Assess Implementation Outcomes Research Articles

Siyakhana: A hybrid type 2 effectiveness-implementation stepped-wedge trial to reduce stigma towards substance use and depression among community health workers in HIV/TB care in South Africa.

Substance use (SU) and other mental health conditions, such as depression, contribute to poor engagement in HIV and TB care in South Africa, a country with the highest global prevalence of HIV and a significant TB burden. Yet, community health workers (CHWs)-frontline lay health workers who play a central role in re-engaging patients in HIV/TB care-receive little-to-no training on supporting patients with SU or other mental health concerns. CHWs also display stigma towards patients with SU and depression, which may contribute to HIV/TB care disengagement. We developed and tested a CHW training ("Siyakhana") to reduce CHW stigma towards SU and depression in HIV/TB care. A cluster randomized, stepped-wedge hybrid type 2 effectiveness-implementation trial (N = 82 CHWs) evaluated Siyakhana across six clinics in a low-resource area of Cape Town, SA. The three-day Siyakhana training included psychoeducation, self-care strategies, non-judgmental communication, problem solving, and contact-based stigma reduction using lived experience narratives. Pre-training and three- and six-months post-training assessments were conducted. Primary effectiveness outcomes were CHW stigma towards SU and depression, assessed using the Social Distance Scale. Primary implementation outcomes were guided by Proctor's model, including fidelity, acceptability, appropriateness, and feasibility, assessed using structured coding of role plays and a validated quantitative measure for assessing implementation outcomes in low- and middle-income countries. Participants were on average 46.8 years old (SD = 8.9), 99 % female, and 100 % Black African. Ninety-five percent of CHWs completed the Siyakhana training, with approximately 90 % retention over six months. A linear mixed effects model showed a significant effect of the Siyakhana training on reducing SU stigma over six months after adjusting for time (β = -1.46, SE = 0.67, p < 0.05), but no effect on depression stigma (β = -0.20, SE = 0.57, p > 0.05). CHW fidelity was 89.4 % (SD = 11.3 %) at six-months. Quantitative implementation outcomes indicated high acceptability (M = 2.85, SD = 0.27), appropriateness (M = 2.77, SD = 0.31), and feasibility (M = 2.41, SD = 0.38). Siyakhana was associated with reductions in CHW SU stigma in the context of HIV/TB care, with promising implementation outcomes. Findings will inform a larger randomized trial evaluating the effectiveness and implementation of Siyakhana and examine whether shifting CHW stigma improves patient-level health outcomes. ClinicalTrials.gov: NCT05282173. Registered on 7 March 2022.

Evaluating the Implementation of Home-Based Sexual Health Care Among Men Who Have Sex with Men: Limburg4zero.

Home-based sexual health care (including self-sampling testing) could reduce barriers to clinic-based testing. This study systematically evaluated the implementation of home-based sexual health care ('Limburg4Zero') among men who have sex with men (MSM) in a mixed urban-rural region of the Netherlands. We systematically assessed implementation outcomes (contextual domains, population reached, effectiveness, adoption by health care providers (HCP), implementation fidelity, and maintenance) using the practical, robust implementation and sustainability model. We used a mixed-methods research design that combined survey and in-depth interview data from our priority population (MSM) and implementers with insights from our community advisory board and field notes from monthly meetings with the implementers. Of 1076 requested tests, 906 MSM received a (self-sampling STI/HIV) test kit and sexual health information. Most participants (median age 31) had a university or college degree and had a Western ethnicity. The return rate for laboratory testing was 67%. Home-based care participants more often never tested HIV before (39%) compared to STI clinic attendees (28%). Adoption by HCP was highly acceptable, although perceived pragmatic and technical challenges were experienced. Key elements of the home-based care service were implemented as designed, with co-created adjustments for optimization during the implementation. Maintaining the innovation in the long term was desirable, although future recommendations for efficient continuation should be considered. Implementation of home-based sexual health care has demonstrably increased care accessibility for MSM who had never previously been tested. Therefore, a systematic approach is crucial to foster the impact of home-based sexual health care.

Evaluation of an HIV-related Education Intervention Scale-up: A Hybrid Type 3 Effectiveness-implementation Study in the Dominican Republic.

We developed an infographic intervention to augment HIV-related education in the Dominican Republic (DR), which demonstrated preliminary success in pilot studies. We then partnered with the United States Agency for International Development's (USAID) HIV Services and Systems Strengthening program in the DR to scale up the intervention. We used a two-tier Training-of-Trainer (TOT) method to teach intervention administration. N = 12 program leaders completed the tier-1 training and subsequently taught N ~ 102 clinical staff to use infographics with people with HIV (PWH) (tier-2 trainings). Study Aim 1 was to assess implementation outcomes; Aim 2 was to explore infographic influences on program-level health outcomes. We conducted a hybrid type 3 effectiveness-implementation study with three data components: (1) Surveys bookending tier-1 and tier-2 trainings; (2) Focus groups with tier-1 and tier-2 trainees; and (3) program-level data. We designed surveys according to Kirkpatrick's Training Evaluation Model and analyzed responses with descriptive statistics and/or Fisher's exact tests. We led four focus groups with a theory-driven guide and analyzed transcripts with conventional qualitative content analysis. We analyzed program-level data by comparing outcomes before and after infographic use with advanced statistical modeling. All 12 program leaders completed tier-1, and 36 staff completed tier-2 surveys; focus groups comprised eight tier-1 and 27 tier-2 trainees; program-level data pertained to 4,318 PWH. Surveys and focus groups indicated the TOT method is feasible, acceptable, and sustainable. Program-level findings showed PWH were more likely to attend scheduled visits and be virally suppressed following infographic implementation. Results indicate our intervention can likely enhance HIV education at large scale.

Transition Guide Dissemination to Foster Patient-Care Team Conversations: A Childhood Arthritis Rheumatology Research Alliance Transition Learning Collaborative Pilot Implementation Study.

Uptake of evidence-informed health care transition processes among pediatric rheumatologists is low despite poor outcomes of transition from pediatric to adult care. We piloted a learning collaborative model to implement transition guides. We dually assessed implementation outcomes and changes in reported patient-care team discussions about transition. This was a type II hybrid effectiveness-implementation pilot study of transition guide dissemination to patients at least 14 years old with rheumatic conditions across nine pediatric rheumatology centers in the Childhood Arthritis Rheumatology Research Alliance Transition Learning Collaborative. We evaluated implementation outcomes (feasibility, adaptations, and fidelity) and the proportion of patients surveyed that reported having discussions with their care team regarding transfer planning. Six sites were retained through the COVID-19 pandemic (below 70% target). Five out of six sites contributed outcome data (met 80% target) but with substantial heterogeneity in how transition guides were shared (eg, in-person, electronic messages, and posted flyers), and data were collected. The pooled proportion of respondents having discussed transfer planning with their care team was 39% preimplementation (n = 239; 95% confidence interval [CI] 32%-46%) and 55% postimplementation (n = 864; 95% CI 36%-73%). After implementation, there were significant increases in the likelihood of respondents recalling receiving a transition guide (odds ratio [OR] 2.58, 95% CI 1.35-4.92) and discussing transfer planning (OR 2.14, 95% CI 1.30-3.52), adjusted for age and site of care. Transition guide dissemination is a simple intervention associated with increased awareness among young people with rheumatic conditions and discussions with their care team about transition preparation. The learning collaborative model facilitated identification of several dissemination strategies adaptable to site-specific resources.

A Randomized Controlled Trial of a Digital Intervention to Improve the Sexual Health of Adolescent and Young Adult Male Emergency Department Patients

PurposeTo assess implementation outcomes and potential efficacy of a user-informed, theory-based digital health intervention developed to improve adolescent and young adult (AYA) male sexual health. MethodsWe conducted a pilot randomized controlled trial of sexually active male emergency department (ED) patients aged 14–21 years. Participants were randomized to the intervention (Dr. Eric, Emergency Room Interventions to improve Care) or usual care. Dr. Eric consists of an ED-based sexual health app followed by 3 months of interactive text messages. We assessed the feasibility, adoption, and fidelity among users. Condom use, defined as the number of sexual encounters with condoms divided by the total number of sexual encounters over the past 4 weeks, was the primary efficacy outcome. ResultsWe enrolled 119 patients; mean age was 17.9 years, 87% were Hispanic, and half used condoms at last intercourse. Dr. Eric demonstrated feasibility, with high rates of consent (86.2%) and follow-up (81.5%). Intervention participants found Dr. Eric acceptable, liking (86.2%) and recommending (87.9%) the program. 98% of intervention participants interacted with all five app modules; one-quarter opted out of text messaging. At 6-week follow-up, the intervention group more often used a condom compared to the control group [OR 3.57, 95% confidence interval (1.93, 6.60)], p < .001]; however, this significant difference did not sustain at 13 weeks. DiscussionDr. Eric was feasible to deliver and acceptable to male AYA patients. To our knowledge, Dr. Eric is the first intervention to demonstrate evidence of short-term efficacy for improving condom use among male AYA in the ED.

PrEPárate: Evaluation of a Community-Driven PrEP Social Marketing Intervention Tailored to Latino/a/x Individuals.

Latino/a/x sexual minority men (SMM) and transgender women remain disproportionately impacted by HIV, with higher HIV incidence and lower uptake of pre-exposure prophylaxis (PrEP) than their non-Hispanic White peers. Disparities in PrEP uptake among Latino/a/x populations have been found to be due to structural, social, and personal barriers. Social marketing interventions have been shown to effectively address barriers and increase PrEP uptake in other populations, and thus offer potential as a tool to increase PrEP uptake for Latino/a/x populations. The PrEPárate campaign was developed through community based participatory research and ran from April to September 2022 in Cook County, Illinois. We conducted a mixed methods evaluation through surveys (N = 515) and semi-structured interviews with survey participants and community partners (N = 14). We examined cross-sectional associations of campaign exposure with PrEP awareness and uptake in adjusted multivariable regression models. We used rapid qualitative methods to analyze interviews and assess implementation outcomes following the RE-AIM framework. The campaign reached over 118,000 people on social media, with additional reach over public transit and local events. PrEPárate exposure was associated with increased PrEP awareness (aOR = 5.23; 95% CI [2.58, 10.63]) and PrEP uptake (aOR = 1.69; 95% CI [1.09, 2.62]). Survey respondents expressed that the campaign name, visuals, ambassadors, and distribution were effective in engaging the target audience. Community partners felt the campaign was implemented with fidelity to the original vision and identified future directions for PrEPárate. Social marketing campaigns, anchored in community engagement, may be an effective strategy to increase PrEP awareness and uptake among underserved Latino/a/x populations.

Design and implementation of a Type-2 hybrid, prospective randomized trial of opioid agonist therapies integration into primary care clinics in Ukraine

IntroductionUkraine has high HIV prevalence, concentrated among people who inject drugs (PWID), mostly of opioids. Maintenance on opioid agonist therapies (OAT) is the most effective evidence-based treatment for opioid use disorder. As PWID experience high morbidity and mortality from preventable and treatable non-communicable diseases, international agencies recommend integrating OAT into primary care centers (PCC). MethodsA randomized, type-2 hybrid implementation trial was carried out to compare outcomes of OAT integration in PCC to OAT delivery at specialty treatment centers (STC) – standard-of-care. Tele-education supporting PCC providers in managing OAT, HIV, tuberculosis and non-communicable diseases along with pay-for-performance incentives were used to facilitate implementation. Consenting patients underwent 1:2 randomization to either STC or PCC. Quality health indicators (QHIs), a composite percentage of recommended primary and specialty services accessed by patients (blood/urine tests, cancer screenings, etc.), were defined as efficacy outcomes and were assessed by participant self-report at baseline and every 6 months over 24 months and electronic chart reviews after the completion of the follow-up. The primary outcome is defined as the difference in composite QHI scores at 24 months, in which a repeated measures likelihood-based mixed model with missing at random assumptions will be used. Providers at PCC completed surveys at baseline, 12 and 24 months to assess implementation outcomes including changes in stigma and attitudes towards OAT and PWID. Preliminary resultsAmong the 1459 participants allocated to STC (N = 509) or PCC (N = 950), there were no differences in clinical and demographic characteristics. Self-reported prevalences were available for HIV (42 %), HCV (57 %), and prior tuberculosis (17 %). Study retention at 6, 12, 18, and 24 months was as 91 %, 85 %, 80 %, and 74 %, respectively. ConclusionPWID have a high prevalence of medical comorbidities and integrating OAT into primary care settings has the potential to improve the health of PWID. Findings from this study can help guide implementation of integrated care in Ukraine and throughout similar low-resource, high-burden countries in the Eastern European and Central Asian region.

Protocol for a mixed-methods study to explore implementation outcomes of the Phone-based Interventions under Nurse Guidance after Stroke (PINGS-II) across 10 hospitals in Ghana

BackgroundStroke survivors are at a substantially higher risk for adverse vascular events driven partly by poorly controlled vascular risk factors. Mobile health interventions supported by task shifting strategies have been...

Implementation outcomes from a multi-site stepped wedge cluster randomized family caregiver skills training trial.

To assess whether a team collaboration strategy (CONNECT) improves implementation outcomes of a family caregiver skills training program (iHI-FIVES). iHI-FIVES was delivered to caregivers at eight Veterans Affairs (VA) medical centers. Data sources were electronic health records, staff surveys, and interviews. In a stepped wedge cluster randomized trial, sites were randomized to a 6-month time interval start date for iHI-FIVES launch. Sites were then randomized 1:1 to either (i) CONNECT, a team collaboration training strategy plus Replicating Effective Programs (REP), brief technical support training for staff, or (ii) REP only (non-CONNECT arm). Implementation outcomes included reach (proportion of eligible caregivers enrolled) and fidelity (proportion of expected trainings delivered). Staff interviews and surveys assessed team function including communication, implementation experience, and their relation to CONNECT and iHI-FIVES implementation outcomes. The sample for assessing implementation outcomes included 571 Veterans referred to VA home- and community-based services and their family caregivers eligible for iHI-FIVES. Prior to iHI-FIVES launch, staff completed 65 surveys and 62 interviews. After the start of iHI-FIVES, staff completed 52 surveys and 38 interviews. Mixed methods evaluated reach and fidelity by arm. Fidelity was high overall with 88% of expected iHI-FIVES trainings delivered, and higher among REP only (non-CONNECT) compared with CONNECT sites (95% vs. 80%). Reach was 18% (average proportion of reach across eight sites) and higher among non-CONNECT compared with CONNECT sites (22% vs. 14%). Qualitative interviews revealed strong leadership support at high-reach sites. CONNECT did not influence self-reported team function. A team collaboration strategy (CONNECT), added to REP, required more resources to implement iHI-FIVES than REP only and did not substantially enhance reach or fidelity. Leadership support was a key condition of implementation success and may be an important factor for improving iHI-FIVES reach with national expansion.

Models of survivorship care in patients with head and neck cancer in regional, rural, and remote areas: a systematic review.

Rural people with head and neck cancers (HNC) are likely to experience poorer health outcomes due to limited access to health services, so many benefit from models of care that account for rurality. The aim of this review was to synthesise literature on models of care in this population. Studies were identified using seven databases: PubMed, PsycINFO, Scopus, Embase, CINAHL, Medline, and Web of Science. Studies that tested or reported a model of care in rural HNC survivors were included. Data on characteristics and outcomes of the models were synthesised according to the domains in the Cancer Survivorship Care Quality Framework, and study quality was appraised. Seventeen articles were included. Eight were randomised controlled trials (seven with a control group and one single-arm study). Three models were delivered online, nine via telehealth, and five in-person. Majority were led by nurses and allied health specialists and most addressed management of physical (n = 9) and psychosocial effects (n = 6), while only a few assessed implementation outcomes such as cost-effectiveness. None evaluated the management of chronic health conditions. Positive outcomes were reported for domains of survivorship care that were measured; however, further evaluation of models of care for rural people with HNC is needed to assess effectiveness across all domains of care. Rural cancer survivors are a diverse population with unique needs. Alternative models of care such as shared care, or models personalised to the individual, could be considered to reduce disparities in access to care and outcomes.

Nurse-led sequential multiple assignment randomized trial of nudging intervention for early antiretroviral therapy initiation among patients with HIV/AIDS: Implementation study protocol.

In China, more than 30% of patients have not initiated treatment within 30 days of HIV diagnosis. Delayed initiation has a detrimental influence on disease outcomes and increases HIV transmission. The study aims to evaluate the effectiveness of a nurse-led antiretroviral therapy initiation nudging intervention for people newly diagnosed with HIV in China to find the optimal intervention implementation strategy. A Hybrid Type II sequential multiple assignment randomized trial will be conducted at four Centers for Disease Control and Prevention in Hunan, China. This study will recruit 447 people newly diagnosed with HIV aged ≥18 years and randomly assign them into two intervention groups and one control group. On top of the regular counselling services and referrals, intervention groups will receive a 4-week, 2-phase intervention based on the dual-system theory and the nudge theory. The control group will follow the currently recommended referral procedures. The primary outcomes are whether treatment is initiated, as well as the length of time it takes. The study outcomes will be measured at the baseline, day 15, day 30, week 12, week 24 and week 48. Generalized estimating equations and survival analysis will be used to compare effectiveness and explore factors associated with antiretroviral therapy initiation. Both qualitative and quantitative information will be collected to assess implementation outcomes. Existing strategies mostly target institutional-level factors, with little consideration given to patients' decision-making. To close this gap, we aim to develop an effective theory-driven nudging strategy to improve early ART initiation. This nurse-led study will help to prevent delayed initiation by employing implementation science strategies for people newly diagnosed with HIV. This study contributes to the United Nations' objective of ending the AIDS pandemic by 2030. Chinese Clinical Trial Registry ChiCTR2300070140. The trial was prospectively registered before the first participant was recruited. The nudging intervention was finalized through the Nominal Group Technique where we invited five experts in the related field and five people living with HIV to participate.

Testing effectiveness and implementation of a standardized approach to sexual dysfunction screening among adolescent and young adult-aged survivors of childhood cancer: A type I hybrid, mixed methods trial protocol: Effectiveness of sexual dysfunction screening among AYA cancer survivors: a study protocol.

Approximately 20-50% of adolescent and young adult-aged childhood cancer survivors (AYA-CCS) experience sexual dysfunction (SD), although this healthcare need is widely underrecognized. Previous research from both AYA-CCS patients and their providers report that SD needs are unaddressed despite patient desires for SD discussions to be incorporated as part of their care. Patients and providers agree that standardized use of a patient-reported outcome measure may facilitate SD discussions; an SD screening approach was developed with patient and provider input. This study will measure the effectiveness of a standardized SD screening intervention and assess implementation outcomes and multilevel barriers and facilitators to guide future research. This multi-site, mixed methods, type 1 effectiveness-implementation hybrid trial will be evaluated using a pre-post design (NCT05524610). The trial will enroll 86 AYA-CCS (ages 15-39) from two cancer centers in the United States. The SD intervention consists of core fundamental functions with a "menu" of intervention options to allow for flexibility in delivery and tailoring in variable contexts. Effectiveness of the intervention on facilitating SD communication will be measured through patient surveys and clinical data; multivariable logistic regression will be used for the binary outcome of self-reported SD screening, controlling for patient-level predictors. Implementation outcomes will be assessed using mixed methods (electronic health record abstraction, patient and provider surveys, and provider interviews. Quantitative and qualitative findings will be merged using a joint display to understand factors affecting intervention success. Identification and treatment of SD in AYA-CCS is an important and challenging quality of life concern. The type 1 hybrid design will facilitate rapid translation from research to practice by testing the effects of the intervention while simultaneously identifying multilevel barriers and facilitators to real-world implementation. This approach will inform future testing and dissemination of the SD screening intervention.

Implementation science and psycho-oncology: Advancing the translation of evidence into practice.

This Special issue of Psycho-Oncology highlights examples of the application of implementation science to research in psycho-oncology. The aim is to demonstrate the different ways that implementation science is being used to generate evidence that can more readily translate evidence into changes in clinical practice. We hope this issue fosters greater interest in using the tools of implementation science to improve the lives of people affected by cancer. The papers in the issue were selected from among those that responded to a call for submissions on the application of implementation science frameworks and methods to issues in psycho-oncology. The focus included but was not limited to research on: understanding barriers and facilitators of intervention/practice adoption; assessing implementation outcomes, evaluating implementation strategies, and improving behavioural and/or clinical outcomes. The 11 papers in this issue were grouped for presentation purposes into four common topics: barriers and facilitators to implementation; feasibility as a key implementation outcome; the design, selection and adaptation of implementation strategies; and building the foundation for psycho-oncology research translation via systematic reviews that focus on implementation strategy design. These papers demonstrate the breadth of current applications of implementation science to research in psycho-oncology. Alongside the studies featured in this issue, including cost-effectiveness analyses, tests of nationally-focused strategies and proactive planning for adaptation, we look forward to other innovations that will promote further growth of both disciplines to improve the integration of psycho-oncology interventions across healthcare systems.

Hub and Spokes-Implementation of Basic Palliative Care into University Hospital Practice-A Pilot Study.

Background: The aim is to implement knowledge of basic palliative care in selected departments by the Hub and Spokes model. Methods: Implementation of basic palliative care was designed as a stepwise training model by skills lectures over a time period of 2 years. In each of the six selected oncological and nononcological departments, one physician and two nurses were trained in semi-annual half-day meetings as expert representatives within their departments. Results: Semi-structured interviews were conducted to assess implementation outcomes with 12 nurses and 6 physicians. Overall acceptability was high for all departments and professions. Feasibility was given in all departments. Adoption and penetration of a trained expert representative differed between medical and nursing professions. Implementation was more appropriate in the stationary sector. Implementation costs were low. Conclusion: Expansion of the system into a second follow-up period, including more departments, is planned to ensure sustainability.

Systematic review of applications and properties of the NoMAD instrument for assessing implementation outcomes: Study protocol.

Implementation outcomes measures can be used to assess the implementation of complex health and social care interventions, but evidence for the use of these measures, and their psychometric properties, remains limited. The NoMAD ( Normalisation Me asure Development) survey, based on Normalisation Process Theory, was developed to assess, monitor, or measure factors likely to affect normalisation of a new practice from the perspective of participants who are engaged in an implementation process. Since publication in 2015, NoMAD has been translated into several languages and is increasingly being used in health and care research. This systematic review will identify, appraise, and synthesise the existing literature on the use of NoMAD as an implementation outcome measure, focusing on use and application across different studies and settings, and on its properties as a measurement tool. We will systematically search the bibliographic databases Web of Science, Scopus and PubMed for articles reporting empirical data in peer-reviewed journals. A citation search will also be undertaken in Google Scholar for primary NoMAD publications. Studies will be eligible for inclusion if they: (a) specify using NoMAD as a method and report results from using it, and/or (b) report a translation and/or validation study of NoMAD's measurement properties. Screening of abstracts and full text articles will be done independently by two researchers. Data extraction will be structured to allow collection and descriptive synthesis of data on study characteristics, use of NoMAD, psychometric results, and authors' reflections and recommendations. This review will provide the first synthesis of how NoMAD has been applied in health and care research, and evidence on its properties as an outcome measure since its publication. This will be used to update existing freely accessible guidance for researchers and other users, and disseminated through peer-reviewed publications, and engagement activities with researchers and practitioners.

Alternatives to dental opioid prescribing after tooth extraction (ADOPT): protocol for a stepped wedge cluster randomized trial

BackgroundDentists and oral surgeons are leading prescribers of opioids to adolescents and young adults (AYA), who are at high risk for developing problematic opioid use after an initial exposure. Most opioids are prescribed after tooth extraction, but non-opioid analgesics provide similar analgesia and are recommended by multiple professional organizations.MethodsThis multi-site stepped wedge cluster-randomized trial will assess whether a multicomponent behavioral intervention can influence opioid prescribing behavior among dentists and oral surgeons compared to usual practice. Across up to 12 clinical practices (clusters), up to 33 dentists/oral surgeons (provider participants) who perform tooth extractions for individuals 12–25 years old will be enrolled. After enrollment, all provider participants will receive the intervention at a time based on the sequence to which their cluster is randomized. The intervention consists of prescriber education via academic detailing plus provision of standardized patient post-extraction instructions and blister packs of acetaminophen and ibuprofen. Provider participants will dispense the blister packs and distribute the patient instructions at their discretion to AYA undergoing tooth extraction, with or without additional analgesics. The primary outcome is a binary, patient-level indicator of electronic post-extraction opioid prescription. Data for the primary outcome will be collected from the provider participant’s electronic health records quarterly throughout the study. Provider participants will complete a survey before and approximately 3 months after transitioning into the intervention condition to assess implementation outcomes. AYA patients undergoing tooth extraction will be offered a survey to assess pain control and satisfaction with pain management in the week after their extraction. Primary analyses will use generalized estimating equations to compare the binary patient-level indicator of being prescribed a post-extraction opioid in the intervention condition compared to usual practice. Secondary analyses will assess provider participants’ perceptions of feasibility and appropriateness of the intervention, and patient-reported pain control and satisfaction with pain management. Analyses will adjust for patient-level factors (e.g., sex, number of teeth extracted, etc.).DiscussionThis real-world study will address an important need, providing information on the effectiveness of a multicomponent intervention at modifying dental prescribing behavior and reducing opioid prescriptions to AYA.ClinicalTrials.govNCT06275191.

Leveraging Single-Case Experimental Designs to Promote Personalized Psychological Treatment: Step-by-Step Implementation Protocol with Stakeholder Involvement of an Outpatient Clinic for Personalized Psychotherapy

Our objective is to implement a single-case experimental design (SCED) infrastructure in combination with experience-sampling methods (ESM) into the standard diagnostic procedure of a German outpatient research and training clinic. Building on the idea of routine outcome monitoring, the SCED infrastructure introduces intensive longitudinal data collection, individual effectiveness measures, and the opportunity for systematic manipulation to push personalization efforts further. It aims to empower psychotherapists and patients to evaluate their own treatment (idiographic perspective) and to enable researchers to analyze open questions of personalized psychotherapy (nomothetic perspective). Organized around the principles of agile research, we plan to develop, implement, and evaluate the SCED infrastructure in six successive studies with continuous stakeholder involvement: In the project development phase, the business model for the SCED infrastructure is developed that describes its vision in consideration of the context (Study 1). Also, the infrastructure's prototype is specified, encompassing the SCED procedure, ESM protocol, and ESM survey (Study 2 and 3). During the optimization phase, feasibility and acceptability are tested and the infrastructure is adapted accordingly (Study 4). The evaluation phase includes a pilot implementation study to assess implementation outcomes (Study 5), followed by actual implementation using a within-institution A-B design (Study 6). The sustainability phase involves continuous monitoring and improvement. We discuss to what extent the generated data could be used to address current questions of personalized psychotherapy research. Anticipated barriers and limitations during the implementation processes are outlined.

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

BackgroundAntibiotic 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.MethodsThis 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.DiscussionReducing 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 registrationClinicaltrials.gov NCT06106204 on 10/30/23

Adaptations of a community-based integrated care model for frail home-dwelling older adults using the results of a feasibility evaluation

Introduction: The WHO recommends implementing integrated care models to overcome fragmented care for frail older adults. However, their effectiveness remains inconclusive, due to limited assessment of implementation processes and outcomes. As population ages, the Swiss Canton Basel-Landschaft adopted a legal framework requiring creation of Information and Advice Centers (IAC) for home-dwelling older adults. INSPIRE and the Canton are collaborating to develop, implement, and evaluate an integrated care model for the IACs. INSPIRE is a multiphase implementation science project: Phase 1 included participatory development of the INSPIRE care model by involving cantonal and local stakeholders. Stakeholder involvement is still maintained, through bi-yearly meetings. Phase 2, the present study, aimed to evaluate its feasibility and implementation and describe the adaptations needed&#x0D; Methods: Design: Using a mixed-methods design, we evaluated the feasibility and implementation of the INSPIRE care model and the IAC by: a) measuring fidelity to the implementation strategies to promote the IAC; b) describing IAC visitors; and c) assessing implementation outcomes of the care model.&#x0D; Sample: All IAC visitors; 18 older adults 65+; a nested sample of 8 frail older adults 75+; 8 informal caregivers; IAC nurse and social worker.&#x0D; Data sources: qualitative data from interviews (older adults/informal caregivers) and meetings (IAC staff); quantitative data from the IAC administrative information and health records&#x0D; &#x0D; &#x0D; Results: &#x0D; &#x0D; Aim a &amp; b: IAC promotion: 63 out of 83 planned promotional activities were delivered by the IAC leadership (e.g., letters to older adults 75+) but not delivered to all target stakeholders. IAC visitors: Between Jan-Sept 2022, 113 older adults aged 65-74 and 362 aged 75+ visited the IAC. From the 65-74 group, 12 individuals were identified as pre-frail/frail and from those, 2 received the INSPIRE care model. From the 75+ group, 162 individuals were considered pre-frail/frail and 47 of them received the care model. The care model reached 4.8% of the target population. Referral source: 92 (aged 65-74) and 174 (aged 75+) self-referred to the IAC; few referrals by community care providers. Services requested: The main requested service in the 65-74-year-old group was social services (32/113) while for those 75+ it was a needs assessment (141/362).&#x0D; Aim c: Qualitative information: the nurse showed higher acceptability of the model compared to the social worker. High acceptability and feasibility of the model were perceived by older adults and their caregivers. Quantitative information: fidelity to the model core components mean score: 33/48; lowest scores for care coordination and follow-up.&#x0D; &#x0D; &#x0D; Implications: The high acceptability of the INSPIRE care model by older adults who acceded to the intervention and their caregivers shows that integrated care approaches may have potential to enhance quality of care although adaptations might be needed to increase its fit. In parallel, in order to increase reach, more efforts and supportive leadership are needed to promote the IAC, enhance community care providers engagement in the referral process.&#x0D; Next steps: Adaptation of the care model and implementation strategies to increase referrals to the IAC, thus improving reach of the intervention, and contributing to better recruitment for the effectiveness evaluation.

Assessing implementation outcomes for launching balanced energy protein supplementation: A formative study in rural Bangladesh.

Balanced energy protein (BEP) supplementation is an efficacious intervention in pregnancy for improving birthweight and is recommended by World Health Organization (WHO) in countries with high maternal undernutrition. Few countries have implemented BEP programmes due in part to high cost, lack of data on acceptability and feasibility, and complexity of delivery. We sought to address implementation gaps in BEP interventions through a formative study designed to understand implementation outcomes. We conducted 52 in-depth interviews and 8 focus-group discussions with married women of reproductive age, family members, health care providersand pharmacists in three unions of the Gaibandha district in rural Bangladesh. Interviews were translated and transcribed in English and analysed using an analytic framework for implementation science in nutrition. BEP was viewed as an acceptable and appropriate intervention to combat undernutrition in this setting. There was a lack of clarity on who should or could be responsible for providing/distributing BEP in a way convenient to mothers. Many participants preferred door-to-door delivery and thought this approach could address social and gender inequities, but providers mentioned already being overworked and worried about adding new tasks. Participants were concerned about the affordability of BEP and opportunity costs associated with travel to proposed distribution sites such as ANC or pharmacies. Women in these communities do not always have the agency to travel without supervision or make purchasing decisions. BEP supplementation is a complex intervention; future trials seek to assess ways to overcome these implementation challenges and inform a long-term systems-owned BEP intervention.