative effectiveness and cost-effectiveness of integrated symptom tracking in people with RA over and above usual care, while generating insights on factors for successful implementation. Methods: In this superiority stepped wedge cluster-randomized controlled trial with continuous recruitment short exposure design, 16 rheumatology outpatient departments (clusters) recruit a total of 732 people with active RA. They initially offer clinic visits according to standard of care before switching in pairs to visits with integrated symptom tracking. Clusters switch in randomized order every 3 weeks. Integrated symptom tracking consists of (1) a mobile app for patients to track their symptoms daily and other RA aspects weekly/monthly, and (2) an interactive dashboard visualizing the app data, which healthcare professionals access from their electronic health record system. Clinic visits happen according to usual practice, with tracked symptom data only reviewed during visits. Our primary outcome is a difference in marginal mean disease activity score at 12 ± 3 months between standard of care and integrated symptom tracking, after accounting for baseline values, cluster, and other covariates. Secondary outcomes include patient-reported disease activity, quality of life and quality-adjusted life-years, medication/resource use, consultation and decision-making experience, self-management, and illness perception. We also conduct interviews and observations as part of a parallel process evaluation to gather information on implementation. Discussion: Our trial will generate high-quality evidence of comparative and cost-effectiveness of integrated symptom tracking compared to standard of care in people with RA, with our process evaluation delivering knowledge on successful implementation. This optimizes the chances of integrated symptom tracking being adopted more widely if we find it is (cost-) effective. Trial registration: Registered 4-Jun-2024 on https://www.isrctn.com/, ISRCTN51539448. Trial open science framework repository: https://osf.io/sj9ha/. [ABSTRACT FROM AUTHOR]

This study investigates the effectiveness of using Hospital Fit as part of usual care physiotherapy on the physical activity (PA) behavior of hospitalized patients compared to patients who received physiotherapy before implementation of Hospital Fit. In addition, a process evaluation is conducted. A prospective, multi-center, mixed-methods stepped wedge cluster randomized trial was performed at the cardiology and medical oncology departments of two Dutch university medical centers. Patients were included in the non-intervention or intervention phase. During the non-intervention phase, patients received usual care physiotherapy. During the intervention phase, Hospital Fit was additionally used. Mean time spent walking, standing, lying/sitting per day and the number of postural transitions from lying/sitting to standing/walking positions were measured using an accelerometer and analyzed using linear mixed models. A process evaluation was performed using questionnaires and semi-structured interviews with patients and focus-group interviews with healthcare professionals. A total of 77 patients were included, and data from 63 patients were used for data analysis. During the intervention phase, the average time spent walking per day was 20 min (95% confidence interval: −2 to 41 min) higher than during the non-intervention phase (p = 0.075). No significant differences were found for mean time spent standing per day, mean time spent lying/sitting per day, or the number of postural transitions per day either. During the intervention phase, 87% of patients used Hospital Fit at least once, with a median daily use of 2.5 to 4.0 times. Patients and healthcare professionals believed that Hospital Fit improved patients' PA behavior and recovery. Insufficient digital skills and technical issues were described as challenges. Although patients and healthcare professionals described Hospital Fit as an added value, no statistically significant effects were found. [ABSTRACT FROM AUTHOR]

A study conducted in Uganda suggests that using C-reactive protein (CRP) levels to guide the evaluation of young children with lower respiratory tract infections (LRTIs) may help reduce the prescription of antimicrobial therapy without increasing treatment failure rates. LRTIs are a leading cause of morbidity and mortality in children, but there is no clinically feasible reference standard for their diagnosis. The study found that incorporating CRP into the routine management of LRTIs among young children resulted in a nearly 25% reduction in antimicrobial therapy prescriptions, with no difference in clinical outcomes. However, further research is needed to determine the optimal CRP level for withholding antimicrobial therapy and to consider the potential inconveniences and costs associated with implementing this approach. [Extracted from the article]

Background: Poor person-centered maternal care (PCMC) contributes to high maternal mortality and morbidity, directly and indirectly, through lack of, delayed, inadequate, unnecessary, or harmful care. While evidence on poor PCMC prevalence, as well as inequities, expanded in the last decade, there is still a significant gap in evidence-based interventions to address PCMC. We describe the protocol for a trial to test the effectiveness of the "Caring for Providers to Improve Patient Experience" (CPIPE) intervention, which includes five strategies, targeting provider stress and bias as intermediate factors to improve PCMC and address inequities. Methods: The trial will assess the effect of CPIPE on PCMC, as well as on intermediate and distal outcomes, using a two-arm cluster randomized controlled trial in 40 health facilities in Migori and Homa Bay Counties in Kenya and Upper East and Northeast Regions in Ghana. Twenty facilities in each country will be randomized to 10 intervention and 10 control sites. The primary intervention targets are all healthcare workers who provide maternal health services. The intervention impact will be assessed among healthcare workers in the study health facilities and among women who give birth in the study health facilities. The primary outcome is PCMC measured with the PCMC scale, via multiple cross-sectional surveys of mothers who gave birth in the preceding 12 weeks in study facilities at baseline (prior to the intervention), midline (6 months after intervention start), and endline (12 months post-baseline) (N = 2000 across both countries at each time point). Additionally, 400 providers in the study facilities across both countries will be followed longitudinally at baseline, midline, and endline, to assess intermediate outcomes. The trial incorporates a mixed-methods design; survey data alongside in-depth interviews (IDIs) with healthcare facility leaders, providers, and mothers to qualitatively explore factors influencing the outcomes. Finally, we will collect process and cost data to assess intervention fidelity and cost-effectiveness. Discussion: This trial will be the first to rigorously assess an intervention to improve PCMC that addresses both provider stress and bias and will advance the evidence base for interventions to improve PCMC and contribute to equity in maternal and neonatal health. Trial registration: ClinicalTrials.gov: NCT06085105. Protocol version and date: v2-11-07-23 [ABSTRACT FROM AUTHOR]

Background: Hypertension is a major public health challenge, globally. Recently, we reported findings from cluster randomized trial in 8 primary care clinics in Singapore and showed that a multicomponent "SingHypertension" intervention comprising 1) motivational conversation by trained nurses, 2) telephone-based follow-ups, 3) standardized algorithm with single-pill combination (SPC) antihypertensive medications, and 4) subsidy on SPC antihypertensive drugs was effective on improving BP control. This paper presents the acceptability of SingHypertension multicomponent intervention among the key stakeholders. Methods: We conducted post-implementation interviews of 38 stakeholders, including 18 patients and 20 healthcare providers (HCPs) in 4 primary care clinics randomized to the multicomponent "SingHypertension" intervention in Singapore. We used Theoretical Framework for Acceptability (TFA) framework with a focus on affective attitude, burden, ethicality, intervention coherence, opportunity cost, perceived effectiveness and self-efficacy to assess stakeholders' acceptability of the intervention. Results: SingHypertension multicomponent intervention had high perceived effectiveness and a good fit with the value system and ethics of patients and HCPs. Physicians appreciated the guidance from standardized training in hypertension management. Although workload was increased, the nurses felt rewarded for their positive interactions with the patients during motivational conversation sessions and the telephone follow-ups. Most patients reported high self-efficacy levels, improved lifestyles, and adherence to antihypertensive medications. The limited choice of SPC medication, lack of subsidy beyond the trial duration, and shortage of nurses were significant challenges to wide-scale implementation. All HCPs and patients supported scaling up the intervention across primary care clinics. Conclusion: SingHypertension multicomponent intervention is acceptable to the key stakeholders in Singapore. Taken together with the effectiveness of the intervention, our findings make a compelling case for scaling-up SingHypertension in primary care clinics in Singapore and possibly other countries with similar healthcare infrastructure. [ABSTRACT FROM AUTHOR]

Background: Clinical practice guidelines are crucial for enhancing healthcare quality and patient outcomes. Yet, their implementation remains inconsistent across various professions and disciplines. Previous findings on the implementation of the German guideline for schizophrenia (2019) revealed low adherence rates among healthcare professionals. Barriers to guideline adherence are multifaceted, influenced by individual, contextual, and guideline-related factors. This study aims to investigate the effectiveness of a digital guideline version compared to print/PDF formats in enhancing guideline adherence. Methods: A multicenter, cluster-randomized controlled trial was conducted in South Bavaria, Germany, involving psychologists and physicians. Participants were divided into two groups: implementation of the guideline using a digital online version via the MAGICapp platform and the other using the traditional print/PDF version. The study included a baseline assessment and a post-intervention assessment following a 6-month intervention phase. The primary outcome was guideline knowledge, which was assessed using a guideline knowledge questionnaire. Results: The study included 217 participants at baseline and 120 at post-intervention. Both groups showed significant improvements in guideline knowledge; however, no notable difference was found between both study groups regarding guideline knowledge at either time points. At baseline, 43.6% in the control group (CG) and 52.5% of the interventional group (IG) met the criterion. There was no significant difference in the primary outcome between the two groups at either time point (T0: Chi2(1) = 1.65, p = 0.199, T1: Chi2(1) = 0.34, p = 0.561). At post-intervention, both groups improved, with 58.2% in the CG and 63.5% in the IG meeting this criterion. Conclusions: While the study did not include a control group without any implementation strategy, the overall improvement in guideline knowledge following an implementation strategy, independent of the format, was confirmed. The digital guideline version, while not superior in enhancing knowledge, showed potential benefits in shared decision-making skills. However, familiarity with traditional formats and various barriers to digital application may have influenced these results. The study highlights the importance of tailored implementation strategies, especially for younger healthcare providers. Trial registration: https://drks.de/search/de/trial/DRKS00028895 [ABSTRACT FROM AUTHOR]

Background: Indigenous populations globally have significantly high rates of type 2 diabetes compared to their non-Indigenous counterparts. This study aims to implement and evaluate the effectiveness of a culturally and contextually informed Aboriginal Diabetes Workforce Training Program on Aboriginal primary health care workforce knowledge, attitude, confidence, skill and practice relating to diabetes care. Methods: A Cluster Randomised Crossover Control Trial with two arms (Group A and Group B) will be conducted with Aboriginal primary health care services in South Australia. These services primarily provide primary health care to Aboriginal and Torres Strait Islander people. All healthcare service sites will be randomised into groups A and B to receive the training program. The training program consists of three components: 1) Peer support network, 2) E-Learning modules and 3) onsite support. Aboriginal Health Workers of participating sites will be invited to participate in the monthly online peer support network and all chronic disease staff are eligible to participate in the E-Learning modules and onsite support. The Peer Support Network runs for the entirety of the study, 17 months. Training components 2 and 3 occur simultaneously and are 2.5 months in length, with a six-month washout period between the two randomised groups undertaking the training. All primary outcomes of the study relate to diabetes management in a primary health care settings and measure participants' knowledge, attitude, confidence, practice and skills. These will be collected at seven time points across the entire study. Secondary outcomes measure satisfaction of the peer support network using a survey, interviews to understand enablers and barriers to participation, health service systems characteristics through focus groups, and medical record review to ascertain diabetes patients' care received and their clinical outcomes up to 12 months post training intervention. Discussion: The findings will explore the effectiveness of the training program on Aboriginal primary health care provider knowledge, attitude, confidence, skill and practice relating to diabetes care. The final findings will be published in 2027. Trial registration: The study was prospectively registered in The Australian New Zealand Clinical Trials Registry (ANZCTR), with registration number ACTRN12623000749606 at ANZCTR - Registration. Universal Trial Number (UTN) U1111-1283-5257. [ABSTRACT FROM AUTHOR]

Background: Laboratory test overuse in hospitals is a form of healthcare waste that also harms patients. Developing and evaluating interventions to reduce this form of healthcare waste is critical. We detail the protocol for our study which aims to implement and evaluate the impact of an evidence-based, multicomponent intervention bundle on repetitive use of routine laboratory testing in hospitalized medical patients across adult hospitals in the province of British Columbia, Canada. Methods: We have designed a stepped-wedge cluster randomized trial to assess the impact of a multicomponent intervention bundle across 16 hospitals in the province of British Columbia in Canada. We will use the Knowledge to Action cycle to guide implementation and the RE-AIM framework to guide evaluation of the intervention bundle. The primary outcome will be the number of routine laboratory tests ordered per patient-day in the intervention versus control periods. Secondary outcome measures will assess implementation fidelity, number of all common laboratory tests used, impact on healthcare costs, and safety outcomes. The study will include patients admitted to adult medical wards (internal medicine or family medicine) and healthcare providers working in these wards within the participating hospitals. After a baseline period of 24 weeks, we will conduct a 16-week pilot at one hospital site. A new cluster (containing approximately 2–3 hospitals) will receive the intervention every 12 weeks. We will evaluate the sustainability of implementation at 24 weeks post implementation of the final cluster. Using intention to treat, we will use generalized linear mixed models for analysis to evaluate the impact of the intervention on outcomes. Discussion: The study builds upon a multicomponent intervention bundle that has previously demonstrated effectiveness. The elements of the intervention bundle are easily adaptable to other settings, facilitating future adoption in wider contexts. The study outputs are expected to have a positive impact as they will reduce usage of repetitive laboratory tests and provide empirically supported measures and tools for accomplishing this work. Trial Registration: This study was prospectively registered on April 8, 2024, via ClinicalTrials.gov Protocols Registration and Results System (NCT06359587). https://classic.clinicaltrials.gov/ct2/show/NCT06359587?term=NCT06359587&recrs=ab&draw=2&rank=1 [ABSTRACT FROM AUTHOR]

Introduction: Community-based health interventions often demonstrate efficacy in clinical trial settings but fail to be implemented in the real-world. We sought to identify the key operational and contextual elements of the Los Angeles Barbershop Blood Pressure Study (LABBPS), an objectively successful community-based health intervention primed for real-world implementation. LABBPS was a cluster randomized control trial that paired the barbers of Black-owned barbershops with clinical pharmacists to manage uncontrolled hypertension in Black male patrons, demonstrating a substantial 21.6 mmHg reduction in systolic blood pressure. Despite this success, the LABBPS intervention has not expanded beyond the original clinical trial setting. The aim of this study was to determine the facilitating and limiting factors to expansion of the LABBPS intervention. Methods: We undertook a qualitative assessment of semi-structured interviews with study participants performed after trial completion. Interviews included a total of 31 participants including 20 (6%) of the 319 LABBPS program participants ("patrons"), 10 (19%) barbers, and one (50%) clinical pharmacist. The semi-structured interviews were focused on perceptions of the medical system, study intervention, and influence of social factors on health. Results: Several common themes emerged from thematic analysis of interview responses including: importance of care provided in a convenient and safe environment, individual responsibility for health and health-related behaviors, and engagement of trusted community members. In particular, patrons reported that receiving the intervention from their barber in a familiar environment positively influenced the formation of relationships with clinical pharmacists around shared efforts to improve medication adherence and healthy habits. All interviewee groups identified the trust diad, comprising the familiar environment and respected community member, as instrumental in increasing health-related behaviors to a degree not usually achieved by traditional healthcare providers. Discussion: In conclusion, participants of an objectively successful community-based intervention trial consistently identified key features that could facilitate wider implementation and efficacy: social trust relationships, soliciting insights of trust bearers, and consistent engagement in a familiar community setting. These findings can help to inform the design and operations of future community-based studies and programs aiming to achieve a broad and sustainable impact. [ABSTRACT FROM AUTHOR]

Background: Although AIDS-related deaths have reduced with increased access to antiretroviral care, cardiovascular disease-related morbidities among persons living with HIV are rising. Contributing to this is the higher incidence of Hypertension among Persons Living with HIV. The duration of exposure to the virus and antiretroviral drugs plays a vital role in the pathogenesis, putting perinatally infected children and adolescents at higher risk than behaviorally-infected ones, supporting the calls for increased surveillance of Hypertension among them. Despite the availability of guidelines to support this surveillance, the blood pressure (BP) of adolescents living with HIV (ADLHIV) is not checked during clinical visits. This study aims to assess the effect of a theory-based intervention on healthcare workers' adherence to the guidelines for hypertension screening among adolescents. Methods: A multi-facility cluster-randomized study will be conducted. The clusters will be 20 antiretroviral therapy sites in the Greater Accra Region of Ghana with the highest adolescent caseload. Data will be extracted from the folders of adolescents (10–17 years) who received care in these facilities six months before the study. The ART staff of intervention facilities will receive a multicomponent theory of planned behaviour-based intervention. This will include orientation on hypertension risk among ADLHIV, provision of job aids and pediatric sphygmomanometers. Six months after the intervention, the outcome measure will be the change from baseline in the proportion of ADLHIV whose BP was checked during clinical visits. The calculated sample size is 400 folders. Implications of findings: This study will generate evidence on the effectiveness of a multicomponent theory-based intervention for improving the implementation of clinical practice guidelines. Trial registration: PACTR202205641023383. [ABSTRACT FROM AUTHOR]

Background: The use of systems engineering tools, including the development and use of care cascades using routinely collected data, process mapping, and continuous quality improvement, is used for frontline healthcare workers to devise systems level change. South Africa experiences high rates of tuberculosis (TB) infection and disease as well as HIV co-infection. The Department of Health has made significant gains in HIV services over the last two decades, reaching their set "90–90-90" targets for HIV. However, TB services, although robust, have lagged in comparison for both disease and infection. The Systems Analysis and Improvement Approach (SAIA) is a five-step implementation science method, drawn from systems engineering, to identify, define, and implement workflow modifications using cascade analysis, process mapping, and repeated quality improvement cycles within healthcare facilities. Methods: This stepped-wedge cluster randomized trial will evaluate the effectiveness of SAIA on TB (SAIA-TB) cascade optimization for patients with TB and high-risk contacts across 16 clinics in four local municipalities in the Sarah Baartman district, Eastern Cape, South Africa. We hypothesize that SAIA-TB implementation will lead to a 20% increase in each of: TB screening, TB preventive treatment initiation, and TB disease treatment initiation during the 18-month intervention period. Focus group discussions and key informant interviews with clinic staff will also be conducted to determine drivers of implementation variability across clinics. Discussion: This study has the potential to improve TB screening, treatment initiation, and completion for both active disease and preventive measures among individuals with and without HIV in a high burden setting. SAIA-TB provides frontline health care workers with a systems-level view of their care delivery system with the aim of sustainable systems-level improvements. Trial registration: Clinicaltrials.gov, NCT06314386. Registered 18 March 2024, https://clinicaltrials.gov/study/NCT06314386. NCT06314386. [ABSTRACT FROM AUTHOR]

Background: Women living with HIV (WLWH) face unique reproductive health (RH) barriers which increase their risks of unmet need for contraception, contraceptive failure, unintended pregnancy, and pregnancy-related morbidity and mortality and may prevent them from achieving their reproductive goals. Patient-centered counseling interventions that support health care workers (HCWs) in providing high-quality RH counseling, tailored to the needs of WLWH, may improve reproductive health outcomes. Methods and design: We are conducting a non-blinded cluster randomized controlled trial (cRCT) of a digital health intervention for WLWH (clinicaltrials.gov #NCT05285670). We will enroll 3,300 WLWH seeking care in 10 HIV care and treatment centers in Nairobi and Western Kenya. WLWH at intervention sites receive the Mobile WACh Empower intervention, a tablet-based RH decision-support counseling tool administered at baseline and SMS support during two years of follow-up. WLWH at control sites receive the standard of care FP counseling. The decision-support tool is a logic-based tool for family planning (FP) counseling that uses branching logic to guide RH questions based on participants' reproductive life plans, tailoring counseling based on the responses. Follow-up SMSs are based in the Information-Motivation-Behavioral (IMB) Skills model of behavioral change and are tailored to participant characteristics and reproductive needs through separate SMS "tracks". Follow-up visits are scheduled quarterly for 2 years to assess plans for pregnancy, pregnancy prevention, and contraceptive use. The primary outcome, FP discontinuation, will be compared using an intent-to-treat analysis. We will also assess the unmet need for FP, dual method use, viral load suppression at conception and unintended pregnancy. Discussion: The Mobile WACh Empower intervention is innovative as it combines a patient-centered counseling tool to support initial reproductive life decisions with longitudinal SMS for continued RH support and may help provide RH care within the context of provision of HIV care. [ABSTRACT FROM AUTHOR]

OBJECTIVES: To determine the effect of a standardized program for family participation in essential care activities in the ICU on symptoms of anxiety, depression, posttraumatic stress and satisfaction among relatives, and perceptions and experiences of ICU healthcare providers (HCPs). DESIGN: Multicenter stepped-wedge cluster randomized controlled trial. SETTING: Seven adult ICUs, one university, and six general teaching hospitals. PARTICIPANTS: Three hundred six relatives and 235 ICU HCPs. INTERVENTIONS: A standardized program to facilitate family participation inpatient communication, amusement/distraction, comfort, personal care, breathing, mobilization, and nutrition. MEASUREMENTS AND MAIN RESULTS: Data were collected through surveys among relatives and ICU HCPs. There were no significant differences in symptoms of anxiety in relatives in the intervention period compared with the control period (median Hospital Anxiety and Depression Scale [HADS] 5 [interquartile range (IQR) 2-10] vs 6 [IQR 3-9]; median ratio [MR] 0.72; 95% CI, 0.46-1.13; p = 0.15), depression (median HADS 4 [IQR 2-6] vs 3 [IQR 1-6]; MR 0.85; 95% CI, 0.55-1.32; p = 0.47) or posttraumatic stress (median Impact of Event Scale-Revised score 0.45 [IQR 0.27-0.82] vs 0.41 [IQR 0.14-1]; MR 0.94; 95% CI, 0.78-1.14; p = 0.54). Reported satisfaction was slightly lower in the intervention period (mean 8.90 [sd 1.10] vs mean 9.06 [sd 1.10], difference -0.60; 95% CI, -1.07 to -0.12; p = 0.01). ICU HCPs perceived that more relatives knew how to participate: 47% in the intervention period versus 22% in the control period (odds ratio [OR] 3.15; 95% CI, 1.64-6.05; p < 0.01). They also reported relatives having sufficient knowledge (41% vs 16%; OR 3.56; 95% CI, 1.75-7.25; p < 0.01) and skills (44% vs 25%; OR 2.38; 95% CI, 1.22-4.63; p = 0.01) to apply family participation. CONCLUSIONS: Application of a standardized program to facilitate family participation did not change mental health symptoms in relatives of ICU patients 3 months after discharge. ICU HCPs reported increased clarity, knowledge, and skills among relatives and ICU HCPs. [ABSTRACT FROM AUTHOR]

This article discusses a study conducted in Peru that aimed to assess the effectiveness of replacing sodium chloride with a salt substitute in reducing blood pressure and the incidence of hypertension in a community-wide setting. The study utilized a stepped-wedge cluster randomized trial design, where the intervention was introduced in a phased manner across different villages. The results showed that the salt substitute was associated with a modest reduction in blood pressure and a lower incidence of hypertension, particularly among individuals with hypertension at baseline. The study suggests that this intervention could be implemented on a population-wide basis. However, it is important to note that the study design used does not provide the same level of evidence as a randomized controlled trial. [Extracted from the article]

The article discusses the challenges faced by people with diabetes who undergo surgical interventions, including increased risks of complications and mortality. It emphasizes the importance of implementing effective systems for perioperative diabetes care, such as using national guidelines, setting glycemic target ranges, and employing networked blood glucose meters with alert systems. The article highlights the need for consistent adherence to guidelines and the potential benefits of proactive diabetes teams. It also discusses different models of care, including the integration of electronic medical records and networked blood glucose meters, as well as a patient journey approach. The article concludes by suggesting future directions for improving inpatient diabetes care, including the use of artificial intelligence and wearable sensors. Overall, the article provides evidence that investment in various aspects of inpatient diabetes care can lead to improved outcomes and patient experience. [Extracted from the article]

Background: Acutely ill and frail older adults and their next of kin are often poorly involved in treatment and care decisions. This may lead to either over- or undertreatment and unnecessary burdens. The aim of this project is to improve user involvement and health services for frail older adults living at home, and their relatives, by implementing advance care planning (ACP) in selected hospital wards, and to evaluate the clinical and the implementation interventions. Methods: This is a cluster randomized trial with 12 hospital units. The intervention arm receives implementation support for 18 months; control units receive the same support afterwards. The ACP intervention consists of 1. Clinical intervention: ACP; 2. Implementation interventions: Implementation team, ACP coordinator, network meetings, training and supervision for health care personnel, documentation tools and other resources, and fidelity measurements with tailored feedback; 3. Implementation strategies: leadership commitment, whole ward approach and responsive evaluation. Fidelity will be measured three times in the intervention arm and twice in the control arm. Here, the primary outcome is the difference in fidelity changes between the arms. We will also include 420 geriatric patients with one close relative and an attending clinician in a triadic sub-study. Here, the primary outcomes are quality of communication and decision-making when approaching the end of life as perceived by patients and next of kin, and congruence between the patient's preferences for information and involvement and the clinician's perceptions of the same. For patients we will also collect clinical data and health register data. Additionally, all clinical staff in both arms will be invited to answer a questionnaire before and during the implementation period. To explore barriers and facilitators and further explore the significance of ACP, qualitative interviews will be performed in the intervention units with patients, next of kin, health care personnel and implementation teams, and with other stakeholders up to national level. Lastly, we will evaluate resource utilization, costs and health outcomes in a cost-effectiveness analysis. Discussion: The project may contribute to improved implementation of ACP as well as valuable knowledge and methodological developments in the scientific fields of ACP, health service research and implementation science. Trial registration: ClinicalTrials.gov Identifier NCT05681585. Registered 03.01.23. [ABSTRACT FROM AUTHOR]

Background: Tuberculosis (TB) preventive treatment (TPT) substantially reduces the risk of developing active TB for people living with HIV (PLHIV). We utilized a novel implementation strategy based on choice architecture (CAT) which makes TPT prescribing the default option. Through CAT, health care workers (HCWs) need to "opt-out" when choosing not to prescribe TPT to PLHIV. We assessed the prospective, concurrent, and retrospective acceptability of TPT prescribing among HCWs in Malawi who worked in clinics participating in a cluster randomized trial of the CAT intervention. Methods: 28 in-depth semi-structured interviews were conducted with HCWs from control (standard prescribing approach) and intervention (CAT approach) clinics. The CAT approach was facilitated in intervention clinics using a default prescribing module built into the point-of-care HIV Electronic Medical Record (EMR) system. An interview guide for the qualitative CAT assessment was developed based on the theoretical framework of acceptability and on the normalization process theory. Thematic analysis was used to code the data, using NVivo 12 software. Results: We identified eight themes belonging to the three chronological constructs of acceptability. HCWs expressed no tension for changing the standard approach to TPT prescribing (prospective acceptability); however, those exposed to CAT described several advantages, including that it served as a reminder to prescribe TPT and routinized TPT prescribing (concurrent acceptability). Some felt that CAT may reduce HCW´s autonomy and might lead to inappropriate TPT prescribing (retrospective acceptability). Conclusions: The default prescribing module for TPT has now been incorporated into the point-of-care EMR system nationally in Malawi. This seems to fit the acceptability of the HCWs. Moving forward, it is important to train HCWs on how the EMR can be leveraged to determine who is eligible for TPT and who is not, while acknowledging the autonomy of HCWs. [ABSTRACT FROM AUTHOR]

Although the use of the cluster randomized trial (CRT) design to evaluate vaccines, public health interventions or health systems is increasing, the ethical issues posed by the design are not adequately addressed, especially in low- and middle-income country settings (LMICs). To help reveal ethical challenges, qualitative interviews were conducted with key stakeholders experienced in designing and conducting two selected CRTs in Malawi. The 18 interviewed stakeholders included investigators, clinicians, nurses, data management personnel and community workers who were invited to share their experiences related to implementation of CRTs. Data analysis revealed five major themes with ethical implications: (1) The moral obligation for health care providers to participate in health research and its compensation; (2) Suboptimal care services compromising the integrity of CRT; (3) Ensuring scientific validity and withholding care service; (4) Obtaining valid consent and permission for waiver of consent; and (5) Inadequate risk assessment for trial participation. Understanding key ethical issues posed by CRTs in Malawi could improve ethical review and research oversight of this particular study design. [ABSTRACT FROM AUTHOR]

Background: Clostridioides difficile infection (CDI) is associated with considerable morbidity and mortality in hospitalized patients, especially among older adults. Probiotics have been evaluated to prevent hospital-acquired (HA) CDI in patients who are receiving systemic antibiotics, but the implementation of timely probiotic administration remains a challenge. We evaluated methods for effective probiotic implementation across a large health region as part of a study to assess the real-world effectiveness of a probiotic to prevent HA-CDI (Prevent CDI-55 +). Methods: We used a stepped-wedge cluster-randomized controlled trial across four acute-care adult hospitals (n = 2,490 beds) to implement the use of the probiotic Bio-K + ® (Lactobacillus acidophilus CL1285®, L. casei LBC80R® and L. rhamnosus CLR2®; Laval, Quebec, Canada) in patients 55 years and older receiving systemic antimicrobials. The multifaceted probiotic implementation strategy included electronic clinical decision support, local site champions, and both health care provider and patient educational interventions. Focus groups were conducted during study implementation to identify ongoing barriers and facilitators to probiotic implementation, guiding needed adaptations of the implementation strategy. Focus groups were thematically analyzed using the Theoretical Domains Framework and the Consolidated Framework of Implementation Research. Results: A total of 340 education sessions with over 1,800 key partners and participants occurred before and during implementation in each of the four hospitals. Site champions were identified for each included hospital, and both electronic clinical decision support and printed educational resources were available to health care providers and patients. A total of 15 individuals participated in 2 focus group and 7 interviews. Key barriers identified from the focus groups resulted in adaptation of the electronic clinical decision support and the addition of nursing education related to probiotic administration. As a result of modifying implementation strategies for identified behaviour change barriers, probiotic adherence rates were from 66.7 to 75.8% at 72 h of starting antibiotic therapy across the four participating acute care hospitals. Conclusions: Use of a barrier-targeted multifaceted approach, including electronic clinical decision support, education, focus groups to guide the adaptation of the implementation plan, and local site champions, resulted in a high probiotic adherence rate in the Prevent CDI-55 + study. [ABSTRACT FROM AUTHOR]

Introduction: Optimizing HIV prevention may require structured approaches for providing client‐centred choices as well as community‐based entry points and delivery. We evaluated the effect of a dynamic choice model for HIV prevention, delivered by community health workers (CHWs) with clinician support, on the use of biomedical prevention among persons at risk of HIV in rural East Africa. Methods: We conducted a cluster randomized trial among persons (≥15 years) with current or anticipated HIV risk in 16 villages in Uganda and Kenya (SEARCH; NCT04810650). The intervention was a client‐centred HIV prevention model, including (1) structured client choice of product (pre‐exposure prophylaxis [PrEP] or post‐exposure prophylaxis [PEP]), service location (clinic or out‐of‐clinic) and HIV testing modality (self‐test or rapid test), with the ability to switch over time; (2) a structured assessment of patient barriers and development of a personalized support plan; and (3) phone access to a clinician 24/7. The intervention was delivered by CHWs and supported by clinicians who oversaw PrEP and PEP initiation and monitoring. Participants in control villages were referred to local health facilities for HIV prevention services, delivered by Ministry of Health staff. The primary outcome was biomedical prevention coverage: a proportion of 48‐week follow‐up with self‐reported PrEP or PEP use. Results: From May to July 2021, we enrolled 429 people (212 intervention; 217 control): 57% women and 35% aged 15–24 years. Among intervention participants, 58% chose PrEP and 58% chose PEP at least once over follow‐up; self‐testing increased from 52% (baseline) to 71% (week 48); ≥98% chose out‐of‐facility service delivery. Among 413 (96%) participants with the primary outcome ascertained, average biomedical prevention coverage was 28.0% in the intervention versus 0.5% in the control: a difference of 27.5% (95% CI: 23.0–31.9%, p<0.001). Impact was larger during periods of self‐reported HIV risk: 36.6% coverage in intervention versus 0.9% in control, a difference of 35.7% (95% CI: 27.5–43.9, p<0.001). Intervention effects were seen across subgroups defined by sex, age group and alcohol use. Conclusions: A client‐centred dynamic choice HIV prevention intervention, including the option to switch between products and CHW‐based delivery in the community, increased biomedical prevention coverage by 27.5%. However, substantial person‐time at risk of HIV remained uncovered. [ABSTRACT FROM AUTHOR]

Knowledge brokering is a knowledge translation strategy used in healthcare settings to facilitate the implementation of evidence into practice. How healthcare providers perceive and respond to various knowledge translation approaches is not well understood. This qualitative study used the Theoretical Domains Framework to examine healthcare providers' experiences with receiving one of two knowledge translation strategies: a remote knowledge broker (rKB); or monthly emails, for encouraging delivery of mood management interventions to patients enrolled in a smoking cessation program. Semi-structured interviews were conducted with 21 healthcare providers recruited from primary care teams. We used stratified purposeful sampling to recruit participants who were allocated to receive either the rKB, or a monthly email-based knowledge translation strategy as part of a cluster randomized controlled trial. Interviews were structured around domains of the Theoretical Domains Framework (TDF) to explore determinants influencing practice change. Data were coded into relevant domains. Both knowledge translation strategies were considered helpful prompts to remind participants to deliver mood interventions to patients presenting depressive symptoms. Neither strategy appeared to have influenced the health care providers on the domains we probed. The domains pertaining to knowledge and professional identity were perceived as facilitators to implementation, while domains related to beliefs about consequences, emotion, and environmental context acted as barriers and/or facilitators to healthcare providers implementing mood management interventions. Both strategies served as reminders and reinforced providers' knowledge regarding the connection between smoking and depressed mood. The TDF can help researchers better understand the influence of specific knowledge translation strategies on healthcare provider behavior change, as well as potential barriers and facilitators to implementation of evidence-informed interventions. Environmental context should be considered to address challenges and facilitate the movement of knowledge into clinical practice. [ABSTRACT FROM AUTHOR]

Background: Atrial fibrillation (AF) is a common arrhythmia that requires anticoagulation therapy to prevent stroke. However, there is still a significant under-/over-treatment in stroke prevention for patients with AF. The adherence and the risk of bleeding associated with oral anticoagulation therapy (OACs) are major concerns. Shared decision-making (SDM) is an approach that involves patients and healthcare providers in making decisions about treatment options. This study aims to assess the effectiveness of a novel SDM tool for anticoagulation management in AF. Methods: The study will be a prospective, cluster randomized controlled trial involving 440 patients with AF in 8 community health service centers (clusters) in Shanghai, China. The SDM group will receive anticoagulation management through the novel SDM tool, while the control group will receive standard care. The follow-up period will be at least 2 years. The primary outcome will be any bleeding event, while secondary outcomes include the accordance of stroke prophylaxis for AF according to the current guidelines, time in therapeutic range (TTR), the occurrences of major bleeding and thrombosis events, and patient knowledge, adherence, and satisfaction. Discussion: This study will provide evidence of the effectiveness of shared decision-making in improving the appropriateness of OAC use in Chinese AF patients. The findings may inform the development of guidelines and policies for the management of AF and anticoagulation therapy in China and other countries. Trial registration: ChiCTR ChiCTR2200062123. Registered on 23 July 2022. [ABSTRACT FROM AUTHOR]

Background: Prompt recognition of delirium is the first key step in its proper management. A previous study has demonstrated that nurses' delirium screening using the usual paper version assessment tool has no effect on clinical outcomes. Clinical decision assessment systems have been demonstrated to improve patients' adherence and clinical outcomes. Therefore, We developed a clinical decision assessment system (3D-DST) based on the usual paper version (3-min diagnostic interview for CAM-defined delirium), which was developed for assessing delirium in older adults with high usability and accuracy. However, no high quality evidence exists on the effectiveness of a 3D-DST in improving outcomes of older adults compared to the usual paper version. Methods: A pair-matched, open-label, parallel, cluster randomized controlled superiority trial following the SPIRIT checklist. Older patients aged 65 years or older admitted to four medical wards of a geriatric hospital will be invited to participate in the study. Prior to the study, delirium prevention and treatment interventions will be delivered to nurses in both the intervention and control groups. The nurses in the intervention group will perform routine delirium assessments on the included older patients with 3D-DST, while the nurses in the control group will perform daily delirium assessments with the usual paper version. Enrolled patients will be assessed twice daily for delirium by a nurse researcher using 3D-DST. The primary outcome is delirium duration. The secondary outcomes are delirium severity, incidence of delirium, length of stay, in-hospital mortality, adherence to delirium assessment, prevention, and treatment of medical staff. Discussion: This study will incorporate the 3D-DST into clinical practice for delirium assessment. If our study will demonstrate that 3D-DST will improve adherence with delirium assessment and clinical outcomes in older patients, it will provide important evidence for the management of delirium in the future. Trial registration: Chinese Clinical Trial Registry, Identifier: ChiCTR1900028402. https://www.chictr.org.cn/showproj.aspx?proj=47127. Protocol version: 1, 29/7/22. [ABSTRACT FROM AUTHOR]

Background: Incorrect inhalation technique (IT) is an important issue for chronic obstructive pulmonary disease (COPD) patients and healthcare professionals. Studies in which counseling is carried out with healthcare professionals beforehand so that they can properly educate their patients are required. The objective of the present trial is to assess the improvement in the performance of the IT in subjects with COPD and prescribed inhaled therapy after the implementation of an educational intervention conducted by their general practitioners. Methods: A cluster randomized clinical trial was conducted. A total of 286 COPD patients received scheduled inhalation therapy from 27 general practices in seven primary care centers. A teach-back educational intervention was implemented for both healthcare professionals and patients. The primary outcome of this study was the performance of the correct inhalation technique. It is considered a good technique if all steps in the inhalation data sheet are correctly performed. The secondary outcomes were assessed using forced spirometry, the basal dyspnea index, the Medical Research Council dyspnea scale, St George's Respiratory Questionnaire (SGRQ), and EuroQoL5D-5L for health-related quality of life. A one-year follow-up was conducted using an intention-to-treat analysis. Results: After the intervention, incorrect IT was observed in 92% of professionals and patients, with rates reaching 50% and 69.2%, respectively. The effectiveness in patients was significant, with a number needed to treat of 2.14 (95% CI 1.79-2.66). Factors related to correct IT in patients included the type of intervention, length of intervention (>25 min), good pulmonary function, age (youngest <=65, oldest >83), and less limitation of activity due to dyspnea. There was no relation with the cluster. Conclusion: This study shows the effectiveness of direct inhaler technique training provided by a trained professional on an appropriate timescale (for example, a specific consultation for medication reviews), aiming to help subjects improve their performance using the teach-back method. This could be an encouraging intervention to improve medication adherence and health promotion in people with COPD. Clinical Trial Registration: clinicaltrials.gov, identifier ISRCTN93725230. [ABSTRACT FROM AUTHOR]

Background: A birth companion is a simple and low-cost intervention that can improve both maternal and newborn health outcomes. The evidence that birth companionship improves labor outcomes and experiences of care has been available for many years. Global and national policies exist in support of birth companions. Many countries including Ethiopia, Kenya, and Nigeria have not yet incorporated birth companions into routine practice in health facilities. This paper presents the protocol for a trial that aims to assess if a package of interventions that addresses known barriers can increase the coverage of birth companions. Methods: This two parallel arm cluster randomized controlled trial will evaluate the impact of a targeted intervention package on scale-up of birth companionship at public sector health facilities in Ethiopia (five study sites encompassing 12 facilities), Kenya (two sites encompassing 12 facilities in Murang'a and 12 facilities in Machakos counties), and Nigeria (two sites encompassing 12 facilities in Kano and 12 facilities in Nasarawa states). Baseline and endline assessments at each site will include 744 women who have recently given birth in the quantitative component. We will interview a maximum of 16 birth companions, 48 health care providers, and eight unit managers quarterly for the qualitative component in each country. Discussion: Ample evidence supports the contribution of birth companions to positive health outcomes for mothers and newborns. However, limited data are available on effective strategies to improve birth companion coverage and inform scale-up efforts. This trial tests a birth companion intervention package in diverse clinical settings and cultures to identify possible barriers and considerations to increasing uptake of birth companions. Findings from this study may provide valuable evidence for scaling up birth companionship in similar settings. Trial registration: Trial is registered with ClinicalTrials.gov with identifier: NCT05565196, first posted 04/10/ 2022. [ABSTRACT FROM AUTHOR]

Background: Decreasing or flattening funding for vertical HIV services means that new and innovative ways of providing care are necessary. This study aimed to assess the determinants of readiness for integration of Antiretroviral Therapy (ART) services at the departmental level among primary health care providers (PHCP) at selected health facilities in Lira District. Methods: A cross-sectional survey employing mixed methods approaches was conducted between January and February 2022 among 340 primary healthcare practitioners (PHCP) at selected health facilities in Lira district. An interviewer-administered questionnaire was used to collect quantitative data. Quantitative data was analyzed using Stata version 15. and presented as proportions, means, percentages, frequencies, and odds ratios. Logistic regression was used to determine associations of the factors with readiness for ART integration at a 95% level of significance. Thematic analysis was used to analyze qualitative data. Results: The majority 75.2% (95% CI; 0.703–0.795) of the respondents reported being ready for the integration of ART services. PHCPs who were aware of the integration of services and those who had worked in the same facility for at least 6 years had higher odds of readiness for integration of ART, compared with their counterparts [aOR = 7.36; 95% CI = 3.857–14.028, p-value <0.001] for knowledge and duration at the current facility [aOR = 2.92; 95% CI = 1.293–6.599, p-value < 0.05] respectively. From the qualitative data, the dominant view was that integration is a good thing that should be implemented immediately. However, several challenges were noted, key among which include limited staffing and drug supplies at the facilities, coupled with limited space. Conclusions: The study reveals a high level of readiness for the integration of ART services at departmental levels among Primary Healthcare Providers. Notably, PHCPs knowledgeable about integration and those who spent at least six years at the current health facility of work, were strong determinants for the integration of ART services in resource limited settings. In light of these findings, we recommend that policymakers prioritize the implementation of training programs aimed at upskilling healthcare workers. Furthermore, we advocate that a cluster randomized controlled trial be conducted, to evaluate the long-term effects of this integration on overall health outcomes. [ABSTRACT FROM AUTHOR]

Cluster randomized trials often exhibit a three-level structure with participants nested in subclusters such as health care providers, and subclusters nested in clusters such as clinics. While the average treatment effect has been the primary focus in planning three-level randomized trials, interest is growing in understanding whether the treatment effect varies among prespecified patient subpopulations, such as those defined by demographics or baseline clinical characteristics. In this article, we derive novel analytical design formulas based on the asymptotic covariance matrix for powering confirmatory analyses of treatment effect heterogeneity in three-level trials, that are broadly applicable to the evaluation of cluster-level, subcluster-level, and participant-level effect modifiers and to designs where randomization can be carried out at any level. We characterize a nested exchangeable correlation structure for both the effect modifier and the outcome conditional on the effect modifier, and generate new insights from a study design perspective for conducting analyses of treatment effect heterogeneity based on a linear mixed analysis of covariance model. A simulation study is conducted to validate our new methods and two real-world trial examples are used for illustrations. [ABSTRACT FROM AUTHOR]

To assess the effects of a novel multicomponent neuromuscular warm-up program on lower-extremity injury incidence in basketball players competing at the regional level. A cluster randomized controlled experimental design was adopted to compare injury incidence between players exposed to the injury prevention warm-up program and those exposed to a typical warm-up program across an entire basketball season. Four teams consisting of 57 players (male: n = 42; female: n = 15) were allocated to the intervention group (age: 21.6 ± 2.5 years; height: 186.2 ± 8.8 cm; body mass: 80.0 ± 10.4 kg) and four teams consisting of 55 players (male: n = 43; female: n = 12) were allocated to the control group (age: 21.6 ± 2.6 years; height: 186.9 ± 9.1 cm; body mass: 81.5 ± 10.9 kg). The novel warm-up combined running exercises with active stretching, plyometrics, balance, strength, and agility drills. Coaching and medical staff provided details on injury incidence each week. Data analyses included the use of poisson regression analyses and the incidence rate ratio (IRR) with 95% confidence intervals (CI). The intervention group experienced a significantly lower ankle sprain incidence rate (IRR = 0.26, 95% CI = 0.05, 0.98, p = 0.02) and a tendency toward a lower knee injury incidence rate (IRR = 0.32, 95% CI = 0.03, 1.78, p = 0.07) compared to the control group. Considering only non-contact lower-extremity injuries of any type, the intervention group experienced a significantly lower incidence rate compared to the control group (IRR = 0.26, 95% CI = 0.05, 0.98, p < 0.001). This multi-team study demonstrated a novel multicomponent warm-up program resulted in less lower-extremity injuries, particularly ankle sprains and knee injuries, compared to a typical warm-up program in regional-level male and female basketball players. [ABSTRACT FROM AUTHOR]

Background: To reduce adverse outcomes of low hospital mobility, we need interventions that are scalable in everyday practice. This study assessed the feasibility and acceptability of the INTOMOB multilevel intervention addressing barriers to hospital mobility without requiring unavailable resources. Methods: The INTOMOB intervention, targeting older patients, healthcare professionals (HCPs) and the hospital environment, was implemented on acute general internal medicine wards of three hospitals (12/2022–03/2023). Feasibility and acceptability of the intervention were assessed and two types of accelerometers compared in a mixed methods study (patient and HCP surveys and interviews). Quantitative data were analyzed descriptively and qualitative data using a deductive approach. Results were integrated through meta-inferences. Results: Of 20 patients (mean age 74.1 years), 90% found the intervention helpful and 82% said the environment intervention (posters) stimulated mobility. The majority of 44 HCPs described the intervention as clear and helpful. There was no major implementation or technical issue. About 60% of patients and HCPs preferred a wrist-worn over an ankle-worn accelerometer. Conclusions: The INTOMOB intervention is feasible and well accepted. Patients' and HCPs' feedback allowed to further improve the intervention that will be tested in a cluster randomized trial and provides useful information for future mobility-fostering interventions. [ABSTRACT FROM AUTHOR]

Discontinuing antidepressant medication (ADM) can be challenging for patients and clinicians. In the current study we investigated if Mindfulness-Based Cognitive Therapy (MBCT) added to supported protocolized discontinuation (SPD) is more effective than SPD alone to help patients discontinue ADM. This study describes a prospective, cluster-randomized controlled trial (completed). From 151 invited primary care practices in the Netherlands, 36 (24%) were willing to participate and randomly allocated to SPD+MBCT (k = 20) or SPD (k = 16). Adults using ADM > 9 months were invited by GPs to discuss tapering, followed by either MBCT+SPD, or SPD alone. Exclusion criteria included current psychiatric treatment; substance use disorder; non-psychiatric indication for ADM; attended MBCT within past 5 years; cognitive barriers. From the approximately 3000 invited patients, 276 responded, 119 participated in the interventions and 92 completed all assessments. All patients were offered a decision aid and a personalized tapering schedule (with GP). MBCT consisted of eight group sessions of 2.5 hours and one full day of practice. SPD was optional and consisted of consultations with a mental health assistant. Patients were assessed at baseline and 6, 9 and 12 months follow-up, non-blinded. In line with our protocol, primary outcome was full discontinuation of ADM within 6 months. Secondary outcomes were depression, anxiety, withdrawal symptoms, rumination, well-being, mindfulness skills, and self-compassion. Patients allocated to SPD + MBCT (n = 73) were not significantly more successful in discontinuing (44%) than those allocated to SPD (n = 46; 33%), OR 1.60, 95% CI 0.73 to 3.49, p =.24, number needed to treat = 9. Only 20/73 allocated to MBCT (27%) completed MBCT. No serious adverse events were reported. In conclusion, we were unable to demonstrate a significant benefit of adding MBCT to SPD to support discontinuation in general practice. Actual participation in patient-tailored interventions was low, both for practices and for patients. (Trial registration: ClinicalTrials.gov PRS ID: NCT03361514 registered December 2017) [ABSTRACT FROM AUTHOR]

Background: Managing the multimorbidity of diabetes and depression remains a clinical challenge for patients and healthcare professionals due to the fragmented healthcare delivery system. To effectively cope with multimorbidity, there is an urgent need for the health system to transform into people-centered integrated care (PCIC) system globally. Therefore, this paper describes the protocol of community-based integrated care for patients with diabetes and depression (CIC-PDD) project, an integrated and shared-care intervention project. Methods/design: CIC-PDD project is conducted in two phases, namely "care model development" and "implementation and evaluation." In the first phase, CIC-PDD model was designed and developed based on the four criteria of collaborative care model (CCM) and was subsequently adjusted to align with the context of China. The second phase entails a pragmatic, two-arm, cluster randomized controlled implementation trial, accompanied by parallel mixed-methods process evaluation and cost-effectiveness analysis. Discussion: We anticipate CIC-PDD project will facilitate the development and innovation of PCIC model and related theories worldwide, particularly in low- and middle-income countries (LMICs). In addition, CIC-PDD project will contribute to the exploration of primary health care (PHC) in addressing the multimorbidity of physical and mental health issues. Trial registration: ClinicalTrials.gov registration ChiCTR2200065608 (China Clinical Trials Registry https://www.chictr.org.cn). Registered on November 9, 2022. [ABSTRACT FROM AUTHOR]

Background: Service providers' attitudes toward interventions are essential for adopting and implementing novel interventions into healthcare settings, but evidence of evaluations in the HIV context is still limited. This study is part of the CombinADO cluster randomized trial (ClinicalTrials.gov NCT04930367), which is investigating the effectiveness of a multi-component intervention package (CombinADO strategy) aimed at improving HIV outcomes among adolescents and young adults living with HIV (AYAHIV) in Mozambique. In this paper we present findings on key stakeholder attitudes toward adopting study interventions into local health services. Methods: Between September and December 2021, we conducted a cross-sectional survey with a purposive sample of 59 key stakeholders providing and overseeing HIV care among AYAHIV in 12 health facilities participating in the CombinADO trial, who completed a 9-item scale on attitudes towards adopting the trial intervention packages in health facilities. Data were collected in the pre-implementation phase of the study and included individual stakeholder and facility-level characteristics. We used generalized linear regression to examine the associations of stakeholder attitude scores with stakeholder and facility-level characteristics. Results: Overall, service-providing stakeholders within this setting reported positive attitudes regarding adopting intervention packages across study clinic sites; the overall mean total attitude score was 35.0 ([SD] = 2.59, Range = [30–41]). The study package assessed (control or intervention condition) and the number of healthcare workers delivering ART care in participating clinics were the only significant explanatory variables to predict higher attitude scores among stakeholders (β = 1.57, 95% CI = 0.34–2.80, p = 0.01 and β = 1.57, 95% CI = 0.06–3.08, p = 0.04 respectively). Conclusions: This study found positive attitudes toward adopting the multi-component CombinADO study interventions among HIV care providers for AYAHIV in Nampula, Mozambique. Our findings suggest that adequate training and human resource availability may be important in promoting the adoption of novel multi-component interventions in healthcare services by influencing healthcare provider attitudes. [ABSTRACT FROM AUTHOR]

Background: The transition to parenthood represents a critical life period with psychosocial, and behavioral changes and challenges for parents. This often increases stress and leads to unhealthy weight gain in families, especially in psychosocially burdened families. Although universal and selective prevention programs are offered to families, specific support often fails to reach psychosocially burdened families. Digital technologies are a chance to overcome this problem by enabling a low-threshold access for parents in need. However, there is currently a lack of smartphone-based interventions that are tailored to the needs of psychosocially burdened families. Aims: The research project I-PREGNO aims to develop and evaluate a self-guided, smartphone-based intervention in combination with face-to-face counseling delivered by healthcare professionals for the prevention of unhealthy weight gain and psychosocial problems. The intervention is specifically tailored to the needs of psychosocially burdened families during the pregnancy and postpartum period. Methods: In two cluster randomized controlled trials in Germany and Austria (N = 400) psychosocially burdened families will be recruited and randomized to i) treatment as usual (TAU), or ii) I-PREGNO intervention (self-guided I-PREGNO app with counseling sessions) and TAU. We expect higher acceptance and better outcomes on parental weight gain and psychosocial stress in the intervention group. Discussion: The intervention offers a low cost and low-threshold intervention and considers the life situation of psychosocially burdened families who are a neglected group in traditional prevention programs. After positive evaluation, the intervention may easily be implemented in existing perinatal care structures in European countries such as Germany and Austria. Trial registration: Both trials were registered prospectively at the German Clinical Trials Register (Germany: DRKS00029673; Austria: DRKS00029934) in July and August 2022. [ABSTRACT FROM AUTHOR]

Objective: Empathy has deteriorated throughout clinical training and medical practice, and little is known about the effect of empathy training on the empathy level of healthcare providers. To address this gap, we assessed the effect of empathy training on the empathy level of healthcare providers in Ethiopia. Design: A cluster randomized controlled trial study design was conducted from 20 December 2021 to 20 March 2022. The empathy training intervention was conducted for three consecutive days. Setting: The study was conducted in five fistula treatment centers in Ethiopia. Participants: The participants were all randomly selected healthcare providers. Main outcome measures: Total mean score, percentage changes, and Cohen’s effect size were computed. A linear mixed effects model and independent t-test were used for data analysis. Results: A majority of the study participants were nurses in the profession, married, and first-degree holders. There was no statistically significant difference in the baseline empathy score of the intervention arm across their socio-demographic features. At the baseline, the mean empathy scores of the control and intervention arms were 102.10 ± 15.38 and 101.13 ± 17.67, respectively. The effect of empathy training on the total mean score changes of empathy of the intervention arm compared to the control arm at each follow-up time had a statistically significant difference. After a week, a month, and three months of post-intervention, the total mean empathy scores between the intervention and control arms were as follows: (intervention 112.65 ± 18.99, control 102.85 ± 15.65, d = 0.55, p = 0.03); (intervention 109.01 ± 17.79, control 100.52 ± 12.57, d = 0.53, p = 0.034); and (intervention 106.28 ± 16.24, control 96.58 ± 14.69, d = 0.60, p = 0.016) with the overall percentage changes of 11, 8, and 5% from the baseline scores, respectively. Conclusion: In this trial, the empathy training intervention was found to have more than a medium effect size. However, over the follow-up intervals, there was a decreasing trend in the total mean empathy scores of healthcare providers; suggesting that there should be continued empathy training and integration of it into educational and training curriculums to enhance and sustain the empathy of healthcare providers. [ABSTRACT FROM AUTHOR]

Background: Despite recognition of the adverse impacts of the mistreatment of women during pregnancy, labour and birth, there remains limited evidence on interventions that could reduce mistreatment and build a culture of respectful maternity care (RMC) in health facilities. The sustainability of effective individual interventions and their adaptability to various global contexts remain uncertain. In this systematic review, we aimed to synthesise the best available evidence that has been shown to be effective in reducing the mistreatment of women and/or enhancing RMC during women's maternity care in health facilities. Methods: We searched the online databases PubMed, CINAHL, EBSCO Nursing/Academic Edition, Embase, African Journals Online (AJOL), Scopus, Web of Science, and grey literature using predetermined search strategies. We included cluster randomized controlled trials (RCTs) and pre-and-post observational studies and appraised them using JBI critical appraisal checklists. The findings were synthesised narratively without conducting a meta-analysis. The certainty of evidence was assessed using GRADE criteria. Results: From the 1493 identified records, 11 studies from six sub-Sahara African countries and one study from India were included: three cluster RCTs and nine pre- and post-studies. We identified diverse interventions implemented via various approaches including individual health care providers, health systems, and policy amendments. Moderate certainty evidence from two cluster RCTs and four pre- and post-studies suggests that multi-component interventions can reduce the odds of mistreatment that women may experience in health facilities, with odds of reduction ranging from 18 per cent to 66 per cent. Similarly, women's perceptions of maternity care as respectful increased in moderate certainty evidence from two cluster RCTs and five pre- and post-studies with reported increases ranging from 5 per cent to 50 per cent. Conclusions: Multi-component interventions that address attitudes and behaviors of health care providers, motivate staff, engage the local community, and alleviate health facility and system constraints have been found to effectively reduce mistreatment of women and/or increase respectful maternity care. Such interventions which go beyond a single focus like staff training appear to be more likely to bring about change. Therefore, future interventions should consider diverse approaches that incorporate these components to improve maternal care. [ABSTRACT FROM AUTHOR]

Background: Non-communicable diseases (NCDs) are the leading cause of death worldwide, with hypertension being the leading risk factor. Ischemic heart disease and stroke are the leading causes of Disability Adjusted Life years (DALYs) in people aged 50 and older, and high systolic blood pressure is responsible for 19.2% of all deaths worldwide. The global NCD priority is to reduce hypertension prevalence by 25% by 2025. Strategies such as early detection, treatment, and control, cost sharing, and benefit designs can help reduce unfavourable health outcomes associated with hypertension. Objectives: The current study is a Community Interventional Trial for Hypertension Control in Rural Maharashtra, India to determine if a community-based intervention delivered to community and healthcare workers in a rural area can be effective in controlling hypertension and if any beneficial effects can be sustained in the long term. Materials & Methods: The study was conducted in the Coverage area of two Primary Health Centers in Palghar District of Maharashtra from Jan 2018 to Dec 2022. It was a Cluster randomized controlled trial with 1850 people in each Sub-center. Comprehensive communitybased intervention was implemented in one Subcenter under Primary Health Centre of Kaman and second subcenter in the Primary Health Centre of Satpati in rural area of Maharashtraand its effect was assessed. Results: The baseline characteristics of the study population were similar in both sub-centres. Recommended Physical activity was less in both subcentres, with most of the participants consuming 2000-2499 Kcal/Day. Overweight was higher in Kaman, while central obesity was higher in both PHCs. The prevalence of known cases of both Diabetes Mellitus and Hypertension was 3.4% in Kaman, while Suspected Hypertension cases was higher in Kaman. In Kaman there were 27.5% of confirmed cases of hypertension and after intervention it has reduced to 17.5%. There was a decrease of 10%. In Satpati there were 25.2% of confirmed cases of hypertension and after intervention it has reduced to 21.6%. There was a decrease of 3.6%. Conclusion: A high number of cases of Hypertension is found in rural population. 27.5% of the participants were newly diagnosed with Hypertension. Screening and early detection and treatment of Hypertension is highly needed in rural areas. Community-based intervention is equally important to focus on prevention, promotion, and enable lifestyle changes to prevent and control Hypertension and avoid risk factors. [ABSTRACT FROM AUTHOR]

Delay or refusal of childhood vaccines is common and may be increasing. Pediatricians are parents' most trusted source for vaccine information, yet many struggle with how to communicate with parents who resist recommended vaccines. Evidence-based communication strategies for vaccine conversations are lacking. In this manuscript, we describe the development and perceived usefulness of a curriculum to train clinicians on a specific vaccine communication strategy as part of the PIVOT with MI study, a cluster randomized trial testing the effectiveness of this communication strategy on increasing childhood vaccination uptake among 24 pediatric practices in Colorado and Washington. The communication strategy is based on the existing evidence-based communication strategies of a presumptive format for initiating vaccine conversations and use of motivational interviewing if hesitancy persists. Focus groups and semi-structured interviews with pediatric clinicians helped inform the development of the training curriculum, which consisted of an introductory video module followed by 3 training sessions. Between September 2019 and January 2021, 134 pediatric clinicians (92 pediatricians, 42 advanced practice providers) participated in the training as part of the PIVOT with MI study. Of these, 92 % viewed an introductory video module, 93 % attended or viewed a baseline synchronous training, 82 % attended or viewed a 1st refresher training, and 77 % attended or viewed a 2nd refresher training. A follow-up survey was administered August 2020 through March 2021; among respondents (n = 100), >95 % of participants reported that each component of the training program was very or somewhat useful. These data suggest that the PIVOT with MI training intervention is a useful vaccine communication resource with the potential for high engagement among pediatric clinicians. [ABSTRACT FROM AUTHOR]

Background: With the worldwide rising obesity epidemic and the aging population, it is essential to deliver (cost-)effective care that results in enhanced societal participation among knee arthroplasty patients. The purpose of this study is to describe the development, content, and protocol of our (cost-)effectiveness study that assesses a perioperative integrated care program, including a personalized eHealth app, for knee arthroplasty patients aimed to enhance societal participation post-surgery compared to care as usual. Methods: The intervention will be tested in a multicentre randomized controlled trial with eleven participating Dutch medical centers (i.e., hospitals and clinics). Working patients on the waiting-list for a total- or unicompartmental knee arthroplasty with the intention to return to work after surgery will be included. After pre-stratification on medical centre with or without eHealth as usual care, operation procedure (total- or unicompartmental knee arthroplasty) and recovery expectations regarding return to work, randomization will take place at the patient-level. A minimum of 138 patients will be included in both the intervention and control group, 276 in total. The control group will receive usual care. On top of care as usual, patients in the intervention group will receive an intervention consisting of three components: 1) a personalized eHealth intervention called ikHerstel ('I Recover') including an activity tracker, 2) goal setting using goal attainment scaling to improve rehabilitation and 3) a referral to a case-manager. Our main outcome is quality of life, based on patient-reported physical functioning (using PROMIS-PF). (Cost-)effectiveness will be assessed from a healthcare and societal perspective. Data collection has been started in 2020 and is expected to finish in 2024. Discussion: Improving societal participation for knee arthroplasty is relevant for patients, health care providers, employers and society. This multicentre randomized controlled trial will evaluate the (cost-)effectiveness of a personalized integrated care program for knee arthroplasty patients, consisting of effective intervention components based on previous studies, compared to care as usual. Trial registration: Trialsearch.who.int; reference no. NL8525, reference date version 1: 14–04-2020. [ABSTRACT FROM AUTHOR]

Background: Acutely ill and frail older adults and their next of kin are often poorly involved in treatment and care decisions. This may lead to either over- or undertreatment and unnecessary burdens. The aim of this project is to improve user involvement and health services for frail older adults living at home, and their relatives, by implementing advance care planning (ACP) in selected hospital wards, and to evaluate the clinical and the implementation interventions. Methods: This is a cluster randomized trial with 12 hospital units. The intervention arm receives implementation support for 18 months; control units receive the same support afterwards. The ACP intervention consists of 1. Clinical intervention: ACP; 2. Implementation interventions: Implementation team, ACP coordinator, network meetings, training and supervision for health care personnel, documentation tools and other resources, and fidelity measurements with tailored feedback; 3. Implementation strategies: leadership commitment, whole ward approach and responsive evaluation. Fidelity will be measured three times in the intervention arm and twice in the control arm. Here, the primary outcome is the difference in fidelity changes between the arms. We will also include 420 geriatric patients with one close relative and an attending clinician in a triadic sub-study. Here, the primary outcomes are quality of communication and decision-making when approaching the end of life as perceived by patients and next of kin, and congruence between the patient's preferences for information and involvement and the clinician's perceptions of the same. For patients we will also collect clinical data and health register data. Additionally, all clinical staff in both arms will be invited to answer a questionnaire before and during the implementation period. To explore barriers and facilitators and further explore the significance of ACP, qualitative interviews will be performed in the intervention units with patients, next of kin, health care personnel and implementation teams, and with other stakeholders up to national level. Lastly, we will evaluate resource utilization, costs and health outcomes in a cost-effectiveness analysis. Discussion: The project may contribute to improved implementation of ACP as well as valuable knowledge and methodological developments in the scientific fields of ACP, health service research and implementation science. Trial registration: ClinicalTrials.gov Identifier NCT05681585. Registered 03.01.23. [ABSTRACT FROM AUTHOR]

This cluster randomized clinical trial assesses whether the use of population-based electronic screening in addition to standard targeted clinician education increases the early detection of psychosis and decreases the duration of untreated psychosis, compared with clinician education alone. Key Points: Question: Does population-based electronic screening for first-episode psychosis (FEP) or psychosis spectrum disorder in community settings increase early detection and reduce the duration of untreated psychosis? Findings: In this cluster randomized clinical trial, a population-based technology-enhanced screening plus clinician education identified more individuals with psychosis spectrum disorder than clinician education alone. No significant difference in duration of untreated psychosis for FEP across groups was detected. Meaning: Population-based screening for FEP in community mental health settings substantially increases identification of individuals with psychosis spectrum disorders but does not reduce the overall duration of untreated psychosis, so reduction efforts must also specifically target delays between symptom onset and first contact with mental health services. Importance: Reducing the duration of untreated psychosis (DUP) is essential to improving outcomes for people with first-episode psychosis (FEP). Current US approaches are insufficient to reduce DUP to international standards of less than 90 days. Objective: To determine whether population-based electronic screening in addition to standard targeted clinician education increases early detection of psychosis and decreases DUP, compared with clinician education alone. Design, Setting, and Participants: This cluster randomized clinical trial included individuals aged 12 to 30 years presenting for services between March 2015 and September 2017 at participating sites that included community mental health clinics and school support and special education services. Eligible participants were referred to the Early Diagnosis and Preventative Treatment (EDAPT) Clinic. Data analyses were performed in September and October 2019 for the primary and secondary analyses, with the exploratory subgroup analyses completed in May 2021. Interventions: All sites in both groups received targeted education about early psychosis for health care professionals. In the active screening group, clients also completed the Prodromal Questionnaire–Brief using tablets at intake; referrals were based on those scores and clinical judgment. In the group receiving treatment as usual (TAU), referrals were based on clinical judgment alone. Main Outcomes and Measures: Primary outcomes included DUP, defined as the period from full psychosis onset to the date of the EDAPT diagnostic telephone interview, and the number of individuals identified with FEP or a psychosis spectrum disorder. Exploratory analyses examined differences by site type, completion rates between conditions, and days from service entry to telephone interview. Results: Twenty-four sites agreed to participate, and 12 sites were randomized to either the active screening or TAU group. However, only 10 community clinics and 4 school sites were able to fully implement population screening and were included in the final analysis. The total potentially eligible population size within each study group was similar, with 2432 individuals entering at active screening group sites and 2455 at TAU group sites. A total of 303 diagnostic telephone interviews were completed (178 [58.7%] female individuals; mean [SD] age, 17.09 years [4.57]). Active screening sites reported a significantly higher detection rate of psychosis spectrum disorders (136 cases [5.6%], relative to 65 [2.6%]; P <.001) and referred a higher proportion of individuals with FEP and DUP less than 90 days (13 cases, relative to 4; odds ratio, 0.30; 95% CI, 0.10-0.93; P =.03). There was no difference in mean (SD) DUP between groups (active screening group, 239.0 days [207.4]; TAU group 262.3 days [170.2]). Conclusions and Relevance: In this cluster trial, population-based technology-enhanced screening across community settings detected more than twice as many individuals with psychosis spectrum disorders compared with clinical judgment alone but did not reduce DUP. Screening could identify people undetected in US mental health services. Significant DUP reduction may require interventions to reduce time to the first mental health contact. Trial Registration: ClinicalTrials.gov Identifier: NCT02841956 [ABSTRACT FROM AUTHOR]

Background: India contributes 15% of the total global maternal mortality burden. An increasing proportion of these deaths are due to Pregnancy Induced Hypertension (PIH), Gestational Diabetes Mellitus (GDM), and anaemia. This study aims to evaluate the effectiveness of a tablet-based electronic decision-support system (EDSS) to enhance routine antenatal care (ANC) and improve the screening and management of PIH, GDM, and anaemia in pregnancy in primary healthcare facilities of Telangana, India. The EDSS will work at two levels of primary health facilities and is customized for three cadres of healthcare providers – Auxiliary Nurse Midwifes (ANMs), staff nurses, and physicians (Medical Officers). Methods: This will be a cluster randomized controlled trial involving 66 clusters with a total of 1320 women in both the intervention and control arms. Each cluster will include three health facilities—one Primary Health Centre (PHC) and two linked sub-centers (SC). In the facilities under the intervention arm, ANMs, staff nurses, and Medical Officers will use the EDSS while providing ANC for all pregnant women. Facilities in the control arm will continue to provide ANC services using the existing standard of care in Telangana. The primary outcome is ANC quality, measured as provision of a composite of four selected ANC components (measurement of blood pressure, blood glucose, hemoglobin levels, and conducting a urinary dipstick test) by the healthcare providers per visit, observed over two visits. Trained field research staff will collect outcome data via an observation checklist. Discussion: To our knowledge, this is the first trial in India to evaluate an EDSS, targeted to enhance the quality of ANC and improve the screening and management of PIH, GDM, and anaemia, for multiple levels of health facilities and several cadres of healthcare providers. If effective, insights from the trial on the feasibility and cost of implementing the EDSS can inform potential national scale-up. Lessons learned from this trial will also inform recommendations for designing and upscaling similar mHealth interventions in other low and middle-income countries. Trial Registration. ClinicalTrials.gov, NCT03700034, registered 9 Oct 2018, https://www.clinicaltrials.gov/ct2/show/NCT03700034 CTRI, CTRI/2019/01/016857, registered on 3 Mar 2019, http://www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=28627&EncHid=&modid=&compid=%27,%2728627det%27 [ABSTRACT FROM AUTHOR]

KID-PROTEKT is a child-centred psychosocial healthcare intervention which aims at improving the identification of psychosocial needs and navigation in the outpatient gynaecologic and paediatric setting. In this cluster randomizedcontrolled trail we examined the effect of KID-PROTEKT on the referrals (to support services) in comparison to the regular gynaecologic and paediatric outpatient healthcare . A variant based on the qualification of the healthcare providers (qualified treatment, QT) and a variant with social worker (supported treatment, ST) were compared to the regular healthcare (treatment as usual, TAU). Twenty-four gynaecologic and paediatric practices were randomized to one of three study arms. Therefore 8,458 pregnant women and families recruited in one of these practices were enrolled in the study. Participating patients reported on average 1.73 (SD = 1.34) psychosocial risks. In total 522 patients were linked to a support service. Compared to TAU, the probability of a referral was significantly higher in QT (OR = 10.70) and ST (OR = 11.28). Also, a higher number of psychosocial risks were linked to a referral (OR = 2.72). These findings support the importance of a psychosocial assessment in the gynaecologic and paediatric setting. [ABSTRACT FROM AUTHOR]

This article discusses the development of a curriculum for neonatal intensive care units (NICUs) that focuses on integrating parents into the care team. The curriculum includes training in communication, education, and support for parents. The article highlights the positive effects of this approach on infant and parent outcomes and emphasizes the need for standardized implementation in NICUs. The document provides a list of references that explore various aspects of family-centered care in NICUs, including experiences of parents, effects on infant development, and implementation strategies. It offers a comprehensive overview of current research and practices in this area. [Extracted from the article]

The article shares insight on the influence of supracrestal tissue adhesion (STAd) on dental implant marginal bone loss patterns. It discusses the importance of STAd in both implant surgical therapy and prosthetic therapy as a way of predicting initial peri-implant bone remodeling, also known as aseptic bone resorption. Suggested treatment strategies for bone-level implants based on thickness of the vertical mucosa, as well as the implant-prosthetic abutment junction relationship are cited.

Introduction: There is insufficient evidence on the effectiveness and costeffectiveness of psychological interventions to enhance frontline responders' mental health proficiency and competence in emergency settings. This paper describes the methods for the evaluation of the effectiveness and costeffectiveness of Psychological First Aid training, to determine whether the intervention is effective and cost-effective as a mental health intervention in public health emergencies. A pilot to evaluate the acceptability of the PFA training found participants were either satisfied (55.6%) or extremely satisfied (44.4%) with the training program. Method: This paper describes the protocol for a cluster randomized two-arm controlled trial. A total of 1,399 non-specialist health care workers will be recruited in 42 hospitals and health care centers across six provinces in China. Participants will be assigned according to hospital or health care center site to one of two groups (n = 699 for intervention group and 709 for control group) to receive system based PFA training or PFA training as usual. Both groups will receive one-day of training, comprising six modules including PFA core concepts, knowledge, skills and practice. Their knowledge, skills, competency, self-efficacy, resilience, and professional quality of life will be assessed immediately after the training; and reassessed after 1 and 2 months. Analysis: For effectiveness outcomes, repeated measures will be used in a multi-level linear mixed model. The pooled standard deviations will be used to calculate the effect sizes (Cohen's d) within and between groups. Appropriate statistical tests will be used to explore differences between intervention and control groups. For economic outcomes, a health service sector perspective will be adopted, with intervention costs and outcomes collected prospectively. Within-trial cost-effectiveness analysis (CEA) will quantify the incremental costs and PFA proficiency gains of the intervention compared with training as usual at 2 months post training. CEA will present results as cost per unit of mental health proficiency gained. A cost-utility analysis (CUA) model will extend the population to emergency health service users.in order to identify potential for incremental cost offsets attributable to mental health improvement arising from intervention. Intervention costs and effects will be extrapolated to the population of patients who receive the emergency health service in clinical wards and will be modeled over the cohort's lifetime. Modeled CUA results will be calculated as quality-adjusted life-years saved and healthcare cost savings in preventing mental disorders. Ethics and dissemination: Ethics approval was obtained from the Second Xiangya Hospital, Central South University Clinical Research Ethics Committee (2021) Ethical Review [Clinical Research] #067). Data about the economic evaluation of the intervention will be stored in the KCL OneDrive at King's College London, UK. The trial protocol was registered with the China Clinical Trials Registry: ChiCTR2200060464. Study findings will be disseminated through peer-reviewed academic papers, and participating hospitals. [ABSTRACT FROM AUTHOR]

Background: For people living with dementia (PLWD) the overuse of potentially inappropriate medications (PIMs) remains a persistent problem. De-prescribing trials in the elderly have mixed results. Clinician champions may be uniquely suited to lead efforts to address this challenge. Here we describe the study protocol for a 24-month embedded pragmatic cluster-randomized clinical trial within two accountable care organizations (ACOs) of such a clinician champion intervention. The specific aims are to (1) assess the effectiveness of a clinician champion on de-implementing PIMs in PLWD, (2) determine if the intervention is associated with a reduction in emergency department (ED) visits and hospitalizations attributed to a fall, and (3) examine five implementation outcomes: appropriateness, feasibility, fidelity, penetration, and equity.Methods/design: Two ACOs agreed to participate: United States Medical Management (USMM) and Oschner Health System. The unit of randomization will be the primary care clinic. A clinician champion will be recruited from each of the intervention clinics to participate in a 6-month training program and then work with clinicians and staff in their clinic for 12 months to reduce the use of PIMs in their PLWD population. For aims 1 and 2, Medicare claims data will be used to assess outcomes. The outcome for aim #1 will be medication possession rates per quarter, for the three therapeutic classes of PIMs among patients with dementia in intervention clinics versus control clinics. For aim #2, we will assess the incidence of falls using a previously validated algorithm. For both aims 1 and 2, we will construct hierarchical models with time period observations nested within patient using generalized estimating equations (GEE) with robust standard errors. The key variable of interest will be the treatment indicator assigned based on practice. For aim #3, we will conduct qualitative thematic analysis of documentation by the clinician champions in their project workbooks to evaluate the five implementation outcomes.Discussion: This embedded pragmatic trial will add to our existing knowledge regarding the effectiveness of a clinician champion strategy to de-prescribe potentially inappropriate medication among patients with dementia as well as its appropriateness, feasibility, fidelity, penetration, and equity.Trial Registration: Clinicaltrials.gov NCT05359679 , Registered May 4, 2022. [ABSTRACT FROM AUTHOR]