Evaluating the Barriers and Facilitators to Implementing a Novel Referral System for Outpatient Geriatric Services: The Geri-Hub Quality Improvement Initiative.

Background: In healthcare systems prioritizing care of older adults, resource limitations and escalating demand often impede access to outpatient specialized geriatric services. Objectives: This study, theoretically guided by the Consolidated Framework for Implementation Research (CFIR), aimed to explore barriers and facilitators in implementing a centralized "Geri-Hub." The Geri-Hub is a centralized intake system established within 2 hospital systems to coordinate outpatient and community-based services for older adults, aiming to connect them with the most appropriate care in a timely manner. Methods: Qualitative insights were gathered from healthcare professionals at 2 academic institutions in the process of consolidating services. Through open-ended surveys and semi-structured interviews, we solicited feedback on referral management, waiting times, and overall work experiences. Results: Thirteen frequently referring providers and a cohort of 9 geriatricians, along with 4 administrators, contributed to the study. Geriatricians emphasized streamlined referrals, flexible scheduling for urgent cases, and a target wait time of 3 months. Administrators stressed standardized referral procedures, defined roles, and accessible referral information. Discussion: The findings underscored the need for straightforward referral processes, enhanced communication on referral statuses, and reduced wait times. Optimizing these processes could potentially mitigate resource utilization issues and improve patient outcomes in healthcare systems. This research highlights the critical role of timely access to geriatric services during transformative phases in healthcare delivery.

Building capacity for local public health: lessons from a mixed-methods evaluation of an academic-public health partnership used in response to COVID-19.

Introduction: The Massachusetts Academic Health Department Consortium (AHD) established the Academic Public Health Volunteer Corps (APHVC) to support Local Health Departments (LHDs, n = 351) to meet rapidly emerging needs during the COVID-19 pandemic through engaging student volunteers. A program evaluation captured lessons learned and informed recommendations for sustainability and future replication. Methods: The mixed-methods evaluation leveraged the Consolidated Framework for Implementation Research (CFIR). Data were stratified by LHD engagement with APHVC. Quantitative surveys informed probes for qualitative focus groups and interviews; findings were categorized into CFIR constructs using a deductive approach. Results: One-fifth of LHDs (n = 76, 27 used APHVC services, 45 did not) completed the survey. Eleven employees participated in follow-up focus groups or interviews. APHVC filled resource gaps, built capacity, and provided high-quality deliverables. LHDs experienced issues with reliability and communication of volunteers and lacked time to train volunteers. Conclusions: CFIR aided in evaluating APHVC in real time, producing actionable recommendations for best practices, dissemination, and future iterations of the program. Results are being used to enhance program effectiveness and sustainability, community health, and health equity across Massachusetts, and may help inform academic practice-based programs across the United States.

Multilevel perspectives on the implementation of the collaborative care model for depression and anxiety in primary care.

BACKGROUND: The Collaborative Care Model (CoCM) is an evidence-based mental health treatment in primary care. A greater understanding of the determinants of successful CoCM implementation, particularly the characteristics of multi-level implementers, is needed. METHODS: This study was a process evaluation of the Collaborative Behavioral Health Program (CBHP) study (NCT04321876) in which CoCM was implemented in 11 primary care practices. CBHP implementation included screening for depression and anxiety, referral to CBHP, and treatment with behavioral care managers (BCMs). Interviews were conducted 4- and 15-months post-implementation with BCMs, practice managers, and practice champions (primary care clinicians). We used framework-guided rapid qualitative analysis with the Consolidated Framework for Implementation Research, Version 2.0, focused on the Individuals domain, to analyze response data. These data represented the roles of Mid-Level Leaders (practice managers), Implementation Team Members (clinicians, support staff), Innovation Deliverers (BCMs), and Innovation Recipients (primary care/CBHP patients) and their characteristics (i.e., Need, Capability, Opportunity, Motivation). RESULTS: Mid-level leaders (practice managers) were enthusiastic about CBHP (Motivation), appreciated integrating mental health services into primary care (Need), and had time to assist clinicians (Opportunity). Although CBHP lessened the burden for implementation team members (clinicians, staff; Need), some were hesitant to reallocate patient care (Motivation). Innovation deliverers (BCMs) were eager to deliver CBHP (Motivation) and confident in assisting patients (Capability); their opportunity to deliver CBHP could be limited by clinician referrals (Opportunity). Although CBHP alleviated barriers for innovation recipients (patients; Need), it was difficult to secure services for those with severe conditions (Capability) and certain insurance types (Opportunity). CONCLUSIONS: Overall, respondents favored sustaining CoCM and highlighted the positive impacts on the practice, health care team, and patients. Participants emphasized the benefits of integrating mental health services into primary care and how CBHP lessened the burden on clinicians while providing patients with comprehensive care. Barriers to CBHP implementation included ensuring appropriate patient referrals, providing treatment for patients with higher-level needs, and incentivizing clinician engagement. Future CoCM implementation should include strategies focused on education and training, encouraging clinician buy-in, and preparing referral paths for patients with more severe conditions or diverse needs. TRIAL REGISTRATION: ClinicalTrials.gov(NCT04321876). Registered: March 25,2020. Retrospectively registered.

Understanding pathways from implementation to sustainment: a longitudinal, mixed methods analysis of promising practices implemented in the Veterans Health Administration.

BACKGROUND: The Veterans Health Administration (VHA) is the United States largest learning health system. The Diffusion of Excellence (DoE) program is a large-scale model of diffusion that identifies and diffuses evidence-informed practices across VHA. During the period of 2016-2021, 57 evidence-informed practices were implemented across 82 VHA facilities. This setting provides a unique opportunity to understand sustainment determinants and pathways. Our objective was to characterize the longitudinal pathways of practices as they transition from initial implementation to long-term sustainment at each facility. METHODS: A longitudinal, mixed-methods evaluation of 82 VHA facilities. Eighty-two facility representatives, chosen by leadership as points-of-contact for 57 DoE practices, were eligible for post-implementation interviews and annual sustainment surveys. Primary outcomes (implementation, sustainment), and secondary outcomes (institutionalization, effectiveness, anticipated sustainment) at four time-points were collected. We performed descriptive statistics and directed content analysis using Hailemariam et al.'s factors influencing sustainment. RESULTS: After approximately five years post-implementation (e.g., 2021 sustainment outcomes), of the 82 facilities, about one-third fully sustained their practice compared to one-third that did not fully sustain their practice because it was in a "liminal" stage (neither sustained nor discontinued) or permanently discontinued. The remaining one-third of facilities had missing 2021 sustainment outcomes. A higher percentage of facilities (70%) had inconsistent primary outcomes (changing over time) compared to facilities (30%) with consistent primary outcomes (same over time). Thirty-four percent of facilities with sustained practices reported resilience since they overcame implementation and sustainment barriers. Facilities with sustained practices reported more positive secondary outcomes compared to those that did not sustain their practice. Key factors facilitating practice sustainment included: demonstrating practice effectiveness/benefit, sufficient organizational leadership, sufficient workforce, and adaptation/alignment with local context. Key factors hindering practice sustainment included: insufficient workforce, not able to maintain practice fidelity/integrity, critical incidents related to the COVID-19 pandemic, organizational leadership did not support sustainment of practice, and no ongoing support. CONCLUSIONS: We identified diverse pathways from implementation to sustainment, and our data underscore that initial implementation outcomes may not determine long-term sustainment outcomes. This longitudinal evaluation contributes to understanding impacts of the DoE program, including return on investment, achieving learning health system goals, and insights into achieving high-quality healthcare in VHA.

Strategies for Implementing an Electronic Patient-Reported Outcomes-Based Symptom Management Program Across Six Cancer Centers.

Background: Electronic patient-reported outcome (ePRO)-based symptom management improves cancer patients' outcomes. However, implementation of ePROs is challenging, requiring technical resources for integration into clinical systems, substantial buy-in from clinicians and patients, novel workflows to support between-visit symptom management, and institutional investment. Methods: The SIMPRO Research Consortium developed eSyM, an electronic health record-integrated, ePRO-based symptom management program for medical oncology and surgery patients and deployed it at six cancer centers between August 2019 and April 2022 in a type II hybrid effectiveness-implementation cluster randomized stepped-wedge study. Sites documented implementation strategies monthly using REDCap, itemized them using the Expert Recommendations for Implementation Change (ERIC) list and mapped their target barriers using the Consolidated Framework for Implementation Research (CFIR) to inform eSyM program enhancement, facilitate inter-consortium knowledge sharing and guide future deployment efforts. Results: We documented 226 implementation strategies: 35 'foundational' strategies were applied consortium-wide by the coordinating center and 191 other strategies were developed by individual sites. We consolidated these 191 site-developed strategies into 64 unique strategies (i.e., removed duplicates) and classified the remainder as either 'universal', consistently used by multiple sites (N=29), or 'adaptive', used only by individual sites (N=35). Universal strategies were perceived as having the highest impact; they addressed eSyM clinical preparation, training, engagement of patients/clinicians, and program evaluation. Across all documented SIMPRO strategies, 44 of the 73 ERIC strategies were addressed and all 5 CFIR barriers were addressed. Conclusion: Methodical collection of theory-based implementation strategies fostered the identification of universal, high-impact strategies that facilitated adoption of a novel care-delivery intervention by patients, clinicians, and institutions. Attention to the high-impact strategies identified in this project could support implementation of ePROs as a component of routine cancer care at other institutions.

Perspectives of key informants before and after implementing UPSIDES peer support in mental health services: qualitative findings from an international multi-site study.

BACKGROUND: Peer support is an essential part of recovery-oriented care worldwide. Contextual factors have an impact on the implementation of peer support work. However, research has paid little attention to similarities and differences of implementation factors in settings varying by income-level and cultural values. The aim of this study is to assess the factors influencing the implementation of a peer support intervention across study sites in low-, middle- and high-income countries in line with the Consolidation Framework for Implementation Research (CFIR). METHOD: 6 focus groups with a total of 54 key informants with relevant contextual (organisational) knowledge regarding implementation facilitators and barriers were conducted at six study sites Ulm and Hamburg (Germany), Butabika (Uganda), Dar es Salaam (Tanzania), Be'er Sheva (Israel), and Pune (India) before and 1.5 years after the start of UPSIDES peer support. Transcripts were analysed using qualitative content analysis. RESULTS: Across study sites key informants reported benefits of peer support for service users and peer support workers as implementation facilitators. At study sites with lower resources, reduced workload for mental health workers and improved access to mental health services through peer support were perceived as implementation facilitators (CFIR Domain 1: Intervention characteristics). The degree of engagement of mental health workers (CFIR Domain 3: Inner Setting/Domain 4: Individuals involved) varied across study sites and was seen either as a barrier (low engagement) or a facilitator (high engagement). Across study sites, adequate training of peer support workers (CFIR Domain 5: Implementation process) was seen as animplementation facilitator, while COVID-19 as well as low resource availability were reported as implementation barriers (CFIR Domain 2: Outer setting). CONCLUSIONS: This study highlights the importance of considering contextual factors when implementing peer support, including previous experience and perceived benefits. Particular attention should be given to organisational benefits such as workload reduction and the allocation of sufficient resources as key drivers in LMICs. In HICs, the potential of organisational benefits for successful implementation should be further investigated and promoted.

Findings from an Organizational Context Survey to Inform the Implementation of a Collaborative Care Study for Co-occurring Disorders.

Primary care is an opportune setting to deliver treatments for co-occurring substance use and mental health disorders; however, treatment delivery can be challenging due multi-level implementation barriers. Documenting organizational context can provide insight into implementation barriers and the adaptation of new processes into usual care workflows. This study surveyed primary care and behavioral health staff from 13 clinics implementing a collaborative care intervention for opioid use disorders co-occurring with PTSD and/or depression as part of a multisite randomized controlled trial. A total of 323 completed an online survey for a 60% response rate. The Consolidated Framework for Implementation Research guided this assessment of multi-level factors that influence implementation. Most areas for improvement focused on inner setting (organizational level) constructs whereas individual-level constructs tended to be strengths. This work addresses a research gap regarding how organizational analyses can be used prior to implementation and provides practical implications for researchers and clinic leaders.

Reflection on the application of the Consolidated Framework for Implementation Research to a national policy to improve inclusion of people with disabilities.

People with disabilities face many barriers in the built environment impacting their mobility, health, and social participation. In the US, under the Americans with Disabilities Act (ADA), municipalities were required to develop and implement barrier-removal plans for pedestrian infrastructure, called ADA transition plans, but very few have done so. Many communities know they need a plan but do not know how to get it done because of a lack of understanding of the many different implementation considerations. Implementation science offers a useful approach for understanding complex policy implementation such as ADA plans. This paper provides a reflection on the adaptation of the Consolidated Framework for Implementation Research (CFIR) to evaluate the implementation of ADA transition planning. To apply the CFIR, we tailored the construct definitions and modified them to fit the specific context of the ADA transition planning process. We documented the constructs that were more challenging to apply, those that were not relevant, and those that were particularly useful. This paper can serve as a valuable example that other researchers can use when considering adapting the CFIR or other implementation frameworks for the evaluation of complex social policy beyond the ADA.

Implementation determinants and strategies in integration of PrEP into maternal and child health and family planning services: experiences of frontline healthcare workers in Kenya.

Background: Delivery of PrEP to adolescent girls and young women (AGYW) and to pregnant women through maternal and child health (MCH) and family planning (FP) clinics is scaling up in Kenya. Evaluation of implementation challenges and strategies is critical to optimize delivery. Methods: We conducted focus group discussions (FGDs) with healthcare workers (HCWs) in MCH and FP clinics offering PrEP in a large implementation project in Kisumu, Kenya. Discussion guides were based on the Consolidated Framework for Implementation Research (CFIR). FGDs were audio recorded and transcribed. Directed content analysis was used to identify implementation challenges and strategies to overcome them. Results: Fifty HCWs from 26 facilities participated in 8 FGDs. HCWs believed PrEP integration was appropriate because it met the needs of AGYW and pregnant women by providing a female-controlled prevention strategy and aligned with policy priorities of elimination of vertical HIV transmission. They were universally accepting of PrEP provision, especially through MCH clinics, noting the relative advantage of this approach because it: (1) enabled high coverage, (2) harmonized PrEP and MCH visits, and (3) minimized stigma compared to PrEP offered through HIV care clinics. However, HCWs noted implementation challenges affecting feasibility and adoption including: (1) increased workload and documentation burden amid workforce shortages, (2) insufficient health care worker knowledge (3) multiple implementing partners with competing priorities (4) drug and documentation form stockouts. HCWs employed various implementation strategies to overcome challenges, including task shifting from nurses to HIV testing providers, patient flow modifications (e.g., fast-tracking PrEP clients to reduce wait times), PrEP demand generation and myth clarification during health talks, provider education, dedicated PrEP delivery rooms, and coordination with adolescent-friendly services. Additional suggested strategies to improve PrEP integration included community education to increase broader PrEP awareness and enable shorter counseling sessions, and task-shifting data entry and client risk assessments. Conclusions: HCWs were enthusiastic about the appropriateness and acceptability of integrating PrEP services into MCH and FP clinics but noted challenges to adoption and feasibility. Strategies to address challenges focused on improving provider time and space constraints, and increasing provider and client knowledge.

Implementing medication adherence interventions in four Dutch living labs; context matters.

BACKGROUND: Despite the abundant availability of effective medication adherence interventions, uptake of these interventions into routine care often lacks. Examples of effective medication adherence interventions include telephone counseling, consult preparation and the teach-back method. Assessing context is an important step in understanding implementation success of interventions, but context is often not reported or only moderately described. This study aims to describe context-specific characteristics in four living labs prior to the implementation of evidence-based interventions aiming to improve medication adherence. METHODS: A qualitative study was conducted within four living labs using individual interviews (n = 12) and focus groups (n = 4) with project leaders and involved healthcare providers. The four living labs are multidisciplinary collaboratives that are early adopters of medication adherence interventions in the Dutch primary care system. Context is defined as the environment or setting in which the proposed change is to be implemented. Interview topics to assess context were formulated based on the 'inner setting' and 'outer setting' domains of the Consolidated Framework for Implementation Research (CFIR). Interviews were recorded and transcribed verbatim. Transcripts were deductively analyzed. RESULTS: A total of 39 community pharmacists, pharmacy technicians, general practitioners and a home care employee participated in the (focus group) interviews. All four living labs proved to be pharmacy-driven and characterized by a high regard for innovation by staff members, a positive implementation climate, high levels of leadership engagement and high compatibility between the living labs and the interventions. Two living labs were larger in size and characterized by more formal communication. Two living labs were characterized by higher levels of cosmopolitanism which resulted in more adaptable interventions. Worries about external policy, most notably lack of reimbursement for sustainment and upscaling of the interventions, were shared among all living labs. CONCLUSIONS: Contextual characteristics of four living labs that are early adopters of medication adherence interventions provide detailed examples of a positive implementation setting. These can be used to inform dissemination of medication adherence interventions in settings less experienced in implementing medication adherence interventions.

Healthcare worker perceived barriers and facilitators to implementing a tuberculosis preventive therapy program in rural South Africa: a content analysis using the consolidated framework for implementation research.

BACKGROUND: South African national tuberculosis (TB) guidelines, in accordance with the World Health Organization, recommend conducting routine household TB contact investigation with provision of TB preventive therapy (TPT) for those who qualify. However, implementation of TPT has been suboptimal in rural South Africa. We sought to identify barriers and facilitators to TB contact investigations and TPT management in rural Eastern Cape, South Africa, to inform the development of an implementation strategy to launch a comprehensive TB program. METHODS: We collected qualitative data through individual semi-structured interviews with 19 healthcare workers at a district hospital and four surrounding primary-care clinics referring to the hospital. The consolidated framework for implementation research (CFIR) was used to develop interview questions as well as guide deductive content analysis to determine potential drivers of implementation success or failure. RESULTS: A total of 19 healthcare workers were interviewed. Identified common barriers included lack of provider knowledge regarding efficacy of TPT, lack of TPT documentation workflows for clinicians, and widespread community resource constraints. Facilitators identified included healthcare workers high interest to learn more about the effectiveness of TPT, interest in problem-solving logistical barriers in provision of comprehensive TB care (including TPT), and desire for clinic and nurse-led TB prevention efforts. CONCLUSION: The use of the CFIR, a validated implementation determinants framework, provided a systematic approach to identify barriers and facilitators to TB household contact investigation, specifically the provision and management of TPT in this rural, high TB burden setting. Specific resources-time, trainings, and evidence-are necessary to ensure healthcare providers feel knowledgeable and competent about TPT prior to prescribing it more broadly. Tangible resources such as improved data systems coupled with political coordination and funding for TPT programming are essential for sustainability.

Anticipated benefits and challenges of implementing group care in Suriname's maternity and child care sector: a contextual analysis.

BACKGROUND: Suriname is a uppermiddle-income country with a relatively high prevalence of preventable pregnancy complications. Access to and usage of high-quality maternity care services are lacking. The implementation of group care (GC) may yield maternal and child health improvements. However, before introducing a complex intervention it is pivotal to develop an understanding of the local context to inform the implementation process. METHODS: A context analysis was conducted to identify local needs toward maternity and postnatal care services, and to assess contextual factor relevant to implementability of GC. During a Rapid Qualitative Inquiry, 63 online and face-to-face semi-structured interviews were held with parents, community members, on-and off-site healthcare professionals, policy makers, and one focus group with parents was conducted. Audio recordings were transcribed in verbatim and analysed using thematic analysis and Framework Method. The Consolidated Framework for Implementation Research served as a base for the coding tree, which was complemented with inductively derived codes. RESULTS: Ten themes related to implementability, one theme related to sustainability, and seven themes related to reaching and participation of the target population in GC were identified. Factors related to health care professionals (e.g., workload, compatibility, ownership, role clarity), to GC, to recipients and to planning impact the implementability of GC, while sustainability is in particular hampered by sparse financial and human resources. Reach affects both implementability and sustainability. Yet, outer setting and attitudinal barriers of health professionals will likely affect reach. CONCLUSIONS: Multi-layered contextual factors impact not only implementability and sustainability of GC, but also reach of parents. We advise future researchers and implementors of GC to investigate not only determinants for implementability and sustainability, but also those factors that may hamper, or facilitate up-take. Practical, attitudinal and cultural barriers to GC participation need to be examined. Themes identified in this study will inspire the development of adaptations and implementation strategies at a later stage.

Qualitative Assessment of Key Implementation Factors in a Faith-Based Response to Intimate Partner Violence.

BACKGROUND: Faith-based organizations (FBOs) have a scant history in the literature of implementing intimate partner violence (IPV) initiatives, though many members of faith communities consider it an important issue. Furthermore, the limited studies on this topic have not explored organizational factors that are important in the implementation of such efforts. PURPOSE: To investigate factors that influence the implementation of IPV prevention and response by one Catholic organization at both diocesan and parish levels. METHODS: We conducted sixteen semi-structured interviews with members of Archdiocese of Chicago Domestic Violence Outreach (ACDVO) leadership. Using deductive content analysis, we drew on all 14 constructs and sub-constructs from the inner setting domain of the Consolidated Framework for Implementation Research (CFIR) for coding transcripts and characterizing factors influencing implementation success. RESULTS: Seven CFIR constructs were useful in identifying factors that influenced implementation success of ACDVO. At the diocesan level, the organization's leadership structure, their driven culture, and in-kind available resources propelled their work. At the level of parish ministries, successful implementation was facilitated by networking and communication among parishes. At the diocesan-level, access to knowledge and information through ACDVO's Parish Support Committee, compatibility with parish values, leadership engagement, and available resources from parishes supported implementation. CONCLUSIONS: We identified modifiable and reproducible inner setting factors that influence implementation of a Catholic IPV initiative at the diocesan-level and support parish ministries in their local activities. Future work should validate these findings in other dioceses and examine non-Catholic FBO settings.

Assessing drivers of implementing "Scaling-up the Systems Analysis and Improvement Approach" for Prevention of Mother-to-Child HIV Transmission in Mozambique (SAIA-SCALE) over implementation waves.

BACKGROUND: The Systems Analysis and Improvement Approach (SAIA) is an evidence-based package of systems engineering tools originally designed to improve patient flow through the prevention of Mother-to-Child transmission of HIV (PMTCT) cascade. SAIA is a potentially scalable model for maximizing the benefits of universal antiretroviral therapy (ART) for mothers and their babies. SAIA-SCALE was a stepped wedge trial implemented in Manica Province, Mozambique, to evaluate SAIA's effectiveness when led by district health managers, rather than by study nurses. We present the results of a qualitative assessment of implementation determinants of the SAIA-SCALE strategy during two intensive and one maintenance phases. METHODS: We used an extended case study design that embedded the Consolidated Framework for Implementation Research (CFIR) to guide data collection, analysis, and interpretation. From March 2019 to April 2020, we conducted in-depth individual interviews (IDIs) and focus group discussions (FGDs) with district managers, health facility maternal and child health (MCH) managers, and frontline nurses at 21 health facilities and seven districts of Manica Province (Chimoio, Báruè, Gondola, Macate, Manica, Sussundenga, and Vanduzi). RESULTS: We included 85 participants: 50 through IDIs and 35 from three FGDs. Most study participants were women (98%), frontline nurses (49.4%), and MCH health facility managers (32.5%). An identified facilitator of successful intervention implementation (regardless of intervention phase) was related to SAIA's compatibility with organizational structures, processes, and priorities of Mozambique's health system at the district and health facility levels. Identified barriers to successful implementation included (a) inadequate health facility and road infrastructure preventing mothers from accessing MCH/PMTCT services at study health facilities and preventing nurses from dedicating time to improving service provision, and (b) challenges in managing intervention funds. CONCLUSIONS: The SAIA-SCALE qualitative evaluation suggests that the scalability of SAIA for PMTCT is enhanced by its fit within organizational structures, processes, and priorities at the primary level of healthcare delivery and health system management in Mozambique. Barriers to implementation that impact the scalability of SAIA include district-level financial management capabilities and lack of infrastructure at the health facility level. SAIA cannot be successfully scaled up to adequately address PMTCT needs without leveraging central-level resources and priorities. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03425136 . Registered on 02/06/2018.

A picture is worth a thousand words: advancing the use of visualization tools in implementation science through process mapping and matrix heat mapping.

BACKGROUND: Identifying key determinants is crucial for improving program implementation and achieving long-term sustainment within healthcare organizations. Organizational-level complexity and heterogeneity across multiple stakeholders can complicate our understanding of program implementation. We describe two data visualization methods used to operationalize implementation success and to consolidate and select implementation factors for further analysis. METHODS: We used a combination of process mapping and matrix heat mapping to systematically synthesize and visualize qualitative data from 66 stakeholder interviews across nine healthcare organizations, to characterize universal tumor screening programs of all newly diagnosed colorectal and endometrial cancers and understand the influence of contextual factors on implementation. We constructed visual representations of protocols to compare processes and score process optimization components. We also used color-coded matrices to systematically code, summarize, and consolidate contextual data using factors from the Consolidated Framework for Implementation Research (CFIR). Combined scores were visualized in a final data matrix heat map. RESULTS: Nineteen process maps were created to visually represent each protocol. Process maps identified the following gaps and inefficiencies: inconsistent execution of the protocol, no routine reflex testing, inconsistent referrals after a positive screen, no evidence of data tracking, and a lack of quality assurance measures. These barriers in patient care helped us define five process optimization components and used these to quantify program optimization on a scale from 0 (no program) to 5 (optimized), representing the degree to which a program is implemented and optimally maintained. Combined scores within the final data matrix heat map revealed patterns of contextual factors across optimized programs, non-optimized programs, and organizations with no program. CONCLUSIONS: Process mapping provided an efficient method to visually compare processes including patient flow, provider interactions, and process gaps and inefficiencies across sites, thereby measuring implementation success via optimization scores. Matrix heat mapping proved useful for data visualization and consolidation, resulting in a summary matrix for cross-site comparisons and selection of relevant CFIR factors. Combining these tools enabled a systematic and transparent approach to understanding complex organizational heterogeneity prior to formal coincidence analysis, introducing a stepwise approach to data consolidation and factor selection.

Implementing a Community-Led Arsenic Mitigation Intervention for Private Well Users in American Indian Communities: A Qualitative Evaluation of the Strong Heart Water Study Program.

Arsenic is a naturally occurring toxicant in groundwater, which increases cancer and cardiovascular disease risk. American Indian populations are disproportionately exposed to arsenic in drinking water. The Strong Heart Water Study (SHWS), through a community-centered approach for intervention development and implementation, delivered an arsenic mitigation program for private well users in American Indian communities. The SHWS program comprised community-led water arsenic testing, point-of-use arsenic filter installation, and a mobile health program to promote sustained filter use and maintenance (i.e., changing the filter cartridge). Half of enrolled households received additional in-person behavior change communication and videos. Our objectives for this study were to assess successes, barriers, and facilitators in the implementation, use, and maintenance of the program among implementers and recipients. We conducted 45 semi-structured interviews with implementers and SHWS program recipients. We analyzed barriers and facilitators using the Consolidated Framework for Implementation Research and the Risks, Attitudes, Norms, Abilities, and Self-regulation model. At the implementer level, facilitators included building rapport and trust between implementers and participating households. Barriers included the remoteness of households, coordinating with community plumbers for arsenic filter installation, and difficulty securing a local supplier for replacement filter cartridges. At the recipient level, facilitators included knowledge of the arsenic health risks, perceived effectiveness of the filter, and visual cues to promote habit formation. Barriers included attitudes towards water taste and temperature and inability to procure or install replacement filter cartridges. This study offers insights into the successes and challenges of implementing an arsenic mitigation program tailored to American Indian households, which can inform future programs in partnership with these and potentially similar affected communities. Our study suggests that building credibility and trust between implementers and participants is important for the success of arsenic mitigation programs.

The domestication of the African Union model law on medical products regulation: Perceived benefits, enabling factors, and challenges.

Introduction: In 2016, the African Union (AU) Model Law on Medical Products Regulation was endorsed by AU Heads of State and Government. The aims of the legislation include harmonisation of regulatory systems, increasing collaboration across countries, and providing a conducive regulatory environment for medical product/health technology development and scale-up. A target was set to have at least 25 African countries domesticating the model law by 2020. However, this target has not yet been met. This research aimed to apply the Consolidated Framework for Implementation Research (CFIR) in analysing the rationale, perceived benefits, enabling factors, and challenges of AU Model Law domestication and implementation by AU Member States. Methods: This study was a qualitative, cross-sectional, census survey of the national medicines regulatory authorities (NRAs) of Anglophone and Francophone AU Member States. The heads of NRAs and a senior competent person were contacted to complete self-administered questionnaires. Results: The perceived benefits of model law implementation include enabling the establishment of an NRA, improving NRA governance and decision-making autonomy, strengthening the institutional framework, having streamlined activities which attract support from donors, as well as enabling harmonisation, reliance, and mutual recognition mechanisms. The factors enabling domestication and implementation are the presence of political will, leadership, and advocates, facilitators, or champions for the cause. Additionally, participation in regulatory harmonisation initiatives and the desire to have legal provisions at the national level that allow for regional harmonisation and international collaboration are enabling factors. The challenges encountered in the process of domesticating and implementing the model law are the lack of human and financial resources, competing priorities at the national level, overlapping roles of government institutions, and the process of amending/repealing laws being slow and lengthy. Conclusion: This study has enabled an improved understanding of the AU Model Law process, the perceived benefits of its domestication, and the enabling factors for its adoption from the perspective of African NRAs. NRAs have also highlighted the challenges encountered in the process. Addressing these challenges will result in a harmonised legal environment for medicines regulation in Africa and be an important enabler for the effective operation of the African Medicines Agency.

Assessing the use of constructs from the consolidated framework for implementation research in U.S. rural cancer screening promotion programs: a systematic search and scoping review.

BACKGROUND: Cancer screening is suboptimal in rural areas, and interventions are needed to improve uptake. The Consolidated Framework for Implementation Research (CFIR) is a widely-used implementation science framework to optimize planning and delivery of evidence-based interventions, which may be particularly useful for screening promotion in rural areas. We examined the discussion of CFIR-defined domains and constructs in programs to improve cancer screening in rural areas. METHODS: We conducted a systematic search of research databases (e.g., Medline, CINAHL) to identify studies (published through November 2022) of cancer screening promotion programs delivered in rural areas in the United States. We identified 166 records, and 15 studies were included. Next, two reviewers used a standardized abstraction tool to conduct a critical scoping review of CFIR constructs in rural cancer screening promotion programs. RESULTS: Each study reported at least some CFIR domains and constructs, but studies varied in how they were reported. Broadly, constructs from the domains of Process, Intervention, and Outer setting were commonly reported, but constructs from the domains of Inner setting and Individuals were less commonly reported. The most common constructs were planning (100% of studies reporting), followed by adaptability, cosmopolitanism, and reflecting and evaluating (86.7% for each). No studies reported tension for change, self-efficacy, or opinion leader. CONCLUSIONS: Leveraging CFIR in the planning and delivery of cancer screening promotion programs in rural areas can improve program implementation. Additional studies are needed to evaluate the impact of underutilized CFIR domains, i.e., Inner setting and Individuals, on cancer screening programs.

Sustainment of diverse evidence-informed practices disseminated in the Veterans Health Administration (VHA): initial development and piloting of a pragmatic survey tool.

BACKGROUND: There are challenges associated with measuring sustainment of evidence-informed practices (EIPs). First, the terms sustainability and sustainment are often falsely conflated: sustainability assesses the likelihood of an EIP being in use in the future while sustainment assesses the extent to which an EIP is (or is not) in use. Second, grant funding often ends before sustainment can be assessed. The Veterans Health Administration (VHA) Diffusion of Excellence (DoE) program is one of few large-scale models of diffusion; it seeks to identify and disseminate practices across the VHA system. The DoE sponsors "Shark Tank" competitions, in which leaders bid on the opportunity to implement a practice with approximately 6 months of implementation support. As part of an ongoing evaluation of the DoE, we sought to develop and pilot a pragmatic survey tool to assess sustainment of DoE practices. METHODS: In June 2020, surveys were sent to 64 facilities that were part of the DoE evaluation. We began analysis by comparing alignment of quantitative and qualitative responses; some facility representatives reported in the open-text box of the survey that their practice was on a temporary hold due to COVID-19 but answered the primary outcome question differently. As a result, the team reclassified the primary outcome of these facilities to Sustained: Temporary COVID-Hold. Following this reclassification, the number and percent of facilities in each category was calculated. We used directed content analysis, guided by the Consolidated Framework for Implementation Research (CFIR), to analyze open-text box responses. RESULTS: A representative from forty-one facilities (64%) completed the survey. Among responding facilities, 29/41 sustained their practice, 1/41 partially sustained their practice, 8/41 had not sustained their practice, and 3/41 had never implemented their practice. Sustainment rates increased between Cohorts 1-4. CONCLUSIONS: The initial development and piloting of our pragmatic survey allowed us to assess sustainment of DoE practices. Planned updates to the survey will enable flexibility in assessing sustainment and its determinants at any phase after adoption. This assessment approach can flex with the longitudinal and dynamic nature of sustainment, including capturing nuances in outcomes when practices are on a temporary hold. If additional piloting illustrates the survey is useful, we plan to assess the reliability and validity of this measure for broader use in the field.

Factors That Support Sustainability of Health Systems Change to Increase Colorectal Cancer Screening in Primary Care Clinics: A Longitudinal Qualitative Study.

BACKGROUND: From 2015 to 2020, the Centers for Disease Control and Prevention's Colorectal Cancer Control Program (CRCCP) supported 30 awardees in partnering with primary care clinics to implement evidence-based interventions (EBIs) and supporting activities (SAs) to increase colorectal cancer (CRC) screening. This study identified factors that facilitated early implementation and sustainability within partner clinics. METHODS: We conducted longitudinal qualitative case studies of four CRCCP awardees and four of their partner clinics. We used the Consolidated Framework for Implementation Research (CFIR) to frame understanding of factors related to implementation and sustainability. A total of 41 semi-structured interviews were conducted with key staff and stakeholders exploring implementation practices and facilitators to sustainability. Qualitative thematic analysis of interview transcripts identified emerging themes across awardees and clinics. RESULTS: Qualitative themes related to six CFIR inner setting constructs-structural characteristics, readiness for implementation, networks and communication, culture, and implementation climate-were identified. Themes related to early implementation included conducting readiness assessments to tailor implementation, providing moderate funding to clinics, identifying clinic champions, and coordinating EBIs and SAs with existing clinic practices. Themes related to sustainability included the importance of ongoing electronic health record (EHR) support, clinic leadership support, team-based care, and EBI and SA integration with clinic policies, workflows, and procedures. IMPLICATIONS: Findings help to inform future scale-up of and decision-making within CRC screening programs and other chronic disease prevention programs implementing EBIs and SAs within primary care clinics and also highlight factors that maximize sustainability within these programs.