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Implementation Science at UW

Keywords: Hybrid Designs

✪ Getting to Implementation: applying data-driven implementation strategies to improve guideline concordant surveillance for hepatocellular carcinoma

Authors:

Vera Yakovchenko, Chaeryon Kang, Brittney Neely, Carolyn Lamorte, Heather McCurdy, Dawn Scott, Anna Nobbe, Gwen Robins, Nsikak R. Ekanem, Monica Merante, Sandra Gibson, Patrick Spoutz, Linda Chia, Rachel I. Gonzalez, Matthew J. Chinman, David Ross, Maggie Chartier, Lauren A. Beste, Jasmohan S. Bajaj, Tamar Taddei, Timothy R. Morgan & Shari S. Rogal

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: December 2025

Read the full text in the open access journal Implementation Science

Abstract:

Background

While guidelines recommend twice-yearly liver cancer (hepatocellular carcinoma, HCC) surveillance for people with cirrhosis, adherence to these guidelines remains variable. We aimed to empirically identify and apply successful implementation strategies through Getting to Implementation (GTI), a manualized facilitation approach.

Method

A hybrid type III, stepped-wedge, cluster-randomized trial was conducted at 12 underperforming Veterans Health Administration (VA) sites between October 2020 and October 2022. GTI included a stepwise approach to guide sites to detail their current state, set implementation goals, identify implementation barriers, select implementation strategies, make a work plan, conduct an evaluation, and sustain their work. Outcomes were defined using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.

Results

Facilitators supported site teams with an average of 20±6 facilitation hours over a 12-month period. Ten of 12 sites (83%) adopted GTI and applied a median of five strategies (e.g., dashboard use, small tests of change, direct patient outreach). Reach, the primary outcome, increased from mean 29.1% to mean 38.8% at-risk Veterans receiving HCC surveillance from pre- to post-intervention, and further increasing to 41.3% in the sustainment period. In both unadjusted and adjusted models, the odds of HCC surveillance were significantly higher during intervention (adjusted odds ratio, aOR=1.67, 95% CI:1.59, 1.75) and during sustainment (aOR=1.69, 95% CI:1.60, 1.78) compared with baseline, and with difference between active and sustainment periods, indicating sustained improvement after active facilitation ended.

Conclusions

GTI sustainably improved HCC surveillance, suggesting that applying data-driven implementation strategies within a manualized facilitation approach can improve care.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Study protocol for testing the efficacy of the Helping Educational Leaders Mobilize Evidence (HELM) implementation strategy in elementary schools: a hybrid type 3 effectiveness-implementation randomized controlled trial

Authors:

Jill Locke, Nathaniel J. Williams, Aksheya Sridhar, Mark G. Ehrhart, Alex Dopp, Marissa Thirion, Christine Espeland, Brandon Riddle, Kelcey Schmitz, Kurt Hatch, Lindsey Buehler & Aaron R. Lyon

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: April 2025

Read the full text in the open access journal Implementation Science

Abstract:

Background

Schools need to implement universal student supports that prevent social, emotional, and behavioral difficulties; minimize associated risks; and promote social, emotional, and behavioral competencies. The purpose of this study is to examine the efficacy of the Helping Educational Leaders Mobilize Evidence (HELM) implementation strategy for promoting school-level implementation leadership, implementation climate, and high-fidelity delivery of an evidence-based practice. We will test HELM with an exemplar EBP, Positive Behavioral Interventions and Supports (PBIS). The specific aims of the study are to: 1) experimentally evaluate the effects of HELM versus PBIS training and technical assistance only (control condition); and 2) explore for whom, under what conditions, how equitably, and through which processes HELM works to improve outcomes, as well as its cost-effectiveness.

Methods

This study will use a hybrid type 3 effectiveness-implementation trial to provide a rigorous test of the effects of HELM in elementary schools. Schools will be randomly assigned to HELM + PBIS training and technical assistance (n = 21 schools; n = 210 educators) or PBIS training and technical assistance only (n = 21 schools; n = 210 educators) in a 1:1 ratio within cohorts using covariate constrained randomization that accounts for degree of prior PBIS exposure (measured using the Tiered Fidelity Inventory at baseline) and school size. A series of mixed effects models (time within educator, educator within school) will test within-subject/between-subject interactions across three timepoints (12 months total) to examine whether HELM will show steeper gains than the control on implementation leadership (primary outcome), implementation climate, PBIS fidelity, and student outcomes. Mediational analyses will test hypothesized mechanisms of change (i.e., implementation leadership and climate) of HELM on PBIS fidelity. Sequential mixed-methods data collection and analyses will further explore how organizational mechanisms are linked to implementation outcomes. Cost-effectiveness analyses will compare costs and outcomes of PBIS training and technical assistance only versus PBIS implementation with HELM.

Discussion

The nature of leadership support in schools can make the difference between successful and unsuccessful EBP implementation. Testing HELM within the context of PBIS implementation will provide rigorous evidence about whether and how HELM can equitably address important EBP and student outcomes.

Trial Registration

Clinical Trials ID: NCT06586723. Date of Registration: August 27, 2024. Prospectively registered. URL of Trial Registry Record: https://clinicaltrials.gov/study/NCT06586723?intr=helm&rank=1

Contributions to the Literature

  • Few effective strategies to enhance evidence-based practice implementation in schools address implementation leadership and climate, and those that do have only been evaluated qualitatively.
  • Schools have unique organizational characteristics, and it is important to test whether organizational implementation strategies developed in other contexts can be effective in improving implementation outcomes in schools.
  • This study will evaluate the effects of a tailored adaptation of the Leadership and Organizational Change for Implementation (LOCI) strategy for schools, entitled Helping Educational Leaders Mobilize Evidence (HELM), on implementation mechanisms (implementation leadership and implementation climate), PBIS fidelity, and student outcomes.
  • This study also will explore for whom, under what conditions, and how equitably HELM demonstrates its effects, providing critical information about influence on – and the limitations of – the impact of this organizational implementation strategy.
  • Finally, the study will evaluate the processes through which HELM works to improve outcomes, contributing to the emerging literature on implementation mechanisms, as well as its cost-effectiveness.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

Name of the registry
clinicaltrials.gov.

Peer Review reports

✪ A framework for designing hybrid effectiveness-implementation trials for digital health interventions

Authors:

Theresa E. Matson, Eric D.A. Hermes, Aaron R. Lyon, Andrew Quanbeck, Stephen M. Schueller, Sarah M. Wilson, and Joseph E. Glass

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: February 2025

Read the full text open access in the journal Annals of Epidemiology

Abstract:

This article proposes methods for designing randomized controlled trials studying the implementation and effectiveness of digital interventions, meaning websites or applications ("apps") that patients use in healthcare. Deploying digital interventions for behavioral health differs from implementing traditional interventions such as medications or human-delivered therapy. Prior trial design guidance has ignored the existence of international governmental evidence standards, has paid insufficient attention to implementation reporting guidelines, and has not described methods for empirically testing the approach for organizing the delivery of digital interventions.

This framework for designing hybrid effectiveness-implementation trials of digital behavioral health interventions helps researchers articulate research questions that matter to decision-makers and meaningfully contribute to implementation. The framework outlines three phases: 1) frame effectiveness and implementation questions in terms of the digital intervention components, types of clinical support for the digital intervention, and specific strategies for implementing the digital intervention; 2) define and delineate actors, activities, action targets, dose, temporality, and outcomes to maximize inference and reproducibility; and 3) specify trial design features used for hybrid classification.

We illustrate the utility of this framework with two effectiveness-implementation studies of digital interventions for substance use. This framework can help researchers decide on appropriate methodology and help decision-makers apply findings.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

Design of a pragmatic trial integrating human papillomavirus (HPV) self-sampling into primary care to reduce cervical cancer screening disparities in Somali American individuals: The Isbaar project

Authors:

John Lin, Rachel L. Winer, Christina Bliss, Barsness, Jay Desai, Kristi Fordyce, Rahel Ghebre, Anisa M. Ibrahim, Sharif Mohamed, Timothy Ramer, Adam A. Szpiro, Bryan J. Weiner, Sophia Yohe, Rebekah Pratt

University of Washington affiliated authors are displayed in bold.

Subscription Required for Full Text Access

Published: January 2025

Read the full text in the subscription access journal Contemporary Clinical Trials

✪ Study protocol for a hybrid type 3 effectiveness-implementation trial of a team-based implementation strategy to support educators’ use of a social engagement intervention

Authors:

Jill Locke, Aksheya Sridhar, Wendy Shih, Stephanie Shire, Andria B. Eisman, Emily Kim, Adora Du, Christine Espeland, & Connie Kasari

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: January 2025

Read the full text in the open access journal Implementation Science

Abstract:

Background

Remaking Recess (RR) is a school-based evidence-based peer social engagement intervention for autistic students. RR involves direct training and coaching with educators; however, educators face several barriers to implementation at both the individual- and organizational-levels. This protocol paper describes a multi-site study that will test whether an educator-level implementation strategy, coaching, with or without a school-level implementation strategy, school-based teams, will maximize educators’ use (fidelity and sustainment) of RR for autistic students and their peers who are socially-isolated, rejected, or peripheral and may need additional support during recess.

Methods

This study will employ a hybrid type-3 effectiveness-implementation trial. Fifty-five elementary schools will be recruited as well as 121 educators (e.g., classroom assistants, aides), 55 general and special educator teachers, and 83–138 other school personnel (e.g., administrators). Additionally, at least 118 autistic students and allistic or non-autistic classmates will be recruited as RR recipients. Participants will complete baseline assessments at the beginning of the year, and all schools will be provided RR training. Schools will be randomized to coaching with or without school-based teams. This study will measure RR fidelity (primary outcome), RR sustainment, as well as peer engagement, social network inclusion, and social skills (secondary outcomes). It is expected that coaching with school-based teams will improve both RR fidelity and social network inclusion, while coaching with and without school-based teams will result in improved peer engagement and social skills.

Discussion

Previous research has documented barriers to RR implementation at both the individual- (provider) and organization-level (school). Using multi-level implementation strategies such as coaching with school-based teams may address these barriers and support RR implementation in schools. Findings from this study may guide future efforts to scale up tailored implementation strategies for use in public school districts, with the ultimate goal of increasing intervention access and improving student outcomes.

Trial registration

Name of the Registry: clinicaltrials.gov.
Trial Registration: Clinical Trials ID: NCT06559267.
Date of Registration: August 15, 2024. Prospectively registered.

Contributions to the literature

Remaking Recess (RR) is an intervention that improves peer engagement and classroom inclusion in autistic students. Educators, who play an important role in supporting autistic youth and their peers who are socially-isolated, rejected, or peripheral during the school day and at recess, can deliver RR.
Schools face many challenges, at both the individual- (i.e., educator) and organizational-levels (i.e., school), when implementing new interventions.
This study will evaluate the impact of two implementation strategies on the fidelity and sustainment of RR: (a) individual direct coaching for educators (coaching), and (b) supporting a team of school personnel (school-based teams) in addition to coaching.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Implementing evidence-based practices to improve primary care for high-risk patients: study protocol for the VA high-RIsk VETerans (RIVET) type III effectiveness-implementation trial

Authors:

Elvira E. Jimenez, Ann-Marie Rosland, Susan E. Stockdale, Ashok Reddy, Michelle S. Wong, Natasha Torrence, Alexis Huynh & Evelyn T. Chang

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: July 2024

Read the full text in the open access journal Implementation Science Communications

Abstract:

Background

Patients with significant multimorbidity and other factors that make healthcare challenging to access and coordinate are at high risk for poor health outcomes. Although most (93%) of Veterans’ Health Administration (VHA) patients at high risk for hospitalization or death (“high-risk Veterans”) are primarily managed by primary care teams, few of these teams have implemented evidence-based practices (EBPs) known to improve outcomes for the high-risk patient population’s complex healthcare issues. Effective implementation strategies could increase adoption of these EBPs in primary care; however, the most effective implementation strategies to increase evidence-based care for high-risk patients are unknown.

The high-RIsk VETerans (RIVET) Quality Enhancement Research Initiative (QUERI) will compare two variants of Evidence-Based Quality Improvement (EBQI) strategies to implement two distinct EBPs for high-risk Veterans: individual coaching (EBQI-IC; tailored training with individual implementation sites to meet site-specific needs) versus learning collaborative (EBQI-LC; implementation sites trained in groups to encourage collaboration among sites). One EBP, Comprehensive Assessment and Care Planning (CACP), guides teams in addressing patients’ cognitive, functional, and social needs through a comprehensive care plan. The other EBP, Medication Adherence Assessment (MAA), addresses common challenges to medication adherence using a patient-centered approach.

Methods

We will recruit and randomize 16 sites to either EBQI-IC or EBQI-LC to implement one of the EBPs, chosen by the site. Each site will have a site champion (front-line staff) who will participate in 18 months of EBQI facilitation.

Analysis

We will use a mixed-methods type 3 hybrid Effectiveness-Implementation trial to test EBQI-IC versus EBQI-LC versus usual care using a Concurrent Stepped Wedge design. We will use the Practical, Robust Implementation and Sustainability Model (PRISM) framework to compare and evaluate Reach, Effectiveness, Adoption, Implementation, and costs. We will then assess the maintenance/sustainment and spread of both EBPs in primary care after the 18-month implementation period. Our primary outcome will be Reach, measured by the percentage of eligible high-risk patients who received the EBP.

Discussion

Our study will identify which implementation strategy is most effective overall, and under various contexts, accounting for unique barriers, facilitators, EBP characteristics, and adaptations. Ultimately this study will identify ways for primary care clinics and teams to choose implementation strategies that can improve care and outcomes for patients with complex healthcare needs.

Trial registration

ClinicalTrials.gov, NCT05050643. Registered September 9th, 2021, https://clinicaltrials.gov/study/NCT05050643

Protocol version

This protocol is Version 1.0 which was created on 6/3/2020.

Contributions to the literature
  • The first study to compare the effectiveness of Evidence-Based Quality Improvement (EBQI) conducted individually with one site or conducted with a group of sites.
  • Implementation of evidence-based practices to improve care for high-risk patients in primary care.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Integrating HPV self-collect into primary care to address cervical cancer screening disparities

Authors:

Rebekah Pratt, Christina Bliss Barsness, John Lin, Jay Desai, Kristi Fordyce, Rahel Ghebre, Faiza Hassan, Anisa Ibrahim, Tim Ramer, Adam Szpiro, Bryan J. Weiner, Serena Xiong, Sophia Yohe, and Rachel L. Winer

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: January 2024

Read the full text in the open access journal Preventative Medicine Reports

Abstract:

Human papillomavirus (HPV) self-collect shows promise to increase cervical cancer screening rates in underscreened populations, such as Somali patients, but little is known about how to integrate such an approach in primary care. In this study, primary care providers and staff who provide primary care services to Somali women were asked for their views on integrating HPV self-collect into routine care to address cervical cancer screening disparities. Thirty primary care providers and staff participated in semi-structured interviews exploring their views on HPV self-collect and their anticipated needs or barriers to implementing this approach into the clinic generally and with specific patient populations, such as Somali women. A thematic analysis using the constructivist version of grounded theory was undertaken. Providers and staff anticipate positive patient reaction to the option of HPV self-collect, and were interested in using this approach both for Somali patients and for all patients in general. HPV self-collect was viewed as straightforward to integrate into existing clinic workflows. Providers largely lacked awareness of the evidence supporting primary HPV testing and HPV self-collect specifically, sharing concerns about effectiveness of self-collect and the lack of a physical exam. Providers felt clinic-wide staff education and patient education, along with strategies to address disparities, such as cultural and linguistic tailoring would be needed for successful implementation. Integrating HPV self-collect as an option in the cervical cancer screening process in a primary care clinical encounter offers considerable opportunity to address health disparities and may benefit all patients

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Protocol for a hybrid type 3 effectiveness-implementation trial of a pragmatic individual-level implementation strategy for supporting school-based prevention programming

Authors:

Aaron R. Lyon, Clayton R. Cook, Madeline Larson, Maria L. Hugh, Alex Dopp, Corinne Hamlin, Peter Reinke, Mahasweta Bose, Amy Law, Roger Goosey, Annie Goerdt, Nicole Morrell, Alisha Wackerle-Hollman & Michael D. Pullmann

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: January 2024

Read the full text in the open access journal Implementation Science

Abstract:

Background

For approximately one in five children who have social, emotional, and behavioral (SEB) challenges, accessible evidence-based prevention practices (EBPPs) are critical. In the USA, schools are the primary setting for children’s SEB service delivery. Still, EBPPs are rarely adopted and implemented by front-line educators (e.g., teachers) with sufficient fidelity to see effects. Given that individual behavior change is ultimately required for successful implementation, focusing on individual-level processes holds promise as a parsimonious approach to enhance impact.

Beliefs and Attitudes for Successful Implementation in Schools for Teachers (BASIS-T) is a pragmatic, multifaceted pre-implementation strategy targeting volitional and motivational mechanisms of educators’ behavior change to enhance implementation and student SEB outcomes. This study protocol describes a hybrid type 3 effectiveness-implementation trial designed to evaluate the main effects, mediators, and moderators of the BASIS-T implementation strategy as applied to Positive Greetings at the Door, a universal school-based EBPP previously demonstrated to reduce student disruptive behavior and increase academic engagement.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**