Hybrid Effectiveness-implementation Trial Research Articles

The effect of audit and feedback and implementation support on guideline adherence and patient outcomes in cardiac rehabilitation: a study protocol for an open-label cluster-randomized effectiveness-implementation hybrid trial

Background Providing secondary prevention through structured and comprehensive cardiac rehabilitation programmes to patients after a myocardial infarction (MI) reduces mortality and morbidity and improves health-related quality of life. Cardiac rehabilitation has the highest recommendation in current guidelines. While treatment target attainment rates at Swedish cardiac rehabilitation centres is among the highest in Europe, there are considerable differences in service delivery and variations in patient-level outcomes between centres. In this trial, we aim to study whether centre-level guideline adherence and patient-level outcomes across Swedish cardiac rehabilitation centres can be improved through a) regular audit and feedback of cardiac rehabilitation structure and processes through a national quality registry and b) supporting cardiac rehabilitation centres in implementing guidelines on secondary prevention. Furthermore, we aim to evaluate the implementation process and costs.MethodsThe study is an open-label cluster-randomized effectiveness-implementation hybrid trial including all 78 cardiac rehabilitation centres (attending to approximately 10 000 MI patients/year) that report to the SWEDEHEART registry. The centres will be randomized 1:1:1 to three clusters: 1) reporting cardiac rehabilitation structure and process variables to SWEDEHEART every six months (audit intervention) and being offered implementation support to implement guidelines on secondary prevention (implementation support intervention); 2) audit intervention only; or 3) no intervention offered. Baseline cardiac rehabilitation structure and process variables will be collected. The primary outcome is an adherence score measuring centre-level adherence to secondary prevention guidelines. Secondary outcomes include patient-level secondary prevention risk factor goal attainment at one-year after MI and major adverse coronary outcomes for up to five-years post-MI. Implementation outcomes include barriers and facilitators to guideline adherence evaluated using semi-structured focus-group interviews and relevant questionnaires, as well as costs and cost-effectiveness assessed by a comparative health economic evaluation.DiscussionOptimizing cardiac rehabilitation centres’ delivery of services to meet standards set in guidelines may lead to improvement in cardiovascular risk factors, including lifestyle factors, and ultimately a decrease in morbidity and mortality after MI.Trial registrationClinicalTrials.gov. Identifier: NCT05889416. Registered 2023-03-23.

Editorial: Hybrid effectiveness-implementation trial designs—critical assessments, innovative applications, and proposed advancements

Editorial: Hybrid effectiveness-implementation trial designs—critical assessments, innovative applications, and proposed advancements

Implementation and dissemination of physical activity-related health competence in vocational nursing training: study protocol for a cluster-randomized controlled intervention trial

BackgroundAlthough the nursing sector gains growing importance in an aging society, students representing the future workforce often show insufficient health. Acknowledging the health-enhancing effects of adequate physical activity, the educational system in Bavaria, Germany, has recently integrated the promotion of physical activity-related health competence (PAHCO) into the nursing curriculum. However, it cannot be assumed that PAHCO has sufficiently permeated the educational practices and routines of the nursing schools. Therefore, the goal of the present study is to examine and compare the effectiveness as well as implementation of different intervention approaches to address PAHCO in the Bavarian nursing school system.MethodsWe randomly assign 16 nursing schools (cluster-based) to four study arms (bottom-up, top-down led by teachers, top down led by external physical activity experts, control group). Schools in intervention group 1 (IG-1) develop multicomponent inventions to target PAHCO via cooperative planning (preparation, planning, and implementation phase). Intervention groups 2 and 3 (IG-2, IG-3) receive both an expert-based intervention (developed through intervention mapping) via trained mediators to address PAHCO. External physical activity experts deliver the structured PAHCO intervention in IG-2, while teachers from the nursing schools themselves conduct the PAHCO intervention in IG-3. In line with a hybrid effectiveness implementation trial, we apply questionnaire-based pre-post measurements across all conditions (sample size calculation: nfinal = 636) to examine the effectiveness of the intervention approaches and, simultaneously, draw on questionnaires, interview, and protocol data to examine their implementation. We analyze quantitative effectiveness data via linear models (times-group interaction), and implementation data using descriptive distributions and content analyses.ConclusionThe study enables evidence-based decisions about the suitability of three intervention approaches to promote competencies for healthy, physically active lifestyles among nursing students. The findings inform dissemination activities to effectively reach all 185 schools of the Bavarian nursing system.Trial registrationClinical trials NCT05817396. Registered on April 18, 2023.

Barriers to dental utilization among Medicaid-enrolled young children from primary care practices in Northeast Ohio.

To evaluate the individual and community factors that contribute to dental utilization among young children on Medicaid utilizing the Anderson Model and the Socio-Ecological Framework. This observational cross-sectional study was conducted using baseline data (socio-demographics, clinical dental need) from a cluster-randomized hybrid effectiveness-implementation trial among 1021 child-parent dyads recruited from primary care practices across northeast Ohio. The baseline data were then linked to dental Medicaid claims data (categorized as any dental visit, volume, and type in the past 12 months) and ICD-10 codes from the child's EHR data (individual-level) together with Dental Health Provider Shortage Area (HPSA) status and Area Deprivation Index (ADI) which were obtained at the neighbourhood-level using home address of each dyad (community-level). Multivariable analyses using generalized estimating equations (GEE) accounted for clustering by practice, and models included individual-level alone, and individual + community-level factors to evaluate their effects on dental utilization. Medicaid claims data indicated that among the 1021 children (mean age: 4.3 ± 1.1 years; 54.4% males; 43.8% Black, Non-Hispanic), a majority of children were seeing the dentist at least once a year by the age of 4 (56.1%). The mean ADI of their neighbourhoods was 109.22 (20.2) and 27.5% lived in a HPSA area. The GEE analyses revealed that individual factors such as older children, parents being married, and continuous Medicaid enrollment were associated with significantly higher dental utilization. Among community factors, being in a HPSA had an OR = 1.53 (CI: 1.03, 2.27) associated with higher dental utilization. Being in a HPSA was associated with higher dental utilization possibly due to dentists or safety net dental clinics in these areas accepting Medicaid-eligible children.

Colonoscopy Outreach for Rural Communities (CORC): A study protocol of a pragmatic randomized controlled trial of a patient navigation program to improve colonoscopy completion for colorectal cancer screening

BackgroundColonoscopy is one of the primary methods of screening for colorectal cancer (CRC), a leading cause of cancer mortality in the United States. However, up to half of patients referred to colonoscopy fail to complete the procedure, and rates of adherence are lower in rural areas. ObjectivesColonoscopy Outreach for Rural Communities (CORC) is a randomized controlled trial to test the effectiveness of a centralized patient navigation program provided remotely by a community-based organization to six geographically distant primary care organizations serving rural patients, to improve colonoscopy completion for CRC. MethodsCORC is a type 1 hybrid implementation-effectiveness trial. Participants aged 45–76 from six primary care organizations serving rural populations in the northwestern United States are randomized 1:1 to patient navigation or standard of care control. The patient navigation is delivered remotely by a trained lay-person from a community-based organization. The primary effectiveness outcome is completion of colonoscopy within one year of referral to colonoscopy. Secondary outcomes are colonoscopy completion within 6 and 9 months, time to completion, adequacy of patient bowel preparation, and achievement of cecal intubation. Analyses will be stratified by primary care organization. DiscussionTrial results will add to our understanding about the effectiveness of patient navigation programs to improve colonoscopy for CRC in rural communities. The protocol includes pragmatic adaptations to meet the needs of rural communities and findings may inform approaches for future studies and programs. Trial registration: National Clinical Trial Identifier: NCT05453630.Trial registration: ClinicalTrials.gov. Identifier: NCT05453630. Registered July 6, 2022.

Clinical Remote Monitoring of Individuals With Spinal Cord Injury at Risk for Pressure Injury Recurrence Using mHealth: Protocol for a Pilot, Pragmatic, Hybrid Implementation Trial.

Pressure injuries are one of the most challenging secondary conditions for individuals with spinal cord injuries and related disorders (SCI/D) owing to inherent, lifelong risk factors that include a lack of sensory and motor function below the level of injury and reliance on a wheelchair for daily mobility, resulting in prolonged periods of sitting. Although many factors contribute to the development of pressure injuries, the pressure between the skin and a surface is always a factor and the development of injury is dependent on the magnitude and duration of the pressure. Clinically, broad recommendations for relieving pressure are used because we know very little about the unique day-to-day life patterns of the individual wheelchair user. Typically, it is after the occurrence of a pressure injury that the therapist will check equipment fit and the effectiveness of pressure offloading and ask about other surfaces they sit on in their home and community. This time-lapsed, largely self-reported data are fraught with recall bias and inaccuracies that the therapist incorporates into a plan of care. This study's objective is to pilot-test the implementation and clinical effectiveness of a telehealth model of care combined with our mobile health (mHealth) Assisted Weight-Shift device for remote monitoring of factors related to maintaining skin health and wheelchair setup. Our overall hypothesis is that this study will result in an effective implementation plan, and the enhanced connected model of care using remote monitoring of pressure management will result in pilot-level, improved clinical outcomes for adults with spinal cord injury at high risk for pressure injury recurrence. For all aims, we will use a mixed methods design using an exploratory, sequential approach to include the strengths of both qualitative and quantitative data. For aims 1 and 2, we will iteratively collect qualitative data from therapists, patients with SCI/D, and other stakeholders. For aim 3, we will perform a hybrid effectiveness-implementation randomized controlled trial to pilot-test the intervention. The projected results include an iteratively developed and tested implementation plan that meets moderate to high levels of acceptability, feasibility, and appropriateness. Additionally, the pilot trial results are expected to show positive trends in relevant clinical outcomes related to reduced pressure injury incidence, recurrence, and improved healing when compared with the standard of care. Currently, 6 participants have been recruited for our aim-1 qualitative study. This study will expand upon our previous study to move the Assisted Weight-Shift system into routine clinical care, which was a strong desire of adults with SCI/D for improved individualized care plans to prevent pressure injuries. The results of this study will guide the next steps in a full, hybrid effectiveness-implementation trial with the goal of improving care to prevent pressure injuries. DERR1-10.2196/51849.

Study protocol for a type-II hybrid effectiveness-implementation trial to reach teenagers using mobile money shops to reduce unintended pregnancies in Uganda

IntroductionUnintended teenage pregnancies have become a global public health challenge, particularly in sub-Saharan Africa. There is a notably high prevalence of unintended pregnancies among unmarried teenagers in Uganda. This study...

Prostate Cancer Survivorship Essentials for men with prostate cancer on androgen deprivation therapy: protocol for a randomised controlled trial of a tele-based nurse-led survivorship care intervention (PCEssentials Hormone Therapy Study)

IntroductionAndrogen deprivation therapy (ADT) is commonly used to treat men with locally advanced or metastatic prostate cancer. Men receiving ADT experience numerous side effects and frequently report unmet supportive care...

Dietetics student contribution to addressing malnutrition in residential aged care facilities.

To test a model of malnutrition screening and assessment conducted by dietetics students on placement in residential aged care facilities. The secondary aim was to identify possible facilitators and barriers to the implementation of the model. The type 1 hybrid effectiveness-implementation trial study design and reporting outcomes were developed using the Consolidated Framework for Implementation Research. An innovative placement model was developed, where students on voluntary placement visited three residential aged care facilities to identify residents at risk of malnutrition using currently available screening tools for older people. Students completed malnutrition assessments for all residents using the subjective global assessment tool. Thirty-two students participated; 31 completed all three sessions, with malnutrition screening completed for 207 residents and malnutrition assessment for 187 residents (July and September 2022). Based on the subjective global assessment, 31% (n = 57) of residents were mildly/moderately malnourished, and 3% (n = 5) were severely malnourished. The Innovation Domain of the Framework was the most important consideration before implementation. Whilst previous research documented student learning opportunities in residential aged care facilities, this study provides the first available evidence of the direct contribution students can make to the health of aged care residents through malnutrition screening and assessment. The model enables students to conduct malnutrition screening and assessment feasibly and efficiently in facilities that do not routinely collate and act on these data. With a limited nursing aged care workforce to undertake this vital task, the potential role of student dietitians to fulfil this role must be considered.

Using a theory-based, customized video game as an educational tool to improve physicians’ trauma triage decisions: study protocol for a randomized cluster trial

Background Transfer of severely injured patients to trauma centers, either directly from the field or after evaluation at non-trauma centers, reduces preventable morbidity and mortality. Failure to transfer these patients appropriately (i.e., under-triage) remains common, and occurs in part because physicians at non-trauma centers make diagnostic errors when evaluating the severity of patients’ injuries. We developed Night Shift, a theory-based adventure video game, to recalibrate physician heuristics (intuitive judgments) in trauma triage and established its efficacy in the laboratory. We plan a type 1 hybrid effectiveness-implementation trial to determine whether the game changes physician triage decisions in real-life and hypothesize that it will reduce the proportion of patients under-triaged.MethodsWe will recruit 800 physicians who work in the emergency departments (EDs) of non-trauma centers in the US and will randomize them to the game (intervention) or to usual education and training (control). We will ask those in the intervention group to play Night Shift for 2 h within 2 weeks of enrollment and again for 20 min at quarterly intervals. Those in the control group will receive only usual education (i.e., nothing supplemental). We will then assess physicians’ triage practices for older, severely injured adults in the 1-year following enrollment, using Medicare claims, and will compare under-triage (primary outcome), 30-day mortality and re-admissions, functional independence, and over-triage between the two groups. We will evaluate contextual factors influencing reach, adoption, implementation, and maintenance with interviews of a subset of trial participants (n = 20) and of other key decision makers (e.g., patients, first responders, administrators [n = 100]).DiscussionThe results of the trial will inform future efforts to improve the implementation of clinical practice guidelines in trauma triage and will provide deeper understanding of effective strategies to reduce diagnostic errors during time-sensitive decision making.Trial registrationClinicalTrials.gov; NCT06063434. Registered 26 September 2023.

Early sepsis care with the National Early Warning Score 2-guided Sepsis Hour-1 Bundle in the emergency department: hybrid type 1 effectiveness-implementation pilot stepped wedge randomised controlled trial (NEWS-1 TRIPS) protocol

IntroductionEarly sepsis treatment in the emergency department (ED) is crucial to improve patient survival. Despite international promulgation, the uptake of the Surviving Sepsis Campaign (SSC) Hour-1 Bundle (lactate measurement, blood...

Evaluation of strategies to support implementation of a hospital walking program: protocol for a type III effectiveness-implementation hybrid trial

BackgroundSTRIDE is a supervised walking program designed to address the negative consequences of immobility during hospitalization for older adults. In an 8-hospital stepped wedge randomized controlled trial, STRIDE was associated with reduced odds of hospital discharge to skilled nursing facility. STRIDE has the potential to become a system-wide approach to address hospital-associated disability in Veteran’s Affairs; however, critical questions remain about how best to scale and sustain the program. The overall study goal is to compare the impact of two strategies on STRIDE program penetration (primary), fidelity, and adoption implementation outcomes.MethodsReplicating Effective Programs will be used as a framework underlying all implementation support activities. In a parallel, cluster randomized trial, we will use stratified blocked randomization to assign hospitals (n = 32) to either foundational support, comprised of standard, low-touch activities, or enhanced support, which includes the addition of tailored, high-touch activities if hospitals do not meet STRIDE program benchmarks at 6 and 8 months following start date. All hospitals begin with foundational support for 6 months until randomization occurs. The primary outcome is implementation penetration defined as the proportion of eligible hospitalizations with ≥ 1 STRIDE walks at 10 months. Secondary outcomes are fidelity and adoption with all implementation outcomes additionally examined at 13 and 16 months. Fidelity will be assessed for STRIDE hospitalizations as the percentage of eligible hospital days with “full dose” of the program, defined as two or more documented walks or one walk for more than 5 min. Program adoption is a binary outcome defined as ≥ 5 patients with a STRIDE walk or not. Analyses will also include patient-level effectiveness outcomes (e.g., discharge to nursing home, length of stay) and staffing and labor costs. We will employ a convergent mixed-methods approach to explore and understand pre-implementation contextual factors related to differences in hospital-level adoption.DiscussionOur study results will dually inform best practices for promoting successful implementation of an evidence-based hospital-based walking program. This information may support other programs by advancing our understanding of how to apply and scale-up national implementation strategies.Trial registrationThis study was registered on June 1, 2021, at ClinicalTrials.gov (identifier NCT04868656).

Use of implementation mapping in the planning of a hybrid type 1 pragmatic clinical trial: the BeatPain Utah study

BackgroundConsiderable disparities in chronic pain management have been identified. Persons in rural, lower income, and minoritized communities are less likely to receive evidence-based, nonpharmacologic care. Telehealth delivery of nonpharmacologic, evidence-based interventions for persons with chronic pain is a promising strategy to lessen disparities, but implementation comes with many challenges. The BeatPain Utah study is a hybrid type 1 effectiveness-implementation pragmatic clinical trial investigating telehealth strategies to provide nonpharmacologic care from physical therapists to persons with chronic back pain receiving care in ommunity health centers (CHCs). CHCs provide primary care to all persons regardless of ability to pay. This paper outlines the use of implementation mapping to develop a multifaceted implementation plan for the BeatPain study.MethodsDuring a planning year for the BeatPain trial, we developed a comprehensive logic model including the five-step implementation mapping process informed by additional frameworks and theories. The five iterative implementation mapping steps were addressed in the planning year: (1) conduct needs assessments for involved groups; (2) identify implementation outcomes, performance objectives, and determinants; (3) select implementation strategies; (4) produce implementation protocols and materials; and (5) evaluate implementation outcomes.ResultsCHC leadership/providers, patients, and physical therapists were identified as involved groups. Barriers and assets were identified across groups which informed identification of performance objectives necessary to implement two key processes: (1) electronic referral of patients with back pain in CHC clinics to the BeatPain team and (2) connecting patients with physical therapists providing telehealth. Determinants of the performance objectives for each group informed our choice of implementation strategies which focused on training, education, clinician support, and tailoring physical therapy interventions for telehealth delivery and cultural competency. We selected implementation outcomes for the BeatPain trial to evaluate the success of our implementation strategies.ConclusionsImplementation mapping provided a comprehensive and systematic approach to develop an implementation plan during the planning phase for our ongoing hybrid effectiveness-implementation trial. We will be able to evaluate the implementation strategies used in the BeatPain Utah study to inform future efforts to implement telehealth delivery of evidence-based pain care in CHCs and other settings.Trial registrationClinicalTrials.gov Identifier: NCT04923334. Registered June 11, 2021.

193 Implementation of a standardized protocol for labor induction: a type I hybrid effectiveness-implementation trial

193 Implementation of a standardized protocol for labor induction: a type I hybrid effectiveness-implementation trial

Analysis of implementation processes in a hybrid effectiveness-implementation trial of interpersonal psychotherapy (IPT) for major depressive disorder in prisons: Training, supervision, and recommendations.

There are 10 million admissions to U.S. prisons and jails each year. More than half of those admitted have mental health problems. The goal of this article is to inform: (1) implementation of evidence-based mental health treatments in prisons and jails, an important effort that needs more evidence to guide it; (2) psychotherapy and interpersonal psychotherapy (IPT) training efforts, especially in low-resource settings. A randomized hybrid effectiveness-implementation trial of group IPT for major depressive disorder (MDD) in state prisons found that IPT increased rates of MDD remission and lowered posttraumatic stress disorder symptoms relative to prison treatment as usual. The trial used prison counselors, only some of whom had prior psychotherapy training/experience, to deliver IPT. IPT treatment adherence was high (96%), but trial training and supervision were too costly to be scalable outside the trial. The current article reports results from a planned qualitative analysis of 460 structured implementation and supervision documents in that trial to describe training and supervision processes and lessons learned, inform training recommendations, and facilitate future work to optimize training and supervision for under-resourced settings. Themes identified in implementation and supervision process notes reflected: work on psychotherapy basics (reflective listening, focusing on emotions, open-ended questions, specific experiences), IPT case conceptualization (forming a conceptualization, what is and is not therapeutic work, structure and limit setting, structure vs. flexibility), IPT techniques (enhancing social support, role plays, communication analysis), psychotherapy processes (alliance repair, managing group processes), and managing difficult situations (avoidance, specific clients, challenging work settings). Counselors were receptive to feedback; some relied on study supervisors for support in managing stressful prison working conditions. Findings can be used to make future training and supervision more efficient. Based on our results, we recommend that initial and refresher training focus on IPT case conceptualization, steps for addressing each IPT problem area, and reflective listening. We also recommend supervision through at least counselors' first two rounds of groups. More low-cost, scalable training methods are needed to get mental health treatment to individuals who need it most, who are often served in challenging, low-resource settings such as prisons. This is a mental health access and equity issue. The trial was registered at clinicaltrials.gov (NCT01685294).

Effectiveness-implementation hybrid trial of Spanish language, digital cognitive-behavioral therapy (dCBT) intervention for depression and anxiety – protocol for the SUPERA (SUpport from PEeRs to expand Access) study

BackgroundLimited English Proficiency (LEP) Latinxs experience a longer duration of untreated depression and anxiety. LEP Latinxs have difficulty accessing mental healthcare due to insufficient Spanish-speaking behavioral/mental health clinicians to meet demand. These under-resourced healthcare systems are less likely to be the site for the implementation of innovations. Digital interventions can provide an effective option for overcoming these barriers; yet, when digital evidence-based treatments are available, uptake and engagement is often low. This manuscript presents the protocol for the SUPERA (SUpport from PEeRs to expand Access) study which will evaluate the implementation of an evidence-based, Spanish language, digital cognitive-behavioral therapy (dCBT) intervention (i.e., SilverCloud) in safety-net primary care clinics for LEP Latinx patients with depression or anxiety. MethodsWe will conduct an effectiveness-implementation hybrid trial (Type 2) design comparing engagement and clinical outcomes in two modalities of dCBT delivery (peer-supported vs. unsupported). We will also compare provider-level outreach (using a clinic patient registry) versus inreach (traditional provider referral) to compare rates of initiation, completion, and cost. Participants will be 426 LEP Latinx adults ≥18 years of age, PHQ-9 ≥ 10 or GAD-7 ≥ 8, with access to the internet via smartphone, and not currently receiving individual psychotherapy. We will collect baseline, post-intervention (8 weeks), and follow up (3 months) data. ConclusionThe long-term goal of this research is to aid in the implementation of digital mental health interventions that can be sustainably implemented in low-resourced settings, while reducing the reliance on professionals, overcoming workforce deficits, and increasing relevance for diverse populations.

EMBOLDEN: CATALYZING RESEARCH FOR OLDER ADULTS THROUGH CO-DESIGNED MOBILITY-PROMOTING INTERVENTION RESEARCH

Abstract Mobility and social participation are requisites for optimizing health, independence, and quality of life in older populations. Most mobility-enhancing interventions for older adults have been designed by researchers alone, which often experience implementation challenges and limited effectiveness when translated to real-world contexts. The EMBOLDEN research program aims to i) partner with older adults and service providers to co-design, implement, and evaluate a mobility-promoting intervention and ii) enhance physical and mental health, foster social connections, and support system navigation among older adults living in neighbourhoods with health inequities. EMBOLDEN has completed two phases: (1) intervention co-design based on evidence reviews, environmental scan, qualitative study, and strategic guiding council expertise; (2) a mixed-methods pilot randomized controlled trial. Twenty-seven local older adults (≥55y) and 34 service providers contributed to Phase 1, co-designing an integrated health and social care intervention delivered through collaboration with primary care, public health, and recreation. The three-month community-based program includes a weekly interactive group program of physical activity, healthy eating, socialization, and individual system navigation support. The co-design determined priority intervention features (e.g., addressing social determinants of health, assets-based approaches) and implementation strategies. The pilot study evaluated quantitative and qualitative participant outcomes and experiences and intervention team experiences. The pilot study demonstrated intervention feasibility and acceptability to participants and interventionists, informing a larger pragmatic hybrid implementation-effectiveness trial that is currently underway. EMBOLDEN’s partnership engagement was critical to successfully co-designing intervention research to address identified health, mobility, and social needs of older adults living in neighbourhoods with significant health inequities.

An exposure-based implementation strategy to decrease clinician anxiety about implementing suicide prevention evidence-based practices: protocol for development and pilot testing (Project CALMER)

BackgroundClinicians often report that their own anxiety and low self-efficacy inhibit their use of evidence-based suicide prevention practices, including gold-standard screening and brief interventions. Exposure therapy to reduce clinician maladaptive anxiety and bolster self-efficacy use is a compelling but untested approach to improving the implementation of suicide prevention evidence-based practices (EBPs). This project brings together an interdisciplinary team to leverage decades of research on behavior change from exposure theory to design and pilot test an exposure-based implementation strategy (EBIS) to target clinician anxiety to improve suicide prevention EBP implementation.MethodsWe will develop, iteratively refine, and pilot test an EBIS paired with implementation as usual (IAU; didactic training and consultation) in preparation for a larger study of the effect of this strategy on reducing clinician anxiety, improving self-efficacy, and increasing use of the Columbia Suicide Severity Rating Scale and the Safety Planning Intervention in outpatient mental health settings. Aim 1 of this study is to use participatory design methods to develop and refine the EBIS in collaboration with a stakeholder advisory board. Aim 2 is to iteratively refine the EBIS with up to 15 clinicians in a pilot field test using rapid cycle prototyping. Aim 3 is to test the refined EBIS in a pilot implementation trial. Forty community mental health clinicians will be randomized 1:1 to receive either IAU or IAU + EBIS for 12 weeks. Our primary outcomes are EBIS acceptability and feasibility, measured through questionnaires, interviews, and recruitment and retention statistics. Secondary outcomes are the engagement of target implementation mechanisms (clinician anxiety and self-efficacy related to implementation) and preliminary effectiveness of EBIS on implementation outcomes (adoption and fidelity) assessed via mixed methods (questionnaires, chart-stimulated recall, observer-coded role plays, and interviews).DiscussionOutcomes from this study will yield insight into the feasibility and utility of directly targeting clinician anxiety and self-efficacy as mechanistic processes informing the implementation of suicide prevention EBPs. Results will inform a fully powered hybrid effectiveness-implementation trial to test EBIS’ effect on implementation and patient outcomes.Trial registrationClinical Trials Registration Number: NCT05172609. Registered on 12/29/2021.

Concurrent Hospice and Dialysis Care: Considerations for Implementation.

Hospice positively impacts care at the end of life for patients and their families. However, compared to the general Medicare population, patients on dialysis are half as likely to receive hospice. Concurrent hospice and dialysis care offers an opportunity to improve care for people living with end-stage kidney disease (ESKD). We sought to (1) develop a conceptual model of the Program and (2) identify key components, resources, and considerations for further implementation. We conducted a template analysis of qualitative interviews and convened a community advisory panel (CAP) to get feedback on current concurrent care design and considerations for dissemination and implementation. Thirty-nine patients with late-stage chronic kidney disease (CKD), family caregivers, bereaved family caregivers, hospice clinicians, nephrology clinicians, administrators, and policy experts participated in interviews. A purposive subset of 19 interviewees composed the CAP. Qualitative feedback on concurrent care design refinements, implementation, and resources. Participants identified four themes that define an effective model of concurrent hospice and dialysis: it requires (1) timely goals-of-care conversations and (2) an interdisciplinary approach; (3) clear guidelines ensure smooth transitions for patients and families; and (4) hospice payment policy must support concurrent care. CAP participants provided feedback on the phases of an effective model of concurrent hospice and dialysis, and resources, including written and interactive educational materials, communication tools, workflow processes, and order sets. We developed a conceptual model for concurrent hospice and dialysis care and a corresponding resource list. In addition to policy changes, clinical implementation and educational resources can facilitate scalable and equitable dissemination of concurrent care. Concurrent hospice and dialysis care must be systematically evaluated via a hybrid implementation-effectiveness trial that includes the resources outlined herein, based on our conceptual model of concurrent care delivery.

Physiotherapy-led telehealth and exercise intervention to improve mobility in older people receiving aged care services (TOP UP): protocol for a randomised controlled type 1 hybrid effectiveness-implementation trial

IntroductionDeteriorating mobility and falls reduce independence and quality of life for older people receiving aged care services. This trial aims to establish effectiveness on the mobility of older people, and...