Assessing the implementation of nurse practitioner-led huddles in long-term care using the Consolidated Framework for Implementation Research (CFIR).

BACKGROUND: The COVID-19 pandemic created major challenges in long-term care (LTC) homes across Canada and globally. A nurse practitioner-led interdisciplinary huddle intervention was developed to support staff wellbeing in two LTC homes in Ontario, Canada. The objective of this study was to identify the constructs strongly influencing the process of implementation of huddles across both sites, capturing the overall barriers and facilitators and the intervention's intrinsic properties. METHODS: Nineteen participants were interviewed about their experiences, pre-, post-, and during huddle implementation. The Consolidated Framework for Implementation Research (CFIR) was used to guide data collection and analysis. CFIR rating rules and a cross-comparison analysis was used to identify differentiating factors between sites. A novel extension to the CFIR analysis process was designed to assess commonly influential factors across both sites. RESULTS: Nineteen of twenty selected CFIR constructs were coded in interviews from both sites. Five constructs were determined to be strongly influential across both implementation sites and a detailed description is provided: evidence strength and quality; needs and resources of those served by the organization; leadership engagement; relative priority; and champions. A summary of ratings and an illustrative quote are provided for each construct. CONCLUSION: Successful huddles require long-term care leaders to consider their involvement, the inclusion all team members to help build relationships and foster cohesion, and the integration of nurse practitioners as full-time staff members within LTC homes to support staff and facilitate initiatives for wellbeing. This research provides an example of a novel approach using the CFIR methodology, extending its use to identify significant factors for implementation when it is not possible to compare differences in success.

Implementation fidelity of a smoke-free workplace intervention in a private medical company: A mixed-methods process evaluation.

INTRODUCTION: Smoke-free workplaces are considered an important part of tobacco control strategies. The purpose of this study was to evaluate implementation fidelity and explore the significance of social and contextual factors for the implementation of a strict smoke-free workplace intervention in a large Danish medical company. METHODS: The UK Medical Research Council's guidance for process evaluation was used as a framework. Data were collected from approximately six months before the implementation until ten months after (2019-2020). A mixed method study design was used (a survey of 398 employees, a focus group of four employees and field visits on two days). Data were analyzed separately and later integrated through triangulation. We used the Fisher's exact test in the analysis of the questionnaire. RESULTS: We assessed the implementation fidelity through four key factors: reach, dose and delivery, mechanisms of change, and context for the intervention components. Despite compliance issues, the policy component had high implementation fidelity. However, the implementation fidelity of the smoking cessation support component was low. We identified three social mechanisms influencing the employees' responsiveness towards the policy: expectation, the social aspect of the smoking facilities, and management leadership. COVID-19 was identified as the main contextual factor affecting the implementation. CONCLUSIONS: Although not all elements of the intervention components were implemented as planned, the strict smoke-free workplace intervention is considered implemented. Further strategies can be initiated to raise implementation fidelity through better communication concerning the cessation support component, compliance, and enforcement of the policy.

Implementation of a novel program to support colorectal cancer screening in a community health center consortium before and after the onset of COVID-19: a qualitative study of stakeholders' perspectives.

BACKGROUND: In 2017, the San Francisco Cancer Initiative (SF CAN) established the Colorectal Cancer (CRC) Screening Program to provide technical assistance and financial support to improve CRC screening processes, and outcomes in a consortium of community health centers (CHCs) serving low-income communities in San Francisco. The purpose of this study was twofold: to evaluate the perceived influence of the support provided by the CRC Screening Program's Task Force on CRC screening processes and outcomes in these settings and to identify facilitators and barriers to SF CAN-supported CRC screening activities before and after the onset of the COVID-19 pandemic. METHODS: Semi-structured key informant interviews were conducted with consortium leaders, medical directors, quality improvement team members, and clinic screening champions. Interviews were audio-recorded, professionally transcribed, and analyzed for themes. The Consolidated Framework for Implementation Research (CFIR) was used to develop the interview questions and organize the analysis. RESULTS: Twenty-two participants were interviewed. The most commonly cited facilitators of improved screening processes included the expertise, funding, screening resources, regular follow-up, and sustained engagement with clinic leaders provided by the task force. The most salient barriers identified were patient characteristics, such as housing instability; staffing challenges, such as being understaffed and experiencing high staff turnover; and clinic-level challenges, such as lack of ability to implement and sustain formalized patient navigation strategies, and changes in clinic priorities due to the COVID-19 pandemic and other competing health care priorities. CONCLUSIONS: Implementing CRC screening programs in a consortium of CHCs is inherently challenging. Technical assistance from the Task Force was viewed positively and helped to mitigate challenges both before and during the pandemic. Future research should explore opportunities to increase the robustness of technical assistance offered by groups such as SF CAN to support cancer screening activities in CHCs serving low-income communities.

Healthcare workers' acceptance of the integrated tuberculosis-COVID-19 screening in central Java Private Hospitals, Indonesia.

Objective: COVID-19 pandemic has negatively impacted the diagnosis and management of tuberculosis (TB) cases, and TB-COVID-19 integrated screening was introduced as a strategy to overcome these problems. This study determined the acceptability of the TB-COVID-19 integrated screening by healthcare workers (HCWs) and its impact on achievement of the TB program. Methods: This was a mixed-method study with an embedded design. Data on hospital TB program coverage from the national TB information system for all Muhammadiyah and Aisyiyah Hospitals (MAHs) in Central Java were compared before and after the implementation of TB-COVID-19 integrated screening. The informants consisted of HCWs from 21 MAHs in Central Java. Focus group discussions (FGDs) were carried out with 7 hospital TB, 19 emergency room, 10 outpatient, 6 inpatient, and 4 managerial staff. In-depth interview (IDIs) were also performed with the Technical Officer TB Recovery Head of the Muhammadiyah Center. All IDIs and FGDs were recorded, transcribed verbatim, and subjected to thematic analysis guided by the theoretical framework of acceptability (TFA). Result: Implementation of the TB-COVID-19 integrated screening program led to an increase in the number of new TB case diagnoses at the Central Java Hospitals. Moreover, the program was acceptable based on seven indicators from TFA. Despite the obstacles faced by HCWs during the implementation process, the program still managed to meet the standards. Conclusion: Acceptance by HCWs is a critical factor in the successful implementation of programs, including the TB-COVID-19 integrated screening. Furthermore, a multifaceted and cross-sectoral approach is required to address the constraints associated with the process.

Lessons Learned and Future Actions: Modifying a Stroke Specific Self-Management Program.

Background: Self-management programs have been shown to be effective at providing support to individuals who want to manage chronic health conditions independently. It has been shown that adapting self-management programs for different diagnostic groups, such as stroke, is essential. Objective: To report modifications made during trial implementation, the barriers identified during the delivery of an evidence based, stroke-specific self-management program and minor data (including strategies made) from a small cohort of stroke survivors with multiple chronic conditions. Methods: Prospective type III hybrid implementation-effectiveness trial for stroke survivors, with chronic conditions, living in the community, and interested in self-management. Modifications were reported by the following: (1) researcher reflections (2) barriers to implementation and (3) strategies used to address the barrier using the Consolidated Framework for Implementation Research (CFIR) guidelines from field notes. Results: Twenty-five individuals consented (42% of eligible sample) at the time of acute stroke and five were interested in continuing at the 3-month call. Multiple barriers to implementation were identified, resulting in modifications. For example, before the group sessions began, the COVID-19 pandemic necessitated changes to the intervention delivery. The protocol was modified to an online mode of delivery. In total, there were seven modifications made. Conclusions: The CFIR was a facilitative tool to report barriers and strategies and emphasized the importance of comprehensive reporting. The modifications to the study were an essential first step to address the research climate and needs of this stroke cohort. Next steps include continued research with a larger cohort to implement effective strategies and answer the clinical question of effectiveness of the adapted and modified intervention.

Autopsy of a failed trial part 1: A qualitative investigation of clinician's views on and experiences of the implementation of the DAISIES trial in UK-based intensive eating disorder services.

OBJECTIVE: The DAISIES trial, comparing inpatient and stepped-care day patient treatment for adults with severe anorexia nervosa was prematurely terminated in March 2022 due to poor recruitment. This qualitative study seeks to understand the difficulties faced during the trial by investigating stakeholders' views on and experiences of its implementation. METHOD: Semi-structured interview and focus group transcripts, and trial management and oversight group meeting minutes from May 2020-June 2022 were analysed using thematic analysis. Participants were 47 clinicians and co-investigators involved with the DAISIES trial. The Non-Adoption, Abandonment, Scale-up, Spread, and Sustainability (NASSS) framework was applied to the interpretive themes to classify barriers and facilitators to implementation. RESULTS: Five themes were identified: incompatible participation interests; changing standard practice; concerns around clinical management; systemic capacity and capability issues; and Covid-19 disrupting implementation. Applying the NASSS framework indicated the greatest implementation challenges to arise with the adopters (e.g. patients, clinicians), the organisational systems (e.g. service capacity), and the wider socio-political context (e.g. Covid-19 closing services). CONCLUSIONS: Our findings emphasise the top-down impact of systemic-level research implementation challenges. The impact of the Covid-19 pandemic accentuated pre-existing organisational barriers to trial implementation within intensive eating disorder services, further limiting the capacity for research.

Mapping patient pathways and understanding clinical decision-making in dengue management to inform the development of digital health tools.

BACKGROUND: Dengue is a common viral illness and severe disease results in life-threatening complications. Healthcare services in low- and middle-income countries treat the majority of dengue cases worldwide. However, the clinical decision-making processes which result in effective treatment are poorly characterised within this setting. In order to improve clinical care through interventions relating to digital clinical decision-support systems (CDSS), we set out to establish a framework for clinical decision-making in dengue management to inform implementation. METHODS: We utilised process mapping and task analysis methods to characterise existing dengue management at the Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam. This is a tertiary referral hospital which manages approximately 30,000 patients with dengue each year, accepting referrals from Ho Chi Minh city and the surrounding catchment area. Initial findings were expanded through semi-structured interviews with clinicians in order to understand clinical reasoning and cognitive factors in detail. A grounded theory was used for coding and emergent themes were developed through iterative discussions with clinician-researchers. RESULTS: Key clinical decision-making points were identified: (i) at the initial patient evaluation for dengue diagnosis to decide on hospital admission and the provision of fluid/blood product therapy, (ii) in those patients who develop severe disease or other complications, (iii) at the point of recurrent shock in balancing the need for fluid therapy with complications of volume overload. From interviews the following themes were identified: prioritising clinical diagnosis and evaluation over existing diagnostics, the role of dengue guidelines published by the Ministry of Health, the impact of seasonality and caseload on decision-making strategies, and the potential role of digital decision-support and disease scoring tools. CONCLUSIONS: The study highlights the contemporary priorities in delivering clinical care to patients with dengue in an endemic setting. Key decision-making processes and the sources of information that were of the greatest utility were identified. These findings serve as a foundation for future clinical interventions and improvements in healthcare. Understanding the decision-making process in greater detail also allows for development and implementation of CDSS which are suited to the local context.

Evaluation of a Community Suicide Prevention Project (Roots of Hope): Protocol for an Implementation Science Study.

BACKGROUND: Roots of Hope (RoH) is a multisite Canadian community-based suicide prevention initiative developed by the Mental Health Commission of Canada (MHCC), which is based on evidence for intervention effectiveness and World Health Organization recommendations. Seven communities developed local activities in the following 5 pillars: specialized supports, training and networks, public awareness, means safety, and evaluation research. OBJECTIVE: We aim to use an implementation research approach to understand the RoH model for reducing suicidal behaviors and their impacts in communities, and the lessons learned for the equitable development and implementation of RoH in different contexts. Moreover, we want to understand how the program is implemented in relation to the context, the causal pathways, and the factors influencing successful implementation. The evaluation includes assessments of short-term and intermediate effects at each site and overall. METHODS: The principal investigator (PI) developed a consensus among local research coordinators on common approaches and indicators through ongoing participation in an online community of practice, and regular virtual and in-person meetings. At the completion of the pilot phase, the PI will summarize evaluation results across sites and conduct pooled analyses. The RoH theory of change and evaluation model shows how evaluation activities from the planning phase through the implementation of activities in each of the pillars can help clarify the viability of the RoH model and identify factors that facilitate and inhibit effective and equitable implementation in different contexts. Beginning with a situational analysis to identify resources in each community and local specificities, we will examine the implementation characteristics of conformity, dosage, coverage, quality, utility, equity, appreciation, facilitators, and impediments. Evaluation of short-term effects will focus on changes in knowledge, attitudes, behaviors, help-seeking, service use, stigma, media reports, empowerment, and care experiences. Intermediate effects, long-term effects, and impact will include assessments of the changes in suicides, suicide attempt rates, and suicide risk indicators. A variety of data sources, both quantitative and qualitative, will be used. RESULTS: The quantitative and qualitative data from all sites will be summarized by the PI in March 2023 to draw conclusions to help the MHCC in its improvements to the RoH model, and to inform communities about how to better implement RoH. Since the COVID-19 pandemic occurred at the beginning of program implementation, its impact and influence will be documented. The validity of RoH in contributing to the prevention of suicides and suicidal behaviors will be clarified in a variety of contexts. The final evaluation report will be available in September 2023. CONCLUSIONS: The evaluation results, including the identification of factors that facilitate and inhibit the implementation of RoH and the adaptations to challenges, will be useful to the MHCC, current RoH communities, and those considering adopting the RoH model. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/39978.

Using formative evaluation of a community-based opioid overdose prevention program to inform strategic communication for adoption, implementation, and sustainability.

BACKGROUND: Opioid addiction and overdose is a public health problem in the United States and is expected to remain with substance use increasing due to the COVID-19 pandemic. Communities that approach this issue through multi-sector partnerships experience more positive health outcomes. Understanding motivation for stakeholder engagement in these efforts is essential to successful adoption, implementation, and sustainability particularly in the shifting landscape of needs and resources. METHODS: A formative evaluation was conducted on the C.L.E.A.R. Program in Massachusetts, a state heavily impacted by the opioid epidemic. A stakeholder power analysis identified appropriate stakeholders for the study (n = 9). The Consolidated Framework for Implementation Research (CFIR) guided data collection and analysis. Surveys (n = 8) examined perception and attitudes on the program; motivations and communication for engagement; and, benefits and barriers to collaboration. Stakeholder interviews (n = 6) explored the quantitative findings in more detail. Surveys were analyzed using descriptive statistics and a content analysis with deductive approach was conducted for stakeholder interviews. The Diffusion of Innovation (DOI) Theory guided recommendations for communications to engage stakeholders. RESULTS: Agencies represented a range of sectors and the majority (n = 5) were familiar with the C.L.E.A.R. PROGRAM: Despite the many strengths of the program and existing collaboration, based on the coding densities of each CFIR construct stakeholders identified crucial gaps in the services the program provided and noted that the overall infrastructure of the program could be enhanced. Opportunities for strategic communication to address the stages of DOI align with the gaps identified in the CFIR domains to result in increased agency collaboration and expansion of services into the surrounding communities to ensure sustainability of the C.L.E.A.R. CONCLUSIONS: This study explored factors necessary for ongoing multi-sector collaboration and sustainability of an existing community-based program especially given the changing context from COVID-19. Findings informed both program revisions and communication strategies to promote the program to new and existing collaborating agencies and the community served, and identify effective communication approaches across sectors. This is essential for successful implementation and sustainability of the program, especially as it is adapted and expanded to address post-pandemic times. TRIAL REGISTRATION: This study does not report results of a health care intervention on human participants, however it was reviewed and determined an exempt study with the Boston University Institutional Review Board (IRB #H-42107).

Multidisciplinary implementation of family-based treatment delivered by videoconferencing (FBT-V) for adolescent anorexia nervosa during the COVID-19 pandemic.

Family-Based Treatment (FBT)-the most widely supported treatment for pediatric eating disorders-transitioned to virtual delivery in many programs due to COVID-19. Using a blended implementation approach, we systematically examined therapist adherence to key components of FBT and fidelity to FBT by videoconferencing (FBT-V), preliminary patient outcomes, and team experiences with our FBT-V implementation approach as well as familial perceptions of FBT-V effectiveness. We examined our implementation approach across four pediatric eating disorder programs in Ontario, Canada, using mixed methods. Participants included therapists (n = 8), medical practitioners (n = 4), administrators (n = 6), and families (n = 5; 21 family members in total). We developed implementation teams at each site, provided FBT-V training, and offered clinical and implementation consultation. Therapists submitted video recordings of their first four FBT-V sessions for fidelity rating, and patient outcomes. Therapists self-reported readiness, attitudes, confidence, and adherence to FBT-V. Focus groups were conducted with each team and family after the first four sessions of FBT-V. Quantitative data were analyzed using repeated measures ANOVA. Qualitative data were analyzed using directed and summative content analysis. Therapists adhered to key FBT components and maintained FBT-V fidelity. Changes in therapists' readiness, attitudes, and confidence in FBT-V over time were not significant. All patients gained weight. Focus groups revealed implementation facilitators/barriers, positives/negatives surrounding FBT-V training and consultation, suggestions for improvement, and effectiveness attributed to FBT-V. Our implementation approach appeared to be feasible and acceptable. Future research with a larger sample is required, furthering our understanding of this approach and exploring how organizational factors influence treatment fidelity.

We qualitatively and quantitatively examined the initial implementation (the first four sessions) of Family-Based Treatment (FBT) delivered by videoconferencing (FBT-V) during the COVID-19 pandemic using an evidence-based implementation approach. This included developing implementation teams (consisting of a lead therapist, medical practitioner, and program administrator) at each site, providing FBT-V training to all participants, and offering clinical consultation to all participating therapists and implementation consultation to implementation teams. Therapists were required to submit video recordings of their first four FBT-V sessions. Therapist adherence to key components of FBT as well as fidelity to the FBT-V model, team and family experiences with FBT-V, and preliminary patient outcomes (e.g., weight gain) were examined. Our findings suggest that our implementation approach was feasible and acceptable; therapists adhered to key FBT components and maintained FBT-V fidelity, patients gained weight, and teams and families expressed satisfaction with our intervention. Further research is needed with a larger sample and for a longer duration.

Examining the feasibility of a parental self-help intervention for families awaiting pediatric eating disorder services.

OBJECTIVE: Waitlists for eating disorder (ED) services grew immensely during the COVID-19 pandemic. To address this, we studied the feasibility of a novel parental self-help waitlist intervention. METHOD: Parents of a child/adolescent (7-17 years) awaiting pediatric ED services were provided with our intervention, adapted from the family-based treatment model, and consisting of videos and reading material with no therapist involvement. Parent-reported child/adolescent weight was collected weekly 6 weeks pre-intervention, 2 weeks during the intervention, and 6-week post-intervention. Recruitment and retention rates were calculated. Regression-based interrupted time series analyses were completed to measure changes in the rate of weight gain. RESULTS: Ninety-seven parents were approached, and 30 agreed to participate (31% recruitment rate). All but one completed end-of-study measures (97% retention rate). The average rate of weight gain was 0.24 lbs/week pre-intervention, which increased significantly to 0.78 lbs/week post-intervention (p < .034). DISCUSSION: Our findings provide preliminary evidence that this intervention is feasible. Future research is needed to confirm the efficacy of this intervention on a larger scale. PUBLIC SIGNIFICANCE: The COVID-19 pandemic has resulted in several challenges in providing care for children and adolescents with eating disorders, including long waiting lists and delays in treatment. This study suggests that providing parents on a waitlist with educational videos and reading material is acceptable to parents, and may even help in improving the child's symptoms of an eating disorder.

Contextualising missed opportunities for children's vaccination: A theory-informed qualitative study in primary care settings in Cape Town, South Africa.

This study aimed to explore the contextual factors that may be associated with missed opportunities for vaccination (MOV) from the perspectives of healthcare providers and caregivers attending primary healthcare facilities in the Cape Town Metro Health District, South Africa. The ultimate goal of the assessment was to help inform the design and implementation of a contextually appropriate quality improvement programme targeted at reducing MOV in primary healthcare settings. We used a theory-informed exploratory qualitative research design involving focus group discussions with caregivers of children aged 0-23 months; and in-depth interviews of facility staff. A thematic template analysis approach, integrating the theoretical domains framework (TDF) and the capability, opportunity and motivation model of behavior (COM-B) was used to code and analyze the data. Three focus group sessions were conducted, each consisting of 5-8 caregivers and five in-depth interviews involving facility staff. Capability factors comprised caregivers' knowledge, attitude and behavior toward children's immunization. Opportunity factors included the organization of immunization services, long waiting time, vaccine stock out, staff shortage and health workers' attitude, knowledge and capability to assess children's immunization status and needs. Motivation factors included optimism and beliefs about immunization, fear of vaccine-preventable diseases and immunization safety concerns. This study identified important caregiver-, provider- and health system-related factors, which influence immunization outcomes; offering useful contextual insights for informing quality improvement strategies for reducing MOV at primary healthcare level.

Reduction of early surgical site and other care related infections in 3553 hip fracture patients: lessons learned from the 5-year Safe Hands project.

BACKGROUND: Surgical site infection (SSI) after acute hip fracture surgery is a devastating complication associated with increased suffering and mortality. The aim of the study was to investigate early SSI, sepsis, pneumonia and urinary tract infections over five years, before and after the implementation of the Safe Hands project. METHODS: This was a single-centre observational study with a 5-year longitudinal design, investigating the effects of an infection-prevention intervention targeting the clinical care pathway of individuals with acute hip fracture. Statistical analyses were based on routinely collected patient outcome data comprising 3553 patients. The study conforms to the criteria of the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). RESULTS: The incidence of early SSIs decreased from 2.5% in years 1-2 to 1.1% in years 4-5. Similar results were observed for sepsis (2.7% to 1.3%) and urinary tract infections (14.2% to 4.2%). The multivariable regression results suggest that, for every observed year, the odds of early SSIs decreased. Male gender, procedure time, sepsis and preoperative skin damage increased the odds significantly. CONCLUSIONS: Our preventive bundle, based on partnership between researchers, managers and clinicians and a strong commitment to change from the involved professions, appear to be effective in reducing the frequency of potentially devastating SSIs and other hospital acquired infections after hip fracture surgery. The use of external and internal facilitators was crucial to enable individual and organisational learning and overcoming barriers to improvements. TRIAL REGISTRATION: Clinical Trials.gov ID: NCT02983136 Registered 6 December 2016-Retrospectively registered.

Reporting on the implementation to set up a "care and isolation facility" for mild COVID-19 cases in Tokyo.

The increasing number of COVID-19 cases has placed pressure on medical facilities. Against this backdrop, the Tokyo Metropolitan Government established a facility for mild and asymptomatic COVID-19 cases by using existing hotels. These kinds of facilities were established in several countries, and represented a spectrum from hotel-like to hospital-like care. In this article, we focused on implementation and related strategies for establishing such a facility in Tokyo as implementation research, while ensuring patient and staff safety. This facility had three functions: care, isolation, and buffering. For the implementation strategy, we used several strategies from the Expert Recommendations for Implementing Change (ERIC) to implement functions similar to an ordinary hospital, but using fewer inputs. This experience can be applied to other resource-limited settings such as that in less developed countries.

Mobile Health-Supported Virtual Reality and Group Problem Management Plus: Protocol for a Cluster Randomized Trial Among Urban Refugee and Displaced Youth in Kampala, Uganda (Tushirikiane4MH, Supporting Each Other for Mental Health).

BACKGROUND: Although mental health challenges disproportionately affect people in humanitarian contexts, most refugee youth do not receive the mental health support needed. Uganda is the largest refugee-hosting nation in Africa, hosting over 1.58 million refugees in 2022, with more than 111,000 living in the city of Kampala. There is limited information about effective and feasible interventions to improve mental health outcomes and mental health literacy, and to reduce mental health stigma among urban refugee adolescents and youth in low- and middle-income countries (LMICs). Virtual reality (VR) is a promising approach to reduce stigma and improve mental health and coping, yet such interventions have not yet been tested in LMICs where most forcibly displaced people reside. Group Problem Management Plus (GPM+) is a scalable brief psychological transdiagnostic intervention for people experiencing a range of adversities, but has not been tested with adolescents and youth to date. Further, mobile health (mHealth) strategies have demonstrated promise in promoting mental health literacy. OBJECTIVE: The aim of this study is to evaluate the feasibility and effectiveness of two youth-tailored mental health interventions (VR alone and VR combined with GMP+) in comparison with the standard of care in improving mental health outcomes among refugee and displaced youth aged 16-24 years in Kampala, Uganda. METHODS: A three-arm cluster randomized controlled trial will be implemented across five informal settlements grouped into three sites, based on proximity, and randomized in a 1:1:1 design. Approximately 330 adolescents (110 per cluster) are enrolled and will be followed for approximately 16 weeks. Data will be collected at three time points: baseline enrollment, 8 weeks following enrollment, and 16 weeks after enrollment. Primary (depression) and secondary outcomes (mental health literacy, attitudes toward mental help-seeking, adaptive coping, mental health stigma, mental well-being, level of functioning) will be evaluated. RESULTS: The study will be conducted in accordance with CONSORT (Consolidated Standards of Reporting Trials) guidelines. The study has received ethical approval from the University of Toronto (#40965; May 12, 2021), Mildmay Uganda Research Ethics Committee (MUREC-2021-41; June 24, 2021), and Uganda National Council for Science & Technology (SS1021ES; January 1, 2022). A qualitative formative phase was conducted using focus groups and in-depth, semistructured key informant interviews to understand contextual factors influencing mental well-being among urban refugee and displaced youth. Qualitative findings will inform the VR intervention, SMS text check-in messages, and the adaptation of GPM+. Intervention development was conducted in collaboration with refugee youth peer navigators. The trial launched in June 2022 and the final follow-up survey will be conducted in November 2022. CONCLUSIONS: This study will contribute to the knowledge of youth-tailored mental health intervention strategies for urban refugee and displaced youth living in informal settlements in LMIC contexts. Findings will be shared in peer-reviewed publications, conference presentations, and with community dissemination. TRIAL REGISTRATION: ClinicalTrials.gov NCT05187689; https://clinicaltrials.gov/ct2/show/NCT05187689. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/42342.

Using the Implementation Research Logic Model to design and implement community-based management of possible serious bacterial infection during COVID-19 pandemic in Ethiopia.

BACKGROUND: Community-based treatment of possible serious bacterial infection (PSBI) in young infants, when referral to a hospital is not possible, can result in high treatment coverage and low case fatality. However, in Ethiopia, the coverage of PSBI treatment remains low, worsened by COVID-19. To understand the challenges of delivery of PSBI treatment and design and test adaptative strategies to mitigate the impact of COVID-19 on neonatal mortality, we did implementation research (IR) employing Implementation Research Logic Model (IRLM). In this paper, we describe IRLM application experiences in designing, implementing, and evaluating strategies to improve community-based treatment of PSBI during the COVID-19 pandemic in Ethiopia. METHODS: This IR was conducted between November 2020-April 2022 at Dembecha and Lume woredas of Amhara and Oromia regions, respectively. We employed narrative reviews, formative assessment and facilitated stakeholder engagement to develop the PSBI treatment IRLM to identify barriers, understand the conceptual linkages among determinants, choose implementation strategies, elicit mechanisms, and link to implementation outcomes. In addition, we used the IRLM to structure the capture of emerging implementation challenges and resulting strategy adaptations throughout implementation. RESULTS: This IR identified COVID-19 and multiple pre-existing contextual factors. We designed and implemented implementation strategies to address these challenges. These adaptive strategies were implemented with sufficient strength to maintain the delivery of PSBI services and improve mothers' care-seeking behavior for their sick young infants. The IRLM offers us a clear process and path to prioritize implementation challenges, choose strategies informed by mechanisms of action, and where the adaptive implementation of community-based management of PSBI would lead to high-implementation fidelity and change in mother behavior to seek care for their sick young infants. The IRLM was also an effective tool for stakeholder engagement, easily explained and used to structure discussion and decision-making during co-design meetings. CONCLUSIONS: The use of the IRLM helps us to specify the conceptual links between the implementation challenges, strategies, mechanisms of action, and outcomes to explore the complex community-based management of PSBI during complex contexts to improve high-fidelity implementation and integration of PSBI treatment in the primary healthcare delivery systems through active engagement of stakeholders.

Effectiveness of a community-integrated intermediary care (CIIC) service model to enhance family-based long-term care for Thai older adults in Chiang Mai, Thailand: a cluster-randomized controlled trial TCTR20190412004.

BACKGROUND: Populations around the world are ageing faster, with the majority living in low- and middle-income countries where health and social care are yet to be universal and inclusive for the ageing population. This community-integrated intermediary care (CIIC) model is a novel prevention-based, long-term care model enhancing the family-based care system traditionally practised in Thailand and neighbouring Asian countries, and many low-and middle-income countries globally. This study assessed the effectiveness of the CIIC model in Chiang Mai, Thailand. METHODS: The two-arm parallel intervention study was designed as a cluster-randomized controlled trial. The study population at randomization and analysis was 2788 participants: 1509 in six intervention clusters and 1279 in six control clusters. The research protocol was approved by the WHO Research Ethics Review Committee (WHO/ERC ID; ERC.0003064). The CIIC service intervention model is a combination of formal care and informal care in a subdistrict setting consisting of three components: (1) care prevention delivered as community group exercise and home exercise; (2) care capacity-building of the family caregiver; and (3) community respite service. The primary outcome was family caregivers' burden at 6-month follow-up, and secondary outcome was activities of daily living. Analysis applied the intention-to-treat approach using cluster-level analysis via STATA 16 SE. RESULTS: Baseline characteristics did not differ between the two arms. Loss of follow up was 3.7%. Mean age of the participants was 69.53 years. Women constituted 60%. The COVID-19 pandemic caused delayed implementation. The proportion of families with reduced caregiver burden at 6-month follow-up was higher among the intervention clusters (mean 39.4%) than control clusters (mean 28.62%). The intervention clusters experienced less functional decline and fewer people with depression. CONCLUSIONS: When communities are integrated for preventing care, and families are empowered for giving care, it is possible to secure universal access to health and social care for the older persons, with basic resources mobilized from communities. This study had shown the CIIC model as an effective and potential step to the realization of universal health and long-term care coverage being inclusive of ageing populations in Thailand and globally. TRIAL REGISTRATION: This trial was registered at the Thailand Clinical Trial Registry-Trial registration number TCTR20190412004, https://www.thaiclinicaltrials.org/.

The Potential for Managed Alcohol Programmes in Scotland during the COVID-19 Pandemic: A Qualitative Exploration of Key Areas for Implementation Using the Consolidated Framework for Implementation Research.

People experiencing homelessness and alcohol dependence are at increased risk of a range of harms, including from COVID-19. Managed Alcohol Programmes (MAPs) are an alcohol harm reduction intervention specifically for this group. In this paper we report on qualitative findings of a mixed methods study investigating the potential utility of MAPs during the COVID-19 pandemic in Scotland. Interviews, conducted with 40 participants, explored potential views of implementing MAPs during the pandemic. Theoretically, we drew on the Consolidated Framework for Implementation Research (CFIR) to inform data collection and analysis. Six themes were identified which mapped onto three CFIR domains: perceptions of MAPs and the evidence base; necessary components of MAPs; changing culture of alcohol harm reduction; MAPs as a moral and ethical grey area; addressing a service gap; and securing buy-in and partnership working. Participants were generally positive about MAPs and viewed them as a key intervention to address a service gap. Several necessary components were identified for successful implementation of MAPs. Securing buy-in from a range of stakeholders and partnership working were deemed important. Finally, MAPs require careful, long-term planning before implementation. We conclude that MAPs are needed in Scotland and require long-term funding and appropriate resources to ensure they are successful.