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BACKGROUND: Despite the increased risk of cervical cancer (CC) among women living with HIV (WLHIV), CC screening and treatment (CCST) rates remain low in Africa. The integration of CCST services into established HIV programs in Africa can improve CC prevention and control. However, the paucity of evidence on effective implementation strategies (IS) has limited the success of integration in many countries. In this study, we seek to identify effective IS to enhance the integration of CCST services into existing HIV programs in Nigeria. METHODS: Our proposed study has formative and experimental activities across the four phases of the Exploration, Preparation, Implementation, and Sustainment (EPIS) framework. Through an implementation mapping conducted with stakeholders in the exploration phase, we identified a core package of IS (Core) and an enhanced package of IS (Core+) mostly selected from the Expert Recommendations for Implementing Change. In the preparation phase, we refined and tailored the Core and Core+ IS with the implementation resource teams for local appropriateness. In the implementation phase, we will conduct a cluster-randomized hybrid type III trial to assess the comparative effectiveness of Core versus Core+. HIV comprehensive treatment sites (k = 12) will be matched by region and randomized to Core or Core+ in the ratio of 1:1 stratified by region. In the sustainment phase, we will assess the sustainment of CCST at each site. The study outcomes will be assessed using RE-AIM: reach (screening rate), adoption (uptake of IS by study sites), IS fidelity (degree to which the IS occurred according to protocol), clinical intervention fidelity (delivery of CC screening, onsite treatment, and referral according to protocol), clinical effectiveness (posttreatment screen negative), and sustainment (continued integrated CCST service delivery). Additionally, we will descriptively explore potential mechanisms, including organizational readiness, implementation climate, CCST self-efficacy, and implementation intentions. DISCUSSION: The assessment of IS to increase CCST rates is consistent with the global plan of eliminating CC as a public health threat by 2030. Our study will identify a set of evidence-based IS for low-income settings to integrate evidence-based CCST interventions into routine HIV care in order to improve the health and life expectancy of WLHIV. TRIAL REGISTRATION: Prospectively registered on November 7, 2023, at ClinicalTrials.gov no. NCT06128304. https://classic. CLINICALTRIALS: gov/ct2/show/study/NCT06128304.

BACKGROUND: The University of Californias Diabetes Prevention Program (UC DPP) Initiative was implemented across all 10 UC campuses in 2018. The COVID-19 pandemic and accompanying mandates required swift changes to program delivery, including pivoting from in-person to virtual delivery (i.e., Zoom). Our goal was to assess multilevel constituent perceptions of the use of a virtual platform to deliver UC DPP due to COVID-19 mandates. METHODS: We conducted qualitative interviews with 68 UC DPP participants, coordinators, and leaders to examine the use of virtual platform delivery on the reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) of UC DPP. Transcripts were analyzed using rapid qualitative analysis and emergent themes were categorized using domains corresponding to RE-AIM framework. RESULTS: Among UC DPP participants (n = 42), virtual delivery primarily impacted perceptions of UC DPP effectiveness and implementation. Some participants perceived program effectiveness to be negatively impacted, given their preference for in-person sessions, which they felt provided more engagement, peer support, and accountability. Implementation challenges included problems with virtual format (e.g., Zoom fatigue); however, several benefits were also noted (e.g., increased flexibility, maintenance of DPP connections during campus closures). UC DPP coordinators (n = 18) perceived virtual delivery as positively impacting UC DPP reach, since virtual platforms provided access for some who could not participate in-person, and negatively impacting effectiveness due to reduced engagement and lower peer support. UC leaders (n = 8) perceived that use of the virtual format had a positive impact on reach (e.g., increased availability, accessibility) and negatively impacted effectiveness (e.g., less intensive interactions on a virtual platform). Across constituent levels, the use of a virtual platform had little to no impact on perceptions of adoption and maintenance of UC DPP. CONCLUSION: Perceptions of the reach, effectiveness, and implementation of UC DPP using a virtual platform varied across constituents, although all groups noted a potential negative impact on overall program effectiveness. Unanticipated program adaptations, including virtual delivery, present potential benefits as well as perceived drawbacks, primarily across the effectiveness domain. Understanding differential constituent perceptions of the impact of virtual delivery can help maximize RE-AIM and inform future UC DPP delivery strategies.

Type 2 diabetes disproportionately impacts ethnic minorities and individuals from low socioeconomic status. Diabetes self-management education and support has been shown to improve clinical outcomes in these populations, and mobile health (mHealth) interventions can reduce barriers to access. Dulce Digital-Me (DD-Me) was developed to integrate adaptive mHealth technologies to enhance self-management and reduce disparities in the high-risk, underserved Hispanic population. The objective of the present study was to evaluate reach, adoption, and implementation of an mHealth diabetes self-management education and support intervention in this underrepresented population. The present analysis is a multimethod process evaluation using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. The study was effective in reaching a sample that was representative of the intended population; only modest but significant differences were observed in sex and age. The DD-Me health coach (HC) cited several important facilitators of intervention adoption, including outreach frequency and personalization, and the automated HC report. Implementation fidelity was high, with participants receiving >90% of intended interventions. Participants who received DD-Me with support from a HC were most engaged, suggesting utility and acceptability of integrating HCs with mHealth interventions. Perceptions of implementation among study participants were positive and consistent across study arms. This evaluation revealed the target population was successfully reached and engaged in the digital health interventions, which was implemented with high fidelity. Further studies should evaluate the efficacy and maintenance of the study following the RE-AIM model to determine whether this intervention warrants expansion to additional settings and populations.

INTRODUCTION: To assess healthcare professionals perceptions of rural barriers and facilitators of lung cancer screening program implementation in a Veterans Health Administration (VHA) setting through a series of one-on-one interviews with healthcare team members. METHODS: Based on measures developed using Reach Effectiveness Adoption Implementation Maintenance (RE-AIM), we conducted a cross-sectional qualitative study consisting of one-on-one semi-structured telephone interviews with VHA healthcare team members at 10 Veterans Affairs medical centers (VAMCs) between December 2020 and September 2021. An iterative inductive and deductive approach was used for qualitative analysis of interview data, resulting in the development of a conceptual model to depict rural barriers and facilitators of lung cancer screening program implementation. RESULTS: A total of 30 interviews were completed among staff, providers, and lung cancer screening program directors and a conceptual model of rural barriers and facilitators of lung cancer screening program implementation was developed. Major themes were categorized within institutional and patient environments. Within the institutional environment, participants identified systems-level (patient communication, resource availability, workload), provider-level (attitudes and beliefs, knowledge, skills and capabilities), and external (regional and national networks, incentives) barriers to and facilitators of lung cancer screening program implementation. Within the patient environment, participants revealed patient-level (modifiable vulnerabilities) barriers and facilitators as well as ecological modifiers (community) that influence screening behavior. DISCUSSION: Understanding rural barriers to and facilitators of lung cancer screening program implementation as perceived by healthcare team members points to opportunities and approaches for improving lung cancer screening reach, implementation and effectiveness in VHA rural settings.

Cognitive Symptom Management and Rehabilitation Training (CogSMART) and Compensatory Cognitive Training (CCT) are evidence-based compensatory cognitive training interventions that improve cognition in persons with a history of traumatic brain injury or other neuropsychiatric disorders. Despite demonstrated efficacy, use and effectiveness of CogSMART/CCT in real-world settings is not known.We used a multi-method design to collect and analyze quantitative and qualitative survey data from several domains of the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to gather information about use of CogSMART/CCT in real-world settings from provider and patient perspectives. Surveys were sent to email addresses from persons who registered on the CogSMART website seeking access to training manuals and other resources. Descriptive statistics were generated, and we used Natural Language Processing methods to study the self-report free responses. Using n-gram analysis, we identified the most frequently reported responses.We found CogSMART/CCT was broadly used in real-world settings and delivered by a variety of providers for several patient groups with high attendance and overall high satisfaction. CogSMART/CCT seemed to be offered in VA- or university-related clinics more than in private practice or rehabilitation centers. The diversity of providers and variety of formats by which to deliver CogSMART/CCT (i.e., individual, group, telehealth) seemed to play a role in its widespread implementation, as did its adaptability. Most providers made adaptations to the intervention that reduced the length or number of sessions. These changes were most likely to be based on client characteristics. The low rates of formal training, however, may have contributed to lower levels of perceived helpfulness among patients.Reach and Adoption of a cognitive rehabilitation intervention improved by increasing access to the manuals. Attention to characteristics of dissemination and implementation in the design of an intervention may enhance its use in real-world settings. The relevant outcomes, easy access to training manuals, and adaptability of CogSMART/CCT seem to have been important factors in its use in a variety of settings and for several disorders with cognitive impairment. The adoption of CogSMART/CCT by a variety of providers other than neuropsychologists suggests its use may be broadened to other healthcare providers, if adequately trained, to increase access to an intervention with demonstrated efficacy for cognitive rehabilitation for several neuropsychiatric disorders.

BackgroundThe Practical, Robust Implementation and Sustainability Model (PRISM) was developed in 2008 as a contextually expanded version of the broadly used Reach, Adoption, Effectiveness, Implementation, and Maintenance (RE-AIM) framework. PRISM provides researchers a pragmatic and intuitive model to improve translation of research interventions into clinical and community practice. Since 2008, the use of PRISM increased across diverse topics, populations, and settings. This citation analysis and scoping systematic review aimed to assess the use of the PRISM framework and to make recommendations for future research.MethodsA literature search was conducted using three databases (PubMed, Web of Science, Scopus) for the period of 2008 and September 2020. After exclusion, reverse citation searches and invitations to experts in the field were used to identify and obtain recommendations for additional articles not identified in the original search. Studies that integrated PRISM into their study design were selected for full abstraction. Unique research studies were abstracted for information on study characteristics (e.g., setting/population, design), PRISM contextual domains, and RE-AIM outcomes.ResultsA total of 180 articles were identified to include PRISM to some degree. Thirty-two articles representing 23 unique studies integrated PRISM within their study design. Study characteristics varied widely and included studies conducted in diverse contexts, but predominately in high-income countries and in clinical out-patient settings. With regards to use, 19 used PRISM for evaluation, 10 for planning/development, 10 for implementation, four for sustainment, and one for dissemination. There was substantial variation across studies in how and to what degree PRISM contextual domains and RE-AIM outcomes were operationalized and connected. Only two studies directly connected individual PRISM context domains with RE-AIM outcomes, and another four included RE-AIM outcomes without direct connection to PRISM domains.ConclusionsThis is the first systematic review of the use of PRISM in various contexts. While there were low levels of 'integrated' use of PRISM and few reports on linkage to RE-AIM outcomes, most studies included important context domains of implementation and sustainability infrastructure and external environment. Recommendations are provided for more consistent and comprehensive use of and reporting on PRISM to inform both research and practice on contextual factors in implementation.

ObjectivesThe objective of this paper was to examine the implementation and effectiveness of a community-based intervention for hoarding disorder (HD) using Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST).DesignThis was a mixed-method, pre-post quasi-experimental study informed by the Practical, Robust Implementation and Sustainability Model for implementation science.SettingProgram activities took place in San Diego County, mainly within clients' homes or community, with some activities in-office.ParticipantsParticipants were aged 60 years or older, met eligibility for Medi-Cal or were uninsured, and met criteria for HD.InterventionA manualized, mobile protocol that incorporated CREST was utilized.MeasurementsThe Clutter Image Rating and Hoarding Rating Scale were used as effectiveness outcomes. An investigator-created staff questionnaire was used to evaluate implementation.ResultsThirty-seven clients were reached and enrolled in treatment and 15 completed treatment during the initial 2 years of the program. There were significant changes in hoarding severity and clutter volume. Based on the initial 2 years of the program, funding was provided for expansion to cover additional San Diego County regions and hire more staff clinicians in year three.ConclusionPreliminary data suggest that the CREST intervention can be successfully implemented in a community setting with positive results for older adults with HD.

BackgroundType 2 diabetes can negatively impact long term health outcomes, healthcare costs and quality of life. However, intensive lifestyle interventions, including the Diabetes Prevention Program (DPP), can significantly lower risk of incident type 2 diabetes among overweight adults with prediabetes. Unfortunately, the majority of adults in the US who are at risk of developing diabetes do not engage in DPP-based lifestyle change programs. Increased adoption of evidence-based obesity and diabetes prevention interventions, such as the DPP, may help large employers reduce health risks and improve health outcomes among employees. In 2018, the University of California Office of thePresident (UCOP) implemented the UC DPP Initiative, a novel, multi-component program to address diabetes and obesity prevention across the UC system.MethodsThe goal of our study is to conduct a multifaceted evaluation of the UC DPP Initiative using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Our evaluation will integrate unique and diverse UC data sources, including electronic health record (EHR) data, administrative claims, campus-based DPP cohort data, qualitative interviews and site visits. Our primary outcome of interest is the mean percent weight change among three groups of overweight/obese UC beneficiaries at risk for diabetes at 12-month follow-up. Secondary outcomes include mean percent weight change at 24-month follow-up, barriers and facilitators associated with implementatio, as well as  the degree of program adoption and maintenance.DiscussionOur study will help inform diabetes and obesity prevention efforts across the UC system. Findings from this evaluation will also be highly applicable to universities and large employers, as well as community organizers, healthcare organizations and insurers implementing the DPP and/or other health promotion interventions.

BACKGROUND: Post-9/11 veterans who enroll in VA health care frequently present with suicidal ideation and/or recent suicidal behavior. Most of these veterans are not screened on their day of enrollment and their risk goes undetected. Screening for suicide risk, and associated mental health factors, can lead to early detection and referral to effective treatment, thereby decreasing suicide risk. eScreening is an innovative Gold Standard Practice with evidence to support its effectiveness and implementation potential in transition and care management (TCM) programs. We will evaluate the impact of eScreening to improve the rate and speed of suicide risk screening and referral to mental health care compared to current screening methods used by transition care managers. We will also evaluate the impact of an innovative, multicomponent implementation strategy (MCIS) on the reach, adoption, implementation, and sustained use of eScreening. METHODS: This is an eight-site 4-year, stepped-wedge, mixed-method, hybrid type-II implementation trial comparing eScreening to screening as usual while also evaluating the potential impact of the MCIS focusing on external facilitation and Lean/SixSigma rapid process improvement workshops in TCM. The aims will address: 1) whether using eScreening compared to oral and/or paper-based methods in TCM programs is associated with improved rates and speed of PTSD, depression, alcohol, and suicide screening & evaluation, and increased referral to mental health treatment; 2) whether and to what degree our MCIS is feasible, acceptable, and has the potential to impact adoption, implementation, and maintenance of eScreening; and 3) how contextual factors influence the implementation of eScreening between high- and low-eScreening adopting sites. We will use a mixed methods approach guided by the RE-AIM outcomes of the Practical Robust Implementation and Sustainability Model (PRISM). Data to address Aim 1 will be collected via medical record query while data for Aims 2 and 3 will be collected from TCM staff questionnaires and qualitative interviews. DISCUSSION: The results of this study will help identify best practices for screening in suicide prevention for Post-9/11 veterans enrolling in VA health care and will provide information on how best to implement technology-based screening into real-world clinical care programs. TRIAL REGISTRATION: ClinicalTrials.gov : NCT04506164; date registered: August 20, 2020; retrospectively registered.

BackgroundIndividuals living with sickle cell disease often require aggressive treatment of pain associated with vaso-occlusive episodes in the emergency department. Frequently, pain relief is poor. The 2014 National Heart, Lung, and Blood Institute evidence-based guidelines recommended an individualized treatment and monitoring protocol to improve pain management of vaso-occlusive episodes.ObjectiveThis study will implement an electronic health record-embedded individualized pain plan with provider and patient access in the emergency departments of 8 US academic centers to improve pain treatment for adult patients with sickle cell disease. This study will assess the overall effects of electronic health record-embedded individualized pain plans on improving patient and provider outcomes associated with pain treatment in the emergency department setting and explore barriers and facilitators to the implementation process.MethodsA preimplementation and postimplementation study is being conducted by all 8 sites that are members of the National Heart, Lung, and Blood Institute-funded Sickle Cell Disease Implementation Consortium. Adults with sickle cell disease aged 18 to 45 years who had a visit to a participating emergency department for vaso-occlusive episodes within 90 days prior to enrollment will be eligible for inclusion. Patients will be enrolled in the clinic or remotely. The target analytical sample size of this study is 160 patient participants (20 per site) who have had an emergency department visit for vaso-occlusive episode treatment at participating emergency departments during the study period. Each site is expected to enroll approximately 40 participants to reach the analytical sample size. The electronic health record-embedded individualized pain plans will be written by the patient's sickle cell disease provider, and sites will work with the local informatics team to identify the best method to build the electronic health record-embedded individualized pain plan with patient and provider access. Each site will adopt required patient and provider implementation strategies and can choose to adopt optional strategies to improve the uptake and sustainability of the intervention. The study is informed by the Technology Acceptance Model 2 and the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. Provider and patient baseline survey, follow-up survey within 96 hours of an emergency department vaso-occlusive episode visit, and selected qualitative interviews within 2 weeks of an emergency department visit will be performed to assess the primary outcome, patient-perceived quality of emergency department pain treatment, and additional implementation and intervention outcomes. Electronic health record data will be used to analyze individualized pain plan adherence and additional secondary outcomes, such as hospital admission and readmission rates.ResultsThe study is currently enrolling study participants. The active implementation period is 18 months.ConclusionsThis study proposes a structured, framework-informed approach to implement electronic health record-embedded individualized pain plans with both patient and provider access in routine emergency department practice. The results of the study will inform the implementation of electronic health record-embedded individualized pain plans at a larger scale outside of Sickle Cell Disease Implementation Consortium centers.Trial registrationClinicalTrials.gov NCT04584528; https://clinicaltrials.gov/ct2/show/NCT04584528.International registered report identifier (irrid)DERR1-10.2196/24818.

BACKGROUND:Hydroxyurea prevents disease complications among patients with sickle cell disease (SCD). Although its efficacy has been endorsed by the National Health Lung and Blood Institute evidence-based guidelines, its adoption is low, both by patients with SCD and providers. Mobile health (mHealth) apps provide benefits in improving medication adherence and self-efficacy among patients with chronic diseases and have facilitated prescription among medical providers. However, mHealth has not been systematically tested as a tool to increase hydroxyurea adherence nor has the combination of mHealth been assessed at both patient and provider levels to increase hydroxyurea utilization. OBJECTIVE:This study aims to increase hydroxyurea utilization through a combined two-level mHealth intervention for both patients with SCD and their providers with the goals of increasing adherence to hydroxyurea among patients and improve hydroxyurea prescribing behavior among providers. METHODS:We will test the efficacy of 2 mHealth interventions to increase both patient and provider utilization and knowledge of hydroxyurea in 8 clinical sites of the NHLBI-funded Sickle Cell Disease Implementation Consortium (SCDIC). The patient mHealth intervention, InCharge Health, includes multiple components that address memory, motivation, and knowledge barriers to hydroxyurea use. The provider mHealth intervention, Hydroxyurea Toolbox (HU Toolbox), addresses the clinical knowledge barriers in prescribing and monitoring hydroxyurea. The primary hypothesis is that among adolescents and adults with SCD, adherence to hydroxyurea, as measured by the proportion of days covered (the ratio of the number of days the patient is covered by the medication to the number of days in the treatment period), will increase by at least 20% after 24 weeks of receiving the InCharge Health app, compared with their adherence at baseline. As secondary objectives, we will (1) examine the change in health-related quality of life, acute disease complications, perceived health literacy, and perceived self-efficacy in taking hydroxyurea among patients who use InCharge Health and (2) examine potential increases in the awareness of hydroxyurea benefits and risks, appropriate prescribing, and perceived self-efficacy to correctly administer hydroxyurea therapy among SCD providers between baseline and 9 months of using the HU Toolbox app. We will measure the reach, adoption, implementation, and maintenance of both the InCharge Health and the HU Toolbox apps using the reach, effectiveness, adoption, implementation, and maintenance framework and qualitatively evaluate the implementation of both mHealth interventions. RESULTS:The study is currently enrolling study participants. Recruitment is anticipated to be completed by mid-2021. CONCLUSIONS:If this two-level intervention, that is, the combined use of InCharge Health and HU Toolbox apps, demonstrates efficacy in increasing adherence to hydroxyurea and prescribing behavior in patients with SCD and their providers, respectively, both apps will be offered to other institutions outside the SCDIC through a future large-scale implementation-effectiveness study. TRIAL REGISTRATION:ClinicalTrials.gov NCT04080167; https://clinicaltrials.gov/ct2/show/NCT04080167. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/16319.

BackgroundElectronic consultation is an emerging mode of specialty care delivery that allows primary care providers and their patients to obtain specialist expertise without an in-person visit. While studies of individual programs have demonstrated benefits related to timely access to specialty care, electronic consultation programs have not achieved widespread use in the United States. The lack of common evaluation metrics across health systems and concerns related to the generalizability of existing evaluation efforts may be hampering further growth. We sought to identify gaps in knowledge related to the implementation of electronic consultation programs and develop a set of shared evaluation measures to promote further diffusion.MethodsUsing a case study approach, we apply the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) and the Quadruple Aim frameworks of evaluation to examine electronic consultation implementation across diverse delivery systems. Data are from 4 early adopter healthcare delivery systems (San Francisco Health Network, Mayo Clinic, Veterans Administration, Champlain Local Health Integration Network) that represent varied organizational structures, care for different patient populations, and have well-established multi-specialty electronic consultation programs. Data sources include published and unpublished quantitative data from each electronic consultation database and qualitative data from systems' end-users.ResultsOrganizational drivers of electronic consultation implementation were similar across the systems (challenges with timely and/or efficient access to specialty care), though unique system-level facilitators and barriers influenced reach, adoption and design. Effectiveness of implementation was consistent, with improved patient access to timely, perceived high-quality specialty expertise with few negative consequences, garnering high satisfaction among end-users. Data about patient-specific clinical outcomes are lacking, as are policies that provide guidance on the legal implications of electronic consultation and ideal remuneration strategies.ConclusionA core set of effectiveness and implementation metrics rooted in the Quadruple Aim may promote data-driven improvements and further diffusion of successful electronic consultation programs.

BackgroundConducting 5 A's counseling in clinic and utilizing technology-based resources are recommended to promote physical activity but little is known about how to implement such an intervention. This investigation aimed to determine the feasibility and acceptability, using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework, of a pragmatic, primary care-based intervention that incorporated 5 A's counseling and self-control through an activity monitor.MethodsPrimary care patients (n = 40) 55-74 years of age were recruited and randomized to receive a pedometer or an electronic activity monitor (EAM), Jawbone UP24, to monitor activity for 12 weeks. Participants were also invited to a focus group after completing the intervention. Stakeholders (n = 36) were recruited to provide feedback.ResultsThe intervention recruitment rate was 24.7%. The attrition rate was 20% with a significantly higher rate for the pedometer group (p = 0.02). The EAM group increased their minutes of physical activity by 11.1 min/day while the pedometer maintained their activity (0.2 min/day), with no significant group difference. EAM participants liked using their monitor and would continue wearing it while the pedometer group was neutral to these statements (p