Hybrid Effectiveness-implementation Study Research Articles

Preventing type 2 diabetes in Portugal: a novel person-centered digital intervention

Abstract Introduction Diabetes, particularly type 2 diabetes (T2D), stands as one of the leading noncommunicable diseases worldwide. In Portugal, the prevalence of diabetes has surged, with T2D affecting 14% of adults in 2021. Its repercussions extend beyond individual health, deeply impacting familial, social, and community dynamics, presenting a significant public health challenge globally. Objectives The VA|PREVENTION project (https://doi.org/10.54499/2022.02969.PTDC) aims to assess the (cost-) effectiveness and implementation of an innovative person-centered digital intervention to prevent T2D among high-risk adults. Methodology A comprehensive approach encompasses the Behavior Change Wheel for intervention design, scalability principles, the WHO guidelines for digital health interventions, co-design, and the ISO framework for usability assessment. Evaluation will be pursued through a type 1 hybrid effectiveness-implementation study (randomized controlled trial), supplemented by qualitative and economic studies. Results The web application prototype features Ema, an automated virtual human coach (VHC), educational menus and a dashboard (version 1.0). Co-design included 2 workshops with 11 representatives of end-users and health professionals. Ema uses standardized techniques from an ontology to support behavior change, based on an initial assessment of low-level target behaviors (e.g. walking, fruit consumption, and reducing red meat intake), and barriers to performing these behaviors. Ema communicates in a helpful-cooperative style using a synthetic voice in European Portuguese, with its speech also appearing as subtitles on the interface. Users interact with Ema by pressing buttons or entering data, such as the daily number of steps. Ethics approval was granted for usability assessment with end-users. Conclusions The project is expected to yield health, scientific, technological, and policy impacts, powered by an exploitation and sustainability roadmap. Key messages • Innovative type 2 diabetes prevention through a scalable web app with a virtual human coach. • Comprehensive and robust approach for developing and evaluating the digital behavior change intervention.

A digital iCBT intervention for social anxiety disorder in Quebec and Ontario: protocol for a multi-phase effectiveness-implementation study

BackgroundSocial anxiety disorder (SAD) is one of the most prevalent anxiety disorders in Canada. Viable therapy options for the treatment of SAD include CBT being delivered virtually. In Australia, an innovative internet-delivered cognitive-behavioral therapy (iCBT) program for social anxiety has been developed, implemented, and demonstrated as effective. To make available high-quality and real-time evidence in response to the crucial need to access psychological services to meet population mental health needs, we propose to conduct a Canadian adaptation of the iCBT Shyness Program and to examine the program’s effectiveness, and implementation in two Canadian provinces (Quebec and Ontario).MethodsThe overall study design is a hybrid effectiveness-implementation study of a quasi-experimental parallel group trial. Prior to implementing the iCBT Shyness Program, it will undergo an initial adaptation to the Canadian context and focus groups will be conducted with key actor groups to discuss the adaptations to the graphics, narration of the lessons, and this to better reflect varying socio-cultural context among Canadian French- and English-speaking populations. We will evaluate the effectiveness of the program in three parallel pathways reflecting real-world pathways: (1) self-refer to the intervention; (2) recommended by a health professional without guidance; and (3) recommended by a health professional, with low-intensity guidance. Data collection will be carried out at baseline, at the beginning of each lesson, 12-week and 6-month follow-up. Outcomes measured will include anxiety and depressive symptoms, psychological distress, disability, as well as health service utilization and satisfaction. Semi-structured interviews will then be conducted with study participants and health care providers to explore facilitating factors and barriers to the implementation of the iCBT adapted program.DiscussionThis study will provide evidence on the effectiveness, barriers and facilitating factors to implementing a low-intensity iCBT in the Canadian context for SAD, which will bridge an important care gap for undeserved populations in Canada with SAD. Findings will inform the eventual scaling up of the program in community-based primary care across Canada. This would improve equity of the health care system by helping a large number of Canadians to timely access to mental health services.Trial registrationclinicaltrials.gov NCT06403995. Prospectively registered on 05/03/2024.

Patient and care team experiences with an EHR-integrated symptom management program (eSyM) in routine oncology practice.

324 Background: Clinical trials have shown that collecting electronic patient-reported outcomes (ePROs) improves quality of life and survival in cancer patients. To bolster integration of ePROs into routine care, the SIMPRO Research Consortium developed an electronic symptom management (eSyM) program, deployed it at six cancer centers, and conducted a hybrid effectiveness-implementation study. eSyM, an ePRO toolkit integrated into the Epic EHR, enables patients to report and care teams to triage symptoms in real-time. To assess eSyM, we conducted structured qualitative interviews with patients and clinic staff, including doctors, nurses, advanced practice providers, and administrative staff. We sought to understand eSyM from the patient and staff perspectives. Methods: Using an iterative process, we developed semi-structured interview guides to query the experiences and perceptions of patients and staff exposed to eSyM. Questions were informed by the Consolidated Framework for Implementation Research. One year after eSyM was launched, sites identified and referred participants for interviews or focus groups. Participants must have either used eSyM to submit symptoms (patients) or had access to eSyM at their institution (staff). Patients provided written consent; a consent waiver was obtained for staff. Interviews were recorded and transcribed, and a common analytic codebook was developed. Transcripts were dual or triple-coded and underwent thematic analysis to identify key contexts and concepts within and across patient and staff groups. Results: From 9/28/20 to 4/14/23, 50 staff participated in individual interviews and 29 participated in focus groups (79 total). From 9/14/23 to 3/14/24, 14 patient interviews were conducted. Transcripts revealed that staff and patients held similar beliefs regarding eSyM compatibility, communication, and prioritization. 93% (13/14) of patients and 72% (57/79) of staff believed eSyM was easy to use and improved communication. Both cohorts (66% staff, 36% patients) noted that competing demands often needed to be prioritized over responding to symptom concerns. Discordance emerged in the domains of receptivity and technology; patients were more receptive and capable of using eSyM than staff perceived. Both groups believed eSyM was helpful but perceived that deeper engagement from patients and staff was necessary for sustainability. Conclusions: Most interviewees reported that eSyM added value and was easy to navigate. Competing clinical demands, however, frequently deprioritized use of eSyM. Staff tended to underestimate patients’ receptivity to use eSyM and were more likely to cite competing demands as a barrier to their own use of eSyM. Sites looking to adopt eSyM, or similar ePRO programs, will benefit from understanding the facilitators that need to be incorporated and the barriers that need to be surmounted to optimize success. Clinical trial information: NCT03850912 .

Evaluating the tailored implementation of a multisite care navigation service for mental health in rural and remote Australia (The Bridging Study): protocol for a community-engaged hybrid effectiveness-implementation study

BackgroundA dramatic decline in mental health of people worldwide in the early COVID-19 pandemic years has not recovered. In rural and remote Australia, access to appropriate and timely mental health services has been identified as a major barrier to people seeking help for mental ill-health. From 2020 to 2021 a care navigation model, Navicare, was co-designed with rural and remote communities in the Greater Whitsunday Region of Central Queensland in Australia. The Exploration, Preparation, Implementation and Sustainment (EPIS) framework was used to design and guide multiple aspects of a multisite study, The Bridging Study, to evaluate the implementation of Navicare in Australia.MethodsA community-engaged hybrid effectiveness-implementation study design will focus on the tailored implementation of Navicare at three new sites as well as monitoring implementation at an existing site established since 2021. Study outcomes assessed will include sustained access as the co-primary outcome (measured using access to Navicare mental health referral services) and Proctor’s Implementation Outcomes of feasibility, acceptability, appropriateness, adoption, fidelity, implementation cost, and sustainability. Data collection for the implementation evaluation will include service usage data, community consultations, interviews, and workshops; analysed using mixed methods and guided by EPIS and other implementation frameworks. Pre-post effectiveness and cost-consequence study components are embedded in the implementation and sustainment phases, with comparison to pre-implementation data and value assessed for each EPIS phase using hospital, service, and resource allocation data. A scaling up strategy will be co-developed using a national roundtable forum in the final year of the study. Qualitative exploration of other aspects of the study (e.g., mechanisms of action and stakeholder engagement) will be conducted.DiscussionOur study will use tailoring to local sites and a community-engaged approach to drive implementation of a mental health care navigation service in rural and remote Australia, with expected benefits to mental healthcare access. This approach is consistent with policy recommendations nationally and internationally as building blocks for rural health including the World Health Organization Framework for Action on Strengthening Health Systems to Improve Health Outcomes.Trial registrationProspectively registered on April 2, 2024, on the Australian New Zealand Clinical Trials Registry, no. ACTRN12624000382572. https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=386665&isReview=true.

Effect of a digital school-based intervention on adolescent family planning and reproductive health in Rwanda: a cluster-randomized trial.

We conducted a cluster-randomized hybrid effectiveness-implementation study of CyberRwanda, a digital family planning and reproductive health intervention for Rwandan adolescents. Sixty schools were randomized 1:1:1 to control or to one of two implementation models-self-service (self-guided access on tablets) or facilitated (peer-led clubs plus tablet access) with no masking. Eligible participants were aged 12-19 years, in secondary school levels 1 or 2, and willing to provide consent or assent/parental consent and contact information for follow-up. In 2021, 6,078 randomly selected adolescents were enrolled. At 24 months, 91.3% of participants were retained and included in the primary intention-to-treat analyses (control, n = 1,845; self-service, n = 1,849 and facilitated, n = 1,858). There were no adverse events related to the study. CyberRwanda did not affect the primary outcomes of modern contraceptive use (prevalence ratio (PR) = 1.04; 95% confidence interval (CI) = 0.76, 1.42), childbearing (PR = 1.33; 95% CI = 0.71, 2.50) and HIV testing (PR = 1.00; 95% CI = 0.91, 1.11) in the full sample. Significantly higher modern contraceptive use observed in the CyberRwanda facilitated arm in a prespecified analysis of sexually active participants suggests that longer-term evaluation is needed to examine effects as more of the study population becomes sexually active and has increased demand for contraception. ClinicalTrials.gov registration: NCT04198272 .

Impact of financial incentives on viral suppression among adults initiating HIV treatment in Tanzania: a hybrid effectiveness–implementation trial

Small incentives could improve engagement in HIV care. We evaluated the short-term and longer-term effects of financial incentives for visit attendance on viral suppression among adults initiating antiretroviral therapy (ART) in Tanzania. In a type 1 hybrid effectiveness-implementation study, we randomised (1:1) 32 primary care HIV clinics in four Tanzanian regions to usual care (control group) or the intervention (usual care plus ≤6 monthly incentives [22 500 Tanzanian Shillings, about US$10, each], conditional on visit attendance). Adults (aged ≥18 years) initiating ART (<30 days) who owned a mobile phone and had no plans to transfer to another facility were eligible. The primary outcome was retention on ART with viral suppression (<1000 copies per mL) at 12 months. Secondary outcomes included retention on ART with viral suppression at 6 months and viral suppression at 6 months and 12 months using a lower threshold (<50 copies per mL). Intent-to-treat analysis and a cluster-based permutation test were used to evaluate the effect of financial incentives on outcomes. This trial is registered with ClinicalTrials.gov, NCT04201353, and is completed. Between May 28, 2021, and March 8, 2022, 1990 participants (805 male and 1185 female) were enrolled in the study. 1059 participants were assigned to the intervention group and 931 participants were assigned to the control group. Overall, 1536 (88%) participants at 6 months and 1575 (83%) at 12 months were on ART with viral suppression. At 12 months, 6 months after the intervention ended, 866 (85%) participants in the intervention group compared with 709 (81%) in the control group had viral loads less than 1000 copies per mL (adjusted risk difference [aRD] 4·4 percentage points, 95% CI -1·4 to 10·1, permutation test p=0·35). At 6 months, 858 participants (90%) in the intervention group were on ART with viral loads less than 1000 copies per mL compared with 678 (86%) in the control group (aRD 5·1 percentage points, 95% CI 1·1 to 9·1, permutation test p=0·06). Effects were larger at 6 months and 12 months with the lower threshold for viral suppression, and there was significant effect heterogeneity by region. Adverse events included 106 deaths (56 in the control group and 50 in the intervention group), none related to study participation. Short-term incentives for visit attendance had modest, short term benefits on viral suppression and did not harm retention or viral suppression after discontinuation. These findings suggest the need to understand subgroups who would most benefit from incentives to support HIV care. National Institute of Mental Health. For the Swahili translation of the abstract see Supplementary Materials section.

Strategies, processes, outcomes, and costs of implementing experience sampling-based monitoring in routine mental health care in four European countries: study protocol for the IMMERSE effectiveness-implementation study

BackgroundRecent years have seen a growing interest in the use of digital tools for delivering person-centred mental health care. Experience Sampling Methodology (ESM), a structured diary technique for capturing moment-to-moment variation in experience and behaviour in service users’ daily life, reflects a particularly promising avenue for implementing a person-centred approach. While there is evidence on the effectiveness of ESM-based monitoring, uptake in routine mental health care remains limited. The overarching aim of this hybrid effectiveness-implementation study is to investigate, in detail, reach, effectiveness, adoption, implementation, and maintenance as well as contextual factors, processes, and costs of implementing ESM-based monitoring, reporting, and feedback into routine mental health care in four European countries (i.e., Belgium, Germany, Scotland, Slovakia).MethodsIn this hybrid effectiveness-implementation study, a parallel-group, assessor-blind, multi-centre cluster randomized controlled trial (cRCT) will be conducted, combined with a process and economic evaluation. In the cRCT, 24 clinical units (as the cluster and unit of randomization) at eight sites in four European countries will be randomly allocated using an unbalanced 2:1 ratio to one of two conditions: (a) the experimental condition, in which participants receive a Digital Mobile Mental Health intervention (DMMH) and other implementation strategies in addition to treatment as usual (TAU) or (b) the control condition, in which service users are provided with TAU. Outcome data in service users and clinicians will be collected at four time points: at baseline (t0), 2-month post-baseline (t1), 6-month post-baseline (t2), and 12-month post-baseline (t3). The primary outcome will be patient-reported service engagement assessed with the service attachment questionnaire at 2-month post-baseline. The process and economic evaluation will provide in-depth insights into in-vivo context-mechanism-outcome configurations and economic costs of the DMMH and other implementation strategies in routine care, respectively.DiscussionIf this trial provides evidence on reach, effectiveness, adoption, implementation and maintenance of implementing ESM-based monitoring, reporting, and feedback, it will form the basis for establishing its public health impact and has significant potential to bridge the research-to-practice gap and contribute to swifter ecological translation of digital innovations to real-world delivery in routine mental health care.Trial registrationISRCTN15109760 (ISRCTN registry, date: 03/08/2022).

Validating cognitive screening in young people with first-episode psychosis: The CogScreen protocol.

Cognitive impairments are a core feature of first-episode psychosis (FEP) and one of the strongest predictors of long-term psychosocial functioning. Cognition should be assessed and treated as part of routine clinical care for FEP. Cognitive screening offers the opportunity to rapidly identify and triage those in most need of cognitive support. However, there are currently no validated screening measures for young people with FEP. CogScreen is a hybrid effectiveness-implementation study which aims to evaluate the classification accuracy (relative to a neuropsychological assessment as a reference standard), test-retest reliability and acceptability of two cognitive screening tools in young people with FEP. Participants will be 350 young people (aged 12-25) attending primary and specialist FEP treatment centres in three large metropolitan cities (Adelaide, Sydney, and Melbourne) in Australia. All participants will complete a cross-sectional assessment over two sessions including two cognitive screening tools (Screen for Cognitive Impairment in Psychiatry and Montreal Cognitive Assessment), a comprehensive neuropsychological assessment battery, psychiatric and neurodevelopmental assessments, and other supplementary clinical measures. To determine the test-retest reliability of the cognitive screening tools, a subset of 120 participants will repeat the screening measures two weeks later. The protocol, rationale, and hypotheses for CogScreen are presented. CogScreen will provide empirical evidence for the validity and reliability of two cognitive screening tools when compared to a comprehensive neuropsychological assessment. The screening measures may later be incorporated into clinical practice to assist with rapid identification and treatment of cognitive deficits commonly experienced by young people with FEP.

Telephone support vs. self-guidance in an Internet-based self-administered psychological program for the treatment of depression: Protocol for a hybrid type 1 effectiveness-implementation randomized controlled trial

BackgroundDepression is already the leading psychological disability around the world, impairing daily life, well-being, and social functioning and leading to personal and social costs. Despite the effectiveness of Evidence-Based Psychological Practices (EBPP), a significant percentage of depressive individuals remain untreated, especially in Primary Care (PC) settings in Spain. There are numerous barriers that limit access to EBPPs, including high costs, professional training, and adherence problems. Information and Communication Technologies (ICTs) offer a cost-effective way to disseminate and scale EBPPs to address these barriers. The iCBT program Smiling is Fun has been demonstrated to be a cost-effective treatment for depression in various Randomized Control Trials. However, adherence and implementation problems in real-world settings need to be addressed. Implementation research can help evaluate these challenges by identifying facilitators and barriers to the implementation process in PC. In this regard, including human support has been pointed out as a possible key factor in addressing the population's mental health needs and promoting treatment adherence. ObjectiveThe current study aims to examine the effectiveness, adherence rates, and implementation process of Smiling is Fun to address depression in a PC setting considering the influence of telephone support vs no support. MethodsThe proposed research is a Hybrid Effectiveness-Implementation Type I study, with a two-armed randomized controlled design, which will test a clinical intervention for major depressive disorder while gathering information on its implementation in a real-world setting. The study will include adult patients with mild to moderate symptoms of depression. Participants will be randomly assigned to one of two groups: self-applied psychotherapy or self-applied psychotherapy with psychotherapeutic telephone support. The trial will recruit 110 patient participants, with a loss-to-follow-up rate of 30 %. DiscussionA study protocol for a hybrid effectiveness-implementation study is presented with the aim to assess the implementation of Smiling is Fun for the treatment of depression in PC. The study evaluates the influence of telephone support during a self-administered intervention compared to unguided self-administration. The main goal is to address the barriers and facilitators of the implementation process and to promote treatment adherence. Ultimately, the results of the study could help in the uptake of sustainable resources so that the population could gain better access to psychological interventions in mental health services. RegistrationClinicalTrials.gov; NCT06230237.

Impact of Local Tailoring on Acute Stroke Care in 21 Disparate Emergency Departments: A Prospective Stepped Wedge Type III Hybrid Effectiveness-Implementation Study.

Faster delivery of tPA (tissue-type plasminogen activator) results in better health outcomes for eligible patients with stroke. Standardization of stroke protocols in emergency departments (EDs) has been difficult, especially in nonstroke centers. We measured the effectiveness of a centrally led implementation strategy with local site tailoring to sustain adherence to an acute stroke protocol to improve door-to-needle (DTN) times across disparate EDs in a multihospital health system. Prospective, type III hybrid effectiveness-implementation cohort study measuring performance at 21 EDs in Utah and Idaho (stroke centers [4]/nonstroke centers [17]) from January 2018 to February 2020 using a nonrandomized stepped-wedge design, monthly repeated site measures and multilevel hierarchical modeling. Each site received the implementation strategies in 1 of 6 steps providing control and intervention data. Co-primary outcomes were percentage of DTN times ≤60 minutes and median DTN time. Secondary outcomes included percentage of door-to-activation of neurological consult times ≤10 minutes and clinical effectiveness outcomes. Results were stratified between stroke and nonstroke centers. A total of 855 474 ED patient encounters occurred with 5325 code stroke activations (median age, 69 [IQR, 56-79] years; 51.8% female patients]. Percentage of door-to-activation times ≤10 minutes increased from 47.5% to 59.9% (adjusted odds ratio, 1.93 [95% CI, 1.40-2.67]). A total of 615 patients received tPA of ≤3 hours from symptom onset (median age, 71 [IQR, 58-80] years; 49.6% female patients). The percentage of DTN times ≤60 minutes increased from 72.5% to 86.1% (adjusted odds ratio, 3.38, [95% CI, 1.47-7.78]; stroke centers (77.4%-90.0%); nonstroke centers [59.3%-72.1%]). Median DTN time declined from 46 to 38 minutes (adjusted median difference, -9.68 [95% CI, -17.17 to -2.20]; stroke centers [41-35 minutes]; nonstroke centers [55-52 minutes]). No differences were observed in clinical effectiveness outcomes. A centrally led implementation strategy with local site tailoring led to faster delivery of tPA across disparate EDs in a multihospital system with no change in clinical effectiveness outcomes including rates of complication. Disparities in performance persisted between stroke and nonstroke centers.

Examining strength at home couples to prevent intimate partner violence on a military installation: A randomized controlled trial.

In this study, the effectiveness of a couples-based group intervention to prevent intimate partner violence (IPV), Strength at Home Couples (SAH-C), was examined on a military installation relative to a comparison intervention, Supportive Prevention (SP). It was expected that greater reductions in use of physical, psychological, and sexual IPV behaviors, as well as reduced suicidality, would be found among service members and their partners in SAH-C relative to SP. Participants included 138 couples randomized to SAH-C and SP through a clinical controlled trial embedded in a hybrid effectiveness implementation study which took place on a military installation. The Revised Conflict Tactics Scales and Multidimensional Measure of Emotional Abuse were used to measure IPV, and 13 Military Suicide Research Consortium common data elements were used to assess suicidality. Service members randomized to SAH-C evidenced greater reductions based on effect sizes across the assessment time points for all IPV variables, including use of overall physical IPV, severe physical IPV, sexual IPV, psychological IPV, and coercive control IPV relative to those randomized to SP. Partners of service members demonstrated a similar general pattern for reductions in use of IPV, but findings were not as robust as for service members. Both service members and partners demonstrated greater reductions in suicidality based on effect sizes when randomized to SAH-C relative to SP. Findings extend prior work demonstrating the promising effects of SAH-C delivered in the military context and highlight the possible benefits of SAH-C in preventing self-harm thoughts and behaviors. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Development of an interdisciplinary training program about chronic pain management with a cognitive behavioural approach for healthcare professionals: part of a hybrid effectiveness-implementation study

BackgroundMany applied postgraduate pain training programs are monodisciplinary, whereas interdisciplinary training programs potentially improve interdisciplinary collaboration, which is favourable for managing patients with chronic pain. However, limited research exists on the development and impact of interdisciplinary training programs, particularly in the context of chronic pain.MethodsThis study aimed to describe the development and implementation of an interdisciplinary training program regarding the management of patients with chronic pain, which is part of a type 1 hybrid effectiveness-implementation study. The targeted groups included medical doctors, nurses, psychologists, physiotherapists, occupational therapists, dentists and pharmacists. An interdisciplinary expert panel was organised to provide its perception of the importance of formulated competencies for integrating biopsychosocial pain management with a cognitive behavioural approach into clinical practice. They were also asked to provide their perception of the extent to which healthcare professionals already possess the competencies in their clinical practice. Additionally, the expert panel was asked to formulate the barriers and needs relating to training content and the implementation of biopsychosocial chronic pain management with a cognitive behavioural approach in clinical practice, which was complemented with a literature search. This was used to develop and adapt the training program to the barriers and needs of stakeholders.ResultsThe interdisciplinary expert panel considered the competencies as very important. Additionally, they perceived a relatively low level of healthcare professionals’ possession of the competencies in their clinical practice. A wide variety of barriers and needs for stakeholders were formulated and organized within the Theoretical Domain Framework linked to the COM-B domains; ‘capability’, ‘opportunity’, and ‘motivation’. The developed interdisciplinary training program, including two workshops of seven hours each and two e-learning modules, aimed to improve HCP’s competencies for integrating biopsychosocial chronic pain management with a cognitive behavioural approach into clinical practice.ConclusionWe designed an interdisciplinary training program, based on formulated barriers regarding the management of patients with chronic pain that can be used as a foundation for developing and enhancing the quality of future training programs.

Improving safety and preventing falls using an evidence-based, front-line staff huddling practice: protocol for a pragmatic trial to increase quality of care in State Veterans Homes

IntroductionFalls in nursing homes are a major cause for decreases in residents’ quality of life and overall health. This study aims to reduce resident falls by implementing the LOCK Falls...

Rudi Kundini, Pamoja Kundini (RKPK): study protocol for a hybrid type 1 randomized effectiveness-implementation trial using data science and economic incentive strategies to strengthen the continuity of care among people living with HIV in Tanzania

BackgroundEconomic incentives can improve clinical outcomes among in-care people living with HIV (PLHIV), but evidence is limited for their effectiveness among out-of-care PLHIV or those at risk of disengagement. We propose a type 1 hybrid effectiveness-implementation study to advance global knowledge about the use of economic incentives to strengthen the continuity of HIV care and accelerate global goals for HIV epidemic control.MethodsThe Rudi Kundini, Pamoja Kundini study will evaluate two implementation models of an economic incentive strategy for supporting two groups of PLHIV in Tanzania. Phase 1 of the study consists of a two-arm, cluster randomized trial across 32 health facilities to assess the effectiveness of a home visit plus one-time economic incentive on the proportion of out-of-care PLHIV with viral load suppression (< 1000 copies/ml) 6 months after enrollment (n = 640). Phase 2 is an individual 1:1 randomized controlled trial designed to determine the effectiveness of a short-term counseling and economic incentive program offered to in-care PLHIV who are predicted through machine learning to be at risk of disengaging from care on the outcome of viral load suppression at 12 months (n = 692). The program includes up to three incentives conditional upon visit attendance coupled with adapted counselling sessions for this population of PLHIV. Consistent with a hybrid effectiveness-implementation study design, phase 3 is a mixed methods evaluation to explore barriers and facilitators to strategy implementation in phases 1 and 2. Results will be used to guide optimization and scale-up of the incentive strategies, if effective, to the larger population of Tanzanian PLHIV who struggle with continuity of HIV care.DiscussionInnovative strategies that recognize the dynamic process of lifelong retention in HIV care are urgently needed. Strategies such as conditional economic incentives are a simple and effective method for improving many health outcomes, including those on the HIV continuum. If coupled with other supportive services such as home visits (phase 1) or with tailored counselling (phase 2), economic incentives have the potential to strengthen engagement among the subpopulation of PLHIV who struggle with retention in care and could help to close the gap towards reaching global “95–95-95” goals for ending the AIDS epidemic.Trial registrationPhase 1: ClinicalTrials.gov, NCT05248100, registered 2/21/2022.Phase 2: ClinicalTrials.gov, NCT05373095, registered 5/13/2022.

Study protocol for leaving care-A comparison study of implementation, change mechanisms and effectiveness of transition services for youth.

Youth placed in out-of-home care is a large and highly vulnerable group at high risk of negative developmental outcomes. Given the size and extent of negative developmental outcomes for youth placed in out-of-home care, interventions to help this vulnerable group navigate successfully towards independent living and promote wellbeing across a spectrum of outcome areas are needed. To date, there is a lack of such interventions, particularly in Sweden. Importing interventions from other societies and cultures is associated with difficulties. The aim of the research project is to implement, test, and evaluate interventions that have been recently developed in Swedish practice to close this gap. The project has an ambitious and complex data collection and analysis strategy using qualitative, quantitative, and multiple information methods (hybrid effectiveness-implementation study) over the course of two years. Both the implementation and effectiveness of the interventions will be evaluated. The recently developed My Choice-My Way! leaving care program for youth aged 15+ will be the primary focus of the project and will be compared to usual services. The project has the potential to offer novel insights into how society can promote wellbeing across a spectrum of outcome areas for the high-risk group of youth transitioning from out-of-home care to independent living. As such, the project will have important implications for both research and practice. ClinicalTrials.gov Identifier: NCT05813197.

Population-Based Cancer Prevention Education Intervention Through mHealth: A Randomized Controlled Trial

Despite the high potential of mHealth-related educational interventions to reach large segments of the population, implementation and adoption of such interventions may be challenging. The objective of this study was to gather knowledge on the feasibility of a future cancer prevention education intervention based on the European Code Against Cancer (ECAC), using a population-based mHealth implementation strategy. A type-2 hybrid effectiveness-implementation study was conducted in a sample of the Spanish general population to assess adoption, fidelity, appropriateness, and acceptability of an intervention to disseminate cancer prevention messages, and willingness to consult further digital information. Participation rates, sociodemographic data, mHealth use patterns and implementation outcomes were calculated. Receiving cancer prevention messages through mHealth is acceptable, appropriate (frequency, timing, understandability and perceived usefulness) and feasible. mHealth users reported high access to the Internet through different devices, high ability and confidence to browse a website, and high willingness to receive cancer prevention messages in the phone, despite low participation rates in comparison to the initial positive response rates. Although adoption of the intervention was high, post-intervention fidelity was seriously hampered by the disruptions caused by the Covid-19 pandemic, which may have affected recall bias. In the context of the Europe’s Beating Cancer Plan to increase knowledge about cancer prevention across the European Union, this study contributes to inform the design of future interventions using mHealth at large scale, to ensure a broad coverage and adoption of cancer prevention messages as those promoted by the ECAC.Trial Registration: ClinicalTrials.gov from the U.S. National Library of Medicine, NCT05992792. Registered 15 August 2023 - Retrospectively registered https://clinicaltrials.gov/study/NCT05992792?cond=Cancer&term=NCT05992792&rank=1.

PRO-HOME: AN IMPLEMENTATION SCIENCE FRAMEWORK FOR MULTILEVEL BARRIERS AND FACILITATORS IN LTSS

Abstract Promoting Seniors’ Health with Home Care Aides (Pro-Home) is a randomized controlled trial (RCT) of a gentle physical activity program for frail older adults conducted in a community-based long-term services and supports (LTSS) delivery setting. Pro-Home is a hybrid effectiveness-implementation study, which aims to examine (1) the effectiveness of the program delivered by home care aides (HCAs) in maintaining physical function in older homecare recipients, and (2) how the intervention works in a real-world Medicaid-funded LTSS system. This paper describes barriers and facilitators that have long existed or evolved during the Pro-Home development, using quantitative/qualitative data from the mixed-method study informed by an implementation science framework. Facilitators include the knowledge and partnerships that resulted from multiple preliminary studies that illuminated HCAs’ work/life-related stressors, coping resources, and underutilized capacity and motivation to promote the health of clients and HCAs themselves in the context of the LTSS system. Another facilitator has been the physical activity program developed in another state’s LTSS service setting (not in an academic setting). The program was easy to learn and adapt into a program to be delivered by HCAs (as opposed to care managers). Barriers included turbulent LTSS environments (e.g., rapidly growing managed care presence, COVID-19). Those barriers have been addressed through partnership with stakeholders at multiple levels. Having completed the intervention and data collection phases, we found the project’s planning and implementation challenging but rewarding. Pro-Home has produced rich information that will have many implications for research, practice, and LTSS services delivery and financing systems.

Protocol and statistical analysis plan for the identification and treatment of hypoxemic respiratory failure and acute respiratory distress syndrome with protection, paralysis, and proning: A type-1 hybrid stepped-wedge cluster randomised effectiveness-implementation study

ObjectiveTo describe a study protocol and statistical analysis plan (SAP) for the identification and treatment of hypoxemic respiratory failure (HRF) and acute respiratory distress syndrome (ARDS) with protection, paralysis, and proning (TheraPPP) study prior to completion of recruitment, electronic data retrieval, and analysis of any data. DesignTheraPPP is a stepped-wedge cluster randomised study evaluating a care pathway for HRF and ARDS patients. This is a type-1 hybrid effectiveness-implementation study design evaluating both intervention effectiveness and implementation; however primarily powered for the effectiveness outcome. SettingSeventeen adult intensive care units (ICUs) across Alberta, Canada. ParticipantsWe estimate a sample size of 18816 mechanically ventilated patients, with 11424 patients preimplementation and 7392 patients postimplementation. We estimate 2688 sustained ARDS patients within our study cohort. InterventionAn evidence-based, stakeholder-informed, multidisciplinary care pathway called Venting Wisely that standardises diagnosis and treatment of HRF and ARDS patients. Main outcome measuresThe primary outcome is 28-day ventilator-free days (VFDs). The primary analysis will compare the mean 28-day VFDs preimplementation and postimplementation using a mixed-effects linear regression model. Prespecified subgroups include sex, age, HRF, ARDS, COVID-19, cardiac surgery, body mass index, height, illness acuity, and ICU volume. ResultsThis protocol and SAP are reported using the Standard Protocol Items: Recommendations for Interventional Trials guidance and the Guidelines for the Content of Statistical Analysis Plans in Clinical Trials. The study received ethics approval and was registered (ClinicalTrials.gov-NCT04744298) prior to patient enrolment. ConclusionsTheraPPP will evaluate the effectiveness and implementation of an HRF and ARDS care pathway.

The Longitudinal Implementation Strategy Tracking System (LISTS): feasibility, usability, and pilot testing of a novel method

BackgroundSystematic approaches are needed to accurately characterize the dynamic use of implementation strategies and how they change over time. We describe the development and preliminary evaluation of the Longitudinal Implementation Strategy Tracking System (LISTS), a novel methodology to document and characterize implementation strategies use over time.MethodsThe development and initial evaluation of the LISTS method was conducted within the Improving the Management of SymPtoms during And following Cancer Treatment (IMPACT) Research Consortium (supported by funding provided through the NCI Cancer MoonshotSM). The IMPACT Consortium includes a coordinating center and three hybrid effectiveness-implementation studies testing routine symptom surveillance and integration of symptom management interventions in ambulatory oncology care settings. LISTS was created to increase the precision and reliability of dynamic changes in implementation strategy use over time. It includes three components: (1) a strategy assessment, (2) a data capture platform, and (3) a User’s Guide. An iterative process between implementation researchers and practitioners was used to develop, pilot test, and refine the LISTS method prior to evaluating its use in three stepped-wedge trials within the IMPACT Consortium. The LISTS method was used with research and practice teams for approximately 12 months and subsequently we evaluated its feasibility, acceptability, and usability using established instruments and novel questions developed specifically for this study.ResultsInitial evaluation of LISTS indicates that it is a feasible and acceptable method, with content validity, for characterizing and tracking the use of implementation strategies over time. Users of LISTS highlighted several opportunities for improving the method for use in future and more diverse implementation studies.ConclusionsThe LISTS method was developed collaboratively between researchers and practitioners to fill a research gap in systematically tracking implementation strategy use and modifications in research studies and other implementation efforts. Preliminary feedback from LISTS users indicate it is feasible and usable. Potential future developments include additional features, fewer data elements, and interoperability with alternative data entry platforms. LISTS offers a systematic method that encourages the use of common data elements to support data analysis across sites and synthesis across studies. Future research is needed to further adapt, refine, and evaluate the LISTS method in studies with employ diverse study designs and address varying delivery settings, health conditions, and intervention types.

Design of a dual randomized trial in a type 2 hybrid effectiveness—implementation study

BackgroundDual randomized controlled trials (DRCT) are type 2 hybrid studies that include two randomized trials: one testing implementation strategies and one testing an intervention. We argue that this study design offers efficiency by providing rigorous investigation of both implementation and intervention in one study and has potential to accelerate generation of the evidence needed to translate interventions that work into real-world practice. Nevertheless, studies using this design are rare in the literature.Main textWe construct a paradigm that breaks down the components of the DRCT and provide a step-by-step explanation of features of the design and recommendations for use. A clear distinction is made between the dual strands that test the implementation versus the intervention, and a minimum of three randomized arms is advocated. We suggest an active treatment arm that includes both the implementation strategy and intervention that are hypothesized to be superior. We suggest two comparison/control arms: one to test the implementation strategy and the second to test the intervention. Further, we recommend selection criteria for the two control arms that place emphasis on maximizing the utility of the study design to advance public health practice.ConclusionsOn the surface, the design of a DRCT can appear simple, but actual application is complex. We believe it is that complexity that has limited its use in the literature. We hope that this paper will give both implementation scientists and trialists who are not familiar with implementation science a better understanding of the DRCT design and encouragement to use it.