Practical Robust Implementation And Sustainability Model Research Articles

The Application and Evolution of the Practical, Robust Implementation and Sustainability Model (PRISM): History and Innovations

The Application and Evolution of the Practical, Robust Implementation and Sustainability Model (PRISM): History and Innovations

Evaluation of implementation of evidence-based public health training in sub-Saharan Africa.

The Collaboration for Evidence-based Healthcare and Public Health in Africa (CEBHA+) developed and offered a course on evidence-based public health (EBPH) in five sub-Saharan African (SSA) countries to enhance individual and institutional capacity. This study aims to assess, compare and learn from implementing the CEBHA+ EBPH course using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework and Practical, Robust, Implementation and Sustainability Model (PRISM). This study involved CEHBA+ partner universities in five countries in SSA. We developed a framework that draws on signalling questions for RE-AIM and PRISM dimensions. Country teams reflected on, discussed and mapped unique experiences. Using this framework, we then elicited common themes across countries and distilled country-specific experiences through virtual discussions. Across countries, 130 public health practitioners, researchers and students completed the course (Reach). The course increased EBPH knowledge and skills and the capacity to teach EBPH and resulted in immediate opportunities for applying skills (Effectiveness). Hybrid offering in two countries presented challenges regarding Internet connectivity and hybrid discussions. Facilitators had previous training in teaching EBPH. While learning material was the same across countries, the content was adapted to represent local public health priorities (Implementation, Adoption). Course materials have informed other related training leading to spin-offs (Maintenance). Institutionalisation is dependent on external funding. Strengthening EBPH capacity across contexts is feasible. Curricula containing both core and contextualised elements create an authentic learning environment. Formal evaluations should be embedded within capacity-strengthening initiatives. This is the first study evaluating EBPH training in SSA using an implementation science lens, offering learning about context-relevant adaptations that assist with plans for sustainability and scale.

What works in implementing shared medical appointments for patients with diabetes in primary care to enhance reach: a qualitative comparative analysis from the Invested in Diabetes study

BackgroundDiabetes is a serious public health problem affecting 37.3 million Americans. Diabetes shared medical appointments (SMAs) are an effective strategy for providing diabetes self-management support and education in primary care. However, practices delivering SMAs experience implementation challenges. This analysis examined conditions associated with successful practice implementation of diabetes SMAs in the context of participation in a pragmatic trial.MethodsMixed methods study using qualitative and quantitative data collected from interviews, observations, surveys, and practice-reported data, guided by the practical, robust implementation and sustainability model (PRISM). Data were analyzed using qualitative comparative analysis (QCA). Successful implementation was defined as meeting patient recruitment targets (Reach) during the study period. Participants were clinicians and staff members from 22 primary care practices in Colorado and Missouri, USA.ResultsThe first necessary condition identified from the QCA was the presence of additional resources for patients with diabetes in the practice. Within practices that had these additional resources, we found that a sufficiency condition was the presence of an effective key person to make things happen with the SMAs. A second QCA was conducted to determine conditions underlying the presence of the effective key person (often performing functions of an implementation champion), which revealed factors including low or managed employee turnover, a strong baseline practice culture, and previous experience delivering SMAs.ConclusionsIdentification of key factors necessary and sufficient for implementation of new care processes is important to enhance patient access to evidence-based interventions. This study suggests that practice features and resources have important implications for implementation of diabetes SMAs. There may be opportunities to support practices with SMA implementation by enabling the presence of skilled implementation champions.Trial registrationRegistered at clinicaltrials.gov under trial ID NCT03590041, registered on July 18, 2018.

Implementing evidence-based practices to improve primary care for high-risk patients: study protocol for the VA high-RIsk VETerans (RIVET) type III effectiveness-implementation trial

BackgroundPatients with significant multimorbidity and other factors that make healthcare challenging to access and coordinate are at high risk for poor health outcomes. Although most (93%) of Veterans’ Health Administration (VHA) patients at high risk for hospitalization or death (“high-risk Veterans”) are primarily managed by primary care teams, few of these teams have implemented evidence-based practices (EBPs) known to improve outcomes for the high-risk patient population’s complex healthcare issues. Effective implementation strategies could increase adoption of these EBPs in primary care; however, the most effective implementation strategies to increase evidence-based care for high-risk patients are unknown.The high-RIsk VETerans (RIVET) Quality Enhancement Research Initiative (QUERI) will compare two variants of Evidence-Based Quality Improvement (EBQI) strategies to implement two distinct EBPs for high-risk Veterans: individual coaching (EBQI-IC; tailored training with individual implementation sites to meet site-specific needs) versus learning collaborative (EBQI-LC; implementation sites trained in groups to encourage collaboration among sites). One EBP, Comprehensive Assessment and Care Planning (CACP), guides teams in addressing patients’ cognitive, functional, and social needs through a comprehensive care plan. The other EBP, Medication Adherence Assessment (MAA), addresses common challenges to medication adherence using a patient-centered approach.MethodsWe will recruit and randomize 16 sites to either EBQI-IC or EBQI-LC to implement one of the EBPs, chosen by the site. Each site will have a site champion (front-line staff) who will participate in 18 months of EBQI facilitation.AnalysisWe will use a mixed-methods type 3 hybrid Effectiveness-Implementation trial to test EBQI-IC versus EBQI-LC versus usual care using a Concurrent Stepped Wedge design. We will use the Practical, Robust Implementation and Sustainability Model (PRISM) framework to compare and evaluate Reach, Effectiveness, Adoption, Implementation, and costs. We will then assess the maintenance/sustainment and spread of both EBPs in primary care after the 18-month implementation period. Our primary outcome will be Reach, measured by the percentage of eligible high-risk patients who received the EBP.DiscussionOur study will identify which implementation strategy is most effective overall, and under various contexts, accounting for unique barriers, facilitators, EBP characteristics, and adaptations. Ultimately this study will identify ways for primary care clinics and teams to choose implementation strategies that can improve care and outcomes for patients with complex healthcare needs.Trial registrationClinicalTrials.gov, NCT05050643. Registered September 9th, 2021, https://clinicaltrials.gov/study/NCT05050643Protocol versionThis protocol is Version 1.0 which was created on 6/3/2020.

Rapid jail-based implementation of overdose education and naloxone distribution in response to the COVID-19 pandemic

BackgroundPeople incarcerated in jails are highly impacted by the opioid epidemic, and overdose education and naloxone distribution (OEND) is an effective strategy to reduce opioid overdose deaths. This study examines barriers and facilitators of fast-track OEND implementation within the jails in the Wave 1 Kentucky counties of the HEALing Communities Study during the COVID-19 pandemic.MethodsMeeting minutes with jail stakeholders were qualitatively coded using the Practical, Robust Implementation and Sustainability Model (PRISM) as the coding framework. The analysis highlighted the top barriers and facilitators to fast-track OEND implementation within the PRISM framework.ResultsSpace and staffing shortages related to the COVID-19 pandemic, disruptions in interorganizational programming from pandemic-related service suspensions, and a lack of technological solutions (e.g., reliable Internet access) for socially distanced delivery were the top barriers to fast-track OEND implementation. In addition, there were limitations on non-jail staff access to jails during COVID-19. Top facilitators included jail leadership support, the option to prioritize high-risk groups, and the incorporation of OEND processes into existing communications and management software. While the COVID-19 pandemic strained jail infrastructure, jail and partner agency collaboration led to creative implementation strategies for the successful integration of OEND into jail operations. Urban jails were more likely than rural jails to be early adopters of OEND during the public health emergency.ConclusionsUnderstanding the barriers to and facilitators of OEND within jails will improve implementation efforts seeking to curb opioid overdose deaths. Jail leadership support and interorganizational efforts were key facilitators to implementation; therefore, it is recommended to increase buy-in with multiple agencies to promote success. Challenges brought on by COVID-19 have resulted in a need for innovative solutions for implementation.Clinical trial informationClinicalTrials.gov, NCT04111939, Submitted 30 September 2019, https://clinicaltrials.gov/study/NCT04111939?titles=HEALing%20Communities%20Study&rank=1.

Use of the iPRISM webtool in a learning community to assess implementation context and fit of a novel clinical decision support tool for physical therapy triage in acute care hospitals.

The iPRISM webtool is an interactive tool designed to aid the process of applying the Practical, Robust Implementation and Sustainability Model (PRISM) for the assessment of and fit with context. A learning community (LC) is a multidisciplinary group of partners addressing a complex problem. Our LC coproduced the Physical TheraPy frEqueNcy Clinical decIsion support tooL (PT-PENCIL) to guide the use of physical therapist services in acute care hospitals. To describe our LC's activities to co-produce the PT-PENCIL, use of the iPRISM webtool to assess its preimplementation context and fit, and develop a multicomponent implementation strategy for the PT-PENCIL. A descriptive research design. Three tertiary care hospitals. Thirteen LC partners: six clinical physical therapists, three rehabilitation managers, three researchers, and a bioinformaticist. Not applicable. Using the iPRISM webtool, expected fit of the PT-PENCIL was rated 1 (not aligned) to 6 (well aligned) for each PRISM domain and expected reach, effectiveness, adoption, implementation, and maintenance were rated 1 (not likely at all) to 6 (very likely). Discrete implementation strategies were identified from the Expert Recommendations for Implementing Change. The process spanned 18 meetings over 8 months. Ten LC partners completed the iPRISM webtool. PRISM domains with the lowest expected alignment were the "implementation and sustainability infrastructure" (mean = 4.7 out of 6; range = 3-6) and the "external environment" (mean = 4.9 of 6; range = 4-6). Adoption was the outcome with the lowest expected likelihood (mean = 4.5 out of 6; range = 1-6). Six discrete implementation strategies were identified and combined into a multicomponent strategy. Within a LC, we used existing implementation science resources to co-produce a novel clinical decision support tool for acute care physical therapists and develop a strategy for its implementation. Our methodology can be replicated for similar projects given the public availability of each resource used.

Implementation of a virtual, shared medical appointment program that focuses on food as medicine principles in a population with obesity: the SLIM program.

Multimodal lifestyle interventions, employing food as medicine, stand as the recommended first-line treatment for obesity. The Shared Medical Appointment (SMA) model, where a physician conducts educational sessions with a group of patients sharing a common diagnosis, offers an avenue for delivery of comprehensive obesity care within clinical settings. SMAs, however, are not without implementation challenges. We aim to detail our experience with three implementation models in launching a virtual integrative health SMA for weight management. Eligible patients included individuals 18 years of age or older, having a body mass index (BMI) of 30 kg/m2 or 27 kg/m2 or greater with at least one weight related comorbidity. The Practical, Robust Implementation and Sustainability Model (PRISM), Plan, Do, Study, Act (PDSA), and the Framework for Reporting Adaptations and Modifications-Enhanced (FRAME) models were applied to guide the implementation of the Supervised Lifestyle Integrative Medicine (SLIM) program, a virtually delivered, lifestyle medicine focused SMA program, in a weight management clinic within a major health system. We describe how these models, along with attendance for the initial cohorts, were used for decision-making in the process of optimizing the program. 172 patients completed the SLIM program over two years. Attendance was lowest for sessions held at 8:00 AM and 4:00 PM compared to sessions at 10:00 AM, 1:00 PM, and 3:00 PM, leading to only offering midday sessions (p = 0.032). Attendance data along with feedback from patients, facilitators, and administrative partners led to changes in the curriculum, session number and frequency, session reminder format, and intake visit number. The use of implementation and quality improvement models provided crucial insight for deployment and optimization of a virtual, lifestyle medicine focused SMA program for weight management within a large healthcare system.

Feasibility of Fit24, a Digital Diabetes Prevention Program for Hispanic Adolescents: Qualitative Evaluation Study.

Digital health interventions are promising for reaching and engaging high-risk youth in disease prevention opportunities; however, few digital prevention interventions have been developed for Hispanic youth, limiting our knowledge of these strategies among this population. This study qualitatively assessed the feasibility and acceptability of Fit24, a 12-week goal-setting intervention that uses a Fitbit watch (Fitbit Inc) and theoretically grounded SMS text messages to promote physical activity and sleep among Hispanic adolescents (aged between 14 and 16 years) with obesity. After completing the intervention, a subsample of youth (N=15) participated in an in-depth interview. We categorized the themes into dimensions based on participant perspectives using the Practical, Robust Implementation, and Sustainability Model (PRISM) framework. Participants shared positive perceptions of wearing the Fitbit and receiving SMS text messages. Youth were highly engaged in monitoring their behaviors and perceived increased activity and sleep. Almost all youth organically received social support from a peer or family member and suggested the use of a group chat or team challenge for integrating peers into future interventions. However, most youth also expressed the need to take personal responsibility for the change in their behavior. Barriers that impacted the feasibility of the study included the skin-irritating material on the Fitbit watch band and environmental barriers (eg, lack of resources and school schedules), that limited participation in activity suggestions. Additionally, sync issues with the Fitbit limited the transmission of data, leading to inaccurate feedback. Fit24 is a promising approach for engaging Hispanic youth in a diabetes prevention program. Strategies are needed to address technical issues with the Fitbit and environmental issues such as message timing. While integrating peer social support may be desired by some, peer support strategies should be mindful of youth's desire to foster personal motivation for behavior change. Findings from this study will inform future diabetes prevention trials of Fit24 and other digital health interventions for high-risk pediatric populations.

Developing Community-Level Implementation Networks to Connect Older Adults to Evidence-Based Falls Prevention Programs.

Background: Evidence-based falls prevention programs are available in many communities, but participation in such programs remains low. This study aimed to develop community-based referral networks of organizations to facilitate the uptake of evidence-based falls prevention programs through engaging older adults at risk for falls with the RememberingWhen™ program and connecting them to evidence-based programs in Midwestern communities. Methods: Guided by the Practical, Robust Implementation and Sustainability Model (PRISM), referral networks were developed in two Midwestern communities (urban and micropolitan) through a seven-step community engagement plan: establishing and operationalizing the State-level Advisory Board (SAB), identifying falls prevention resources, conducting community assessments, developing Local Advisory Groups (LAG), operationalizing the LAG, developing referral network and protocols, and implementing the network. Semistructured interviews guided by the RE-AIM framework were conducted with members of the SAB, LAG, administrators and staff from organizations that participated in networks, and older adult participants. Results: After participating in the development of referral networks, participants felt they learned important skills that they can use to develop additional collaborations and networks in the future, emphasized the benefits of building community capacity among organizations with common missions. Interview data yielded strategies on enhancing the referral network's reach, impact, adoption, implementation efficiency, and maintenance. Conclusion: Future sustainability studies of such networks should explore identified challenges and strategies to sustain efforts. Results highlight the importance of ongoing funds to support the efforts of organizational networks in communities.

Factors Impacting the Implementation of Mobile Integrated Health Programs for the Acute Care of Older Adults

Objective Emergency services utilization is increasing in older adult populations. Many such encounters may be preventable with better access to acute care in the community. Mobile integrated health (MIH) programs leverage mobile resources to deliver care and services to patients in the out‐of‐hospital environment and have the potential to improve clinical outcomes and decrease health care costs; however, they have not been widely implemented. We assessed barriers, potential facilitators, and other factors critical to the implementation of MIH programs with key vested partners. Methods Professional and community-member partners were purposefully recruited to participate in recorded structured interviews. The study team used the Practical Robust Implementation and Sustainability Model (PRISM) framework to develop an interview guide and codebook. Coders employed a combination of deductive and inductive coding strategies to identify common themes across partner groups. Results The study team interviewed 22 participants (mean age 56, 68% female). A cohort of professional subject matter experts included physicians, paramedics, public health personnel, and hospital administrators. A cohort of lay community partners included patients and caregivers. Coders identified three prominent themes that impact MIH implementation. First, MIH is disruptive to existing clinical workflows. Second, using MIH to improve patients’ experience during acute care encounters is key to intervention adoption. Finally, legislative action is needed to augment central financial and regulatory policies to ensure the adoption of MIH programs. Conclusions Common themes impacting the implementation of MIH programs were identified across vested partner groups. Multilevel strategies are needed to address patient adoption, clinical partners’ workflow, and legislative policies to ensure the success of MIH programs.

Vaccine communication training using the Brief Motivational Interviewing for Maternal Immunization intervention: A PRISM implementation evaluation.

Improving clinician-patient communication can increase uptake of recommended vaccinations during pregnancy. To evaluate adaptations to and pragmatism of the brief Motivational Interviewing for Maternal Immunizations (MI4MI) intervention and to use the Practical Robust Implementation and Sustainability Model (PRISM) to describe context and implementation outcomes among clinician and staff participants. We incorporated data from study team members, clinicians and staff participants, pregnant patients at participating clinics, and patient medical records. Quantitative and qualitative data were collected using surveys, chart reviews, study team notes, interviews, and focus groups. Adaptations were evaluated using the Framework for Reporting Adaptations and Modifications-Enhanced (FRAME) and pragmatism was measured with PRagmatic Explanatory Continuum Indicator Summary (PRECIS-2). MI4MI was effective at improving participants' vaccine communication experiences. Adoption was limited by our recruitment approach. MI4MI implementation was shaped by contextual factors and associated adaptations related to the COVID pandemic and clinic and participant characteristics. Virtual asynchronous intervention delivery had mixed effects on adoption and implementation that varied across clinics and participants. Participants expressed interest in maintaining the MI4MI intervention moving forward; however, identification of sustainability infrastructure was limited. MI4MI was evaluated to be relatively pragmatic. Contextual factors strongly shaped implementation of MI4MI. Future iterations of MI4MI should include training delivery modes and incentives that accommodate a range of participants across job roles and organizational settings. Future studies including control clinics are needed to measure effectiveness for increasing vaccination and comparing virtual versus hybrid implementation strategies.

Implementation and evaluation of Exercise is Medicine in primary care clinics within a large academic health system

ObjectiveExercise is Medicine (EIM) is a global initiative encouraging healthcare providers to routinely assess and promote physical activity (PA) among patients. The objective of this study was to evaluate the...

Engaging interested parties to optimize wildfire smoke communication in Canada: challenges with initiating change.

In February 2022, an online Wildfire Smoke Communication Workshop series identified priorities and strategies to improve wildfire smoke communication in Canada. We evaluated the engagement methods, the workshop series and workshop summary report, to determine if participants/organizations initiated changes identified in the workshop to optimize wildfire smoke communication plans. Three evaluation surveys were developed using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework dimensions and PRISM (Practical, Robust, Implementation, and Sustainability Model) contextual domains to measure the engagement impact. Surveys 1, 2, and 3 were disseminated to workshop participants between February 2022 (post-workshop series), May 2022 (pre-wildfire season), and September 2022 (post-wildfire season). Likert survey responses were analyzed descriptively using means and standard deviations. Open-ended written responses were analyzed using deductive reasoning and response proportions. Of 69 workshop participants, 28, 19, and 13 responded to surveys 1, 2, and 3, respectively. Workshop participation helped survey 1 respondents consider optimizing wildfire smoke communication (M = 3.93, SD = 0.88). Workshop participation and the summary report helped survey 2 respondents consider new actions to optimize wildfire smoke communication (M = 3.84, SD = 0.74). The most intended action in survey 2 (68%, n = 13) and the most common action taken in survey 3 (62%, n = 8) was to simplify message content. The primary limitation to optimization was capacity. The engagement methods, particularly the summary report, were beneficial for organizations to take action to optimize wildfire smoke communication in Canada. Future engagement methods should examine persisting system-level issues and capacity limitations as they undermine the ability to optimize wildfire smoke communication in Canada.

Implementation and effectiveness of a physician-focused peer support program.

The practice of medicine faces a mounting burnout crisis. Physician burnout leads to worse mental health outcomes, provider turnover, and decreased quality of care. Peer support, a viable strategy to combat burnout, has been shown to be well received by physicians. This study evaluates the Peer Outreach Support Team (POST) program, a physician-focused peer support initiative established in a 2-hospital system, using descriptive statistical methodologies. We evaluate the POST program using the Practical Robust Implementation and Sustainability Model (PRISM) framework to describe important contextual factors including characteristics of the intervention, recipients, implementation and sustainability infrastructure, and external environment, and to assess RE-AIM outcomes including reach, effectiveness, adoption, implementation, and maintenance. This program successfully trained 59 peer supporters across 11 departments in a 2-hospital system over a 3-year period. Trained supporters unanimously felt the training was useful and aided in general departmental culture shift (100% of respondents). After 3 years, 48.5% of physician survey respondents across 5 active departments had had a peer support interaction, with 306 successful interactions recorded. The rate of interactions increased over the 3-year study period, and the program was adopted by 11 departments, representing approximately 60% of all physicians in the 2-hospital system. Important implementation barriers and facilitators were identified. Physician recipients of peer support reported improved well-being, decreased negative emotions and stigma, and perceived positive cultural changes within their departments. We found that POST, a physician-focused peer support program, had widespread reach and a positive effect on perceived physician well-being and departmental culture. This analysis outlines a viable approach to support physicians and suggests future studies considering direct effectiveness measures and programmatic adaptations. Our findings can inform and guide other healthcare systems striving to establish peer support initiatives to improve physician well-being.

Designing an implementation strategy to increase health-related social needs screening: Applying the PRISM framework in a resource-limited clinical setting.

Despite growing acceptability of health-related social needs (HRSN) screening and increasing policy incentives for adoption, clinical implementation of HRSN screening remains low. HRSN screening has been particularly difficult for Community Health Centers (CHCs), which have limited resources to implement and sustain new workflows. While CHCs provide care to patients with disproportionately high levels of unmet social needs, identifying HRSN screening implementation strategies that take CHC-specific contexts into account remains elusive. This study uses the Practical Robust Implementation and Sustainability Model (PRISM) to design an implementation strategy accounting for the unique context of CHCs. We used Rapid Ethnographic Assessment observations and stakeholder focus groups to identify current workflow barriers and facilitators to HRSN screening, and to develop implementation strategies that include multi-level contexts and perspectives. We identified eight themes contributing to low screening implementation: perceived stigma around screening; need for community-based solutions; re-confirming organizational priorities and values; Electronic Medical Record (EMR) limitations; multi-tasking pressures limiting implementation; staff turnover; limited knowledge of regulatory requirements; and community resource availability for referral. Based on the themes, we identified implementation strategies including non-EMR data collection; integration into the workflow for multiple staff members; creation of new training and educational modules; and identification of peer champions for retraining in real time. Administrative requirements are necessary but not sufficient for implementation of HRSN screening in CHCs. Resource-constrained settings benefit from context-specific stakeholder engagement to improve implementation success. The use of PRISM ensured contextual factors were central to the implementation strategy design.

Utilizing PRISM and RE-AIM to implement and evaluate the Rural Telementoring Training Center (RTTC) for health care workforce development in rural communities

IntroductionAmid rural health worker shortages and hospital closures, it is imperative to build and maintain the local workforce. Telementoring (TM) or technology-enabled mentoring, is a tool for improving health care quality and access by increasing workforce capacity and support. The national Rural Telementoring Training Center (RTTC) was developed to compile and disseminate TM best practices by delivering free training, tools, and technical assistance to support the implementation, sustainability, and evaluation of new and current TM programs for rural health workers. This paper details how the Practical, Robust Implementation and Sustainability Model (PRISM) was used to understand the context that shaped implementation as well as how Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) was concurrently applied to frame outcomes.MethodsThe RTTC has three implementation strategies: outreach, training and technical assistance (TTA), and a Quality Measure Toolkit. Ongoing periodic reflections with the RTTC team, informed by PRISM, were collected, as were RE-AIM outcomes. Central to this design was the continuous review of incoming data in team meetings to inform programmatic changes by identifying challenges and applying modifications to strategies in real time.ResultsMajor implementation changes discussed during reflections included providing timely and relevant messaging through various platforms, streamlining and customizing a TTA approach, and offering different options for accessing the Toolkit. The outreach strategy resulted in high Reach across the US, with over 300 organizations contacted. The effectiveness of the RTTC was demonstrated by counts of people engaging with outreach (ex. over 8,300 impressions on LinkedIn), the website (over 6,400 views), and e-bursts (33% open rate). Moreover, there were 32 TTA requests and 70 people accessing the Toolkit. Adoption was demonstrated by 27 people participating in TTA and 14 individuals utilizing the Toolkit.DiscussionThe integration of PRISM and RE-AIM frameworks promoted a holistic implementation and evaluation plan. Using PRISM, the RTTC team was able to reflect on the implementation strategies through the lens of contextual factors and make rapid programmatic changes within team meetings. That process resulted in outcomes framed by RE-AIM. The integration of two frameworks in tandem provided an adaptive and comprehensive approach to implementing a large-scale, national program.

Vitalizing Community for Health Promotion Against Modifiable Risk Factors of Noncommunicable Diseases (V-CaN) in Rural Central India: Protocol for a Hybrid Type II Implementation Effectiveness Trial.

Low- and middle-income countries are facing the emerging burden of chronic noncommunicable diseases (NCDs). Apart from loss of human lives and premature deaths, NCDs result in huge costs for treatment to individuals and the health system. Although NCDs develop in later life, the risk factors begin at an early age. The key to the control of the global epidemic of NCDs is primary prevention based on comprehensive community-based programs. This study aims to develop, implement, and evaluate the effect of a participatory health promotion initiative utilizing the existing mechanisms of Village Health Nutrition and Sanitation Committees (VHNSCs), women's self-help groups (SHGs), and schools on modifiable risk factors for NCDs among young people aged 10-30 years. The proposed type II hybrid effectiveness implementation cluster randomized field trial will be conducted in the catchment area of 4 primary health centers (PHCs) in Wardha district, India, comprising 100 villages with a population of 144,000. Each PHC will be randomly allocated to one of the 3 intervention arms or the control arm. The 3-intervention arm PHCs will utilize a unique strategy with either VHNSC or SHG members or school students as change agents for health action against common modifiable NCD risk factors. This study will be implemented in 3 phases from January 2022 to December 2024. First, the preparatory phase for baseline assessments includes anthropometry, behavioral and biochemical risk factors for NCDs, and participatory development of the health promotion intervention modules. Second, the implementation phase will focus on capacity building of the change agents and implementation of the participatory health promotion initiative. The implementation will include organization of community-based events, 6-monthly participatory assessment of change, and preparation of a sustainability and exit plan toward the end of this phase. Third, the evaluation phase will consist of studying the effectiveness of each intervention strategy in the reduction of risk factor prevalence at the population level. We will assess 12,000 (3000 in each arm) randomly selected individuals for behavioral risk factors and 1600 (400 in each arm) individuals for biochemical risk factors during baseline as well as endline assessments. Difference in differences, ANOVA or multivariate analysis of covariance, and regression analysis will be performed to assess the effectiveness of the interventions. Qualitative methods such as focus group discussions and stories of change will be documented and analyzed using thematic framework analysis. The implementation outcomes will be reported using the PRISM (Practical Robust Implementation and Sustainability Model) RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. The results are expected to be published by mid-2025. This study will show the magnitude of risk factors for NCDs, its determinants, feasibility, effectiveness of community-based interventions, and health promotion models for NCD prevention. Clinical Trials Registration India CTRI/2020/10/028700; https://ctri.nic.in/Clinicaltrials/showallp.php?mid1=47597&EncHid=&userName=V-CaN. DERR1-10.2196/42450.

Implementing shared decision-making interventions in breast cancer clinical practice: a scoping review

BackgroundShared decision-making (SDM) is a collaborative process whereby patients and clinicians jointly deliberate on the best treatment option that takes into account patients’ preferences and values. In breast cancer care, different treatment options have become available to patients in the last decade. Various interventions, including patient decision aids (PtDAs), have been designed to promote SDM in this disease area. This study aimed at investigating the factors that influence the successful adoption and implementation of SDM interventions in real-world healthcare delivery settings.MethodsA scoping review of scientific and grey literature was conducted for the period 2006–2021 to analyse the support for SDM interventions and their adoption in breast cancer clinical practice. The interpretation of findings was based on the Practical, Robust Implementation and Sustainability Model (PRISM) for integrating research findings into practice.ResultsOverall, 19 studies were included for data synthesis, with more than 70% published since 2017. The availability of SDM tools does not automatically translate into their actual use in clinical settings. Factors related to users’ co-creation, the clinical team’s attitude and knowledge, organisational support and regulatory provisions facilitate the adoption of SDM interventions. However, overlooking aspects such as the re-organisation of care pathways, patient characteristics, and assigning of resources (human, financial, and facilities) can hinder implementation efforts.ConclusionsCompared to the mounting evidence on the efficacy of SDM interventions, knowledge to support their sustained implementation in daily care is still limited, albeit results show an increasing interest in strategies that facilitate their uptake in breast cancer care over time. These findings highlight different strategies that can be used to embed SDM interventions in clinical practice. Future work should investigate which approaches are more effective in light of organisational conditions and external factors, including an evaluation of costs and healthcare system settings.

Identifying barriers and facilitators along the hepatitis C care cascade to inform human-centered design of contextualized treatment protocols for vulnerable populations in Austin, Texas: a qualitative study

BackgroundHepatitis C virus (HCV) is a leading cause of liver-related mortality and morbidity. Despite effective direct acting antivirals and a simplified treatment algorithm, limited access to HCV treatment in vulnerable populations, including people experiencing homelessness (PEH) and people who inject drugs (PWID), hinders global elimination. Adapting the evidence-based, simplified HCV treatment algorithm to the organizational and contextual realities of non-traditional clinic settings serving vulnerable populations can help overcome specific barriers to HCV care. The first phase of the Erase Hep C study aimed to identify barriers and facilitators specific to these vulnerable populations to design the site-specific, simplified treatment protocols.MethodsForty-two semi-structured qualitative interviews, guided by the Practical, Robust Implementation and Sustainability Model (PRISM) framework, were conducted with clinic staff, community-based organizations providing screening and linkage to care, and patients diagnosed with HCV, to identify contextual barriers and facilitators to treatment at a local community health center’s Health Care for the Homeless program in Austin, Texas. Audio-recorded interviews were systematically analyzed using thematic analysis informed by the PRISM framework and design thinking, to anchor barriers and facilitators along the HCV care cascade. Findings were fed into human-centered design workshops to co-design, with clinic staff, site-specific, simplified HCV treatment protocols.ResultsThe specific needs of PEH and PWID patient populations informed barriers and facilitators of HCV care. Barriers included tracking patients who miss critical appointments or labs, medication access and adherence, and patient HCV knowledge. Clinical teams leveraged existing facilitators and incorporated solutions to barriers into clinic workflows to improve care coordination and medication access. Actionable solutions included augmenting existing staff roles, employing HCV care navigation throughout the cascade, and standardizing medication adherence counseling.ConclusionsClinic staff identified HCV care facilitators to leverage, and designed actionable solutions to address barriers, to incorporate into site-specific treatment protocols to improve patient HCV outcomes. Methods used to incorporate staff and patient experiential knowledge into the design of contextualized treatment protocols in non-traditional clinic settings could serve as a model for future implementation research. The next phase of the study is protocol implementation and patient enrollment into a single-arm trial to achieve HCV cure.

Development, implementation, and feasibility of site-specific hepatitis C virus treatment workflows for treating vulnerable, high-risk populations: protocol of the Erase Hep C study — a prospective single-arm intervention trial

BackgroundHepatitis C virus (HCV) is the leading indication for liver transplantation and liver-related mortality. The development of direct-acting antivirals (DAA) and a simplified treatment algorithm with a > 97% cure rate should make global elimination of HCV an achievable goal. Yet, vulnerable populations with high rates of HCV still have limited access to treatment. By designing locally contextualized site-specific HCV treatment workflows, we aim to cure HCV in vulnerable, high-risk populations, including people experiencing homelessness (PEH) and people who inject drugs (PWID), in Austin, TX, USA.MethodsOur implementation science study will utilize a qualitative and design thinking approach to characterize patient and systemic barriers and facilitators to HCV treatment in vulnerable, high-risk populations seeking care across seven diverse primary care clinics serving PEHs and PWIDs. Qualitative interviews guided by the Practical, Robust Implementation and Sustainability Model (PRISM) framework will identify barriers and facilitators by leveraging knowledge and experience from both clinic staff and patients. Data synthesized using thematic analysis and design thinking will feed into workshops with clinic stakeholders for idea generation to design site-specific HCV treatment workflows. Providers will be trained on the use of a simplified HCV treatment algorithm with DAAs and clinic staff on the new site-specific HCV treatment workflows. These workflows will be implemented by the seven diverse primary care clinics serving vulnerable, high-risk populations. Implementation and clinical outcomes will be measured using data collected through interviews with staff as well as through medical chart review.DiscussionOur study provides a model of how to contextualize and implement site-specific HCV treatment workflows targeting vulnerable, high-risk populations in other geographic locations. This model can be adopted for future implementation research programs aiming to develop and implement site-specific treatment workflows for vulnerable, high-risk populations and in primary care clinical settings for other disease states beyond just HCV.Trial registrationRegistered on ClinicalTrials.gov on July, 14, 2022. Identifier: NCT05460130.