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Implementation Science at UW

Keywords: Hybrid Type III Effectiveness-Implementation

✪ 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**

✪ Implementation Research at NHLBI: Methodological and Design Challenges and Lessons Learned from the DECIPHeR Initiative

Authors:

David M Murray, Patrick Heagerty, James Troendle, Feng-Chang Lin, Jonathan Moyer, June Stevens, Leslie Lytle, Xinzhi Zhang, Maliha Ilias, Mary Y Masterson, Nicole Redmond, Veronica Tonwe, Dave Clark & George A Mensah

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: April 2024

Read the full text in the open access journal Ethnicity & Disease

Abstract:

NHLBI funded seven projects as part of the Disparities Elimination through Coordinated Interventions to Prevent and Control Heart and Lung Disease Risk (DECIPHeR) Initiative. They were expected to collaborate with community partners to (1) employ validated theoretical or conceptual implementation research frameworks, (2) include implementation research study designs, (3) include implementation measures as primary outcomes, and (4) inform our understanding of mediators and mechanisms of action of the implementation strategy. Several projects focused on late-stage implementation strategies that optimally and sustainably delivered two or more evidence-based multilevel interventions to reduce or eliminate cardiovascular and/or pulmonary health disparities and to improve population health in high-burden communities. Projects that were successful in the three-year planning phase transitioned to a 4-year execution phase. NHLBI formed a Technical Assistance Workgroup during the planning phase to help awardees refine study aims, strengthen research designs, detail analytic plans, and to use valid sample size methods. This paper highlights methodological and study design challenges encountered during this process. Important lessons learned included (1) the need for greater emphasis on implementation outcomes, (2) the need to clearly distinguish between intervention and implementation strategies in the protocol, (3) the need to address clustering due to randomization of groups or clusters, (4) the need to address the cross-classification that results when intervention agents work across multiple units of randomization in the same arm, (5) the need to accommodate time-varying intervention effects in stepped-wedge designs, and (6) the need for data-based estimates of the parameters required for sample size estimation.

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

✪ 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, Katherine Ritchey

Authors:

Princess Nash, Valerie Clark, Eleanor McConnell, Whitney Mills, Robert Morgan, Camilla Pimentel, Katherine Ritchey, Cari Levy, A Lynn Snow, & Christine Hartmann

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: February 2024

Read the full text in the open access journal BMJ Open

Abstract:

Introduction

Falls 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 Programme, an evidence-based quality improvement intervention. The LOCK Falls Programme involves the entire front-line care team in (1) focusing on evidence of positive change, (2) collecting data through systematic observation and (3) facilitating communication and coordination of care through the practice of front-line staff huddles.

Methods and analysis

The study protocol describes a mixed-methods, 4-year hybrid (type 2) effectiveness-implementation study in State Veterans Homes in the USA. The study uses a pragmatic stepped-wedge randomised trial design and employs relational coordination theory and the Reach, Effectiveness, Adoption, Implementation and Maintenance framework to guide implementation and evaluation. A total of eight State Veterans Homes will participate and data will be collected over an 18-month period. Administrative data inclusive of all clinical assessments and Minimum Data Set assessments for Veterans with a State Veterans Home admission or stay during the study period will be collected (8480 residents total). The primary outcome is a resident having any fall. The primary analysis will be a partial intention-to-treat analysis using the rate of participants experiencing any fall. A staff survey (n=1200) and qualitative interviews with residents (n=80) and staff (n=400) will also be conducted. This research seeks to systematically address known barriers to nursing home quality improvement efforts associated with reducing falls.

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

✪ Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics): results of a 28-site cluster-randomized type 3 hybrid trial

Authors:

Sara J. Becker, Tim Janssen, Tim Souza, Bryan Hartzler, Carla J. Rash, Kira DiClemente-Bosco & Bryan R. Garner

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

Contingency management (CM), a behavioral treatment that incentivizes patients for attaining treatment goals, is a highly effective adjunct to medication for opioid use disorder. However, CM is rarely offered in opioid treatment programs in the United States. In a prior pilot trial, the implementation strategy (didactic workshop + feedback + consultation) delivered by the Addiction Technology Transfer Centers (ATTC strategy) promoted CM adoption more effectively than didactic training, but the speed and duration of implementation were sub-optimal. This 28-site type 3 hybrid trial tested the comparative effectiveness of the ATTC strategy versus an Enhanced-ATTC (E-ATTC) strategy that contained two theory-driven techniques targeting implementation climate to improve acceleration and sustainment, respectively: a provider-focused incentivization strategy and a team-focused facilitation strategy. We hypothesized that the E-ATTC strategy would be associated with superior implementation and patient outcomes.

Methods

Twenty-eight opioid treatment programs, 186 providers, and 592 patients were cluster-randomized to receive either the ATTC or E-ATTC strategy. Providers logged their CM sessions in an online CM Tracker and submitted audio-recorded CM sessions, and patients completed surveys about their opioid use at three timepoints. Intention-to-treat analyses examined impacts of the two multi-level strategies on implementation outcomes (CM Exposure, CM Competence, CM Sustainment) and patient outcomes (Opioid Abstinence, Opioid Related Problems).

Results

The pattern of results was identical across unadjusted, propensity score-adjusted, and covariate-adjusted general linear mixed models, though significance varied slightly. Relative to providers receiving the ATTC strategy, those receiving the E-ATTC strategy had significantly higher odds of CM Exposure (covariate adjusted OR = 3.21, p < 0.05) and of attaining the Excellent CM Competence benchmark (propensity-adjusted OR = 4.07, p < 0.05). Patients at the E-ATTC sites had significantly greater likelihood of Opioid Abstinence over time (OR = 2.04, p < 0.05). There were no significant conditional differences in CM Sustainment, though data were measured at the program-level, which limited power to detect differences.

Conclusions

The theory-driven E-ATTC strategy, which targeted implementation climate via facilitation and incentivization, had superior implementation and patient outcomes relative to the ATTC strategy. Results of this study can help inform ongoing CM implementation efforts across the United States.

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

✪ Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics): A cluster-randomized type 3 hybrid effectiveness-implementation trial

Authors:

Sara J. Becker, Cara M. Murphy, Bryan Hartzler, Carla J. Rash, Tim Janssen, Mat Roosa, Lynn M. Madden & Bryan R. Garner

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: October 2021

Read the full text in the open access journal Addiction Science & Clinical Practice
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Abstract:

Background

Opioid-related overdoses and harms have been declared a public health emergency in the United States, highlighting an urgent need to implement evidence-based treatments. Contingency management (CM) is one of the most effective behavioral interventions when delivered in combination with medication for opioid use disorder, but its implementation in opioid treatment programs is woefully limited. Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics) was funded by the National Institute on Drug Abuse to identify effective strategies for helping opioid treatment programs improve CM implementation as an adjunct to medication. Specific aims will test the impact of two different strategies on implementation outcomes (primary aim) and patient outcomes (secondary aims), as well as test putative mediators of implementation effectiveness (exploratory aim).

Methods

A 3-cohort, cluster-randomized, type 3 hybrid design is used with the opioid treatment programs as the unit of randomization. Thirty programs are randomized to one of two conditions. The control condition is the Addiction Technology Transfer Center (ATTC) Network implementation strategy, which consists of three core approaches: didactic training, performance feedback, and on-going consultation. The experimental condition is an enhanced ATTC strategy, with the same core ATTC elements plus two additional theory-driven elements. The two additional elements are Pay-for-Performance, which aims to increase implementing staff’s extrinsic motivations, and Implementation & Sustainment Facilitation, which targets staff’s intrinsic motivations. Data will be collected using a novel, CM Tracker tool to document CM session delivery, session audio recordings, provider surveys, and patient surveys. Implementation outcomes include CM Exposure (number of CM sessions delivered per patient), CM Skill (ratings of CM fidelity), and CM Sustainment (number of patients receiving CM after removal of support). Patient outcomes include self-reported opioid abstinence and opioid-related problems (both assessed at 3- and 6-months post-baseline).

Discussion

There is urgent public health need to improve the implementation of CM as an adjunct to medication for opioid use disorder. Consistent with its hybrid type 3 design, Project MIMIC is advancing implementation science by comparing impacts of these two multifaceted strategies on both implementation and patient outcomes, and by examining the extent to which the impacts of those strategies can be explained by putative mediators.

Trial registration

This clinical trial has been registered with clinicaltrials.gov (NCT03931174).

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

✪ Practice facilitation to implement alcohol-related care in Veterans Health Administration liver clinics: a study protocol

Authors:

Madeline C. Frost, George N. Ioannou, Judith I. Tsui, E. Jennifer Edelman, Bryan J. Weiner, Olivia V. Fletcher & Emily C. Williams

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: July 2020

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

Abstract:

Background

Alcohol-related care, including screening, brief intervention, and provision of/referral to medication or behavioral treatments for alcohol use disorder, could be delivered in liver clinics to better reach patients with chronic liver conditions. However, the provision of alcohol-related care in liver clinics is currently suboptimal. Practice facilitation is an evidence-based implementation strategy that may address barriers, harness facilitators, and optimize the implementation of alcohol-related care in liver clinic settings using a clinic-centered approach. We report the protocol of a study to test a practice facilitation intervention to implement alcohol-related care in four Veterans Health Administration liver clinics.

Methods

This study will employ a Hybrid Type 3 effectiveness-implementation design, in which implementation outcomes are considered primary and clinical outcomes secondary. Intervention and evaluation design were informed by the Consolidated Framework for Implementation Research. Qualitative data collected from clinical stakeholders and patients were used to tailor the intervention. The intervention involves a 6-month period of external practice facilitation, including regular meetings to identify clinic goals, challenges, and solutions; engagement of clinic champions; provision of training and development of educational materials for clinic staff and patients; and performance monitoring and feedback. Ongoing formative evaluation involves the collection of quantitative facilitator tracking data and qualitative data from meeting notes and patient interviews to describe intervention acceptability, feasibility, and adoption, and adjust implementation as needed. In the summative evaluation, implementation outcomes (clinic rates of screening, brief intervention, and treatment referral/receipt) and clinical outcomes (unhealthy alcohol use, liver health) will be assessed among patients in participating clinics using secondary electronic health record data and interrupted time series analysis.

Discussion

This will be the first study to our knowledge to test practice facilitation to implement alcohol-related care in liver clinic settings. Results from formative and summative evaluation will inform a framework for the successful implementation of effective alcohol-related care through practice facilitation in liver clinics, which may ultimately lead to better health outcomes for patients with chronic liver disease.

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

✪ Systems analysis and improvement approach to optimize the hypertension diagnosis and care cascade for PLHIV individuals (SAIA-HTN): A hybrid type III cluster randomized trial

Authors:

Sarah Gimbel, Ana Olga Mocumbi, Kristjana Ásbjörnsdóttir, Joana Coutinho, Leonel Andela, Bonifacio Cebola, Heidi Craine, Jonny Crocker, Leecreesha Hicks, Sarah Holte, Rodrigues Hossieke, Edgar Itai, Carol Levin, Nelia Manaca, Filipe Murgorgo, Miguel Nhumba, James Pfeiffer, Isaias Ramiro, Keshet Ronen, Nona Sotoodehnia, Onei Uetela, Anjuli Wagner, Bryan J. Weiner, & Kenneth Sherr

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: March 2020

Read the full text in the open access journal Implementation Science

Abstract:

Background

Across sub-Saharan Africa, evidence-based clinical guidelines to screen and manage hypertension exist; however, country level application is low due to lack of service readiness, uneven health worker motivation, weak accountability of health worker performance, and poor integration of hypertension screening and management with chronic care services. The systems analysis and improvement approach (SAIA) is an evidence-based implementation strategy that combines systems engineering tools into a five-step, facility-level package to improve understanding of gaps (cascade analysis), guide identification and prioritization of low-cost workflow modifications (process mapping), and iteratively test and redesign these modifications (continuous quality improvement). As hypertension screening and management are integrated into chronic care services in sub-Saharan Africa, an opportunity exists to test whether SAIA interventions shown to be effective in improving efficiency and coverage of HIV services can be effective when applied to the non-communicable disease services that leverage the same platform. We hypothesize that SAIA-hypertension (SAIA-HTN) will be effective as an adaptable, scalable model for broad implementation.

Methods

We will deploy a hybrid type III cluster randomized trial to evaluate the impact of SAIA-HTN on hypertension management in eight intervention and eight control facilities in central Mozambique. Effectiveness outcomes include hypertension cascade flow measures (screening, diagnosis, management, control), as well as hypertension and HIV clinical outcomes among people living with HIV. Cost-effectiveness will be estimated as the incremental costs per additional patient passing through the hypertension cascade steps and the cost per additional disability-adjusted life year averted, from the payer perspective (Ministry of Health). SAIA-HTN implementation fidelity will be measured, and the Consolidated Framework for Implementation Research will guide qualitative evaluation of the implementation process in high- and low-performing facilities to identify determinants of intervention success and failure, and define core and adaptable components of the SAIA-HTN intervention. The Organizational Readiness for Implementing Change scale will measure facility-level readiness for adopting SAIA-HTN.

Discussion

SAIA packages user-friendly systems engineering tools to guide decision-making by front-line health workers to identify low-cost, contextually appropriate chronic care improvement strategies. By integrating SAIA into routine hypertension screening and management structures, this pragmatic trial is designed to test a model for national scale-up.

Trial registration

Registered 09/13/2019; NCT04088656).

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