Kym Ahrens, Natalie Blackburn, Matthew Aalsma, Kevin Haggerty, Kelly Kelleher, Danica K. Knight, Elizabeth Joseph, Carrie Mulford, Ted Ryle & Marina Tolou-Shams
University of Washington affiliated authors are displayed in bold.
Published: July 2023
Douglas Zatzick, Lawrence Palinkas, David A. Chambers, Lauren Whiteside, Kathleen Moloney, Allison Engstrom, Laura Prater, Joan Russo, Jin Wang, Khadija Abu, Matt Iles-Shih & Eileen Bulger
University of Washington affiliated authors are displayed in bold.
Published: April 2023
Over the past two decades, pragmatic and implementation science clinical trial research methods have advanced substantially. Pragmatic and implementation studies have natural areas of overlap, particularly relating to the goal of using clinical trial data to leverage health care system policy changes. Few investigations have addressed pragmatic and implementation science randomized trial methods development while also considering policy impact.
The investigation used the PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) and PRECIS-2-Provider Strategies (PRECIS-2-PS) tools to evaluate the design of two multisite randomized clinical trials that targeted patient-level effectiveness outcomes, provider-level practice changes and health care system policy. Seven raters received PRECIS-2 training and applied the tools in the coding of the two trials. Descriptive statistics were produced for both trials, and PRECIS-2 wheel diagrams were constructed. Interrater agreement was assessed with the Intraclass Correlation (ICC) and Kappa statistics. The Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE) qualitative approach was applied to understanding integrative themes derived from the PRECIS-2 ratings and an end-of-study policy summit.
The ICCs for the composite ratings across the patient and provider-focused PRECIS-2 domains ranged from 0.77 to 0.87, and the Kappa values ranged from 0.25 to 0.37, reflecting overall fair-to-good interrater agreement for both trials. All four PRECIS-2 wheels were rated more pragmatic than explanatory, with composite mean and median scores ≥ 4. Across trials, the primary intent-to-treat analysis domain was consistently rated most pragmatic (mean = 5.0, SD = 0), while the follow-up/data collection domain was rated most explanatory (mean range = 3.14–3.43, SD range = 0.49–0.69). RAPICE field notes identified themes related to potential PRECIS-2 training improvements, as well as policy themes related to using trial data to inform US trauma care system practice change; the policy themes were not captured by the PRECIS-2 ratings.
The investigation documents that the PRECIS-2 and PRECIS-2-PS can be simultaneously used to feasibly and reliably characterize clinical trials with patient and provider-level targets. The integration of pragmatic and implementation science clinical trial research methods can be furthered by using common metrics such as the PRECIS-2 and PRECIS-2-PS. Future study could focus on clinical trial policy research methods development.
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
Doyanne Darnell, Andria Pierson, Joanne D. Whitney, Catherine A. Wolkow, Shannon Dorsey, Edwin D. Boudreaux, Patricia A. Areán & Katherine Anne Comtois
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Published: March 2023
Aaron R. Lyon, Michael D. Pullmann, Shannon Dorsey, Carol Levin, Larissa M. Gaias, Stephanie K. Brewer, Madeline Larson, Catherine M. Corbin, Chayna Davis, Ian Muse, Mahima Joshi, Rosemary Reyes, Nathaniel J. Jungbluth, Rachel Barrett, David Hong, Michael D. Gomez & Clayton R. Cook
University of Washington affiliated authors are displayed in bold.
Published: January 2021
More than two-thirds of youth experience trauma during childhood, and up to 1 in 5 of these youth develops posttraumatic stress symptoms that significantly impair their functioning. Although trauma-focused cognitive behavior therapy (TF-CBT) has a strong evidence base, it is rarely adopted, delivered with adequate fidelity, or evaluated in the most common setting where youth access mental health services—schools. Given that individual behavior change is ultimately required for successful implementation, even when organizational factors are firmly in place, focusing on individual-level processes represents a potentially parsimonious approach. Beliefs and Attitudes for Successful Implementation in Schools (BASIS) is a pragmatic, motivationally focused multifaceted strategy that augments training and consultation and is designed to target precise mechanisms of behavior change to produce enhanced implementation and youth clinical outcomes. This study protocol describes a hybrid type 2 effectiveness-implementation trial designed to concurrently evaluate the main effects, mediators, and moderators of both the BASIS implementation strategy on implementation outcomes and TF-CBT on youth mental health outcomes.
Using a cluster randomized controlled design, this trial will assign school-based mental health (SMH) clinicians and schools to one of three study arms: (a) enhanced treatment-as-usual (TAU), (b) attention control plus TF-CBT, or (c) BASIS+TF-CBT. With a proposed sample of 120 SMH clinicians who will each recruit 4–6 youth with a history of trauma (480 children), this project will gather data across 12 different time points to address two project aims. Aim 1 will evaluate, relative to an enhanced TAU condition, the effects of TF-CBT on identified mechanisms of change, youth mental health outcomes, and intervention costs and cost-effectiveness. Aim 2 will compare the effects of BASIS against an attention control plus TF-CBT condition on theoretical mechanisms of clinician behavior change and implementation outcomes, as well as examine costs and cost-effectiveness.
This study will generate critical knowledge about the effectiveness and cost-effectiveness of BASIS—a pragmatic, theory-driven, and generalizable implementation strategy designed to enhance motivation—to increase the yield of evidence-based practice training and consultation, as well as the effectiveness of TF-CBT in a novel service setting.
ClinicalTrials.gov registration number NCT04451161. Registered on June 30, 2020.
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
Madeline Larson, Clayton R. Cook, Stephanie K. Brewer, Michael D. Pullmann, Corinne Hamlin, James L. Merle, Mylien Duong, Larissa Gaias, Margaret Sullivan, Nicole Morrell, Tara Kulkarni, Mollie Weeks, & Aaron R. Lyon
University of Washington affiliated authors are displayed in bold.
Published: November 2020
Aditi Sharma, Tyler Sasser, Erin Schoenfelder Gonzalez, Ann Vander Stoep, and Kathleen Myers
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Published: August 2020
Lindsey C. McKernan, Michael T.M. Finn, David R. Patterson, Rhonda M. Williams, and Mark P. Jensen
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Published: February 2020
Noah S. Triplett, Georganna Sedlar, Lucy Berliner, Nathaniel Jungbluth, Meredith Boyd, & Shannon Dorsey
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Published: January 2020
Cecilie Varsi, Lise Solberg Nes, Olöf Birna Kristjansdottir, Saskia M Kelders, Una Stenberg, Heidi Andersen Zangi, Elin Børøsund, Karen Elizabeth Weiss, Audun Stubhaug, Rikke Aune Asbjørnsen, Marianne Westeng, Marte Ødegaard, Hilde Eide
University of Washington affiliated authors are displayed in bold.
Published: September 2019
There is growing evidence of the positive effects of electronic health (eHealth) interventions for patients with chronic illness, but implementation of such interventions into practice is challenging. Implementation strategies that potentially impact implementation outcomes and implementation success have been identified. Which strategies are actually used in the implementation of eHealth interventions for patients with chronic illness and which ones are the most effective is unclear.
This systematic realist review aimed to summarize evidence from empirical studies regarding (1) which implementation strategies are used when implementing eHealth interventions for patients with chronic illnesses living at home, (2) implementation outcomes, and (3) the relationship between implementation strategies, implementation outcomes, and degree of implementation success.
A systematic literature search was performed in the electronic databases MEDLINE, Embase, PsycINFO, Scopus, Allied and Complementary Medicine Database, Cumulative Index to Nursing and Allied Health Literature, and Cochrane Library. Studies were included if they described implementation strategies used to support the integration of eHealth interventions into practice. Implementation strategies were categorized according to 9 categories defined by the Expert Recommendations for Implementing Change project: (1) engage consumers, (2) use evaluative and iterative strategies, (3) change infrastructure, (4) adapt and tailor to the context, (5) develop stakeholder interrelationships, (6) use financial strategies, (7) support clinicians, (8) provide interactive assistance, and (9) train and educate stakeholders. Implementation outcomes were extracted according to the implementation outcome framework by Proctor and colleagues: (1) acceptability, (2) adoption, (3) appropriateness, (4) cost, (5) feasibility, (6) fidelity, (7) penetration, and (8) sustainability. Implementation success was extracted according to the study authors’ own evaluation of implementation success in relation to the used implementation strategies.
The implementation strategies management support and engagement, internal and external facilitation, training, and audit and feedback were directly related to implementation success in several studies. No clear relationship was found between the number of implementation strategies used and implementation success.
This is the first review examining implementation strategies, implementation outcomes, and implementation success of studies reporting the implementation of eHealth programs for patients with chronic illnesses living at home. The review indicates that internal and external facilitation, audit and feedback, management support, and training of clinicians are of importance for eHealth implementation. The review also points to the lack of eHealth studies that report implementation strategies in a comprehensive way and highlights the need to design robust studies focusing on implementation strategies in the future.
PROSPERO CRD42018085539
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
Laura K. Murray, Emily E. Haroz, Michael D. Pullmann, Shannon Dorsey, Jeremy Kane, Jura Augustinavicius, Catherine Lee, & Paul Bolton
University of Washington affiliated authors are displayed in bold.
Published: January 2019