Project description:BackgroundIn order to close the gap between discoveries that could improve health, and widespread impact on routine health care practice, there is a need for greater attention to the factors that influence dissemination and implementation of evidence-based practices. Evidence synthesis projects (e.g., systematic reviews) could contribute to this effort by collecting and synthesizing data relevant to dissemination and implementation. Such an advance would facilitate the spread of high-value, effective, and sustainable interventions.ObjectiveThe objective of this paper is to evaluate the feasibility of extracting factors related to implementation during evidence synthesis in order to enhance the replicability of successes of studies of interventions in health care settings.DesignDrawing on the implementation science literature, we suggest 10 established implementation measures that should be considered when conducting evidence synthesis projects. We describe opportunities to assess these constructs in current literature and illustrate these methods through an example of a systematic review.SubjectsTwenty-nine studies of interventions aimed at improving clinician-patient communication in clinical settings.Key resultsWe identified acceptability, adoption, appropriateness, feasibility, fidelity, implementation cost, intervention complexity, penetration, reach, and sustainability as factors that are feasible and appropriate to extract during an evidence synthesis project.ConclusionsTo fully understand the potential value of a health care innovation, it is important to consider not only its effectiveness, but also the process, demands, and resource requirements involved in downstream implementation. While there is variation in the degree to which intervention studies currently report implementation factors, there is a growing demand for this information. Abstracting information about these factors may enhance the value of systematic reviews and other evidence synthesis efforts, improving the dissemination and adoption of interventions that are effective, feasible, and sustainable across different contexts.

Project description:BackgroundChildren in low-and-middle-income countries (LMICs) are facing tremendous mental health challenges. Numerous evidence-based interventions (EBIs) have been adapted to LMICs and shown effectiveness in addressing the needs, but most EBIs have not been adopted widely using scalable and sustainable implementation models that leverage and strengthen existing structures. There is a need to apply implementation science methodology to study strategies to effectively scale-up EBIs and sustain the practices in LMICs. Through a cross-sector collaboration, we are carrying out a second-generation investigation of implementation and effectiveness of a school-based mental health EBI, ParentCorps Professional Development (PD), to scale-up and sustain the EBI in Uganda to promote early childhood students' mental health. Our previous studies in Uganda supported that culturally adapted PD resulted in short-term benefits for classrooms, children, and families. However, our previous implementation of PD was relied on mental health professionals (MHPs) to provide PD to teachers. Because of the shortage of MHPs in Uganda, a new scalable implementation model is needed to provide PD at scale.ObjectivesThis study tests a new scalable and sustainable PD implementation model and simultaneously studies the effectiveness. This paper describes use of collaboration, task-shifting, and Train-the-Trainer strategies for scaling-up PD, and protocol for studying the effectiveness-implementation of ParentCorps-PD for teachers in urban and rural Ugandan schools. We will examine whether the new scale-up implementation approach will yield anticipated impacts and investigate the underlying effectiveness-implementation mechanisms that contribute to success. In addition, considering the effects of PD on teachers and students will influence by teacher wellness. This study also examines the added value (i.e. impact and costs) of a brief wellness intervention for teachers and students.MethodsUsing a hybrid-type II effectiveness-implementation cluster randomized controlled trial (cRCT), we will randomize 36 schools (18 urban and 18 rural) with 540 teachers and nearly 2000 families to one of three conditions: PD + Teacher-Wellness (PDT), PD alone (PD), and Control. Primary effectiveness outcomes are teachers' use of mental health promoting strategies, teacher stress management, and child mental health. The implementation fidelity/quality for the scale-up model will be monitored. Mixed methods will be employed to examine underlying mechanisms of implementation and impact as well as cost-effectiveness.DiscussionThis research will generate important knowledge regarding the value of an EBI in urban and rural communities in a LMIC, and efforts toward supporting teachers to prevent and manage early signs of children's mental health issues as a potentially cost-effective strategy to promote child population mental health in low resource settings.Trial registrationThis trial was registered with ClinicalTrials.gov (registration number: NCT04383327; https://clinicaltrials.gov/ct2/show/NCT04383327 ) on May13, 2020.

Project description:BackgroundThe number of children diagnosed with autism has rapidly outpaced the capacities of many public school systems to serve them, especially under-resourced, urban school districts. The intensive nature of evidence-based autism interventions, which rely heavily on one-to-one delivery, has caused schools to turn to computer-assisted interventions (CAI). There is little evidence regarding the feasibility, effectiveness, and implementation of CAI in public schools. While CAI has the potential to increase instructional time for students with autism, it may also result in unintended consequences such as reduction in the amount of interpersonal (as opposed to computerized) instruction students receive. The purpose of this study is to test the effectiveness of one such CAI-TeachTown-its implementation, and its effects on teachers' use of other evidence-based practices.MethodsThis study protocol describes a type II hybrid cluster randomized effectiveness-implementation trial. We will train and coach 70 teachers in autism support classrooms in one large school district in the use of evidence-based practices for students with autism. Half of the teachers then will be randomly selected to receive training and access to TeachTown: Basics, a CAI for students with autism, for the students in their classrooms. The study examines: (1) the effectiveness of TeachTown for students with autism; (2) the extent to which teachers implement TeachTown the way it was designed (i.e., fidelity); and (3) whether its uptake increases or reduces the use of other evidence-based practices.DiscussionThis study will examine the implementation of new technology for children with ASD in public schools and will be the first to measure the effectiveness of CAI. As importantly, the study will investigate whether adding a new technology on top of existing practices increases or decreases their use. This study presents a unique method to studying both the implementation and exnovation of evidence-based practices for children with autism in school settings.Trial registrationNCT02695693 . Retrospectively registered on July 8, 2016.

Project description:BackgroundLifestyle interventions can improve health-related outcomes for people with severe mental illness (SMI), but few studies evaluate this potential in everyday settings. After a successful approach in routine inpatient mental healthcare (MULTI), we sought to replicate this multidisciplinary lifestyle-enhancing support in people with SMI living in sheltered housing (MULTI_sh).AimsTo evaluate the effectiveness and implementation of MULTI_sh (trial registration: NCT03157557).MethodIn an effectiveness-implementation hybrid cluster-randomised controlled trial, six municipalities with sheltered housing facilities in The Netherlands were randomly assigned to MULTI_sh (n = 3) or treatment as usual (TAU, n = 3). After 12 months, we evaluated effects on metabolic health, sedentary behaviour/physical activity (ActiGraph GT3X+), quality of life (EuroQol 5D, WHOQoL-Bref) and psychopathology (Brief Psychiatric Rating Scale Expanded Version) using multiple regression, adjusting for baseline values and municipalities (intention to treat and per protocol). In addition, implementation fidelity and barriers/facilitators were evaluated (Measurement Instrument for Determinants of Innovation).ResultsOf 177 eligible patients, 74 (42%) could be included in the analyses. Health outcomes did not substantially improve with MULTI_sh (n = 45) compared with TAU (n = 29). MULTI_sh was not implemented as intended. Most patients and all healthcare professionals believed that patients' lifestyle should be part of treatment, but implementation was primarily (in)directly hindered by organisational factors (e.g. staff shortages, complexity of participation, lack of time and difficulty getting patients involved).ConclusionsMULTI_sh was not implemented as intended and no clinical health improvements were found. Organisations are decisive in the success or failure of the implementation of lifestyle interventions for people with SMI. More intensive implementation strategies on this level are warranted in sheltered housing.

Project description:IntroductionMechanisms explain how implementation strategies work. Implementation research requires careful operationalisation and empirical study of the causal pathway(s) by which strategies effect change, and factors that may amplify or weaken their effects. Understanding mechanisms is critically important to replicate findings, learn from negative studies or adapt an implementation strategy developed in one setting to another. Without understanding implementation mechanisms, it is difficult to design strategies to produce expected effects across contexts, which may have disproportionate effects on settings in which priority populations receive care. This manuscript outlines the protocol for an Agency for Healthcare Research and Quality-funded initiative to: (1) establish priorities for an agenda to guide research on implementation mechanisms in health and public health, and (2) disseminate the agenda to research, policy and practice audiences.Methods and analysisA network of scientific experts will convene in 'Deep Dive' meetings across 3 years. A research agenda will be generated through analysis and synthesis of information from six sources: (1) systematic reviews, (2) network members' approaches to studying mechanisms, (3) new proposals presented in implementation proposal feedback sessions, (4) working group sessions conducted in a leading implementation research training institute, (5) breakout sessions at the Society for Implementation Research Collaboration's (SIRC) 2019 conference and (6) SIRC conference abstracts. Two members will extract mechanism-relevant text segments from each data source and a third member will generate statements as an input for concept mapping. Concept mapping will generate unique clusters of challenges, and the network will engage in a nominal group process to identify priorities for the research agenda.Ethics and disseminationThis initiative will yield an actionable research agenda to guide research to identify and test mechanisms of change for implementation strategies. The agenda will be disseminated via multiple channels to solicit feedback and promote rigorous research on implementation mechanisms.

Project description:BackgroundEvaluating implementation of digital health interventions (DHIs) in practice settings is complex, involving diverse users and multistep processes. Proactive planning can ensure desired implementation determinants and outcomes are captured for hybrid studies, but operational guidance for DHI studies is limited.MethodsWe planned a cluster randomized, type II hybrid effectiveness-implementation trial testing PositiveLinks, a smartphone application for HIV care, compared to usual care (n = 6 sites per arm), among HIV outpatient sites in the DC Cohort Longitudinal HIV Study in Washington, DC. Our process included: 1) Defining components of the DHI and associated implementation strategy, 2) Selecting implementation science frameworks to accomplish evaluation aims, 3) Mapping framework dimensions, domains, and constructs to implementation strategy steps, 4) Modifying/creating instruments to collect data for implementation outcome measures and determinants and 5) Developing a compatible implementation science data collection and management plan.ResultsSpecification of components of the DHI and implementation strategy identified relevant platform usage data and necessary implementer actions, toward planning measurement of program reach and adoption. A priori mapping of implementation strategy steps to the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework identified how data would be collected for each step/corresponding outcome measure. The multi-site cohort study provided infrastructure for prospective, scaled implementation research, including site research assistants (RAs) coordinating implementation. Existing cohort tools (periodic site assessments, patient consent logs) were adapted for the evaluation to further capture representativeness and reach/adoption 'denominators.' New survey instruments allowed for framework-guided evaluation of provider adaptations/dose/fidelity to planned implementation across a large number of participants and multiple timepoints. Some aspects of real-world implementation were challenging to mirror within the planned hybrid trial (e.g. RAs selected as de facto site implementation leads) or were modified to preserve internal validity of effectiveness measurement (e.g. PositiveLinks 'community of practice').ConclusionsChallenges and opportunities arose in planning the implementation evaluation for PositiveLinks within a hybrid trial in a cohort population. Prospective hybrid trial planning must balance generalizability of implementation processes to 'real world' conditions, with rigorous trial procedures to measure intervention effectiveness. Rapid, scalable tools require further study to enable evaluations within large, multi-site hybrid studies.

Project description:BackgroundDespite an established taxonomy of implementation strategies, minimal guidance exists for how to select and tailor strategies to specific practices and contexts. We employed a replicable method to obtain stakeholder perceptions of the most feasible and important implementation strategies to increase mental health providers' use of measurement-based care (MBC) in schools. MBC is the routine use of patient-reported progress measures throughout treatment to inform patient-centered, data-driven treatment adjustments.MethodsA national sample of 52 school mental health providers and researchers completed two rounds of modified Delphi surveys to rate the relevance, importance, and feasibility of 33 implementation strategies identified for school settings. Strategies were reduced and definitions refined using a multimethod approach. Final importance and feasibility ratings were plotted on "go-zone" graphs and compared across providers and researchers to identify top-rated strategies.ResultsThe initial 33 strategies were rated as "relevant" or "relevant with changes" to MBC in schools. Importance and feasibility ratings were high overall for both survey rounds; on a scale of 1 to 5, importance ratings (3.61-4.48) were higher than feasibility ratings (2.55-4.06) on average. Survey 1 responses resulted in a reduced, refined set of 21 strategies, and six were rated most important and feasible on Survey 2: (1) assess for readiness and identify barriers and facilitators; (2) identify and prepare champions; (3) develop a usable implementation plan; (4) offer a provider-informed menu of free, brief measures; (5) develop and provide access to training materials; and (6) make implementation easier by removing burdensome documentation tasks. Provider and researcher ratings were not significantly different, with a few exceptions: providers reported higher feasibility and importance of removing burdensome paperwork than researchers, providers reported higher feasibility of train-the trainer approaches than researchers, and researchers reported higher importance of monitoring fidelity than providers.ConclusionsThe education sector is the most common setting for child and adolescent mental health service delivery in the USA. Effective MBC implementation in schools has the potential to elevate the quality of care received by many children, adolescents, and their families. This empirically derived, targeted list of six implementation strategies offers potential efficiencies for future testing of MBC implementation in schools.

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Advancing sustainable implementation of an evidence-based mental health intervention in Sierra Leone’s schools: protocol for a hybrid type 3 implementation-effectiveness trial

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