Establishing evidence criteria for implementation strategies in the US: a Delphi study for HIV services.

BACKGROUND: There are no criteria specifically for evaluating the quality of implementation research and recommending implementation strategies likely to have impact to practitioners. We describe the development and application of the Best Practices Tool, a set of criteria to evaluate the evidence supporting HIV-specific implementation strategies. METHODS: We developed the Best Practices Tool from 2022-2023 in three phases. (1) We developed a draft tool and criteria based on a literature review and key informant interviews. We purposively selected and recruited by email interview participants representing a mix of expertise in HIV service delivery, quality improvement, and implementation science. (2) The tool was then informed and revised through two e-Delphi rounds using a survey delivered online through Qualtrics. The first and second round Delphi surveys consisted of 71 and 52 open and close-ended questions, respectively, asking participants to evaluate, confirm, and make suggestions on different aspects of the rubric. After each survey round, data were analyzed and synthesized as appropriate; and the tool and criteria were revised. (3) We then applied the tool to a set of research studies assessing implementation strategies designed to promote the adoption and uptake of evidence-based HIV interventions to assess reliable application of the tool and criteria. RESULTS: Our initial literature review yielded existing tools for evaluating intervention-level evidence. For a strategy-level tool, additions emerged from interviews, for example, a need to consider the context and specification of strategies. Revisions were made after both Delphi rounds resulting in the confirmation of five evaluation domains - research design, implementation outcomes, limitations and rigor, strategy specification, and equity - and four evidence levels - best, promising, more evidence needed, and harmful. For most domains, criteria were specified at each evidence level. After an initial pilot round to develop an application process and provide training, we achieved 98% reliability when applying the criteria to 18 implementation strategies. CONCLUSIONS: We developed a tool to evaluate the evidence supporting implementation strategies for HIV services. Although specific to HIV in the US, this tool is adaptable for evaluating strategies in other health areas.

Implementation Preparation Costs of Virtual Interview Training in Pre-Employment Transition Services: A Budget Impact Analysis.

Virtual Reality Job Interview Training (VR-JIT) and Virtual Interview Training for Transition Age Youth (VIT-TAY) demonstrated initial effectiveness at increasing employment among transition-age youth with disabilities engaged in pre-employment transition services. We characterized activities and estimated the labor and non-labor costs required to prepare schools to implement VR-JIT or VIT-TAY. Implementation preparation and support teams reported labor hours throughout the implementation preparation process. Implementation preparation labor hours at 43 schools cost approximately $1,427 per school, while non-labor costs were $100 per trainee (student). We estimated the replication of implementation preparation labor activities would cost $1,024 per school (range: $841-$1,208). Most costs were spent in delivery planning and teacher training. Given that implementation preparation costs can be barriers to intervention adoption, our results provide critical information for contemplating future implementation of VR-JIT or VIT-TAY.

A Scoping Review of Tailoring in Pediatric Obesity Interventions.

Background: Families with children who have or are at risk for obesity have differing needs and a one-size-fits-all approach can negatively impact program retention, engagement, and outcomes. Individually tailored interventions could engage families and children through identifying and prioritizing desired areas of focus. Despite literature defining tailoring as individualized treatment informed by assessment of behaviors, intervention application varies. This review aims to exhibit the use of the term "tailor" in pediatric obesity interventions and propose a uniform definition. Methods: We conducted a scoping review following PRISMA-ScR guidelines among peer-reviewed pediatric obesity prevention and management interventions published between 1995 and 2021. We categorized 69 studies into 6 groups: (1) individually tailored interventions, (2) computer-tailored interventions/tailored health messaging, (3) a protocolized group intervention with a tailored component, (4) only using the term tailor in the title, abstract, introduction, or discussion, e) using the term tailor to describe another term, and (5) interventions described as culturally tailored. Results: The scoping review exhibited a range of uses and lack of explicit definitions of tailoring in pediatric obesity interventions including some that deviate from individualized designs. Effective tailored interventions incorporated validated assessments for behaviors and multilevel determinants, and recipient-informed choice of target behavior(s) and programming. Conclusions: We urge interventionists to use tailoring to describe individualized, assessment-driven interventions and to clearly define how an intervention is tailored. This can elucidate the role of tailoring and its potential for addressing the heterogeneity of behavioral and social determinants for the prevention and management of pediatric obesity.

Virtual Job Interview Training: A Dose Response to Improve Employment for Transition-Age Youth With Disabilities.

Virtual Interview Training for Transition Age Youth and Virtual Reality Job Interview Training are job interview simulators with demonstrated effectiveness in randomized controlled trials. We evaluated their dose responses via secondary data analysis of 558 transition-age youth with disabilities in 47 schools where the simulators were implemented in quasi-experimental studies. Cut-point analyses determined dosing efficiency and efficacy to optimize competitive employment. The most efficient dose when accounting for the balance between dose and employment was completing nine virtual interviews. The most efficacious dose to maximize the likelihood of successful employment was 38, but varied across race, IQ, IDEA categories and employment history. This study provides a novel approach to inform implementation guidelines for virtual interview training in pre-employment transition services. Limitations and implications for research and practice are discussed.

A mixed methods evaluation of patient perspectives on the implementation of an electronic health record-integrated patient-reported symptom and needs monitoring program in cancer care.

BACKGROUND: As cancer centers have increased focus on patient-centered, evidenced-based care, implementing efficient programs that facilitate effective patient-clinician communication remains critical. We implemented an electronic health record-integrated patient-reported symptom and needs monitoring program ('cPRO' for cancer patient-reported outcomes). To aid evaluation of cPRO implementation, we asked patients receiving care in one of three geographical regions of an academic healthcare system about their experiences. METHODS: Using a sequential mixed-methods approach, we collected feedback in two waves. Wave 1 included virtual focus groups and interviews with patients who had completed cPRO. In Wave 2, we administered a structured survey to systematically examine Wave 1 themes. All participants had a diagnosed malignancy and received at least 2 invitations to complete cPRO. We used rapid and traditional qualitative methods to analyze Wave 1 data and focused on identifying facilitators and barriers to cPRO implementation. Wave 2 data were analyzed descriptively. RESULTS: Participants (n = 180) were on average 62.9 years old; were majority female, White, non-Hispanic, and married; and represented various cancer types and phases of treatment. Wave 1 participants (n = 37) identified facilitators, including cPRO's perceived value and favorable usability, and barriers, including confusion about cPRO's purpose and various considerations for responding. High levels of clinician engagement with, and patient education on, cPRO were described as facilitators while low levels were described as barriers. Wave 2 (n = 143) data demonstrated high endorsement rates of cPRO's usability on domains such as navigability (91.6%), comprehensibility (98.7%), and relevance (82.4%). Wave 2 data also indicated low rates of understanding cPRO's purpose (56.7%), education from care teams about cPRO (22.5%), and discussing results of cPRO with care teams (16.3%). CONCLUSIONS: While patients reported high value and ease of use when completing cPRO, they also reported areas of confusion, emphasizing the importance of patient education on the purpose and use of cPRO and clinician engagement to sustain participation. These results guided successful implementation changes and will inform future improvements.

Statistical analysis plan for the NU IMPACT stepped-wedge cluster randomized trial.

BACKGROUND: As part of the IMPACT Consortium of three effectiveness-implementation trials, the NU IMPACT trial was designed to evaluate implementation and effectiveness outcomes for an electronic health record (EHR)-embedded symptom monitoring and management program for outpatient cancer care. NU IMPACT uses a unique stepped-wedge cluster randomized design, involving six clusters of 26 clinics, for evaluation of implementation outcomes with an embedded patient-level randomized trial to evaluate effectiveness outcomes. Collaborative, consortium-wide efforts to ensure use of the most robust and recent analytic methodologies for stepped-wedge trials motivated updates to the statistical analysis plan for implementation outcomes in the NU IMPACT trial. METHODS: In the updated statistical analysis plan for NU IMPACT, the primary implementation outcome patient adoption, as measured by clinic-level monthly proportions of patient engagement with the EHR-based cancer symptom monitoring system, will be analyzed using generalized least squares linear regression with auto-regressive errors and adjustment for cluster and time effects (underlying secular trends). A similar strategy will be used for secondary patient and provider implementation outcomes. DISCUSSION: The analytic updates described here resulted from highly iterative, collaborative efforts among statisticians, implementation scientists, and trial leads in the IMPACT Consortium. This updated statistical analysis plan will serve as the a priori specified approach for analyzing implementation outcomes for the NU IMPACT trial.

Navigating grey areas in HIV and mental health implementation science.

INTRODUCTION: Implementation science (IS) offers methods to systematically achieve the Ending the HIV Epidemic goals in the United States, as well as the global UNAIDS targets. Federal funders such as the National Institutes of Mental Health (NIMH) have invested in implementation research to achieve these goals, including supporting the AIDS Research Centres (ARCs), which focus on high-impact science in HIV and mental health (MH). To facilitate capacity building for the HIV/MH research workforce in IS, "grey areas," or areas of IS that are confusing, particularly for new investigators, should be addressed in the context of HIV/MH research. DISCUSSION: A group of IS experts affiliated with NIMH-funded ARCs convened to identify common and challenging grey areas. The group generated a preliminary list of 19 grey areas in HIV/MH-related IS. From the list, the authors developed a survey which was distributed to all ARCs to prioritize grey areas to address in this paper. ARC members across the United States (N = 60) identified priority grey areas requiring clarification. This commentary discusses topics with 40% or more endorsement. The top grey areas that ARC members identified were: (1) Differentiating implementation strategies from interventions; (2) Determining when an intervention has sufficient evidence for adaptation; (3) Integrating recipient perspectives into HIV/MH implementation research; (4) Evaluating whether an implementation strategy is evidence-based; (5) Identifying rigorous approaches for evaluating the impact of implementation strategies in the absence of a control group or randomization; and (6) Addressing innovation in HIV/MH IS grants. The commentary addresses each grey area by drawing from the existing literature (when available), providing expert guidance on addressing each in the context of HIV/MH research, and providing domestic and global HIV and HIV/MH case examples that address these grey areas. CONCLUSIONS: HIV/MH IS is key to achieving domestic and international goals for ending HIV transmission and mitigating its impact. Guidance offered in this paper can help to overcome challenges to rigorous and high-impact HIV/MH implementation research.

Pre-exposure prophylaxis (PrEP) among people who use drugs: a qualitative scoping review of implementation determinants and change methods.

Implementation of pre-exposure prophylaxis (PrEP) to prevent HIV transmission is suboptimal in the United States, particularly among people who use drugs (PWUD). PrEP research among PWUD is scarce, and the factors that impact implementation are largely unknown. Therefore, we conducted a scoping review of implementation determinants (i.e., barriers and facilitators), as well as the change methods (implementation strategies and adjunctive interventions) that have been evaluated to increase PrEP implementation and use among PWUD. We identified 32 peer-reviewed articles assessing determinants and five that evaluated change methods. Determinants were coded using the updated Consolidated Framework for Implementation Research (CFIR), which is an established framework to understand the multilevel barriers and facilitators associated with implementation. Findings indicate that most research was conducted among PrEP recipients (i.e., patients), focusing on awareness and willingness to use PrEP, with less focus on factors impacting clinicians and service delivery systems. Moreover, very few change methods have been evaluated to improve clinician adoption and adherence to CDC guidelines for PrEP provision and/or recipient uptake and adherence to PrEP. Future research is needed that focuses on factors impacting implementation from a clinician standpoint as well as innovative change methods to increase PrEP awareness, reach, adoption, and sustained adherence to guidelines. Implementation Science offers a wealth of knowledge to speed up the effort to end the HIV epidemic in the United States.

Improving Delivery and Use of HIV Pre-Exposure Prophylaxis in the US: A Systematic Review of Implementation Strategies and Adjunctive Interventions.

Implementation of pre-exposure prophylaxis (PrEP) to prevent HIV transmission is suboptimal in the United States. To date, the literature has focused on identifying determinants of PrEP use, with a lesser focus on developing and testing change methods to improve PrEP implementation. Moreover, the change methods available for improving the uptake and sustained use of PrEP have not been systematically categorized. To summarize the state of the literature, we conducted a systematic review of the implementation strategies used to improve PrEP implementation among delivery systems and providers, as well as the adjunctive interventions used to improve the uptake and persistent adherence to PrEP among patients. Between November 2020 and January 2021, we searched Ovid MEDLINE, PsycINFO, and Web of Science for peer reviewed articles. We identified 44 change methods (18 implementation strategies and 26 adjunctive interventions) across a variety of clinical and community-based service settings. We coded implementation strategies and adjunctive interventions in accordance with established taxonomies and reporting guidelines. Most studies focused on improving patient adherence to PrEP and most conducted pilot trials. Just over one-third of included studies demonstrated a positive effect on outcomes. In order to end the human immunodeficiency virus (HIV) epidemic in the U.S., future, large scale HIV prevention research is needed that develops and evaluates implementation strategies and adjunctive interventions for target populations disproportionately affected by HIV.

Pressure Indicator Composite Films via Compressive Deformation of a Translucent Matrix Containing a Contrasting Filler.

A neglected mechanism for pressure-responsive color change is demonstrated using cellulose acetate composites prepared by direct (solvent) immersion annealing (DIA), with different loadings of activated charcoal filler. Namely, compressive plastic deformation of the translucent cellulose acetate leads to a decrease in the optical path length and a concomitant increase in the visibility of the opaque contrasting filler. Composites bearing 1-7 wt% activated charcoal exhibited a linear relationship between applied pressure and resulting pressure mark brightness in the range of 12-56 MPa. Comparison of pressure mark patterns with cross-sectional scanning electron microscopy (SEM) supports the importance of the porous morphology arising from DIA for the tuning of the pressure indicator sensitivity. A simple ball drop test is used to illustrate the robustness and utility of these indicators in optical impact assessment.

Making it "EASI" for pediatricians to determine when toddler tantrums are "more than the terrible twos": Proof-of-concept for primary care screening with the Multidimensional Assessment Profiles-Early Assessment Screener for Irritability (MAPS-EASI).

BACKGROUND: Up to 20% of youth have impairing mental health problems as early as age 3. Early identification and intervention of mental health risks in pediatric primary care could mitigate this crisis via prevention prior to disease onset. The purpose of this study was to establish the feasibility and acceptability of implementing a brief transdiagnostic screening instrument in pediatric primary care for irritability and corollary impairment. METHOD: Five pediatric clinicians in a Midwest clinic implemented the Multidimensional Assessment Profiles-Early Assessment Screener of Irritability (MAPS-EASI) for toddlers (24-30 months) and their families. MAPS-EASI (psychometrically derived from the well-validated MAPS-Scales) includes six items (scored 0-5) about symptoms (e.g., tantrums, grumpy mood), context, and frequency and two items (scored 0-3) assessed impairment. Positive screens (MAPS-EASI ≥ 5 plus impairment ≥ 2) were referred to an evidence-based parenting intervention. We assessed reach and outcomes of MAPS-EASI screening. Follow-up interviews with clinicians assessed perspectives on irritability screening and MAPS-EASI implementation. RESULTS: Of 201 eligible families, 100 (49.8%) completed the screener for a 24- or 30-month well-child visit. Mean MAPS-EASI scores were 5.8 (SD = 3.2), mean impairment scores were 0.9 (SD = 0.9), and 24 (24.0%) screened positive. Clinicians indicated that irritability screening for toddlers was aligned with their prevention-oriented, developmentally based practice. MAPS-EASI had face validity and increased clinician decision-making confidence. Finally, clinicians identified barriers and facilitators to large-scale implementation. CONCLUSIONS: MAPS-EASI proved to be feasible and acceptable in pediatric primary care. Further tailoring will be needed as the MAPS-EASI processes are scaled out to new contexts and populations. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Potential parental determinants of the pace of evidence-based practice change in children's mental health care.

BACKGROUND: Strength of evidence is key to advancing children's mental health care but may be inadequate for driving practice change. The Designing for Accelerated Translation (DART) framework proposes a multifaceted approach: pace of implementation as a function of evidence of effectiveness, demand for the intervention, sum of risks, and costs. To inform empirical applications of DART, we solicited caregiver preferences on key elements. METHOD: In March-April 2022, we fielded a population-representative online survey in Illinois households (caregivers N = 1,326) with ≥1 child <8 years old. Six hypothetical scenarios based on the DART framework were used to elucidate caregivers' preferences on a 0-10 scale (0 = never; 10 = as soon as possible) for pace of implementation of a family-based program to address mental health concerns. RESULTS: Caregivers' pace preference scores varied significantly for each scenario. The highest mean score (7.28, 95% confidence interval [95% CI: 7.06, 7.50]) was for a scenario in which the child's provider thinks the program would be helpful (effectiveness) and the caregiver believes the program is needed (demand). In contrast, the lowest mean score (5.13, 95% CI [4.91, 5.36]) was for a scenario in which online information implies the program would be helpful (effectiveness) and the parent is concerned about the program's financial costs (cost). Caregivers' pace preference scores did not vary consistently by sociodemographic factors. CONCLUSION: In this empirical exploration of the DART framework, factors such as demand, cost, and risk, in combination with evidence of effectiveness, may influence caregivers' preferred pace of implementation for children's mental health interventions. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

A vision for implementing equitable early mental health and resilience support in pediatric primary care: A transdiagnostic, developmental approach.

INTRODUCTION: Primary care is at the forefront of addressing the pediatric mental health (MH) crisis due to its broad reach to young children and prevention and health promotion orientation. However, the promise of the delivery system for population impact remains unrealized due to several barriers, including pragmatic screening, decisional uncertainty, and limited access to evidence-based services. METHOD: This article lays the conceptual foundations for the articles in this Special Section on Mental Health, Earlier in Pediatric Primary Care, which all apply a translational mindset to proposed strategies and solutions to overcome the barriers that have limited the potential of pediatric primary care for improving the MH and wellbeing of all children. RESULTS: Valid, pragmatic, transdiagnostic, developmentally-based screening measures to identify children at heightened risk are needed. Risk screening for MH problems should assess and empirically weight socioecological risk and protective factors, as well as the child's own assets for resilience to determine probabilistic risk. Pediatric clinicians require clear clinical cutoffs and guidelines for action when risk for MH problems is identified. DISCUSSION: These strategies-a developmentally-based screener with associated risk calculator that offers clear guidance to pediatric clinicians-address decisional uncertainty regarding when to worry and when to act. The communication of probabilistic risk requires additional client-centered communication skills to overcome different types of biases (e.g., implicit, benevolent, and cognitive) that contribute to MH inequities and decisional uncertainty in acting on identified risk. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Possible unintended consequences of pediatric clinician strategies for communicating about social-emotional and developmental concerns in diverse young children.

INTRODUCTION: Screening to promote social-emotional well-being in toddlers has positive effects on long-term health and functioning. Communication about social-emotional well-being can be challenging for primary care clinicians for various reasons including lack of time, training and expertise, resource constraints, and cognitive burden. Therefore, we explored clinicians' perspectives on identifying and communicating with caregivers about social-emotional risk in toddlers. METHOD: In 2021, semistructured interviews were conducted with pediatric clinicians (N = 20) practicing in Federally Qualified Health Centers in a single metropolitan area. Most participants identified as female (n = 15; 75%), white non-Hispanic/Latino (n = 14; 70%), and were Doctors of Medicine or Osteopathic Medicine (n = 14; 70%). Thematic analysis was conducted on audio-recorded interview transcripts. RESULTS: Clinicians used various approaches to identify social-emotional concerns which were sometimes difficult to distinguish from other developmental concerns. The clinician-caregiver relationship guided identification and communication practices and cut-across themes. Themes include: starting with caregivers' concerns, communicating concerns with data and sensitivity, navigating labels, culture, and stigma, and limiting communication based on family capacity and interest. DISCUSSION: Prioritizing the clinician-caregiver relationship is consistent with best practice and family-centered care. Yet, the dearth of standardized decision support may undermine clinician confidence and impede timely conversations about social-emotional concerns. An evidence-based approach with developmentally based culturally informed quantitative tools and standardized decision supports could help ensure equitable management and decision making about young children's social and emotional well-being and development. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Vision Loss in Children from Immigrant and Nonimmigrant Households: Evidence from the National Survey of Children's Health 2018-2020.

The aim of this study was to determine whether immigrant generation is associated with caregiver-reported vision loss in children adjusting for sociodemographic characteristics. Nationally representative data from the National Survey of Children's Health (2018-2020) was used. The primary exposure was immigrant generation defined as: first (child and all reported parents were born outside the United States); second (child was born in the United States and at least one parent was born outside the United States); third or higher (all parents in the household were born in the United States). The main outcome was caregiver-reported vision loss in child. Adjusted odds ratios (aOR) and 95% confidence intervals were computed based on immigration generation. The study sample included 84,860 US children aged 3-17 years. First generation children had higher adjusted odds of caregiver-reported vision loss (aOR 2.30; 95% CI 1.21, 4.35) than third or higher generation children after adjusting for demographic characteristics and social determinants of health. For Hispanic families, first generation (aOR 2.99; 95% CI 1.34, 6.66), and second-generation children (aOR 1.70; 95% CI 1.06, 2.74) had a higher adjusted odds of vision loss compared with third or higher generation children. Even when adjusting for sociodemographic characteristics, first generation children had greater odds of vision loss, especially in Hispanic households, than third generation children. Immigration generation should be treated as an independent risk factor for vision loss for children and is a social determinant of eye health.

Project CHARIOT: study protocol for a hybrid type 1 effectiveness-implementation study of comprehensive tele-harm reduction for engagement of people who inject drugs in HIV prevention services.

BACKGROUND: People who inject drugs (PWID) remain a high priority population under the federal Ending the HIV Epidemic initiative with 11% of new HIV infections attributable to injection drug use. There is a critical need for innovative, efficacious, scalable, and community-driven models of healthcare in non-stigmatizing settings for PWID. We seek to test a Comprehensive-TeleHarm Reduction (C-THR) intervention for HIV prevention services delivered via a syringe services program (SSP). METHODS: The CHARIOT trial is a hybrid type I effectiveness-implementation study using a parallel two-arm randomized controlled trial design. Participants (i.e., PWID; n = 350) will be recruited from a syringe services program (SSP) in Miami, Florida. Participants will be randomized to receive either C-THR or non-SSP clinic referral and patient navigation. The objectives are: (1) to determine if the C-THR intervention increases engagement in HIV prevention (i.e., HIV pre-exposure prophylaxis; PrEP or medications for opioid use disorder; MOUD) compared to non-SSP clinic referral and patient navigation, (2) to examine the long-term effectiveness and cost-effectiveness of the C-THR intervention, and (3) to assess the barriers and facilitators to implementation and sustainment of the C-THR intervention. The co-primary outcomes are PrEP or MOUD engagement across follow-up at 3, 6, 9 and 12 months. For PrEP, engagement is confirmed by tenofovir on dried blood spot or cabotegravir injection within the previous 8 weeks. For MOUD, engagement is defined as screening positive for norbuprenorphine or methadone on urine drug screen; or naltrexone or buprenorphine injection within the previous 4 weeks. Secondary outcomes include PrEP adherence, engagement in HCV treatment and sustained virologic response, and treatment of sexually transmitted infections. The short and long term cost-effectiveness analyses and mixed-methods implementation evaluation will provide compelling data on the sustainability and possible impact of C-THR on comprehensive HIV prevention delivered via SSPs. DISCUSSION: The CHARIOT trial will be the first to our knowledge to test the efficacy of an innovative, peer-led telehealth intervention with PWID at risk for HIV delivered via an SSP. This innovative healthcare model seeks to transform the way PWID access care by bypassing the traditional healthcare system, reducing multi-level barriers to care, and meeting PWID where they are. TRIAL REGISTRATION: ClinicalTrials.gov NCT05897099. Trial registry name: Comprehensive HIV and Harm Prevention Via Telehealth (CHARIOT). Registration date: 06/12/2023.

Establishing Evidence Criteria for Implementation Strategies: A Delphi Study for HIV Services.

Background: There are no criteria specifically for evaluating the quality of implementation research and recommend implementation strategies likely to have impact to practitioners. We describe the development and application of the Best Practices Rubric, a set of criteria to evaluate the evidence supporting implementation strategies, in the context of HIV. Methods: We developed the Best Practices Rubric from 2022-2023 in three phases. (1) We purposively selected and recruited by email participants representing a mix of expertise in HIV service delivery, quality improvement, and implementation science. We developed a draft rubric and criteria based on a literature review and key informant interviews. (2) The rubric was then informed and revised through two e-Delphi rounds using a survey delivered online through Qualtrics. The first and second round Delphi surveys consisted of 71 and 52 open and close-ended questions, respectively, asking participants to evaluate, confirm, and make suggestions on different aspects of the rubric. After each survey round, data were analyzed and synthesized as appropriate, and the rubric and criteria were revised. (3) We then applied the rubric to a set of research studies assessing 18 implementation strategies designed to promote the adoption and uptake of pre-exposure prophylaxis, an HIV prevention medication, to assess reliable application of the rubric and criteria. Results: Our initial literature review yielded existing rubrics and criteria for evaluating intervention-level evidence. For a strategy-level rubric, additions emerged from interviews, for example, a need to consider the context and specification of strategies. Revisions were made after both Delphi rounds resulting in the confirmation of five evaluation domains - research design, implementation outcomes, limitations and rigor, strategy specification, and equity - and four evidence levels - best practice, promising practice, more evidence needed, and harmful practices. For most domains, criteria were specified at each evidence level. After an initial pilot round to develop an application process and provide training, we achieved 98% reliability when applying the criteria to 18 implementation strategies. Conclusions: We developed a rubric to evaluate the evidence supporting implementation strategies for HIV services. Although the rubric is specific to HIV, this tool is adaptable for evaluating strategies in other health areas.

Protocol for a parallel cluster randomized trial of a participatory tailored approach to reduce overuse of antibiotics at hospital discharge: the ROAD home trial.

BACKGROUND: Antibiotic overuse at hospital discharge is common, costly, and harmful. While discharge-specific antibiotic stewardship interventions are effective, they are resource-intensive and often infeasible for hospitals with resource constraints. This weakness impacts generalizability of stewardship interventions and has health equity implications as not all patients have access to the benefits of stewardship based on where they receive care. There may be different pathways to improve discharge antibiotic prescribing that vary widely in feasibility. Supporting hospitals in selecting interventions tailored to their context may be an effective approach to feasibly reduce antibiotic overuse at discharge across diverse hospitals. The objective of this study is to evaluate the effectiveness of the Reducing Overuse of Antibiotics at Discharge Home multicomponent implementation strategy ("ROAD Home") on antibiotic overuse at discharge for community-acquired pneumonia and urinary tract infection. METHODS: This 4-year two-arm parallel cluster-randomized trial will include three phases: baseline (23 months), intervention (12 months), and postintervention (12 months). Forty hospitals recruited from the Michigan Hospital Medicine Safety Consortium will undergo covariate-constrained randomization with half randomized to the ROAD Home implementation strategy and half to a "stewardship as usual" control. ROAD Home is informed by the integrated-Promoting Action on Research Implementation in Health Services Framework and includes (1) a baseline needs assessment to create a tailored suite of potential stewardship interventions, (2) supported decision-making in selecting interventions to implement, and (3) external facilitation following an implementation blueprint. The primary outcome is baseline-adjusted days of antibiotic overuse at discharge. Secondary outcomes include 30-day patient outcomes and antibiotic-associated adverse events. A mixed-methods concurrent process evaluation will identify contextual factors influencing the implementation of tailored interventions, and assess implementation outcomes including acceptability, feasibility, fidelity, and sustainment. DISCUSSION: Reducing antibiotic overuse at discharge across hospitals with varied resources requires tailoring of interventions. This trial will assess whether a multicomponent implementation strategy that supports hospitals in selecting evidence-based stewardship interventions tailored to local context leads to reduced overuse of antibiotics at discharge. Knowledge gained during this study could inform future efforts to implement stewardship in diverse hospitals and promote equity in access to the benefits of quality improvement initiatives. TRIAL REGISTRATION: Clinicaltrials.gov NCT06106204 on 10/30/23.

Interventions and contextual factors to improve retention in care for patients with hypertension in primary care: Hermeneutic systematic review.

BACKGROUND: Regular engagement over time in hypertension care, or retention, is a crucial but understudied step in optimizing patient outcomes. This systematic review leverages a hermeneutic methodology to identify, evaluate, and quantify the effects of interventions and contextual factors for improving retention for patients with hypertension. METHODS: We searched for articles that were published between 2000 and 2022 from multiple electronic databases, including MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, clinicaltrials.gov, and WHO International Trials Registry. We followed the latest version of the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guideline to report the findings for this review. We also synthesized the findings using a hermeneutic methodology for systematic reviews, which used an iterative process to review, integrate, analyze, and interpret evidence. RESULTS: From 4686 screened titles and abstracts, 18 unique studies from 9 countries were identified, including 10 (56%) randomized controlled trials (RCTs), 3 (17%) cluster RCTs, and 5 (28%) non-RCT studies. The number of participants ranged from 76 to 1562. The overall mean age range was 41-67 years, and the proportion of female participants ranged from 0% to 100%. Most (n = 17, 94%) studies used non-physician personnel to implement the proposed interventions. Fourteen studies (78%) implemented multilevel combinations of interventions. Education and training, team-based care, consultation, and Short Message Service reminders were the most common interventions tested. CONCLUSIONS: This review presents the most comprehensive findings on retention in hypertension care to date and fills the gaps in the literature, including the effectiveness of interventions, their components, and contextual factors. Adaptation of and implementing HIV care models, such differentiated service delivery, may be more effective and merit further study. REGISTRATION: CRD42021291368. PROTOCOL REGISTRATION: PROSPERO 2021 CRD42021291368. Available at: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=291368.