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Background: Over the past few decades, patient-reported outcomes (PROs) have been used to understand patient health conditions better. Therefore, numerous PRO measures (questionnaires) and guidelines or guidance have been developed. However, it is challenging to select target guidance from among the many available guidance and to understand the chosen guidance. This study comprehensively collected the existing PRO guidance for clinical trials or studies and practices to support novice PRO users in academia, industry, clinical practice, and regulatory and reimbursement decision-making. Methods: For the scoping review, we searched the MEDLINE, Embase, Google Books, WorldCat, and the National Library of Medicine (NLM) Bookshelf databases from 2009 to 2023. The eligibility criteria were PRO guidance for clinical trials, clinical practice, or application such as health technology assessment. Those guidance cover aspects such as quality of life (QOL), PRO, health-related QOL, health state utilities, psychometric requirements, implementation methods, analysis and interpretation, or clinical practice applications. After the systematic search, three researchers individually reviewed the collected data, and the reviewed articles and books were scrutinized using the same criteria. Results: We collected the PRO guidance published in articles and books between 2009 and 2023. From the database searches, 1,455 articles and 387 books were identified, of which one book and 33 articles were finally selected. The collected PRO guidance was categorized into the adoption of PRO measures, design and reporting of trials or studies using PROs, implementation of PRO evaluation in clinical trials or studies or clinical practice, analysis and interpretation of PROs, and application of PRO evaluation. Based on this categorization, we suggest the following for novices: When selecting guidance, novices should clarify the "place" and "purpose" where the guidance will be used. Additionally, they should know that the terminology related to PRO and the scope and expectations of PROs vary by "places" and "purposes". Conclusions: From this scoping review of existing PRO guidance, we provided summaries and caveats to assist novices in selecting guidance that fits their purpose and understanding it. [ABSTRACT FROM AUTHOR]

Background: Anxiety and depression are common among older adults and can intensify during perioperative periods, but few mental health interventions are designed for older surgical patients' unique needs. As part of the feasibility trial, we developed and adapted a perioperative mental health (PMH) bundle for older patients comprised of behavioral activation (BA) and medication optimization (MO) to ameliorate anxiety and depressive symptoms before, during, and after cardiac, orthopedic, and oncologic surgery. Methods: We used mixed-methods including workshop studios with patients, caregivers, clinicians, researchers, and interventionists; intervention refinement and reflection meetings; patient case review meetings; intervention session audio-recordings and documentation forms; and patient and caregiver semi-structured interviews. We used the results to refine our PMH bundle. We used multiple analytical approaches to report the nature of adaptations, including hybrid thematic analysis and content analysis informed by the Framework for Reporting Adaptations and Modifications – Expanded. Results: Adaptations were categorized by content (intervention components), context (how the intervention is delivered, based on the study, target population, intervention format, intervention delivery mode, study setting, study personnel), training, and evaluation. Of 51 adaptations, 43.1% involved content, 41.2% involved context, and 15.7% involved training and evaluation. Several key adaptations were noted: (1) Intervention content was tailored to patient preferences and needs (e.g., rewording elements to prevent stigmatization of mental health needs; adjusting BA techniques and documentation forms to improve patient buy-in and motivation). (2) Cohort-specific adaptations were recommended based on differing patient needs. (3) Compassion was identified by patients as the most important element. Conclusions: We identified evidence-based mental health intervention components from other settings and adapted them to the perioperative setting for older adults. Informed by mixed-methods, we created an innovative and pragmatic patient-centered intervention bundle that is acceptable, feasible, and responsive to the needs of older surgical populations. This approach allowed us to identify implementation strategies to improve the reach, scalability, and sustainability of our bundle, and can guide future patient-centered intervention adaptations. Clinical trials Registration: NCT05110690 (11/08/2021). [ABSTRACT FROM AUTHOR]

Background: Burnout and psychosocial distress are serious and growing issues for healthcare workers (HCWs) and healthcare systems across the globe. Exacerbated by changes in healthcare delivery during and following the Covid-19 pandemic, these issues negatively affect HCW wellbeing, clinical outcomes and patient safety. Art Therapy has demonstrated promise as a suitable but under researched intervention, warranting further investigation. This systematic review aims to ascertain what art therapy-based interventions used to address burnout and / or psychosocial distress in HCWs have been reported in the health and social care literature and how these have been evaluated. Methods: Six databases (PubMed, PsycINFO, MEDLINE, EMBASE, CINAHL, ProQuest Central), Google Scholar and three clinical trial registries (CENTRAL, ICTRP and ClinicalTrials.gov) were searched for studies using art therapy-based methods to engage with burnout risk or psychosocial distress in HCWs. Following screening for eligibility study characteristics and outcomes were extracted by two reviewers independently. Studies were evaluated using the Joanna Briggs Institute (JBI) Critical Appraisal Tools. Outcomes were grouped for analysis. Quantitative and qualitative results were synthesised and integrated using narrative synthesis. Results: Twenty-seven studies, drawn from thirteen countries, spanning five continents were selected for inclusion. Fifty percent were published in the last five years, indicating growing global research in the field. Fourteen studies used quantitative research methods and thirteen used qualitative methods. A total of 1580 participants took part in the studies, with nurses most broadly represented (59%). Interventions were mostly delivered in groups (95%) and by an art therapist (70%). Heterogeneity and insufficient randomised controlled trials precluded the possibility of meta-analysis. However, a review of available data showed evidence of medium to large effects for emotional exhaustion (burnout), work-related stress and common mental health issues. A content analysis of qualitative data of perceived effect complemented quantitative findings. Conclusion: Global research into the use of art therapy-based methods to address burnout and psychosocial distress in HCWs is growing. Whilst further high-quality evidence such as randomised controlled trials would be beneficial, findings suggest that art therapy-based methods should be strongly considered as an acceptable and effective treatment for symptoms of emotional exhaustion (burnout) and psychosocial distress in HCWs. [ABSTRACT FROM AUTHOR]

Introduction: The internet has become a powerful worldwide information source that revolutionized access to knowledge, especially in the fields of health and medicine (health knowledge). Therefore, providing high-quality, accurate, reliable, and relevant information on dependable websites is a possible way of providing the patient with needed information and, thus, achieving the benefits of informed patients regarding outcomes. This study aimed to evaluate the quality and accuracy of breast cancer knowledge among Persian language websites. Methods: Two search engines were searched in the Persian language about breast cancer. The first 30 websites were selected for further evaluation based on the completeness, correctness, transparency, and accessibility of health knowledge. The DISCERN instrument was used to assess the quality of the Persian language websites on this issue. Results: Among the 30 websites, about 23% of websites provide completely correct information and about 30% provide mostly correct information. Sixty percent of the websites provided author information, and 46% of them had a healthcare professional or expert as the author. Sixty percent of the websites stated the creation date on the pages, while 40% of them did not provide any health knowledge. Scores on accessibility were always easy for most of the websites. Based on the quality rating system of DISCERN, about 60% of the websites were presented as very poor. Conclusion: Website rankings enable healthcare professionals to identify and signpost patients to reliable up-to-date websites to ensure that patients receive high-quality knowledge. This review has provided evidence of inadequate and inaccurate health knowledge about breast cancer on the Persian language websites. This issue requires further investigation to understand the barriers and solutions available to provide reliable information about breast cancer and how this information affects the patient's outcomes. Trial registration: The project was found to be in accordance with the ethical principles and the national norms and standards for conducting research in Iran with the approval ID and date of IR.TUMS.IKHC.REC.1399.379 and 2021–01-01 respectively, and is registered with research project number 49890 in the Vice Chancellor for Research and Technology Development of Tehran University of Medical Sciences, Tehran, Iran. URL: https://ethics.research.ac.ir/EthicsProposalViewEn.php?id=170978. [ABSTRACT FROM AUTHOR]

Background: Australia is one of many nations struggling with the challenges of delivering quality primary health care (PHC) to increasing numbers of refugees. The OPTIMISE project represents a collaboration between 12 organisations to generate a model of integrated refugee PHC suitable for uptake throughout Australia. This paper describes the methodology of one component; an outreach practice facilitation intervention, directed towards improving the quality of PHC received by refugees in Australian general practices.Methods: Our mixed methods study will use a cluster stepped wedge randomised controlled trial design set in 3 urban regions of high refugee resettlement in Australia. The intervention was build upon regional partnerships of policy advisors, clinicians, academics and health service managers. Following a regional needs assessment, the partnerships reached consensus on four core areas for intervention in general practice (GP): recording of refugee status; using interpreters; conducting comprehensive health assessments; and referring to refugee specialised services. Refugee health staff trained in outreach practice facilitation techniques will work with GP clinics to modify practice routines relating to the four core areas. 36 general practice clinics with no prior involvement in a refugee health focused practice facilitation will be randomly allocated into early and late intervention groups. The primary outcome will be changes in number of claims for Medical Benefit Service reimbursed comprehensive health assessments among patients identified as being from a refugee background. Changes in practice performance for this and 3 secondary outcomes will be evaluated using multilevel mixed effects models. Baseline data collection will comprise (i) pre-intervention provider survey; (ii) two surveys documenting each practices' structure and approaches to delivery of care to refugees. De-identified medical record data will be collected at baseline, at the end of the intervention and 6 and 12 months following completion.Discussion: OPTIMISE will test whether a regionally oriented practice facilitation initiative can improve the quality of PHC delivered to refugees. Findings have the potential to influence policy and practice in broader primary care settings.Trial Registration: Australian New Zealand Clinical Trials Registry, ACTRN12618001970235 , 05/12/2018, Retrospectively registered. Protocol Version 1, 21/08/2017. [ABSTRACT FROM AUTHOR]

Background: Advance Care Planning (ACP) enables healthcare professionals to embrace the important process where patients think about their values in life and goals for health care, and discuss their future health care preferences with family members for a time when they are not able to make health care decisions. Despite the promotion of ACP last two decades, and well-known benefits of ACP and a written Advance Care Directive (ACD), they are still underutilised in Australia and across the world. Previous studies have provided some insights, however, an uptake of ACP and prevalence of ACDs in community settings is rarely reported.Methods: The aim of this study was to determine the uptake of ACP and prevalence of ACDs among people with chronic diseases in hospital and community settings. A retrospective medical record audit of eligible patients looking for evidence of ACP was conducted in 16 research sites in eight hospital and eight community care settings. Participants included those who were admitted to one of the research sites, and who were aged 18 years and over with at least one of nine nominated chronic diseases. The primary outcome measures included the number of patients with evidence of ACP through the following practices: completion of an ACD, appointment of an Enduring Guardian (EG), or completion of a resuscitation plan.Results: The overall prevalence of ACD was 2.8% (n = 28) out of 1006 audited records, and only 10 (1%) of them were legally binding. The number of EGs appointed was 39 (3.9%) across the sites. A total of 151 (15.4%) resuscitation plans were found across the eight hospital sites. 95% (n = 144) of the resuscitation plans indicated 'Not-for-resuscitation'.Conclusions: The uptake of ACP is very low. Current medical recording system reveals the challenges in ACP lie in the process of storage, access and execution of the ACDs. Given that having an ACD or Enduring Guardian in place is only useful if the treating physician knows how and where to access the information, it has implications for policy, information system, and healthcare professionals' education.Trial Registration: The study was retrospectively registered with the Australian New Zealand Clinical Trials Registry (Trial ID: ACTRN12618001627246 ). The URL of the trial registry record http://www.anzctr.org.au/trial/MyTrial.aspx. [ABSTRACT FROM AUTHOR]

Background: There is limited published data in Lebanon evaluating the impact of supplemental education for anticoagulants use, especially DOACs, on clinical outcomes such as bleeding. The study aims to assess the impact of pharmacist-conducted anticoagulation education and follow-up on bleeding and readmission rates.Methods: This study was a randomized, non-blinded interventional study conducted between August 2017 and July 2019 in a tertiary care teaching Lebanese hospital. Participants were inpatients ≥18 years discharged on an oral anticoagulant for treatment. Block randomization was used. The control group received the standard nursing counseling while the intervention group additionally received pharmacy counseling. Phone call follow-ups were done on day 3 and 30 post-discharge. Primary outcomes included readmission rates and any bleeding event at day 3 and 30 post-discharge. Secondary outcomes included documented elements of education in the medical records and reported mortality upon day 30 post-discharge.Results: Two hundred patients were recruited in the study (100 patients in each study arm) with a mean age of 73.9 years. In the pharmacist-counseled group, more patients contacted their physician within 3 days (14% versus 4%; p = 0.010), received explicit elements of education (p < 0.001) and documentation in the chart was better (p < 0.05). In the standard of care group, patients were more aware of their next physician appointment date (52% versus 31%, p < 0.001). No difference in bleeding rates at day 3 and 30 post-discharge was observed between the groups.Conclusions: Although pharmacist-conducted anticoagulation education did not appear to reduce bleeding or readmission rates at day 30, pharmacist education significantly increased patient communication with their providers in the early days post-discharge.Trial Registration: Lebanon Clinical Trial Registry LBCTR2020033424 . Retrospectively registered. Date of registration: 06/03/2020. [ABSTRACT FROM AUTHOR]

Background: Contemporary perioperative fasting guidelines aim to alleviate patient discomfort before surgery and enhance postoperative recovery whilst seeking to reduce the risk of pulmonary aspiration during anesthesia. The impact of a short message service (SMS) reminder on fasting guideline compliance is unknown. Therefore, we performed a retrospective observational study and quality improvement project aiming to quantify the extent of excessive and prolonged fasting, and then assessed the impact of a SMS reminder in reducing fasting times.Methods: After ethics committee approval we performed a retrospective observational study investigating preoperative fasting times of adult patients undergoing elective surgery. First, we assessed whether the fasting guideline times were adhered to (Standard Care group). All patients received internationally recommended fasting guidelines in the form of a written hospital policy document. We then implemented an additional prompt via a mobile phone SMS 1 day prior to surgery containing a reminder of fasting guideline times (SMS group). The primary aims were to compare fasting times between the Standard Care group and the SMS group.Results: The fasting times of 160 patients in the Standard Care group and 110 patients in the SMS group were evaluated. Adherence to the fasting guidelines for solids occurred in 14 patients (8.8%) in the Standard Care group vs. Twenty-two patients (13.6%) in the SMS group (p=0.01). Adherence to the fasting guidelines for fluids occurred in 4 patients (2.5%) in the Standard Care group vs. Ten patients (6.3%) in the SMS group (p=0.023). Patients in the Standard Care group had a longer median (inter-quartile range (IQR)) fasting time for fluids compared the SMS group [6.5 h (IQR 4.5:11) vs 3.5 h (IQR 3:8.5), p< 0.0001]. Median fasting times for solids were 11 h (IQR 7:14) in the Standard Care group and 11.5 h (IQR 7:13.5) in the SMS group (p=0.756).Conclusion: Adherence to internationally recommended fasting guidelines for patients undergoing elective surgery is poor. The introduction of a fasting guideline reminder via a mobile phone SMS in addition to a written hospital policy improved adherence to fasting advice and reduced the fasting times for fluids but not for solids. The use of an SMS reminder of fasting guidelines is a simple, feasible, low-cost, and effective tool in minimising excessive fasting for fluids among elective surgical patients.Trial Registration: ACTRN12619001232123 (Australia New Zealand Clinical Trials Registry). Registered 6th September 2019 (retrospectively registered). [ABSTRACT FROM AUTHOR]

Background: Transfer of residential aged-care facility (RACF) residents to Emergency Departments (ED) is common, risky and expensive. RACF residents who present to ED are more likely to have hospital readmissions, longer stays and face major risks related to hospital acquired complications. Aged Care Emergency services (ACE) is a nurse led, protocol- guided, telephone RACF/ED outreach model that has been shown to be effective in reducing hospitalisation and length of hospital stay for RACF residents in the Hunter New England Local Health District, New South Wales (NSW). The Partnerships in Aged-Care Emergency services using Interactive Telehealth (PACE-IT) project enhances ACE by incorporating interactive video assessment and consultation. The PACE-IT project's primary aim is to assess whether augmentation of ACE services through the addition of protocol-guided interactive Visual Telehealth Consultation (VTC) for clinical decision-making, plus telephone follow-up, reduces RACF resident transfers to ED.Methods: A stepped-wedge cluster randomised controlled trial will be conducted. The intervention will be delivered sequentially to 8 clusters; each cluster comprises one ED and two RACFs in NSW, Australia. The 16 RACFs in the study will be selected for order of implementation using a computer-generated randomisation sequence. A 2-step randomisation process will be undertaken, randomising the hospital EDs first and then randomising the RACFs aligned with each hospital. The PACE-IT intervention comprises: an initial phone call by RACFs to the ACE service in the ED; the ACE service in ED responds with a protocol-guided VTC, a management plan agreed between all participants; an automated consultation summary letter to the General Practitioner and the RACF; a post VTC 24 h follow-up phone call to the RACF.Discussion: If shown to be effective, the intervention has the potential to improve the clinical care and quality of life for residents. Findings will provide high level evidence that will inform sustainable change and broad translation into practice across NSW. It will show how the change has been achieved and highlight success factors for scalability and sustainability. It will inform review of processes, the development of policy and guidelines that will integrate PACE-IT into existing service models in NSW.Trial Registration: The trial is registered with the Australian New Zealand Clinical Trials Registry (Trial ID ACTR N12619001692123 ) 02/12/2020.). [ABSTRACT FROM AUTHOR]

Background: Medication errors are a leading cause of mortality and morbidity. Clinical pharmacy services provided in hospital can reduce medication errors and medication related harm. However, few rural or remote hospitals in Australia have a clinical pharmacy service. This study will evaluate a virtual clinical pharmacy service (VCPS) provided via telehealth to eight rural and remote hospitals in NSW, Australia.Methods: A stepped wedge cluster randomised trial design will use routinely collected data from patients' electronic medical records (n = 2080) to evaluate the VCPS at eight facilities. The sequence of steps is randomised, allowing for control of potential confounding temporal trends. Primary outcomes are number of medication reconciliations completed on admission and discharge. Secondary outcomes are length of stay, falls and 28 day readmissions. A cost-effectiveness analysis (CEA) and cost-benefit analysis (CBA) will be conducted. The CEA will answer the question of whether the VCPS is more cost-effective compared to treatment as usual; the CBA will consider the rate of return on investing in the VCPS. A patient experience measure (n = 500) and medication adherence questionnaire (n = 100 pre and post) will also be used to identify patient responses to the virtual service. Focus groups will investigate implementation from hospital staff perspectives at each site. Analyses of routine data will comprise generalised linear mixed models. Descriptive statistical analysis will summarise patient experience responses. Differences in medication adherence will be compared using linear regression models. Thematic analysis of focus groups will identify barriers and facilitators to VCPS implementation.Discussion: We aim to demonstrate the effectiveness of virtual pharmacy interventions for rural populations, and inform best practice for using virtual healthcare to improve access to pharmacy services. It is widely recognised that clinical pharmacists are best placed to reduce medication errors. However, pharmacy services are limited in rural and remote hospitals. This project will provide evidence about ways in which the benefits of hospital pharmacists can be maximised utilising telehealth technology. If successful, this project can provide a model for pharmacy delivery in rural and remote locations.Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) -ACTRN12619001757101 Prospectively registered on 11 December 2019. Record available from: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378878&isReview=true. [ABSTRACT FROM AUTHOR]

Background: Community-based screening may be one solution to increase testing and treatment of sexually transmitted infections in sexually active teenagers, but there are few data on the practicalities and cost of running such a service. We estimate the cost of running a 'Test n Treat' service providing rapid chlamydia (CT) and gonorrhoea (NG) testing and same day on-site CT treatment in technical colleges.Methods: Process data from a 2016/17 cluster randomised feasibility trial were used to estimate total costs and service uptake. Pathway mapping was used to model different uptake scenarios. Participants, from six London colleges, provided self-taken genitourinary samples in the nearest toilet. Included in the study were 509 sexually active students (mean 85/college): median age 17.9 years, 49% male, 50% black ethnicity, with a baseline CT and NG prevalence of 6 and 0.5%, respectively. All participants received information about CT and NG infections at recruitment. When the Test n Treat team visited, participants were texted/emailed invitations to attend for confidential testing. Three colleges were randomly allocated the intervention, to host (non-incentivised) Test n Treat one and four months after baseline. All six colleges hosted follow-up Test n Treat seven months after baseline when students received a £10 incentive (to participate).Results: The mean non-incentivised daily uptake per college was 5 students (range 1 to 17), which cost £237 (range £1082 to £88) per student screened, and £4657 (range £21,281 to £1723) per CT infection detected, or £13,970 (range £63,842 to £5169) per NG infection detected. The mean incentivised daily uptake was 19 students which cost £91 per student screened, and £1408/CT infection or £7042/NG infection detected. If daily capacity for screening were achieved (49 students/day), costs including incentives would be £47 per person screened and £925/CT infection or £2774/NG infection detected.Conclusions: Delivering non-incentivised Test n Treat in technical colleges is more expensive per person screened than CT and NG screening in clinics. Targeting areas with high infection rates, combined with high, incentivised uptake could make costs comparable.Trial Registration: ISRCTN58038795, Assigned August 2016, registered prospectively. [ABSTRACT FROM AUTHOR]

Background: It is essential for medical treatment that patients and medical staff can communicate about acute complaints, pre-existing conditions, and the treatment procedure. Misunderstandings can have far-reaching consequences, particularly in time-critical emergencies, which require rapid assessments and decision-making and in which interpreters are rarely available. In this study, we aim to develop a digital communication tool that is to help paramedics communicate with patients who speak hardly any or no German, to monitor its implementation, and to investigate its effect on communication between foreign-language patients and staff. Furthermore, a large amount of data on patients that are cared for in emergency medical services in Germany are collected for the first time.Methods: To consider the complex situations of paramedic care and to meet paramedics' demands, we use an action-oriented research approach to develop the tool. We include the staff of the participating emergency medical service stations and software designers in our approach. The tool is then used and evaluated within an open interventional, non-randomised study with two control groups. Control group 1 (German-speaking patients) and control group 2 (non-German-speaking patients treated without the tool) are recruited starting from the first study phase. In the second study phase, an intervention group is additionally recruited, i.e. non-German-speaking patients with whom the tool is used. The primary outcome of the clinical trial is improved communication with non-German-speaking patients in emergencies by means of the communication tool. The secondary outcome is an improved quality and quantity of the collected information. We exploratively observe on-scene times, demands for emergency physicians, and the usage of the intervention. By recording patients' clinical parameters, we consider the severity of the health restrictions.Discussion: Our study is an innovative research project in paramedic healthcare comprising the development of a digital communication tool to overcome language barriers in emergency medical services and investigating its usability, acceptance, and effect on communication, in short, its usefulness and value for paramedic care. Additonally, we expect to gain comprehensive information on rescue operations.Trial Registration: German Clinical Trials Register, DRKS00016719, registered 08 February 2019, World Health Organization Trial Registration Data Set, http://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00016719. [ABSTRACT FROM AUTHOR]

Background: Patients' understanding of the hemoglobin A1c (HbA1c) has been linked to better diabetes care outcomes (glycemic control, self-care). This is concerning given low documented rates of HbA1c understanding. In this non-blinded, randomized trial, we compared two formats for communicating the HbA1c, selected based on input from people with diabetes, to standard presentation to assess their impact on participants' glycemic control and diabetes-related perceptions.Methods: To design the tested formats, we interviewed 25 patients with diabetes and reviewed a range of possible formats, including color-based scales and graphs. The interviews were recorded, transcribed, and subjected to thematic analysis. Synthesizing interviewees' feedback, we selected two formats, one using a combination of words and colors (Words) and one using a color-coded graph (Graph), for further evaluation. We then randomized adults with poorly controlled diabetes to receive mailed information on their current diabetes control in one of three ways: 1) standard lab report (control), 2) Words format, or 3) Graph format. The primary outcome was HbA1c change at 6 months. Also examined were changes in participants' diabetes-related perceptions and choice of participation incentive.Results: Of the 234 enrolled participants, 76.9% were Black, and their median baseline HbA1c was 9.1% (interquartile range 8.4-10.4). There were no between-arm differences in HbA1c change (- 1.04% [SD 2.2] Control vs. -0.59% [SD 2.0] Words vs. -0.54% [SD 2.1] Graph, p > 0.05 for all comparisons). Participants in the Words arm had an increase in the accuracy of their perceptions of diabetes seriousness (p = 0.04) and in the number of participants reporting a diabetes management goal (p = 0.01).Conclusions: The two patient-informed communication formats did not differentially impact glycemic control among adults with inadequately controlled diabetes. However, a significant proportion of participants in the Words arm had an increase in the accuracy of their perception of diabetes seriousness, a potential mediating factor in positive diabetes-related behavioral changes. With increasing use of patient-facing online portals, thoughtfully designed approaches for visually communicating essential, but poorly understood, information like the HbA1c to patients have the potential to facilitate interpretation and support self-management.Clinical Trial Registration: Prospectively registered as NCT01886170. [ABSTRACT FROM AUTHOR]

Background: Falls in hospitals remain a major challenge to patient safety. All hospitalised adults are at risk of falling during their inpatient stay, though this risk is not always realised by patients and clinicians. This study will evaluate the outcomes of a hospital clinician education program that teaches clinicians how to screen for falls risk and assign mitigation strategies using clinical reasoning, rather than relying on a standardised falls risk assessment tool (FRAT). The education program aims to increase clinician knowledge, motivation and confidence in screening falls risk and selecting individual falls prevention interventions. Perceptions of the education intervention will also be examined.Methods: Participants will be a sample of convenience of nurses and allied health professionals from five Australian hospitals. For each hospital there will be two cohorts. Cohort 1 will be clinical leaders who shall receive a three-hour education program on the latest evidence in hospital falls risk assessment and how to implement a new falls screening and management tool. They will also be taught practical skills to enable them to deliver an effective one-hour in-service training session to Cohort 2. Cohort 2 will be recruited from the workforce as a whole and include nurses and other health professionals involved in routine hospital falls screening and prevention. The investigation will be framed on Keller's Model of Motivational Design and Kirkpatrick's evaluation framework. It will involve a mixed methods pre and post-test questionnaire design inclusive of semi-structured telephone interviews, to triangulate the data from multiple approaches.Discussion: This study will quantify the outcomes of a high-quality clinician education program to increase knowledge of evidence-based practice for falls prevention. It is predicted that positive behavioural changes will occur in health professionals, leading to organisational change and improved patient outcomes. Furthermore, the findings from the study will inform the future refinement of educational delivery to health professionals across hospital sites.Trial Registration: The study has also been approved by the Australian New Zealand Clinical Trials Registry: Preventing Hospital Falls: Optimal Screening UTN U1111-1225-8450. Universal Trial Number (UTN): U1111-1228-0041 (obtained 5/2/19). Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12619000200189 (obtained 12/2/19). [ABSTRACT FROM AUTHOR]

Background: The World Health Organization (WHO) has established a set of items related to study design and administrative information that should build the minimum set of data in a study register. A more comprehensive data set for registration is currently developed by the Ottawa Group. Since nothing is known about the attitudes of academic researchers towards prospective study registration, we surveyed academic researchers about their opinion regarding the registration of study details proposed by the WHO and the Ottawa Group. Methods: This was a web-based survey of academic researchers currently running an investigator-initiated clinical study which is registered with clinicaltrials.gov. In July 2006 we contacted 1299 principal investigators of clinical studies by e-mail explaining the purpose of the survey and a link to access a 52-item questionnaire based on the proposed minimum data set by the Ottawa Group. Two reminder e-mails were sent each two weeks apart. Association between willingness to disclose study details and study phase was assessed using the chi-squared test for trend. To explore the potential influence of non-response bias we used logistic regression to assess associations between factors associated with non-response and the willingness to register study details. Results: Overall response was low as only 282/1299 (22%) principal investigators participated in the survey. Disclosing study documents, in particular the study protocol and financial agreements, was found to be most problematic with only 31% of respondents willing to disclose these publicly. Consequently, only 34/282 (12%) agreed to disclose all details proposed by the Ottawa Group. Logistic regression indicated no association between characteristics of non-responders and willingness to disclose details. Conclusion: Principal investigators of non-industry sponsored studies are reluctant to disclose all data items proposed by the Ottawa Group. Disclosing the study protocol and financial agreements was found to be most problematic. Future discussions on trial registration should not only focus on industry but also on academic researchers. [ABSTRACT FROM AUTHOR]

Background: Emergency department (ED) consultations are on the rise, and frequently consultations by non-urgent patients have been held accountable. Self-referred walk-in (SRW) consulters supposedly represent a predominantly less urgent patient population. The EMACROSS study aimed to explore consultation determinants and motives in SRW patients with respiratory symptoms.Methods: Multicenter survey of adult ED patients with respiratory complaints in eight emergency departments in central Berlin, Germany. Secondary hospital records data including diagnoses was additionally assessed. Characteristics of SRW and non-SRW patients were compared. Determinants of SRW consultation were evaluated by binary logistic regression. Consultation motives were analyzed descriptively. As a supplemental approach, network analysis (lasso-regularized mixed graphical model) was performed to explore connections between consultation determinants, consultation features and motives.Results: Between June 2017 and November 2018, n = 472 participants were included, the median age was 55 years (range 18-96), 53.2% of patients were male and n = 185 cases (39.2%) were SRW consulters. The SRW group showed lower proportions of potentially severe (pneumonia and respiratory failure, p < 0.001, χ2 test) and chronic pulmonary conditions. Determinants of SRW consultation identified by logistic regression were younger age (p < 0.001), tertiary education (p = 0.032), being a first-generation migrant (p = 0.002) or tourist (p = 0.008), having no regular primary care provider (p = 0.036) and no chronic pulmonary illness (p = 0.017). The area under the curve (AUC) for the model was 0.79. Personal distress and access problems in ambulatory care were stated most frequently as consultation motives in the SRW group; network analysis showed the scarcity of associations between demographic and medical SRW determinants and motives triggering the actual decision to consult.Conclusions: As to "who" consults, this study identified demographic and medical predictors of SRW utilization. The said markers seem only remotely connected to "why" people decide for SRW visits. To alleviate ED crowding by addressing frequent SRW consultation motives, interventions focused on the ability for symptom self-assessment and at better-accessible alternative care seem sensible.Trial Registration: German Clinical Trials Register ( DRKS00011930 ); date: 2017/04/25. [ABSTRACT FROM AUTHOR]

Background: Caring for people with dementia at home requires considerable time, organization and commitment. Therefore, informal caregivers of people with dementia are often overburdened. This study examined the effects of the telephone-based Talking Time intervention, which is an approach used to strengthen the psychological health-related quality of life (HRQoL) and social support of informal caregivers of people with dementia living at home.Methods: This study was a Medical Research Council framework phase two randomized controlled trial. The intervention consisted of a preliminary talk, information booklet, six structured telephone-based support group meetings and a structured written self-evaluation of each support group meeting. The control participants performed their usual individual self-organized care. After completing the data collection, the control group received the Talking Time intervention for fidelity reasons. The primary outcome was the self-rated psychological HRQoL of the informal caregivers, which was measured with the mental component summary of the General Health Survey Questionnaire Short Form 12 (SF-12).Results: Thirty-eight informal caregivers and their relatives were included and allocated to the intervention or control groups (n = 19 each). After 3 months, the Talking Time intervention group demonstrated an increase in the self-rated psychological HRQoL scores, whereas the scores decreased in the control group. However, the standardized effect size of 1.65 (95% Confidence Interval, - 0.44 - 3.75) was not significant. Additionally, the secondary outcomes demonstrated no significant results. The differences between the groups in most outcomes were in the expected direction. No adverse effects were identified due to the intervention.Conclusions: The Talking Time intervention is feasible and shows nonsignificant promising results with regard to the self-rated psychological HRQoL. After further adjustment, the intervention needs to be evaluated in a full trial.Trial Registration: Clinical Trials: NCT02806583 , June 9, 2016 (retrospectively registered). [ABSTRACT FROM AUTHOR]

Background: RESPOND is a telephone-based falls prevention program for older people who present to a hospital emergency department (ED) with a fall. A randomised controlled trial (RCT) found RESPOND to be effective at reducing the rate of falls and fractures, compared with usual care, but not fall injuries or hospitalisations. This process evaluation aimed to determine whether RESPOND was implemented as planned, and identify implementation barriers and facilitators.Methods: A mixed-methods evaluation was conducted alongside the RCT. Evaluation participants were the RESPOND intervention group (n = 263) and the clinicians delivering RESPOND (n = 7). Evaluation data were collected from participant recruitment and intervention records, hospital administrative records, audio-recordings of intervention sessions, and participant questionnaires. The Rochester Participatory Decision-Making Scale (RPAD) was used to evaluate person-centredness (score range 0 (worst) - 9 (best)). Process factors were compared with pre-specified criteria to determine implementation fidelity. Six focus groups were held with participants (n = 41), and interviews were conducted with RESPOND clinicians (n = 6). Quantitative data were analysed descriptively and qualitative data thematically. Barriers and facilitators to implementation were mapped to the 'Capability, Opportunity, Motivation - Behaviour' (COM-B) behaviour change framework.Results: RESPOND was implemented at a lower dose than the planned 10 h over 6 months, with a median (IQR) of 2.9 h (2.1, 4). The majority (76%) of participants received their first intervention session within 1 month of hospital discharge with a median (IQR) of 18 (12, 30) days. Clinicians delivered the program in a person-centred manner with a median (IQR) RPAD score of 7 (6.5, 7.5) and 87% of questionnaire respondents were satisfied with the program. The reports from participants and clinicians suggested that implementation was facilitated by the use of positive and personally relevant health messages. Complex health and social issues were the main barriers to implementation.Conclusions: RESPOND was person-centred and reduced falls and fractures at a substantially lower dose, using fewer resources, than anticipated. However, the low dose delivered may account for the lack of effect on falls injuries and hospitalisations. The results from this evaluation provide detailed information to guide future implementation of RESPOND or similar programs.Trial Registration: This study was registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12614000336684 (27 March 2014). [ABSTRACT FROM AUTHOR]

Background: Whilst there are comprehensive guidelines for the rehabilitation of people with severe impairments from stroke, there has been less attention on the health and rehabilitation needs of people with minor stroke. Our study will assess whether a new multi-component service pathway using an integrated model based around primary care will reduce unmet need following minor stroke compared with usual care 1 and 3 months post-hospital discharge.Methods: One hundred ten patients with minor stroke will be recruited within a parallel, randomised controlled trial design comparing a new service pathway and usual care. The new service pathway will comprise a self-management kit, customised General Practitioner checklist, and a series of minor stroke educational topics. Participants will complete assessments pre-hospital discharge and 1 and 3 months later. The primary outcome measure will be the Survey of Unmet Needs and Service Usage. Secondary outcome measures will include assessments of ability, adjustment and participation; social group connectedness; return to work; health-related quality of life; and perceptions of the new service pathway (intervention group only). Mixed model repeated measures will be used to analyse within and between group differences at each time point. Return to work will be analysed using Chi square tests. Perceptions of the new service pathway will be analysed qualitatively.Dissemination Of Results: The project will produce an evidence-based, multicomponent service pathway for minor stroke patients, applicable to other health services nationally and internationally. Dissemination will include publications and presentations.Trial Registration: Prospectively registered - Australian New Zealand Clinical Trials Registry (ACTRN12619000133134p) 30 January 2019. [ABSTRACT FROM AUTHOR]

Background: Cancer patients experience psychological and social distress due to their medical treatment and social issues. However, continuous and specialized social support is still lacking. In Germany, a group of company health insurance funds has developed an approach to support cancer patients with monthly structured interviews conducted by specially trained Social Care Nurses. The nurses will identify patient needs in order to provide help with medical, personal, and social matters. One aim of the scientific evaluation is to analyze the effect of the consultations on various patient-reported outcomes, especially quality of life. The evaluation concept will be described in this study protocol.Methods/design: The evaluation is a non-randomized, controlled, multi-center intervention study with a mixed-method design. It consists of three research modules which include primary data from questionnaires, and claims data from the health insurance funds. In Module 1, cancer patients will be recruited to form an intervention group (OSCAR, n = 150) and a control group (n = 200) in four study centers for a period of 1 year. One baseline and three follow-up questionnaires will be conducted to survey the patient-reported outcomes. Relevant secondary outcomes are health literacy, participation, and physician-patient communication. In Module 2, claims data will be used to analyze cost effects and thereby assess effectivity and hospitalization. Module 3 will involve a qualitative analysis of project diaries kept by the Social Care Nurses. The diaries will record the nurses' practical experiences and the benefits of deploying OSCAR across the German healthcare system.Discussion: OSCAR is an innovative way of providing cancer patients with continuous support to improve their quality of life. The evaluation concept aims to assess the effects of the monthly consultations by the Social Care Nurses on the patients, and will use a mixed-method design. The results are important for assessing the transferability of OSCAR to the healthcare system as a whole.Trial Registration: German Clinical Trials Register (DRKS-ID: DRKS00013640 ). Registered 29 December 2017. [ABSTRACT FROM AUTHOR]

Background: Learning Clubs is a multi-component intervention to address the eight common risk factors for women's health, and infant's health and development in resource-constrained settings. We are testing in a cluster randomized controlled trial in rural Vietnam whether this intervention improves cognitive development in children when they are aged two. There are few comprehensive process evaluations of complex interventions to optimise early childhood development. The aim is to conduct a planned process evaluation of the Learning Clubs intervention in Vietnam.Methods: The evaluation will be conducted alongside the Learning Clubs trial using both qualitative and quantitative methods. Four domains will be included in the evaluation: [1] Context - how contextual factors affect the implementation and outcomes; [2] Implementation - what aspects of the Learning Clubs intervention are actually delivered and how well the intervention is delivered; [3] Mechanism of impact - how the intervention produces changes in the primary and secondary outcomes; and [4] National integration - how the intervention can be scaled up for application nationally. Purposive sampling will be used to recruit project stakeholders from commune, provincial and national levels. Results of the process evaluation will be integrated with those of the outcome and economic evaluations to provide a comprehensive picture of the effectiveness of the Learning Clubs intervention for early childhood development in rural Vietnam.Discussion: Results of the evaluation will provide evidence about the implementation of the intervention and explanations for any differences in the outcomes between participants in intervention and control conditions. The evaluation will be integrated into each stage of the outcome assessments, but will be implemented by a bilingual team independent of the team implementing the intervention. It will therefore provide evidence which will not be influenced by or influence the intervention and will inform both generalisation to other settings and scalability in Vietnam.Trial Registration: Trial registration number ACTRN12617000442303 on the Australian New Zealand Clinical Trials Registry. Registered 27/03/2017. Prospectively registered. [ABSTRACT FROM AUTHOR]

Background: Community-Directed Interventions (CDI) is a participatory approach for delivery of essential healthcare services at community level. It is based on the values and principles of Primary Health Care (PHC). The CDI approach has been used to improve the delivery of services in areas that have previously applied Community-Directed Treatment with ivermectin (CDTi). Limited knowledge is available about its added value for strengthening PHC services in areas without experience in CDTi. This study aimed to assess how best to use the CDI approach to strengthen locally identified PHC services at district level.Methods: This was a comparative intervention study carried out over a period of 12 months and involving four health centres and 16 villages assigned to 1) a conventional Essential Health Package (EHP)/PHC approach at health centre level or 2) an EHP/PHC/CDI approach at community level in addition to EHP/PHC at health centre level. Communities decided which intervention components to be included in the intervention. These were home management of malaria (HMM), long lasting insecticide treated nets (LLIN), vitamin A and treatment against schistosomiasis. The outcomes of the two strategies were compared quantitatively after the intervention was completed with regard to intervention component coverage and costs. Qualitative in-depth interviews with involved health professionals, implementers and beneficiaries were carried out to determine the benefits and challenges of applied intervention components.Results: Implementation of the EHP/PHC/CDI approach at community level as an add-on to EHP/PHC services is feasible and acceptable to health professionals, implementers and beneficiaries. Statistically significant increases were observed in intervention components coverage for LLIN among children under 5 years of age and pregnant women. Increases were also observed for HMM, vitamin A among children under 5 years of age and treatment against schistosomiasis but these increases were not statistically significant. Implementation was more costly in EHP/PHC/CDI areas than in EHP/PHC areas. Highest costs were accrued at health centre level while transport was the most expensive cost driver. The study identified certain critical factors that need to be considered and adapted to local contexts for successful implementation.Conclusion: The CDI approach is an effective means to increase accessibility of certain vital services at community level thereby strengthening delivery of EHP/PHC services. The approach can therefore complement regular EHP/PHC efforts.Trial Registration: The study was retrospectively registered with the Pan African Clinical Trial Registry TRN: PACTR201903883154921 . [ABSTRACT FROM AUTHOR]

Background: A psychometrically robust measurement instrument is prerequisite to tailor and monitor interventions aiming to improve evidence-based practice (EBP). The recently developed "Evidence-based Practice Inventory" (EBPI) questionnaire (five dimensions) provides a sound inventory for a comprehensive assessment of adherence to EBP, and identification of barriers and facilitators for EBP. The aims of this study were to establish a German language version of the EBPI and to examine the instrument's reliability in a diverse sample of healthcare professionals.Methods: The English version of the EBPI was translated, adopted and subsequently test-retest reliability of the German language EBPI was examined in a nationwide online survey. Participants working in Germany were invited to complete the questionnaire twice. For each EBPI dimension, internal consistency reliability (Cronbach's alpha) and the relative test-retest reliability (intraclass correlation coefficient, ICC) were calculated. The standard error of measurement, limits of agreement and minimal detectable change values were estimated to quantify measurement error.Results: A German language version of the EBPI was established. In the online survey, the EBPI was initially completed by 889 healthcare professionals. At follow-up, 344 individuals (39%) completed the questionnaire (74% female; mean work experience: 13.6 years). The ICCs for the five dimensions varied between 0.78 and 0.86. The standard error of measurement varied between 6.5 and 8.8% of the respective dimension scale range, and the limits of agreement between 24 and 37%. For internal consistency reliability, alpha varied between 0.64 and 0.90. There were neither floor nor ceiling effects, nor any other relevant feasibility issues.Conclusions: The German language EBPI can be used to assess EBP adherence of healthcare professionals in clinical practice, and to identify barriers and facilitators for an EBP conform behaviour. Results on test-retest reliability indicate that the EBPI produces reliable scores when used for group comparisons, but the questionnaire seems insufficiently reliable for individual measurements over time. Methods of item response theory or Rasch measurement theory should be used for further evaluation and revision of the EBPI, informed by the results of this study.Trial Registration: German Clinical Trials Register ( DRKS00013792 ). Registered 19 January 2018. [ABSTRACT FROM AUTHOR]

Background: Advanced care planning (ACP) is a process that involves thinking about what medical care one would like should individuals be seriously ill and cannot communicate decisions about treatment for themselves. The literature indicates that ACP leads to increased satisfaction from both patients and healthcare professionals. Despite the well-known benefits of ACP, it is still underutilised in Australia.Methods: The aim of this study is to investigate the effects of normalising ACP in acute and community settings with the use of specially trained normalisation agents. This is a quasi-experimental study, involving 16 sites (8 intervention and 8 control) in two health districts in Australia. A minimum of total 288 participants will be recruited (144 intervention, 144 control). We will train four registered nurses as normalisation agents in the intervention sites, who will promote and facilitate ACP discussions with adult patients with chronic conditions in hospital and community settings. An audit of the prevalence of ACP and Advanced Care Directives (ACDs) will be conducted before and after the 6-month intervention period at the 16 sites to assess the effects of the ACP service delivered by these agents. We will also collect interview and survey data from patients and families who participate, and healthcare professionals who are involved in this service to capture their experiences with ACP.Discussion: This study will potentially contribute to better patient outcomes with their health care services. Completion of ACDs will allow patients to express their wishes for care and receive the care that they wish for, as well as ease their family from the burden of making difficult decisions. The study will contribute to development of a new best practice model to normalise ACP that is sustainable and transferable in the processes of: 1) initiation of conversation; 2) discussion of important issues; 3) documentation of the wishes; 4) storage of the documented wishes; and 5) access and execution of the documented wishes. The study will generate new evidence on the challenges, strategies and benefits of normalising ACP into practice in acute and community settings.Trial Registration: This project has been approved by the Hunter New England Human Research Ethics Committee (Approval No. 17/12/13/4.16). It has also been retrospectively registered on 3 October 2018 with the Australian New Zealand Clinical Trials Registry (Trial ID: ACTRN12618001627246 ). This study will operate in accordance with the National Health and Medical Research Council's National Statement on Ethical Conduct in Human Research (2007) and the CPMP/ICH Note for Guidance on Good Clinical Practice. [ABSTRACT FROM AUTHOR]