Search

The Republic of the Marshall Islands (RMI) is an independent nation and a member of the United States (US) Affiliated Pacific Islands through a Compact of Free Association. Health disparities in the RMI are striking, with high rates of type 2 diabetes mellitus (T2DM). The International Diabetes Federation has documented age-adjusted prevalence of T2DM at 23.0 %, compared to the US (13.2 %) and globally (9.8 %). T2DM has a devastating impact on patients and their families. The purpose of this article is to present the study protocol for the fully powered two-arm cluster randomized controlled trial using a wait-list control to evaluate the effectiveness of a Family Diabetes Self-Management Education and Support (Family DSMES) program when delivered in a group setting by community health workers (CHWs) in faith-based organizations (FBOs) in the RMI. The study used a community engaged approach, and the study protocol includes adaptations based on the results of our one-arm pilot study. This study will provide new and innovative information on the effectiveness of Family DSMES delivered in a group setting by CHWs in FBOs in the RMI. The knowledge gained from this research will inform DSMES interventions conducted with Marshallese and other Pacific Islander communities, as well as DSMES interventions conducted in other low-resource countries. [ABSTRACT FROM AUTHOR]

Prior research demonstrates that nearly all (95 %) people with lung cancer (PwLC) report stigma, and approximately half (48 %) PwLC experience stigma during clinical encounters with oncology care providers (OCPs). When stigma is experienced in a medical context, it can have undesirable consequences including patients' delaying and underreporting of symptoms, misreporting of smoking behavior, and avoiding help-seeking such as psychosocial support and cessation counseling. Multi-level interventions are needed to prevent and mitigate lung cancer stigma. One promising intervention for reducing patient perception and experience of stigma is to train OCPs in responding empathically to patient emotions and promoting empathic communication within clinical encounters. This paper describes the study protocol for a cluster randomized trial comparing Usual Care (waitlist control group) with Empathic Communication Skills (ECS) training (intervention group). For this study, we will recruit 16 community oncology practice sites, 9–11 OCPs per site, and 6 PwLCs per OCP. The goal of this trial is to investigate the effect of the ECS training on (a) OCP primary outcomes (communication and empathic skill uptake) and secondary outcomes (ECS training appraisal – relevance, novelty, clarity; self-efficacy, attitude towards communication with patients); and (b) patient-reported primary outcomes (lung cancer stigma), and secondary outcomes (perceived clinician empathy, satisfaction with OCP communication, psychological distress, social isolation, and appraisal of care). Findings from this trial will advance understanding of the effectiveness of the ECS training intervention and inform future provider-level training interventions that may reduce lung cancer stigma and improve cancer care delivery. ClinicalTrials.gov Identifier : NCT05456841 [ABSTRACT FROM AUTHOR]

Pregnancies conceived within 18 months of a prior delivery (termed short inter-pregnancy interval [IPI]) place mothers and infants at high risk for poor health outcomes. Despite this, nearly one third of U.S. women experience a short IPI. To address the gap in the current model of postpartum (PP) contraception care by developing and implementing a novel approach to link (co-schedule) PP contraception care with newborn well-baby care to improve access to timely PP contraception. The LINCC Trial will take place in seven clinical locations across five community health centers within the U.S. PP patients (planned n = 3150) who are attending a Well-Baby Visit between 0 and 6 months will be enrolled. The LINCC Trial aims to leverage the Electronic Health Record to prompt providers to ask PP patients attending a Well-Baby Visit about their PP contraception needs and facilitate co-scheduling of PP contraception care with routine newborn care visits. The study includes a cluster randomized, cross-sectional stepped wedge design to roll out the intervention across the seven sites. The outcomes of the study include receipt of most or moderately effective methods of contraception by two and six months PP; and rate of short IPI pregnancies. Implementation outcomes will be assessed at baseline and 6 months after site enters intervention period. The LINCC Trial seeks to evaluate the effectiveness and feasibility of a linked care model in comparison to usual care. [ABSTRACT FROM AUTHOR]

Colorectal cancer (CRC) screening utilization is low among low-income, uninsured, and minority populations that receive care in community health centers (CHCs). There is a need for evidence-based interventions to increase screening and follow-up care in these settings. A multilevel, multi-component pragmatic cluster randomized controlled trial is being conducted at 8 CHCs in two metropolitan areas (Boston and Los Angeles), with two arms: (1) Mailed FIT outreach with text reminders, and (2) Mailed FIT-DNA with patient support. We also include an additional CHC in Rapid City (South Dakota) that follows a parallel protocol for FIT-DNA but is not randomized due to lack of a comparison group. Eligible individuals in participating clinics are primary care patients ages 45–75, at average-risk for CRC, and overdue for CRC screening. Participants with abnormal screening results are offered navigation for follow-up colonoscopy and CRC risk assessment. The primary outcome is the completion rate of CRC screening at 90 days. Secondary outcomes include the screening completion rate at 180 days and the rate of colonoscopy completion within 6 months among participants with an abnormal result. Additional goals are to enhance our understanding of facilitators and barriers to CRC risk assessment in CHC settings. This study assesses the effectiveness of two multilevel interventions to increase screening participation and follow-up after abnormal screening in under-resourced clinical settings, informing future efforts to address CRC disparities. NCT05714644 [ABSTRACT FROM AUTHOR]

Cardiovascular disease (CVD) is the primary cause of premature morbidity and mortality in the United States and Tennessee ranks among the highest in CVD events. While patient-centered outcomes research (PCOR) evidence-based approaches that reach beyond the traditional doctor-patient visit hold promise to improve CVD care and prevent serious complications, most primary care providers lack time, knowledge, and infrastructure to implement these proven approaches. Statewide primary care quality improvement (QI) collaboratives hold potential to help address primary care needs, however, little is known regarding their effectiveness in improving uptake of PCOR evidence-based population health approaches and improving CVD outcomes. This study describes the design and implementation of a stepped-wedge cluster randomized controlled trial to assess the effectiveness of participation in a statewide quality improvement cooperative (The Tennessee Heart Health Network [TN-HHN]) on cardiovascular outcomes. The TN-HHN Effectiveness Study randomized 77 practices to 4 waves (i.e., clusters), with each wave beginning three months after the start of the prior wave and lasting for 18 months. All practice clusters received one of three Network interventions, and outcomes are measured for each three months both in the control phase and the intervention phase. Primary outcomes include Center for Medicare and Medicaid Services measures for aspirin use, blood pressure control, cholesterol control, and smoking cessation (ABCS). This trial, upon its conclusion, will allow us to assess the effect of participation in a statewide quality improvement cooperative on cardiovascular outcomes as well as key contributors to successful practice transformation. [ABSTRACT FROM AUTHOR]

As part of the IMPACT Consortium of three effectiveness-implementation trials, the NU IMPACT trial was designed to evaluate implementation and effectiveness outcomes for an electronic health record (EHR)-embedded symptom monitoring and management program for outpatient cancer care. NU IMPACT uses a unique stepped-wedge cluster randomized design, involving six clusters of 26 clinics, for evaluation of implementation outcomes with an embedded patient-level randomized trial to evaluate effectiveness outcomes. Collaborative, consortium-wide efforts to ensure use of the most robust and recent analytic methodologies for stepped-wedge trials motivated updates to the statistical analysis plan for implementation outcomes in the NU IMPACT trial. In the updated statistical analysis plan for NU IMPACT, the primary implementation outcome patient adoption, as measured by clinic-level monthly proportions of patient engagement with the EHR-based cancer symptom monitoring system, will be analyzed using generalized least squares linear regression with auto-regressive errors and adjustment for cluster and time effects (underlying secular trends). A similar strategy will be used for secondary patient and provider implementation outcomes. The analytic updates described here resulted from highly iterative, collaborative efforts among statisticians, implementation scientists, and trial leads in the IMPACT Consortium. This updated statistical analysis plan will serve as the a priori specified approach for analyzing implementation outcomes for the NU IMPACT trial. [ABSTRACT FROM AUTHOR]

This protocol paper describes the overall design for HPV MISTICS, a multilevel intervention to increase human papillomavirus (HPV) vaccination initiation and completion rates among adolescents aged 11–17. We will conduct a hybrid type 1 implementation-effectiveness trial using a stepped-wedge cluster randomized trial in eight federally qualified health centers (FQHCs) in Florida. Intervention components target three levels: system, providers, and parents. Outcomes will be assessed using quantitative (e.g., vaccination data, survey data) and qualitative methods (e.g., staff and parent interviews). We expect to quantify changes in HPV vaccine series initiation and completion rates for adolescents ages 11–17 in the eight FQHCs. We have hypothesized a 20-percentage point increase in HPV vaccine series initiation and a 10-percentage point increase in series completion. We also anticipate being able to explore factors at the system, provider, and patient levels as potential covariates. Implementation outcomes, barriers, and facilitators identified in the study will help characterize the implementation process and inform potential future intervention scale-up. The project is ongoing; effectiveness and implementation outcomes will be determined following project completion. Findings will provide evidence of an equity-informed research design and implementation procedures that could help improve HPV vaccination rates in similar health systems. Clinical trials identifier: NCT05677360 (date registered: 2022-12-22); https://clinicaltrials.gov/study/NCT05677360?lead=Moffitt%20Cancer%20Center%20&aggFilters=status:rec&page=2&rank=17 [ABSTRACT FROM AUTHOR]

Women with atypical hyperplasia (AH) or lobular carcinoma in situ (LCIS) have a significantly increased risk of breast cancer, which can be substantially reduced with antiestrogen therapy for chemoprevention. However, antiestrogen therapy for breast cancer risk reduction remains underutilized. Improving knowledge about breast cancer risk and chemoprevention among high-risk patients and their healthcare providers may enhance informed decision-making about this critical breast cancer risk reduction strategy. We are conducting a cluster randomized controlled trial to evaluate the effectiveness and implementation of patient and provider decision support tools to improve informed choice about chemoprevention among women with AH or LCIS. We have cluster randomized 26 sites across the U.S. through the SWOG Cancer Research Network. A total of 415 patients and 200 healthcare providers are being recruited. They are assigned to standard educational materials alone or combined with the web-based decision support tools. Patient-reported and clinical outcomes are assessed at baseline, after a follow-up visit at 6 months, and yearly for 5 years. The primary outcome is chemoprevention informed choice after the follow-up visit. Secondary endpoints include other patient-reported outcomes, such as chemoprevention knowledge, decision conflict and regret, and self-reported chemoprevention usage. Barriers and facilitators to implementing decision support into clinic workflow are assessed through patient and provider interviews at baseline and mid-implementation. With this hybrid effectiveness/implementation study, we seek to evaluate if a multi-level intervention effectively promotes informed decision-making about chemoprevention and provide valuable insights on how the intervention is implemented in U.S. clinical settings. NCT04496739 [ABSTRACT FROM AUTHOR]

Children, adolescent, and young adult cancer survivors experience overall increased risks of infertility that are preventable through effective fertility preservation services prior to starting cancer treatment. Oncofertility care is the evidence-based practice of informing newly diagnosed cancer patients about their reproductive risks and supporting shared decision-making on fertility preservation services. Despite longstanding clinical guidelines, oncofertility care delivery continues to be limited and highly variable across adult and pediatric oncology settings. We describe the design of a stepped wedge cluster randomized clinical trial to evaluate the effectiveness of the multi-component Telehealth Oncofertility Care (TOC) intervention conducted in 20 adult and pediatric oncology clinics across three health systems in Southern California. Intervention components are: 1) electronic health record-based oncofertility needs screen and referral pathway to a virtual oncofertility hub; 2) telehealth oncofertility counseling through the hub; and 3) telehealth oncofertility financial navigation through the hub. We hypothesize the intervention condition will be associated with increased proportions of patients who engage in goal-concordant oncofertility care (i.e., engagement in reproductive risk counseling and fertility preservation services that meet the patient's fertility goals) and improved patient-reported outcomes, compared to the usual care control condition. We will also evaluate intervention implementation in a mixed-methods study guided by implementation science frameworks. Our overall goal is to speed implementation of a scalable oncofertility care intervention at cancer diagnosis for children, adolescent and young adult cancer patients to improve their future fertility and quality of life. Trial registration : Clinicaltrials.gov Identifier: NCT05443737 [ABSTRACT FROM AUTHOR]

ROSSEY is a community–academic partnership aiming to develop and test a COVID-19 risk communication intervention for elementary school students and families in Yakima County, Washington. We describe the ROSSEY study protocol that will be implemented in the Yakima School District. Aim 1 is to identify the community's social, ethical, and behavioral needs and resources for students to return to school and maintain onsite learning. We will conduct semi-structured interviews with students and school employees and focus groups with parents. Aim 2 is to evaluate the effectiveness of risk communication on students' school attendance. We will conduct a cluster randomized control trial. We will enroll 14 Yakima School District elementary schools with 900 student participants and randomize the schools into the COVID-19 risk communication intervention or control group. Aim 3 will assess implementation of the risk communication intervention and schools' COVID-19 mitigation strategies. We will use the RE-AIM framework to guide this work, which will entail conducting semi-structured interviews with students and school employees and focus groups with parents. Implementation of science-based risk communication can educate the community on the benefits and safety of COVID-19 testing and vaccination. Risk communication may also inform families about the role of COVID-19 testing and vaccines as part of mitigation strategies to allow for safe in-person learning. Schools have extraordinary influence to promote children's health through policy and practice change. Study findings will provide evidence to facilitate policy decisions and best practices at schools that facilitate adoption of COVID-19 risk communication. ClinicalTrials.gov NCT04859699. Registered on April 26, 2021. [ABSTRACT FROM AUTHOR]

Immigrants to the United States face structural barriers that contribute to rising cardiovascular risk factors and obesity after immigration. This manuscript describes the development of the Healthy Immigrant Community protocol and baseline measures for a stepped wedge cluster randomized trial to test the effectiveness of a social network intervention for cardiovascular risk reduction among two immigrant populations. We developed a social network-informed, community-based, participatory research-derived health promotion intervention with Hispanic and Somali immigrant communities in Minnesota consisting of mentoring, educational and motivational sessions, group activities, and a community toolkit for healthy weight loss delivered by culturally concordant health promoters (HPs) to their social networks. Using a stepped wedge cluster randomized design, social network-based groups were randomly assigned to receive the intervention either immediately or after a delay of one year. Outcomes, measured at baseline, 6 months, 12 months, and 24 months, were derived from the American Heart Association's "Life's Simple 7": BMI and waist circumference, blood pressure, fasting blood glucose, total cholesterol, physical activity level, and dietary quality. A total of 51 HPs were enrolled and randomized (29 Hispanic; 22 Somali). There were 475 participants enrolled in the study, representing a mean social network group size of 8 (range, 5–12). The mean BMI of the sample (32.2) was in the "obese" range. Processes and products from this Healthy Immigrant Community protocol are relevant to other communities seeking to reduce cardiovascular risk factors and negative health behaviors among immigrant populations by leveraging the influence of their social networks. [ABSTRACT FROM AUTHOR]

Posttraumatic stress disorder (PTSD) results in substantial costs to society. Prevalence of PTSD among adults is high, especially among those presenting to primary care settings. Evidence-based psychotherapies (EBPs) for PTSD are available but dissemination and implementation within primary care settings is challenging. Building Experience for Treating Trauma and Enhancing Resilience (BETTER) examines the effectiveness of integrating Written Exposure Therapy (WET) within primary care collaborative care management (CoCM). WET is a brief exposure-based treatment that has the potential to address many challenges of delivering PTSD EBPs within primary care settings. The study is a hybrid implementation effectiveness cluster-randomized controlled trial in which 12 Federally Qualified Health Centers (FQHCs) will be randomized to either CoCM plus WET (CoCM+WET) or CoCM only with 60 patients within each FQHC. The primary aim is to evaluate the effectiveness of CoCM+WET to improve PTSD and depression symptom severity. Secondary treatment outcomes are mental and physical health functioning. The second study aim is to examine implementation of WET within FQHCs using FQHC process data and staff interviews pre- and post-intervention. Exploratory aims are to examine potential moderators and mediators of the intervention. Assessments occur at baseline, and 3- and 12-month follow-up. The study has the potential to impact practice and improve clinical and public health outcomes. By establishing the effectiveness and feasibility of delivering a brief trauma-focused EBP embedded within CoCM in primary care, the study aims to improve PTSD outcomes for underserved patients. Trial registration: (Clinicaltrials.gov NCT05330442). • Written Exposure Therapy (WET) is a brief treatment for posttraumatic stress disorder (PTSD). • WET has potential to for uptake in primary care settings that provide care for the poor and underserved. • Access to WET has not previously been tested in primary care settings. • We describe a study to examine the effectiveness and implementation of WET in an underserved primary care setting. [ABSTRACT FROM AUTHOR]

There are no evidence-based models to support the implementation of school-based bullying prevention programs. Our primary objective is to examine the impact of tailored support on the implementation of the KiVa antibullying program. Our second objective is to evaluate whether the offered support influences student outcomes (e.g., victimization, bullying perpetration). We also assess the cost-effectiveness of the provided support and conduct a process evaluation. In a cluster randomized control trial (cRCT), we compare program fidelity between schools that receive implementation support and those that do not. Twenty-four (N = 24) schools in Finland were randomized to either the IMPRES condition (receiving support, n = 12) or the control group (KiVa as usual, n = 12). In the IMPRES condition, pre-assessment and staff training were organized, and a selected team of staff members received four mentoring sessions during one academic year. Staff and students answer questionnaires at the end of school year 0, at post-intervention (year 1) and again at the 1-year follow-up (year 2). Our primary outcomes concern two main program components — universal and indicated actions — reflecting program fidelity. As secondary outcomes, we examine the level of bullying victimization and perpetration as well as students' perception of several program fidelity indicators. Finally, we assess several tertiary outcomes, collect resource data and conduct qualitative interviews to perform additional analyses. This trial will inform us of whether implementation support can boost program fidelity and have a distal impact on bullying prevalence. Trial Registration: ISRCTN15558617 https://doi.org/10.1186/ISRCTN15558617. • Negative consequences of bullying are well-known and a major public health risk. • Low program fidelity put at risk the effectiveness of bullying prevention programs. • Evidence-based models to support schools in program implementation do not exist. • Providing support to schools offers an avenue for improving program fidelity. [ABSTRACT FROM AUTHOR]

COVID-19 vaccination rates among long-term care center (LTCC) workers are among the lowest of all frontline health care workers. Current efforts to increase COVID-19 vaccine uptake generally focus on strategies that have proven effective for increasing influenza vaccine uptake among health care workers including educational and communication strategies. Experimental evidence is lacking on the comparative advantage of educational strategies to improve vaccine acceptance and uptake, especially in the context of COVID-19. Despite the lack of evidence, education and communication strategies are recommended to improve COVID-19 vaccination rates and decrease vaccine hesitancy (VH), especially strategies using tailored messaging for disproportionately affected populations. We describe a cluster-randomized comparative effectiveness trial with 40 LTCCs and approximately 4000 LTCC workers in 2 geographically, culturally, and ethnically distinct states. We compare the effectiveness of two strategies for increasing COVID-19 booster vaccination rates and willingness to promote COVID-19 booster vaccination: co-design processes for tailoring educational messages vs. an enhanced usual care comparator. Our study focuses on the language and/or cultural groups that are most disproportionately affected by VH and low COVID-19 vaccine uptake in these LTCCs. Finding effective methods to increase COVID-19 vaccine uptake and decrease VH among LTCC staff is critical. Beyond COVID-19, better approaches are needed to improve vaccine uptake and decrease VH for a variety of existing vaccines as well as vaccines created to address novel viruses as they emerge. [ABSTRACT FROM AUTHOR]

Enhanced awareness of poor medication adherence could improve patient care. This article describes the original and adapted protocols of a randomized trial to improve medication adherence for cardiometabolic conditions. The original protocol entailed a cluster randomized trial of 28 primary care clinics allocated to either (i) medication adherence enhanced chronic disease care clinical decision support (eCDC-CDS) integrated within the electronic health record (EHR) or (ii) usual care (non-enhanced CDC-CDS). Enhancements comprised (a) electronic interfaces printed for patients and clinicians at primary care encounters that encouraged discussion about specific medication adherence issues that were identified, and (b) pharmacist phone outreach. Study subjects were individuals who at an index visit were aged 18–74 years and not at evidence-based care goals for hypertension (HTN), diabetes mellitus (DM), or lipid management, along with low medication adherence (proportion of days covered [PDC] <80%) for a corresponding medication. The primary study outcomes were improved medication adherence and clinical outcomes (BP and A1C) at 12 months. Protocol adaptation became imperative in response to major implementation challenges: (a) the availability of EHR system-wide PDC calculations that superseded our ability to limit PDC adherence information solely to intervention clinics; (b) the unforeseen closure of pharmacies committed to conducting the pharmacist outreach; and (c) disruptions and clinic closures due to the Covid-19 pandemic. This manuscript details the protocol of a study to assess whether enhanced awareness of medication adherence issues in primary care settings could improve patient outcomes. The need for protocol adaptation arose in response to multiple implementation challenges. [ABSTRACT FROM AUTHOR]

Medical imaging plays an essential role in healthcare. As a diagnostic test, imaging is prone to substantial overuse and potential overdiagnosis, with dire consequences to patient outcomes and health care costs. Clinical decision support systems (CDSSs) were developed to guide referring physicians in making appropriate imaging decisions. This study will evaluate the effect of implementing a CDSS (ESR iGuide) with versus without active decision support in a physician order entry on the appropriate use of imaging tests and ordering behaviour. A protocol for a multi-center cluster-randomized trial with departments acting as clusters, combined with a before-after-revert design. Four university hospitals with eight participating departments each for a total of thirty-two clusters will be included in the study. All departments start in control condition with structured data entry of the clinical indication and tracking of the imaging exams requested. Initially, the CDSS is implemented and all physicians remain blinded to appropriateness scores based on the ESR imaging referral guidelines. After randomization, half of the clusters switch to the active intervention of decision support. Physicians in the active condition are made aware of the categorization of their requests as appropriate, under certain conditions appropriate, or inappropriate, and appropriate exams are suggested. Physicians may change their requests in response to feedback. In the revert condition, active decision support is removed to study the educational effect. The main outcome is the proportion of inappropriate diagnostic imaging exams requested per cluster. Secondary outcomes are the absolute number of imaging exams, radiation from diagnostic imaging, and medical costs. Approval from the Medical Ethics Review Committee was obtained under protocol numbers 20–069 (Augsburg), B 238/21 (Kiel), 20–318 (Lübeck) and 2020–15,125 (Mainz). The trial is registered in the ClinicalTrials.gov register under registration number NCT05490290 [ABSTRACT FROM AUTHOR]

A high number of recent studies have shown that a positive fluid balance is independently associated with impaired prognosis in specific populations of patients hospitalized in intensive care unit (ICU): acute kidney injury, acute respiratory distress syndrome (ARDS), sepsis, high risk surgery. However, to date, there is no evidence that control of fluid overload reduces mortality in critically ill patients. The main objective is to assess the efficacy of a strategy limiting fluid overload on mortality in unselected critically ill patients hospitalized in ICU. We hypothesized that a strategy based on a weight-driven recommendation of restricted fluid intake, diuretics, and ultrafiltration initiated from 48 h up to 14 days after admission in critically ill patients would reduce all-cause mortality as compared to usual care. We use a stepped wedge cluster randomized controlled trial combined with a quasi-experimental (before-and-after) study. Patients under mechanical ventilation, admitted since >48 h and < 72 h in ICU, and with no discharge planned for the next 24 h are eligible. A total of 1440 patients are expected to be enrolled in 12 ICUs. Sociodemographic and clinical data are collected at inclusion, and outcomes are collected during the follow-up. Primary outcome is all-cause mortality at 60 days after admission. Secondary outcomes are patients weight differences between admission and day7 (or day 14), 28-day, in-hospital, and 1-year mortality, end-organ damages, and unintended harmful events. Analyses will be held in intention-to-treat. If POINCARE-2 strategy proves effective, then guidelines on fluid balance control might be extended to all critically ill patients. Trial registration : ClinicalTrials.gov NCT02765009 [ABSTRACT FROM AUTHOR]

The intake of sugar-sweetened beverages (SSB) is disproportionately high in Appalachia, including among adolescents whose intake is more than double the national average and more than four times the recommended daily amount. Unfortunately, there is insufficient evidence for effective strategies targeting SSB behaviors among Appalachian youth in real-world settings, including rural schools. Kids SIP smart ER is a 6-month, school-based, behavior and health literacy program aimed at improving SSB behaviors among middle school students. The program also integrates a two-way short message service (SMS) strategy to engage caregivers in SSB role modeling and supporting home SSB environment changes. Kids SIP smart ER is grounded by the Theory of Planned Behavior and health literacy, media literacy, numeracy, and public health literacy concepts. Guided by the RE-AIM framework (reach, effectiveness, adoption, implementation, and maintenance), this type 1 hybrid design and cluster randomized controlled trial targets 12 Appalachian middle schools in southwest Virginia. The primary aim evaluates changes in SSB behaviors at 7-months among 7th grade students at schools receiving Kids SIP smart ER, as compared to control schools. Secondary outcomes include other changes in students (e.g., BMI, quality of life, theory-related variables) and caregivers (e.g., SSB behaviors, home SSB environment), and 19-month maintenance of these outcomes. Reach is assessed, along with mixed-methods strategies (e.g., interviews, surveys, observation) to determine how teachers implement Kids SIP smart ER and the potential for institutionalization within schools. This paper discusses the rationale for implementing and evaluating a type 1 hybrid design and multi-level intervention addressing pervasive SSB behaviors in Appalachia. Clincialtrials.gov : NCT03740113 [ABSTRACT FROM AUTHOR]

There are over five million people in the United States living with dementia. Most live at home and are cared for by family. These family caregivers often assume care responsibilities without education about the disease, skills training, or support, and in turn become at risk for depression, burden, and adverse health outcomes when compared to non-dementia caregivers. Despite over 200 caregiver interventions with proven benefits, many caregivers lack access to these programs. One approach to enhance access is to embed evidence-based caregiver support programs in existing community-based services for people with dementia such as adult day services (ADS). Here we describe the protocol for an embedded pragmatic trial designed to augment standard ADS known as ADS Plus. ADS Plus provides family caregivers with support via education, referrals, and problem-solving techniques over 12 months, and is delivered on-site by existing ADS staff. Embedding a program in ADS requires an understanding of outcomes and implementation processes in that specific context. Thus, we deploy a hybrid design involving a cluster randomized two-group trial to evaluate treatment effects on caregiver wellbeing, ADS utilization, as well as nursing home placement. We describe implementation practices in 30 to 50 geographically and racially/ethnically diverse participating sites. Clinical trial registration #: NCT02927821 [ABSTRACT FROM AUTHOR]

Low back pain (LBP) is one of the most prevalent and potentially disabling conditions for which people seek health care. Patients, providers, and payers agree that greater effort is needed to prevent acute LBP from transitioning to chronic LBP. The TARGET (Targeted Interventions to Prevent Chronic Low Back Pain in High-Risk Patients) Trial is a primary care-based, multisite, cluster randomized, pragmatic trial comparing guideline-based care (GBC) to GBC + referral to Psychologically Informed Physical Therapy (PIPT) for patients presenting with acute LBP and identified as high risk for persistent disabling symptoms. Study sites include primary care clinics within each of five geographical regions in the United States, with clinics randomized to either GBC or GBC + PIPT. Acute LBP patients at all clinics are risk stratified (high, medium, low) using the STarT Back Tool. The primary outcomes are the presence of chronic LBP and LBP-related functional disability determined by the Oswestry Disability Index at 6 months. Secondary outcomes are LBP-related processes of health care and utilization of services over 12 months, determined through electronic medical records. Study enrollment began in May 2016 and concluded in June 2018. The trial was powered to include at least 1860 high-risk patients in the randomized controlled trial cohort. A prospective observational cohort of approximately 6900 low and medium-risk acute LBP patients was enrolled concurrently. The TARGET pragmatic trial aims to establish the effectiveness of the stratified approach to acute LBP intervention targeting high-risk patients with GBC and PIPT. Trial Registration: ClinicalTrials.gov NCT02647658 Registered Jan. 6, 2016. [ABSTRACT FROM AUTHOR]

Abstract Background Novel approaches to engage community smokers in smoking cessation are needed as smokers typically lack motivation to quit or use evidence-based tobacco dependence treatment. Mobile instant messaging apps (e.g., WhatsApp, Facebook Messenger) are widely used but under-studied as a mobile health modality for delivering smoking cessation support. This paper presents the rationale and study design of a trial which aims to evaluate the effectiveness of a chat-based intervention using mobile instant messaging combined with brief interventions for community smokers. Methods This is a two-arm, parallel, accessor-blinded, pragmatic cluster-randomized controlled trial on an estimated 1172 daily cigarette smokers aged ≥18 years proactively recruited from 68 community sites (cluster) throughout Hong Kong. Subjects in intervention group received three months of chat-based, instant messaging support guided by acceptance and commitment therapy and other behavioural change techniques, integrated with brief advice and active referral to a smoking cessation service using the AWARD (Ask, Warn, Advise, Refer, Do-it-again) intervention model. Control group received brief advice to quit plus a self-help booklet at baseline. Outcomes were assessed at 1-, 2-, 3- and 6-month after baseline. The primary outcome is abstinence validated by exhaled carbon monoxide (<4 ppm) and salivary cotinine (<10 ng/mL) at 6-month after baseline. Primary analyses will be based on intention-to-treat. Comments This is the first trial examining the effectiveness of a chat-based cessation support programme combined with brief interventions in promoting abstinence. The intervention model can be adapted for other behavioural change treatments and more advanced digital smoking cessation intervention. [ABSTRACT FROM AUTHOR]

Abstract Building healthy fruit and vegetable (FV) consumption habits early in life is critical for primary prevention. However, U.S. youth do not come close to meeting national recommendations for FV intake. School-lunch salad bars are one of the most heavily promoted ways to meet FV guidelines. Contrary to popular belief, no rigorous randomized trials have examined whether salad bars increase students' FV consumption. This paper describes the design and rationale of a federally funded trial to evaluate whether introducing salad bars in elementary, middle, and high schools affects students' FV consumption and waste during lunch. A cluster factorial randomized trial will test new salad bars against waitlist controls, with and without an additional marketing intervention (N = 36 schools, N = 6804 students: n = 12 elementary, n = 12 middle and n = 12 high schools). Objective plate waste measurements of individual student's selection of FVs, consumption, and waste will be conducted using digital scales. Primary aim includes comparing FV consumption in schools without salad bars to those with new salad bars by grade level. Secondary aims include: a) whether FV marketing impacts the success of salad bars for FV consumption; b) whether salad bars differentially result in more FV waste compared to traditional serving methods; c) cost-benefit of using salad bars for consumption over traditional serving methods. When complete, this study stands to be one of the most definitive on the effectiveness of salad bars and contextual factors impacting their success. Findings will provide evidence for how to best spend limited federal dollars to improve FV intake in schools. Trial registration: ClinicalTrials.gov Identifier: NCT03283033 (date of registration: 9/14/2017). [ABSTRACT FROM AUTHOR]

Abstract Schools are a recommended place for childhood obesity prevention. Local Wellness Policies (LWPs) establish guidelines for schools to provide opportunities for students to access nutritious foods and be physically active. Little is known about the impact of LWPs, when implemented, on students' behavior and body mass index (BMI). The Wellness Champions for Change trial assesses the student-level impact of providing theory-based training and technical assistance to help schools implement LWPs. This 3-arm, cluster randomized controlled trial will take place in 30 low- or middle-income schools (15 elementary and 15 middle) in five Maryland school districts. Ten schools will receive both Wellness Champions for Change (WCC), which involves training teacher-led wellness teams, and Wellness Champions for Change-Student (WCC-S), which engages students as wellness team members. Ten schools will receive WCC only, and ten control schools will receive a delayed intervention. The RE-AIM framework will guide evaluation. Student Effectiveness measures will include BMI z-scores, self-reported diet patterns, and objectively-measured physical activity. The sample size (1080 students across 30 schools, followed for 2.5 years) will enable power (>0.8) to detect BMI z-score differences. A three-level linear mixed model that accounts for clustering will be used to assess Effectiveness. A mixed methods approach will assess school- and district-level Reach, Adoption, and Implementation. If effective, this approach will represent a sustainable, multi-level, school-based strategy to prevent childhood obesity. The evaluation framework will allow for the description of factors necessary to broadly disseminate this approach for obesity prevention on a large scale. [ABSTRACT FROM AUTHOR]

Guidelines recommend screening for colorectal cancer (CRC), but participation and abnormal test follow up rates are suboptimal, with disparities by demography. Evidence-based interventions exist to promote screening, but community adoption and implementation are limited. The San Diego Accelerating Colorectal Cancer Screening and Follow-up through Implementation Science (ACCSIS) program is an academic-community partnership testing regional implementation of a Hub-and-Spoke model for increasing CRC screening and follow-up. The "hub" is a non-academic, non-profit organization that includes 17 community health center (CHC) systems, serving over 190 rural and urban clinic sites. The "spokes" are 3 CHC systems that oversee 11–28 clinics each, totaling over 60 clinics. Using a cluster-randomized trial design, 9 clinics were randomized to intervention and 16 to usual care. Within intervention clinics, approximately 5000 eligible patients not up-to-date with CRC screening per year were identified for intervention. Interventions include an invitation primer, a mailed fecal immunochemical test with completion instructions, and phone and text-based reminders (hub) and patient navigation protocol to promote colonoscopy completion after abnormal FIT (spoke). Outcomes include: 1) proportion of patients up-to-date with screening after three years in intervention versus non-intervention clinics; 2) proportion of patients with abnormal FIT completing colonoscopy within six months of the abnormal result. Implementation science measures are collected to assess acceptability, intervention and usual care adaptations, and sustainability of the intervention strategies. This large-scale, regional cluster randomized trial among CHCs serving diverse populations is anticipated to accelerate progress in CRC prevention in underserved populations. Trial registration: NCT04941300 [ABSTRACT FROM AUTHOR]

Home Blood Pressure Monitoring (HBPM) that includes a team with a clinical pharmacist is an evidence-based intervention that improves blood pressure (BP). Yet, strategies for promoting its adoption in primary care are lacking. We developed potentially feasible and sustainable implementation strategies to improve hypertension control and BP equity. We assessed barriers and facilitators to HBPM and iteratively adapted implementation strategies through key informative interviews and guidance from a multistakeholder stakeholder team involving investigators, clinicians, and practice administration. Strategies include: 1) pro-active outreach to patients; 2) provision of BP devices; 3) deployment of automated bidirectional texting to support patients through education messages for patients to transmit their readings to the clinical team; 3) a hypertension visit note template; 4) monthly audit and feedback reports on progress to the team; and 5) training to the patients and teams. We will use a stepped wedge randomized trial to assess RE-AIM outcomes. These are defined as follows R each: the proportion of eligible patients who agree to participate in the BP texting; E ffectiveness: the proportion of eligible patients with their last BP reading <140/90 (six months); A doption: the proportion of patients invited to the BP texting; I mplementation: patients who text their BP reading ≥10 of days per month; and M aintenance: sustained BP control post-intervention (twelve months). We will also examine RE-AIM metrics stratified by race and ethnicity. Findings will inform the impact of strategies for the adoption of team-based HPBM and the impact of the intervention on hypertension control and equity. Registration details: www.ClinicalTrials.gov Identifier: NCT05488795. [ABSTRACT FROM AUTHOR]

COVID-19 has resulted in significant disability and loss of life. COVID-19 vaccines effectively prevent severe illness, hospitalization, and death. Nevertheless, many people remain hesitant to accept vaccination. Veterans perceive healthcare providers (HCP) and staff as trusted vaccine information sources and thereby are well suited to initiate vaccine discussions. The overall objective of this study is to implement and test a virtual COVID-19 Vaccine Acceptance Intervention (VAI) training that is informed by motivational interviewing (MI) techniques. The VAI training is being delivered to VA HCPs and staff within a Hybrid Type 2 pragmatic implementation-effectiveness trial using Implementation Facilitation as the implementation strategy. The implementation team includes external facilitators paired with VA Healthcare System (VAHCS)-level internal facilitators. The trial has three aims: 1) Examine the effectiveness of the VAI versus usual care on unvaccinated veterans' vaccination rates in a one-year cluster randomized controlled trial, with randomization at the level of VAHCS. 2) Determine factors associated with veterans' decisions to accept or decline primary COVID-19 vaccination, and better understand how these factors influence vaccination decisions, through survey and qualitative data; and 3) Use qualitative interviews with HCPs and staff from clinics with high and low vaccination rates to learn what was helpful and not helpful about the VAI and implementation strategies. This is the first multisite randomized controlled trial to test an MI-informed vaccine acceptance intervention to improve COVID-19 vaccine acceptance. Information gained can be used to inform healthcare systems' approaches to improve future vaccination and other public health campaigns. ClinicalTrials.gov Identifier: NCT05027464 • COVID-19 vaccines effectively prevent severe illness, hospitalization, and death. • Healthcare providers and staff are trusted sources of vaccine information. • Healthcare providers and staff received COVID-19 Vaccine Acceptance Intervention. • Primary outcome is receipt of COVID-19 vaccination after training started. • Qualitative data is collected from veterans and Healthcare providers and staff. [ABSTRACT FROM AUTHOR]

The term placebo effect refers to the psychobiological effect of a patient's knowledge or belief of being treated. A placebo effect is patient-driven, which makes it fundamentally different from the usual treatment effect resulting from external actions. In modern clinical research, the presence of a placebo effect is often treated as a nuisance issue, something to be "adjusted away" in estimating a treatment effect of primary interest. However, from a patient-centered perspective, we believe that a possible placebo produces substantial improvements in patient-centered outcomes. Understanding placebo effects is therefore an important part of patient-centered outcomes research. The available methods for estimating placebo effects are designed for individually randomized trials and are not directly applicable to cluster randomized trials (CRTs). There are several challenges in estimating placebo effects in CRTs. A major challenge is the possible presence of interference within clusters, in the sense that a subject's outcome may depend on the beliefs subjects in the same cluster about treatment assignment (mentality) and therefore possible correlation in outcome and mentality among subjects exists in the same cluster. In this article, we extend the previously developed causal inference framework to also encompass CRTs, using the G-Computation and inverse probability weighting (IPW) approaches. We also develop methodologies and further extend the G-Computation and IPW approaches to handle missingness for jointly evaluating placebo effect and treatment-specific effect, specifically in the context of CRTs. The proposed methods are demonstrated in simulation studies and a cluster randomized trial on effect of fermented dairy drink. [ABSTRACT FROM AUTHOR]

Abstract Objectives To evaluate the effect of an intervention to optimize TB/HIV integration on patient outcomes. Methods Cluster randomised control trial at 18 primary care clinics in South Africa. The intervention was placement of a nurse (TB/HIV integration officer) to facilitate provision of integrated TB/HIV services, and a lay health worker (TB screening officer) to facilitate TB screening for 24 months. Primary outcomes were i) incidence of hospitalisation/death among individuals newly diagnosed with HIV, ii) incidence of hospitalisation/death among individuals newly diagnosed with TB and iii) proportion of HIV-positive individuals newly diagnosed with TB who were retained in HIV care 12 months after enrolment. Results Of 3328 individuals enrolled, 3024 were in the HIV cohort, 731 in TB cohort and 427 in TB-HIV cohort. For the HIV cohort, the hospitalisation/death rate was 12.5 per 100 person-years (py) (182/1459py) in the intervention arm vs. 10.4/100py (147/1408 py) in the control arms respectively (Relative Risk (RR) 1.17 [95% CI 0.92–1.49]).For the TB cohort, hospitalisation/ death rate was 17.1/100 py (67/ 392py) vs. 11.1 /100py (32/289py) in intervention and control arms respectively (RR 1.37 [95% CI 0.78–2.43]). For the TB-HIV cohort, retention in care at 12 months was 63.0% (213/338) and 55.9% (143/256) in intervention and control arms (RR 1.11 [95% 0.89–1.38]). Conclusions The intervention as implemented failed to improve patient outcomes beyond levels at control clinics. Effective strategies are needed to achieve better TB/HIV service integration and improve TB and HIV outcomes in primary care clinics. Trial registration South African Register of Clinical Trials (registration number DOH-27-1011-3846). [ABSTRACT FROM AUTHOR]

Advance care planning (ACP) is a central tenet of dialysis care, but the vast majority of dialysis patients report never engaging in ACP discussions with their care providers. Over the last decade, we have developed and iteratively tested SPIRIT ( S haring P atient's I llness R epresentation to I ncrease T rust), a theory-based, patient- and family-centered advance care planning intervention. SPIRIT is a six-step, two-session, face-to-face intervention to promote cognitive and emotional preparation for end-of-life decision making for patients with ESRD and their surrogates. In these explanatory trials, SPIRIT was delivered by trained research nurses. Findings consistently revealed that patients and surrogates in SPIRIT showed significant improvement in preparedness for end-of-life decision making, and surrogates in SPIRIT reported significantly improved post-bereavement psychological outcomes after the patient's death compared to a no treatment comparison condition. As a critical next step, we are conducting an effectiveness-implementation study. This study is a multicenter, clinic-level cluster randomized pragmatic trial to evaluate the effectiveness of SPIRIT delivered by dialysis care providers as part of routine care in free-standing outpatient dialysis clinics, compared to usual care plus delayed SPIRIT implementation. Simultaneously, we will evaluate the implementation of SPIRIT, including sustainability. We will recruit 400 dyads of patients at high risk of death in the next year and their surrogates from 30 dialysis clinics in four states. This trial of SPIRIT will generate novel, meaningful insights about improving ACP in dialysis care. Trial registration: ClinicalTrials.gov NCT03138564 , registered 05/01/2017. [ABSTRACT FROM AUTHOR]

The safe, highly-effective human papillomavirus (HPV) vaccine remains underused in the US. The Announcement Approach Training (AAT) has been shown to effectively increase HPV vaccine uptake by training providers to make strong vaccine recommendations and answer parents' common questions. Systems communications, like recall notices, can further improve HPV vaccination by reducing missed clinical opportunities for vaccination. Never tested in supporting HPV vaccination, the ECHO (Extension for Community Healthcare Outcomes) model is a proven implementation strategy to increase best practices among healthcare providers. This trial uses a hybrid effectiveness-implementation design (type II) to evaluate two ECHO-delivered interventions intended to increase HPV vaccination rates. This 3-arm cluster randomized controlled trial will be conducted in 36 primary care clinics in Pennsylvania. Aim 1 evaluates the impact of HPV ECHO (AAT to providers) and HPV ECHO+ (AAT to providers plus recall notices to vaccine-declining parents) versus control on HPV vaccination (≥1 dose) among adolescents, ages 11–14, between baseline and 12-month follow-up (primary outcome). Using a convergent mixed-methods approach, Aim 2 evaluates the implementation of the HPV ECHO and HPV ECHO+ interventions. Aim 3 explores exposure to and impact of vaccine information from providers and other sources (e.g., social media) on secondary acceptance among 200 HPV vaccine-declining parents within 12 months. We expect to demonstrate the effectiveness and evaluate the implementation of two highly scalable interventions to increase HPV vaccination in primary care clinics. Our study seeks to address the communication needs of both providers and parents, increase HPV vaccination, and, eventually, prevent HPV-related cancers. Trial registration: ClinicalTrials.gov NCT04587167. Registered on October 14, 2020. [ABSTRACT FROM AUTHOR]

Primary care physicians (PCPs) provide the majority of medical care to patients with non-dialysis dependent CKD. However, PCPs report numerous limitations to providing expert CKD care, including poor patient education, inadequate diagnostic evaluation, suboptimal use of medications, and time limitations. The Kidney Coordinated HeAlth Management Partnership (Kidney CHAMP) trial is a cluster randomized controlled trial to evaluate the effectiveness of a novel centralized electronic health records (EHR)-delivered population health management (PHM) strategy for high-risk CKD patients on patient care, safety, and other outcomes of interest to patients, providers, and payors. Over a 42-month period, the trial will compare the effectiveness of a multifaceted intervention that combines early identification of high-risk patients, timely nephrology guidance, pharmacist-led medication management services, and CKD patient education to usual care and enroll 1650 high-risk CKD patients from 100 primary care practices. The primary outcome will be ≥40% decline in estimated glomerular filtration rate (eGFR) or end stage kidney disease. Key secondary outcomes will include blood pressure, renin-angiotensin aldosterone system inhibitors use, and exposure to potentially unsafe medications. If successful, our treatment approach could improve CKD care delivery and safety, resource allocation, and adoption of evidence-based CKD guideline-concordant care. [ABSTRACT FROM AUTHOR]

Among 96 million U.S. adults with prediabetes, adoption of evidence-based treatment to prevent diabetes remains low. Primary care represents an essential venue for preventing diabetes, yet providers in this setting have limited time to address prevention. This highlights the need for low-touch interventions that promote diabetes prevention and are not delivered by primary care providers. Text messaging and decision aids displaying disease risk and treatment information have improved outcomes in prior research. However, these approaches have not been definitively studied for managing prediabetes. The Behavioral Nudges for Diabetes Prevention (BEGIN) trial is a pragmatic, cluster randomized trial testing the effectiveness of text messaging about diabetes prevention and a prediabetes decision aid. These interventions are being studied in 8 primary care clinics using a 2 × 2 factorial design, in which pairs of clinics are randomized in a 1:1:1:1 ratio to receive usual care, text messaging alone, prediabetes decision aid alone, or both interventions. A total of 656 patients are recruited to participate, receive the study interventions, and contribute data at baseline and 12 months. The primary outcome is 12-month weight change, and the secondary outcome is adoption of evidence-based treatment to prevent diabetes. Change in hemoglobin A1c is an exploratory outcome that will be assessed among participants with available values. Findings from the BEGIN trial will provide evidence about the effectiveness of two novel, low-touch interventions focused on diabetes prevention in primary care, where patients are diagnosed with prediabetes and there is little prior research. TRIAL REGISTRY: NCT04869917 [ABSTRACT FROM AUTHOR]

Heart-to-Heart (H2H) is a church-based behavioral cluster randomized trial to measure the effectiveness of a lifestyle education program for reducing blood pressure (BP) in African American adults with uncontrolled BP. Design and implementation of this study were informed by our ALIVE pilot study conducted with church pastors and leaders using a community-based participatory research methodology. The current study employs a cross-over design in which all participants receive two 6-month programs in different orders: the intervention arm receives the H2H program first, followed by a financial education program, and the comparator arm receives the programs in the reverse order. Approximately 34 churches will be randomized with the aim of including at least 272 participants across churches. The H2H program consists of 24 weekly dietitian-led diet and lifestyle virtual education sessions, 12 Bible studies taught by the church pastor reinforcing positive dietary behaviors from a biblical perspective, daily self-monitoring of BP, and, as needed, one-on-one support from a community health worker to assist with medication adherence. The Money Smart program consists of 14 financial education sessions and 12 Bible studies teaching the biblical basis of good financial management over a 6-month period. The primary outcome measure is systolic BP at 6 months with a follow-up at 12 months. Secondary outcome measures include medication adherence, Dietary Approaches to Stop Hypertension (DASH) diet adherence, self-efficacy for hypertension self-care, social support for eating a healthy diet, hypertension and nutrition knowledge, beliefs about medicines, barriers to medication use, depression, and financial knowledge and behaviors. [ABSTRACT FROM AUTHOR]

Previous research highlights the need for effective lifestyle interventions for men. Hockey Fans in Training (Hockey FIT) was developed as a pragmatic healthy lifestyle program tailored to men with overweight or obesity. This paper overviews the rationale, program details, and design of a recently completed cluster randomized controlled trial (RCT) of Hockey FIT. Participant engagement and baseline characteristics are also described. The RCT evaluated the effectiveness, cost-effectiveness, and implementation of Hockey FIT. Forty-two sites in Canada and the United States were randomized to either the Hockey FIT intervention group or wait-list control group. Participants were men, aged 35–65 years, with a body mass index (BMI) ≥27 kg/m2. Hockey FIT is a group-based, off-ice, in-person healthy lifestyle program, including both a 3 - month active phase and a 9-month minimally-supported phase. Outcomes were assessed at baseline, 3, and 12 months. The primary outcome was weight loss at 12 months. The design of the cluster RCT incorporates evaluations of participant health outcomes, program implementation, and broader healthcare system impact. In the RCT, 1397 participants were assessed for eligibility and 997 were enrolled. Most participants heard about the program through social media or hockey team emails. Participants averaged 49 years of age, had BMI values of 35.3 kg/m2, were predominately white, and had varying levels of education. The intended audience for Hockey FIT was recruited successfully, however, targeted recruitment to better engage diverse populations is warranted. This paper affords a useful outline for evaluating future lifestyle interventions tailored to men. This trial was registered on August 17, 2018 with ClinicalTrials.gov (identifier: NCT03636282). [ABSTRACT FROM AUTHOR]

Only half of patients with hypertension have adequately controlled blood pressure. Clinical decision support (CDS) has the potential to overcome barriers to delivering guideline-recommended care and improve hypertension management. However, optimal strategies for scaling CDS have not been well established, particularly in small, independent primary care practices which often lack the resources to effectively change practice routines. Practice facilitation is an implementation strategy that has been shown to support process changes. Our objective is to evaluate whether practice facilitation provided with hypertension-focused CDS can lead to improvements in blood pressure control for patients seen in small primary care practices. We will conduct a cluster randomized control trial to compare the effect of hypertension-focused CDS plus practice facilitation on BP control, as compared to CDS alone. The practice facilitation intervention will include an initial training in the CDS and a review of current guidelines along with follow-up for coaching and integration support. We will randomize 46 small primary care practices in New York City who use the same electronic health record vendor to intervention or control. All patients with hypertension seen at these practices will be included in the evaluation. We will also assess implementation of CDS in all practices and practice facilitation in the intervention group. The results of this study will inform optimal implementation of CDS into small primary care practices, where much of care delivery occurs in the U.S. Additionally, our assessment of barriers and facilitators to implementation will support future scaling of the intervention. ClinicalTrials.gov Identifier: NCT05588466 [ABSTRACT FROM AUTHOR]

Introduction High rates of adolescent relationship abuse (ARA) and sexual violence (SV) reported among adolescents point to the need for prevention among middle school-age youth. This is a cluster randomized controlled trial to test an athletic coach-delivered ARA/SV prevention program in 41 middle schools (38 clusters). Trained coaches talk to their male athletes about 1) what constitutes harmful vs. respectful relationship behaviors, 2) dispelling myths that glorify male sexual aggression and promoting more gender-equitable attitudes, and 3) positive bystander intervention when aggressive male behaviors toward females are witnessed. Methods A total of 973 male athletes (ages 11–14, grades 6–8) are participating. Athletes complete surveys at the beginning and end of sports season (Time 2), and one year later (Time 3). The primary outcome is an increase in positive bystander behaviors (i.e., intervening in peers' disrespectful or harmful behaviors); secondary outcomes are changes in recognition of what constitutes abusive behavior, intentions to intervene, and gender equitable attitudes (Time 2 and 3) as well as reduction in abuse perpetration (Time 3). Results Participating schools have a greater proportion of non-White students and students on free/reduced lunch compared to schools that declined participation. Participants' self-reported ethnicities are 54.5% White, 29.0% Black, 1.4% Hispanic and the remainder, multi-racial, other, or not reported. Conclusions This study will evaluate the effectiveness of a coach-delivered ARA/SV prevention program for middle school male athletes. Findings will add to the evidence base regarding developmentally appropriate violence prevention programs as well as the role of coaches in adolescent health promotion. Clinical Trials #: NCT02331238 [ABSTRACT FROM AUTHOR]

Patients eligible for lung cancer screening (LCS) are those at high risk of lung cancer due to their smoking histories and age. While screening for LCS is effective in lowering lung cancer mortality, primary care providers are challenged to meet beneficiary eligibility for LCS from the Centers for Medicare & Medicaid Services, including a patient counseling and shared decision-making (SDM) visit with the use of patient decision aid(s) prior to screening. We will use an effectiveness-implementation type I hybrid design to: 1) identify effective, scalable smoking cessation counseling and SDM interventions that are consistent with recommendations, can be delivered on the same platform, and are implemented in real-world clinical settings; 2) examine barriers and facilitators of implementing the two approaches to delivering smoking cessation and SDM for LCS; and 3) determine the economic implications of implementation by assessing the healthcare resources required to increase smoking cessation for the two approaches by delivering smoking cessation within the context of LCS. Providers from different healthcare organizations will be randomized to usual care (providers delivering smoking cessation and SDM on site) vs. centralized care (smoking cessation and SDM delivered remotely by trained counselors). The primary trial outcomes will include smoking abstinence at 12-weeks and knowledge about LCS measured at 1-week after baseline. This study will provide important new evidence about the effectiveness and feasibility of a novel care delivery model for addressing the leading cause of lung cancer deaths and supporting high-quality decisions about LCS. NCT04200534 ClinicalTrials.gov NCT04200534 [ABSTRACT FROM AUTHOR]

Despite evidence that eHealth approaches can be effective in reducing HIV risk, their implementation requirements for public health scale up are not well established, and effective strategies to bring these programs into practice are still unknown. Keep It Up! (KIU!) is an online program proven to reduce HIV risk among young men who have sex with men (YMSM) and ideal candidate to develop and evaluate novel strategies for implementing eHealth HIV prevention programs. KIU! 3.0 is a Type III Hybrid Effectiveness-Implementation cluster randomized trial designed to 1) compare two strategies for implementing KIU!: community-based organizations (CBO) versus centralized direct-to-consumer (DTC) recruitment; 2) examine the effect of strategies and determinants on variability in implementation success; and 3) develop materials for sustainment of KIU! after the trial concludes. In this article, we describe the approaches used to achieve these aims. Using county-level population estimates of YMSM, 66 counties were selected and randomized 2:1 to the CBO and DTC approaches. The RE-AIM model was used to drive outcome measurements, which were collected from CBO staff, YMSM, and technology providers. Mixed-methods research mapped onto the domains of the Consolidated Framework for Implementation Research will examine determinants and their relationship with implementation outcomes. In comparing our implementation recruitment models, we are examining two strategies which have shown effectiveness in delivering health technology interventions in the past, yet little is known about their comparative advantages and disadvantages in implementation. The results of the trial will further the understanding of eHealth prevention intervention implementation. • Design of hybrid implementation-effectiveness cluster-randomized trial description. • Comparison of eHealth HIV prevention intervention implementation strategies. • Post-launch amendments to trial protocol addressing challenges during COVID-19. • Description of strategies to effectively scale up eHealth HIV prevention programs. [ABSTRACT FROM AUTHOR]

Emerging adults with sickle cell disease (EASCD) experience significant challenges transitioning from pediatric to adult care. Acute care utilization increases, quality of life (QOL) declines, with an increased risk of mortality. Currently, there are no practice standards to guide emerging adults through the transition process. We are creating a structured transition education (STE) based program for EASCD by customizing the Six Core Elements (6 CE) of Health Care Transition model and are evaluating the effectiveness of adding peer mentoring (PM). The Sickle Cell Trevor Thompson Transition Project (ST3P-UP) is an ongoing multi-site, cluster randomized clinical trial with a target enrollment of 537 EASCD aged 16 to 25 years in pediatric care. Each site (n = 14) comprises a pediatric clinic, adult clinic, and a sickle cell disease (SCD) community-based organization (CBO). Sites are randomized 1:1 to either STE or STE + PM. EASCDs are followed prospectively for 24 months. Rapid cycle plan-do-study-act quality improvement (QI) methods are used to implement the STE. The primary objective is to compare the effectiveness of STE + PM versus STE only at decreasing the number of acute care visits per year over 24 months. The secondary objectives are to compare overall healthcare utilization and patient-reported QOL outcomes at 24 months. We aim to demonstrate the feasibility of using a QI approach to implement 6 CE-based practice standards at 14 disparate SCD clinical programs to guide EASCD through the transition process. We hypothesize that adding PM to the STE program will improve acute care reliance, QOL, and satisfaction with transition outcomes. [Display omitted] • Developing a structured transition education-based program for sickle cell disease. • Customizing the Six Core Elements of Health Care transition model. • Comparing the effectiveness of adding peer mentoring to the transition program. • Hypothesize that adding peer mentoring will improve acute care reliance. [ABSTRACT FROM AUTHOR]

Latino communities within the U.S. are disproportionately affected by persistent, high levels of untreated mental illness. Limited mental health literacy, stigma, and cultural factors are major contributors to Latino mental health treatment disparities. Although Latino individuals may be reluctant to seek out mental health professionals, they often rely on religious congregations when confronted with mental illness. However, religious congregations report major obstacles to collaborating with the mental health sector including the lack of mental health training, staffing, and resources. Strategic partnerships between religious congregations and community-based organizations can be leveraged to target sources of Latino mental health treatment disparities. The National Alliance on Mental Illness (NAMI), the nation's largest grassroots mental health organization, has developed a host of programs tailored to the different needs and segments of the community affected by mental illness, including programs designed to address culturally diverse and faith-based communities. This cluster-randomized controlled trial leverages the collective resources of NAMI and the Diocese of San Bernardino to deliver and evaluate the effectiveness of a multi-level, parish-based, intervention to decrease stigma, increase mental health literacy, and improve access to mental health services among Latino parishioners. This study will enroll 1400 participants from 14 parishes that will be randomly assigned to receive the intervention immediately or a wait-list control condition. The intervention could enrich awareness of mental health issues, shape norms about mental illness, facilitate treatment access, and add support from religious congregations to target Latino mental health disparities using culturally and faith-based tailored approaches. [ABSTRACT FROM AUTHOR]

Uncontrolled hypertension is a major risk factor for cardiovascular disease. Evidence-based interventions to improve hypertension control in high-income countries have not been translated equally in sub-Saharan Africa (SSA). The objective of the Addressing Hypertension Care in Africa (ADHINCRA) Study was to test the feasibility and signal of efficacy of a multilevel, nurse-led, mobile health enhanced intervention in improving hypertension control in Ghana. Using a cluster randomized controlled pilot trial design, four hospitals in Kumasi, Ghana, were randomized to the intervention arm (2 hospitals) and enhanced usual care arm (2 hospitals). A total of 240 patients with uncontrolled hypertension defined as systolic blood pressure (BP) ≥140 mmHg on their most recent visit were included (60 patients per hospital). Patients in the intervention arm received an intervention that consisted of nurse-led task-shifting and a mobile health application (Medtronic® Labs' Empower Health), and home BP monitoring. The enhanced usual care arm received usual care as determined by their providers, plus short text messages on health. The intervention was administered for six months, after which it was withdrawn, and patients were followed for six more months to assess outcomes. Feasibility measures included recruitment and dropout rates of study participants, protocol adherence in both arms. Clinical outcomes included changes in BP control status and systolic BP levels from baseline. Secondary outcomes included change in glycemic control, rates of hypertensive urgencies/emergencies, cardiovascular disease events, and medication adherence. Findings from this study will provide critical pilot data to inform the conduct of a larger scale trial and the development of scalable health system and policy interventions to improve hypertension control in low-resource settings. Trial registration NCT04010344. Registered on July 8, 2019 at ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT04010344 [ABSTRACT FROM AUTHOR]

People with serious mental illness (SMI) and intellectual disabilities and/or developmental disabilities (ID/DD) living in group homes (GHs) and residential staff are at higher risk for COVID-19 infection, hospitalization, and death compared with the general population. We describe a hybrid type 1 effectiveness-implementation cluster randomized trial to assess evidence-based infection prevention practices to prevent COVID-19 for residents with SMI or ID/DD and the staff in GHs. The trial will use a cluster randomized design in 400 state-funded GHs in Massachusetts for adults with SMI or ID/DD to compare effectiveness and implementation of "Tailored Best Practices" (TBP) consisting of evidence-based COVID-19 infection prevention practices adapted for residents with SMI and ID/DD and GH staff; to "General Best Practices" (GBP), consisting of required standard of care reflecting state and federal standard general guidelines for COVID-19 prevention in GHs. External (i.e., community-based research staff) and internal (i.e., GH staff leadership) personnel will facilitate implementation of TBP. The primary effectiveness outcome is incident SARS-CoV-2 infection and secondary effectiveness outcomes include COVID-19-related hospitalizations and mortality in GHs. The primary implementation outcomes are fidelity to TBP and rates of COVID-19 vaccination. Secondary implementation outcomes are adoption, adaptation, reach, and maintenance. Outcomes will be assessed at baseline, 3-, 6-, 9-, 12-, and 15-months post-randomization. This study will advance knowledge on comparative effectiveness and implementation of two different strategies to prevent COVID-19-related infection, morbidity, and mortality and promote fidelity and adoption of these interventions in high-risk GHs for residents with SMI or ID/DD and staff. Clinical Trial Registration Number: NCT04726371. [ABSTRACT FROM AUTHOR]

Concerns about the rise in adolescent vaping and cannabis use suggest the need for effective substance use prevention programs. Botvin LifeSkills Training (LST) has a strong evidence base at the middle school level for preventing or reducing tobacco use and related problems. A high school (grades 9–10) version of the LST program was also developed and shows promising initial evidence for reducing tobacco use in a single pilot study. However, the high school version of LST has not been sufficiently tested in an experimental trial, despite being widely implemented in high schools across the U.S. This paper outlines the study protocol for a large-scale cluster randomized trial of Botvin High School LST, with objectives of documenting the design of prospective research and promoting transparency. A total of 60 high schools in Colorado and Ohio were randomized to the 10-session, teacher-led intervention group (n = 33 schools) or business-as-usual control group (n = 27 schools). Across two cohorts of schools, 9th-grade students complete self-report surveys at pretest, immediate posttest, 1-year follow-up, and 21-month follow-up. Primary outcomes are tobacco (nicotine) use and cannabis use. Secondary outcomes are alcohol use, illicit drug use, psychosocial behaviors (e.g., violence and mental health), and academic achievement. Intent-to-treat analyses will use multilevel modeling to estimate intervention effects across assessment points. This independent evaluation will help to determine whether the intervention is appropriate for large-scale adoption. This trial is preregistered with the Open Science Framework (https://osf.io/dnz5q/). [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic has had negative psychosocial impacts on young children; teachers in childcare centers continue to be overwhelmed by how to address the downstream psychological effects children are experiencing. This randomized controlled trial will study the role of a community-based, childcare center-support system in improving resilience and mitigating the long-term impacts of COVID-19 on children's development. This study will be modeled on a successful Early Childhood Mental Health Consultation (ECMHC) intervention which utilizes mental health consultants to deliver a Jump Start+: COVID 19 Support (JS + CS) virtual toolkit to childcare centers in Miami-Dade County via a Kubi robot. The toolkit comprises four strength-based strategies likely to be effective in improving resiliency following disasters: Safety Planning, Effective Communication, Adult Self-Care, and Trauma-Informed Behavior Support. Our first aim will utilize a cluster randomized trial to examine the effectiveness of JS + CS on improving the psychosocial functioning of young children, as compared to an obesity prevention intervention control group. Children will be followed at 6, 12, 18, and 24 months. The second aim will examine the mechanisms that contribute to effective uptake by teachers of the JS + CS support strategies on child outcomes. The third aim will explore implementation barriers/facilitators as well as potential societal contextual factors (e.g., vaccine uptake) to help centers serving disproportionately affected minority communities recover from and prepare for future crises. This design will inform the refinement and scaling of JS + CS and generalize impacts to other childcare center interventions in the context of disasters. [ABSTRACT FROM AUTHOR]

Limited guidance exists regarding implementation strategies that best facilitate cancer screening practice substitution and achieve optimal stakeholder-centered outcomes. Here we describe the protocol for a randomized pragmatic trial comparing two implementation strategies to facilitate substitution of primary HPV screening for Pap and HPV co-testing to perform routine cervical cancer screening of women aged 30–65 years at Kaiser Permanente Southern California (KPSC). Twelve service areas within KPSC will be randomized to a "centrally-administered system-wide implementation + local-tailored implementation" strategy or a "centrally-administered system-wide implementation only" strategy. The centrally-administered strategy comprises clinician and staff educational activities. Sites in the local-tailored arm will then conduct a structured local needs assessment followed by site-specific selection and deployment of implementation interventions. Surveys and interviews will be conducted among women and providers from the primary care and ob/gyn departments prior to the system-wide transition, shortly after the transition, and after the completion of local-tailored interventions. A stakeholder advisory committee will assist with study design, defining stakeholder-centered outcomes, and developing data collection tools. The primary outcome of interest is uptake of primary HPV screening. Secondary provider-centered outcomes include provider knowledge, delivery of patient education, satisfaction with the practice substitution process, and resistance to primary HPV screening. Secondary patient-centered outcomes include patient knowledge, stigma, and satisfaction with the screening process. Intervention fidelity will also be measured via surveys. Findings from this study will help inform future use of a local-tailored implementation strategy for adopting primary HPV screening at large health care systems. Findings may also be applicable to other types of practice substitution. • Protocol of a study comparing implementation strategies for facilitating practice change. • A randomized pragmatic trial that evaluates strategies in implementing primary HPV screening. • The implementation strategies are "local-tailored" approach and the "prescribed" approach. [ABSTRACT FROM AUTHOR]

In a cluster randomized trial, groups of individuals (e.g., clinics, schools) are randomized to conditions. The design and analysis of cluster randomized trials can require more care than individually randomized trials. Past reviews have noted deficiencies in the use of appropriate statistical methods for such trials. We reviewed cluster randomized trials of cancer screening interventions published 1995–2019 to determine whether appropriate statistical methods had been used for sample size calculation and outcome analysis and whether they reported intraclass correlation coefficient (ICC) values. This work expanded a previous review of articles published 1995–2010. Our search identified 88 articles published 1995–2020 that reported outcomes of cluster randomized trials of breast, cervix, and colorectal cancer screening interventions. There was increased reporting of the trials' sample size calculations over time, with the percentage increasing from 31% in 1995–2004 to 77% in 2014–2019. However, the percentage of calculations failing to account for cluster randomization did not change over time and was 17% of studies in 2014–2019. There was a nonsignificant trend towards increased use of outcome analysis methods that accounted for the cluster randomized design. However, in lower impact journals, use of appropriate analysis methods was only 80% in 2014–2019. Only 33% of studies reported ICC values in 2014–2019. For cluster randomized trials with cancer screening outcomes, there have been improvements in the reporting of sample size calculations but methodological and reporting deficiencies persist. Efforts to disseminate, adopt and report the use of appropriate statistical methodologies are still needed. [ABSTRACT FROM AUTHOR]

Obesity is a key risk factor for Type 2 diabetes (T2D). Alarmingly, 87% of US adults have overweight or obesity, with non-Hispanic black adults having higher obesity and T2D prevalence than non-Hispanic white. The Diabetes Prevention Program (DPP) demonstrated the clinical benefits of lifestyle intervention (LI). While the DPP LI is effective, some participants don't achieve clinically significant weight loss in the current group-based translation paradigm. Black adults have the lowest adjusted weight loss (3.2%) among all racial/ethnic groups. Early intervention nonresponse defined as ≤1% weight loss at intervention week 4 is linked to lower probability of achieving weight loss goals. This paper describes the design and methods of a cluster randomized controlled trial among black weight loss nonresponders nested in 20 community sites (primarily churches). Descriptions of the adaptations made to transition the program to virtual format during the COVID-19 pandemic are also included. Trained community health workers deliver a group-based, 6-month long DPP over 18 sessions via Zoom. Additionally, nonresponders in the enhanced group receive weekly telephone support to provide individual-level intervention to help overcome weight loss barriers. Outcomes include weight, physical activity level, blood pressure, and dietary behaviors; these are compared between nonresponders in the enhanced intervention group and nonresponders in the active control group. Cost, mediators, and moderators are explored. If found to efficacious, these enhanced strategies could be standardized as a supplement for use with DPP nonresponders. [ABSTRACT FROM AUTHOR]

Regular physical activity (PA) contributes to positive health outcomes, but a minority of US adults meet minimum guidelines for moderate-to-vigorous PA (MVPA) and muscle-strengthening, and Latinos are less likely than whites to meet these guidelines. Public parks can be leveraged for community PA but tend to be underutilized, while churches have reach within Latino communities and can influence parishioners' health. We are conducting a cluster randomized controlled trial to examine the impact of a multilevel, faith-based intervention linking Catholic parishes (n = 14) to their local parks on adult Latino parishioners' (n = 1204) MVPA and health-related outcomes. Our approach targets multiple levels (individual, group, church, and neighborhood-park) to promote health-enhancing PA through park-based exercise classes led by kinesiology students, peer leader-led walking groups, park-based church events, church-based PA support activities, and environmental advocacy. Data are collected at churches by trained bilingual/bicultural research assistants using accelerometry, surveys, and biometric procedures. We will implement a set of hierarchical repeated-measure linear models to examine effects on the primary outcome (MVPA) and secondary outcomes (self-reported PA, heart rate/fitness, waist circumference, waist-to-hip ratio, body fat, mental health, and perceived social support for PA). We will also conduct a process evaluation. To our knowledge, this will be the first study examining efficacy of an integrated church and park-based intervention on Latino adults' PA and represents a scalable model of PA programming for low-income communities. The intervention makes use of innovative partnerships within and across sectors – faith-based, local parks/city government, and local universities – further facilitating sustainability. ClinicalTrials.gov ID : NCT03858868 [ABSTRACT FROM AUTHOR]

Counseling to identify and support individuals' desires for family formation is a key component of preventive health care that is often absent in primary care visits. This study evaluates a novel, web-based, person-centered intervention to increase the frequency and quality of communication about reproductive goals and healthcare needs in Veterans Health Administration (VA) primary care. We describe a hybrid type 1 effectiveness-implementation cluster randomized controlled trial in seven VA healthcare systems testing a web-based reproductive health decision support tool (MyPath). VA primary care providers are enrolled and randomized to intervention or usual care arms. Veterans scheduled to see intervention-arm providers receive a text message inviting them to use MyPath ahead of their appointment; Veterans scheduled to see control-arm providers receive usual care. Target enrollment is 36 providers and 456 Veterans. Outcomes are assessed by Veteran self-report after the visit and at 3- and 6-months follow-up. The primary outcome is occurrence of reproductive health discussions involving shared decision making; secondary outcomes include measures of communication, knowledge, decision conflict, contraceptive utilization, and receipt of services related to prepregnancy health. Data on implementation barriers, facilitators and cost are collected. The trial is ongoing with no results to report. We have enrolled 36 primary care providers across 7 VA healthcare systems and recruitment of Veterans is ongoing. Results will inform efforts to increase the quality and person-centeredness of reproductive healthcare delivery in primary care and to operationalize and scale up use of digital decision support tools in clinical settings. Trial Registration: http://ClinicalTrials.gov Identifier: NCT04584294 Trial Status: Recruiting. [ABSTRACT FROM AUTHOR]

Due to underrepresentation of racial/ethnic minority and low-income groups in clinical studies, there is a call to improve the recruitment and retention of these populations in research. Pilot studies can test recruitment and retention practices for better inclusion of medically underserved children and families in subsequent clinical trials. We examined this using a school-based asthma intervention, in preparation for a larger clinical trial in which our goal is to include an underserved study population. We recruited children with poorly controlled asthma in a two-site pilot cluster randomized controlled trial of school-supervised asthma therapy versus enhanced usual care (receipt of an educational asthma workbook). We sought a study population with a high percentage of children and families from racial/ethnic minority and low-income groups. The primary outcome of the pilot trial was recruitment/retention over 12 months. Strategies used to facilitate recruitment/retention of this study population included engaging pre-trial multi-level stakeholders, selecting trial sites with high percentages of underserved children and families, training diverse medical providers to recruit participants, conducting remote trial assessments, and providing multi-lingual study materials. Twenty-six children [42.3% female, 11.5% Black, 30.8% Multiracial (Black & other), 76.9% Hispanic, and 92.3% with family income below $40,000] and their caregivers were enrolled in the study, which represents 55.3% of those initially referred by their provider, with 96.2%, 92.3%, and 96.2% retention at 3-, 6-, and 12-month follow-up, respectively. Targeted strategies facilitated the inclusion of a medically underserved population of children and families in our pilot study, prior to expanding to a larger trial. • Clinical trials often struggle to recruit and retain medically underserved populations, especially children and families • This threatens health equity, as underserved children and families experience disproportionate morbidity from disease • We suggest targeted strategies to increase recruitment and retention of medically underserved children and families [ABSTRACT FROM AUTHOR]