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Evaluating the effectiveness and implementation of evidence-based treatment: A multisite hybrid design.

ABSTRACT: The gap between treatment development and efficacy testing to scaled up implementations of evidence-based treatment (EBT) is an estimated 20 years, and hybrid research designs aim to reduce the gap. One was used for a multisite study in cancer control, testing coprimary aims: (a) determine the feasibility and utility of a flexible EBT implementation strategy and (b) determine the clinical effectiveness of an EBT as implemented by newly trained providers. Therapists from 15 diverse sites implemented the biobehavioral intervention (BBI) for cancer patients (N = 158) as part of standard care. For implementation, therapists determined treatment format, number of sessions, and so forth and reported session-by-session fidelity. Patients completed fidelity and outcome assessments. Results showed therapists BBI implementation was done with fidelity, for example, session "dose" (59%), core content coverage (60-70%), and others. Patient reported fidelity was favorable and comparable to the BBI efficacy trial. Effectiveness data show the primary outcome, patients' scores on the Profile of Mood States total mood disturbance, significantly improved (R² = 0.06, ? = -0.24, p < .01) as did a secondary outcome, physical activity (R² = 0.02, ? = 0.13, p < .05). This first use of a hybrid design in health psychology provided support for a novel strategy that allowed providers implementation flexibility. Still, the EBT was delivered with fidelity and in addition, therapists generated novel procedures to enhance setting-specific usage of BBI and its ultimate effectiveness with patients. This research is an example of translational research spanning theory and efficacy tests to dissemination and implementation. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

SUBMITTER: Ashmore JA

PROVIDER: S-EPMC6339615 | biostudies-literature | 2019 May-Jun

REPOSITORIES: biostudies-literature

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Evaluating the effectiveness and implementation of evidence-based treatment: A multisite hybrid design.

Ashmore Jamile A JA Ditterich Kirk W KW Conley Claire C CC Wright Melissa R MR Howland Peggy S PS Huggins Kelly L KL Cooreman Jena J Andrews Priscilla S PS Nicholas Donald R DR Roberts Lind L Hewitt Larissa L Scales Joan N JN Delap Jenny K JK Gray Christine A CA Tyler Lynelle A LA Collins Charlotte C Whiting Catherine M CM Brothers Brittany M BM Ryba Marlena M MM Andersen Barbara L BL

The American psychologist 20180719 4

The gap between treatment development and efficacy testing to scaled up implementations of evidence-based treatment (EBT) is an estimated 20 years, and hybrid research designs aim to reduce the gap. One was used for a multisite study in cancer control, testing coprimary aims: (a) determine the feasibility and utility of a flexible EBT implementation strategy and (b) determine the clinical effectiveness of an EBT as implemented by newly trained providers. Therapists from 15 diverse sites implemen ...[more]

PMID: 30024215

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Project description:IntroductionCancer symptom monitoring and management interventions can address concerns that may otherwise go undertreated. However, such programmes and their evaluations remain largely limited to trials versus healthcare systemwide applications. We previously developed and piloted an electronic patient-reported symptom and need assessment ('cPRO' for cancer patient-reported outcomes) within the electronic health record (EHR). This study will expand cPRO implementation to medical oncology clinics across a large healthcare system. We will conduct a formal evaluation via a stepped wedge trial with a type 2 hybrid effectiveness-implementation design.Methods and analysisAim 1 comprises a mixed method evaluation of cPRO implementation. Adult outpatients will complete cPRO assessments (pain, fatigue, physical function, depression, anxiety and supportive care needs) before medical oncology visits. Results are available in the EHR; severe symptoms and endorsed needs trigger clinician notifications. We will track implementation strategies using the Longitudinal Implementation Strategy Tracking System. Aim 2 will evaluate cPRO's impact on patient and system outcomes over 12 months via (a) a quality improvement study (n=4000 cases) and (b) a human subjects substudy (n=1000 patients). Aim 2a will evaluate EHR-documented healthcare usage and patient satisfaction. In aim 2b, participating patients will complete patient-reported healthcare utilisation and quality, symptoms and health-related quality of life measures at baseline, 6 and 12 months. We will analyse data using generalised linear mixed models and estimate individual trajectories of patient-reported symptom scores at baseline, 6 and 12 months. Using growth mixture modelling, we will characterise the overall trajectories of each symptom. Aim 3 will identify cPRO implementation facilitators and barriers via mixed methods research gathering feedback from stakeholders. Patients (n=50) will participate in focus groups or interviews. Clinicians and administrators (n=40) will complete surveys to evaluate implementation. We will graphically depict longitudinal implementation survey results and code qualitative data using directed content analysis.Ethics and disseminationThis study was approved by the Northwestern University Institutional Review Board (STU00207807). Findings will be disseminated via local and conference presentations and peer-reviewed journals.Trial registration numberNCT04014751; ClinicalTrials.gov.

Project description:INTRODUCTION:Two of the most acute and feared complications in type 1 diabetes (T1D) are hypoglycaemia and severe hypoglycaemia (SH). While impaired awareness of hypoglycaemia (IAH) can lead to SH with cognitive and motivational barriers implicated, the available education does not integrate behavioural change techniques to address these. A novel Hypoglycaemia Awareness Restoration Programme despite optimised care (HARPdoc) is currently being tested against an established blood glucose awareness training (BGAT) within a parallel, two-arm, group randomised, blinded trial (with its own protocol; NCT02940873) with adults with T1D whose problems with hypoglycaemia and SH have persisted despite otherwise optimised insulin management. While both programmes are aimed at reducing hypoglycaemia, SH and IAH, it is the former that integrates behavioural change techniques.The aim of the current (implementation) study is to evaluate delivery of both HARPdoc and BGAT and explore associations between implementation outcomes and trial endpoints; as well as to develop an evidence-based implementation blueprint to guide implementation, sustainment and scale-up of the effective programmes. METHODS AND ANALYSIS:Guided by the implementation science tools, frameworks, methods and principles, the current study was designed through a series of focus groups (n=11) with the key intervention stakeholders (n=28)-including (1) individuals with lived experience of T1D, IAH and a pilot version of the HARPdoc (n=6) and (2) diabetes healthcare professionals (n=22). A mixed-methods approach will be used throughout. Stakeholder engagement has underpinned study design and materials to maximise relevance, feasibility and impact. ETHICS AND DISSEMINATION:The protocol has been reviewed and received ethical approval by the Harrow Research Ethics Committee (18/LO/1020; 240752) on 1 October 2018. The findings will be submitted to a peer-reviewed journal and presented at scientific meetings. TRIAL REGISTRATION NUMBER:NCT02940873; Pre-results.

Project description:IntroductionPatients with long-term conditions consistently report a lack of information around services and support available to them. This unmet need for information is significant among people with dementia and family carers. A quality improvement intervention is being carried out to tackle this issue as part of a co-creation initiative in the North East of England (UK). The intervention consists of the dissemination (via the local Community Mental Health Services for Older People) of a leaflet about services available to people with dementia and their family carers in the study site. This protocol is reported in accordance with the Standards for Reporting Implementation Studies.Methods and analysisThis effectiveness-implementation hybrid type 2 study aims at understanding (1) the unfolding and outcomes of the implementation strategy, (2) the outcomes of the intervention (for people with dementia and family carers, staff implementing the intervention and local service providers) and (3) the contribution of co-creation to the design and implementation of the intervention and its outcomes. The prospective theory of change of the intervention articulated by local stakeholders is used as a reference framework against which to assess the implementation and outcomes of the intervention. Evaluation data will be collected through in-depth interviews with people with dementia and family carers receiving the intervention, staff implementing the intervention and managers from local service providers. Referral data from local service providers will be collected to triangulate the interview data. A focus group with key stakeholders will support the sense-making of findings. The realist configuration of mechanism-context-outcome, operationalised using an information behaviour model, will inform data analysis and interpretation.Ethics and disseminationEthical and research governance approvals have been obtained from the West Midlands-South Birmingham Research Ethics Committee. The results of the study will be submitted for publication in peer-reviewed journals and disseminated through conferences.

Project description:Rural African Americans are disproportionately exposed to numerous stressors such as poverty that place them at risk for experiencing elevated levels of depressive symptoms. Effective treatments for decreasing depressive symptoms exist, but rural African Americans often fail to receive adequate and timely care. Churches have been used to address physical health outcomes in rural African American communities, but few have focused primarily on addressing mental health outcomes. Our partnership, consisting of faith community leaders and academic researchers, adapted an evidence-based behavioral activation intervention for use with rural African American churches. This 8-session intervention was adapted to include faith-based themes, Scripture, and other aspects of the rural African American faith culture (e.g. bible studies) This manuscript describes a Hybrid-II implementation trial that seeks to test the effectiveness of the culturally adapted evidence-based intervention (Renewed and Empowered for the Journey to Overcome in Christ: REJOICE) and gather preliminary data on the strategies necessary to support the successful implementation of this intervention in 24 rural African American churches. This study employs a randomized one-way crossover cluster design to assess effectiveness in reducing depressive symptoms and gather preliminary data regarding implementation outcomes, specifically fidelity, associated with 2 implementation strategies: training only and training+coaching calls. This project has the potential to generate knowledge that will lead to improvements in the provision of mental health interventions within the rural African American community. Further, the use of the Hybrid-II design has the potential to advance our understanding of strategies that will support the implementation of and sustainability of mental health interventions within rural African American faith communities.Trial registrationNCT02860741. Registered August 5, 2016.

Project description:BACKGROUND: Despite the availability of evidence-based psychotherapies for depression and anxiety, they are underused in non-mental health specialty settings such as primary care. Hybrid effectiveness-implementation designs have the potential to evaluate clinical and implementation outcomes of evidence-based psychotherapies to improve their translation into routine clinical care practices. METHODS: This protocol article discusses the study methodology and implementation strategies employed in an ongoing, hybrid, type 2 randomized controlled trial with two primary aims: (1) to determine whether a brief, manualized cognitive behavioral therapy administered by Veterans Affairs Primary Care Mental Health Integration program clinicians is effective in treating depression and anxiety in a sample of medically ill (chronic cardiopulmonary diseases) primary care patients and (2) to examine the acceptability, feasibility, and preliminary outcomes of a focused implementation strategy on improving adoption and fidelity of brief cognitive behavioral therapy at two Primary Care-Mental Health Integration clinics. The study uses a hybrid type 2 effectiveness/implementation design to simultaneously test clinical effectiveness and to collect pilot data on a multifaceted implementation strategy that includes an online training program, audit and feedback of session content, and internal and external facilitation. Additionally, the study engages the participation of an advisory council consisting of stakeholders from Primary Care-Mental Health Integration, as well as regional and national mental health leaders within the Veterans Administration. It targets recruitment of 320 participants randomized to brief cognitive behavioral therapy (n?=?200) or usual care (n?=?120). Both effectiveness and implementation outcomes are being assessed using mixed methods, including quantitative evaluation (e.g., intent-to-treat analyses across multiple time points) and qualitative methods (e.g., focus interviews and surveys from patients and providers). Patient-effectiveness outcomes include measures of depression, anxiety, and physical health functioning using blinded independent evaluators. Implementation outcomes include patient engagement and adherence and clinician brief cognitive behavioral therapy adoption and fidelity. CONCLUSIONS: Hybrid designs are needed to advance clinical effectiveness and implementation knowledge to improve healthcare practices. The current article describes the rationale and challenges associated with the use of a hybrid design for the study of brief cognitive behavioral therapy in primary care. Although trade-offs exist between scientific control and external validity, hybrid designs are part of an emerging approach that has the potential to rapidly advance both science and practice. TRIAL REGISTRATION: NCT01149772 at http://www.clinicaltrials.gov/ct2/show/NCT01149772.

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Evaluating the effectiveness and implementation of evidence-based treatment: A multisite hybrid design.

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Evaluating the effectiveness and implementation of evidence-based treatment: A multisite hybrid design.

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