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Implementation Science at UW

Keywords: Stepped Wedge Design

Tailored strategies to increase the use of an evidence-based psychotherapy for posttraumatic stress disorder: A stepped-wedge randomized trial in military clinics

Authors:

Craig S Rosen, Alan L Peterson, David S Riggs, Christopher K Haddock, Chunki Fong, Stacey Young-McCaughan, Jeffrey Cook, Katherine Anne Comtois, Elisa V Borah, C Adrian Davis, Katherine A Dondanville, Erin P Finley, Sara A Jahnke, Melissa Mistretta, Andrea Neitzer, Shannon Wiltsey-Stirman, Erin R Frick, Olivia Hayes, Spencer Clayton, Allison M Conforte, Araceli Flores, Jeremy Jinkerson , Zachary K Jones, Hana J Kim, Margaret Letendre, Jared S Link, Debra Nofziger, Erik N Ringdahl, John W Waggoner, Craig Woodworth, Emily Ho, Carmen P McLean & TACTICS Research Group

University of Washington affiliated authors are displayed in bold.

Subscription Required for Full Text Access

Published: October 2025

Read the full text in the subscription access journal Journal of Anxiety Disorders

Conducting an implementation intervention study with American Indian and Alaska Native communities: Methodological considerations

Authors:

Margaret M. Paschen-Wolff, Aimee N.C. Campbell, Ángel Vásquez, Jill Kessler, Kelley Jansen, Catherine P. Arnatt, Carmen Rosa, Hanna M. Hebden, Sandra Radin, Antony Stately, Jennifer Shaw, Favian Kennedy, Abigail G. Matthews, & Kamilla L. Venner

University of Washington affiliated authors are displayed in bold.

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Published: August 2025

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

✪ “When he is around, I’ll take the PrEP, but when he is not, I will not take PrEP”: key influences on PrEP use decisions among women attending family planning clinics in Kenya

Authors:

Vallery Ogello, Kristin Beima-Sofie, Sandra Urusaro, Mercy Awuor, Annabell Dollah, Winnie Atieno, Cynthia Wandera, Daniel Matemo, Jennifer F Morton, Kenneth Ngure, John Kinuthia & Kenneth K Mugwanya

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: July 2025

Read the full text in the open access journal Frontiers in Medicine

Abstract:

Background

Women of childbearing age in sub-Saharan Africa (SSA) face a disproportionately high risk of HIV acquisition. Although oral PrEP has been universally scaled up for individuals at significant risk of HIV, its uptake and sustained use remain suboptimal. Understanding PrEP use decisions offers insights into context-specific barriers and facilitators to its utilization.

Methods

From September to November 2023, we conducted a qualitative study nested in a larger prospective, open-label clinical trial (FP-Plus). We conducted in-depth interviews (IDIs) with younger women (ages 15–24) and older women (ages ≥25) who declined, delayed, discontinued, or restarted PrEP during the study. IDIs were conducted at two FP clinics by trained Kenyan social scientists and were audio recorded, translated, and transcribed. We analyzed data using inductive and deductive thematic analysis through the lens of the theory of planned behavior (TPB) to explore experiences, beliefs, and rationale among women who made various PrEP decisions.

Results

We interviewed 64 women, including 40 younger women and 24 older women, all of whom declined, delayed, discontinued, or restarted PrEP (n = 16 women/category). The median age of these women was 24 years (IQR, 23–30). The majority of participants (86%, 55/64) were using family planning methods, primarily injectables (42%, 23/64). PrEP discontinuation or restart was primarily influenced by changes in HIV risk dynamics. Agency and perceived HIV risk were pivotal factors in PrEP use decisions, shaping participants’ ability to practice effective prevention adherence (TPB: perceived behavioral control). Women who declined PrEP cited a lack of autonomy, partner influence, and insufficient information (TPB: social and subjective norms). Low self-efficacy influenced decisions to delay or decline PrEP (TPB: behavioral beliefs and attitudes). In addition, challenges with PrEP pill size, taste, and texture were perceived as barriers to swallowing pills among all groups of women. Participants expressed a preference for alternative PrEP formulations, such as injectable PrEP, due to perceived ease of use, privacy, and potential to support adherence.

Conclusions

PrEP discontinuation and restart cycles largely reflected changes in HIV risk. Women who decline or delay PrEP may benefit from personalized support to improve their autonomy, recognizing that HIV risk persists during periods of PrEP delay.

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

Treating seizures faster: The quality improvement in time to treat status epilepticus (QuITT-SE) multicenter randomized stepped wedge clinical trial protocol

Authors:

Adam P. Ostendorf, Tobias Loddenkemper, Lindsey A. Morgan, Brian Appavu, Raquel Farias-Moeller, Dana Harrar, Craig Press, Nicholas S. Abend, William D. Gaillard, Shasha Bai, Mariah Eisner, Lauren McHenry, Emily Kroshus, Kathryn Vannatta, and Howard P. Goodkin

University of Washington affiliated authors are displayed in bold.

Subscription Required for Full Text Access

Published: February 2025

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

✪ 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**

✪ Systems analysis and improvement approach to optimize tuberculosis (SAIA-TB) screening, treatment, and prevention in South Africa: a stepped-wedge cluster randomized trial

Authors:

Brittney J. van de Water, Meredith B. Brooks, Refiloe Matji, Betty Ncanywa, Freck Dikgale, Nadia N. Abuelezam, Bulelwa Mzileni, Miyakazi Nokwe, Singilizwe Moko, Lindiwe Mvusi, Marian Loveday, & Sarah Gimbel

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: April 2024

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

Abstract:

Background

The use of systems engineering tools, including the development and use of care cascades using routinely collected data, process mapping, and continuous quality improvement, is used for frontline healthcare workers to devise systems level change. South Africa experiences high rates of tuberculosis (TB) infection and disease as well as HIV co-infection. The Department of Health has made significant gains in HIV services over the last two decades, reaching their set “90–90-90” targets for HIV. However, TB services, although robust, have lagged in comparison for both disease and infection. The Systems Analysis and Improvement Approach (SAIA) is a five-step implementation science method, drawn from systems engineering, to identify, define, and implement workflow modifications using cascade analysis, process mapping, and repeated quality improvement cycles within healthcare facilities.

Methods

This stepped-wedge cluster randomized trial will evaluate the effectiveness of SAIA on TB (SAIA-TB) cascade optimization for patients with TB and high-risk contacts across 16 clinics in four local municipalities in the Sarah Baartman district, Eastern Cape, South Africa. We hypothesize that SAIA-TB implementation will lead to a 20% increase in each of: TB screening, TB preventive treatment initiation, and TB disease treatment initiation during the 18-month intervention period. Focus group discussions and key informant interviews with clinic staff will also be conducted to determine drivers of implementation variability across clinics.

Discussion

This study has the potential to improve TB screening, treatment initiation, and completion for both active disease and preventive measures among individuals with and without HIV in a high burden setting. SAIA-TB provides frontline health care workers with a systems-level view of their care delivery system with the aim of sustainable systems-level improvements.

Trial registration

Clinicaltrials.gov, NCT06314386. Registered 18 March 2024, https://clinicaltrials.gov/study/NCT06314386. NCT06314386.

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

✪ Scaling-up and scaling-out the Systems Analysis and Improvement Approach to optimize the hypertension diagnosis and care cascade for HIV infected individuals (SCALE SAIA-HTN): a stepped-wedge cluster randomized trial

Authors:

Carmen E. Hazim , Igor Dobe, Stephen Pope, Kristjana H. Ásbjörnsdóttir, Orvalho Augusto, Fernando Pereira Bruno, Sergio Chicumbe, Norberto Lumbandali, Inocêncio Mate, Elso Ofumhan, Sam Patel, Riaze Rafik, Kenneth Sherr, Veronica Tonwe, Onei Uetela, David Watkins, Sarah Gimbel, & Ana O. Mocumbi

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: March 2024

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

Abstract:

Background

Undiagnosed and untreated hypertension is a main driver of cardiovascular disease and disproportionately affects persons living with HIV (PLHIV) in low- and middle-income countries. Across sub-Saharan Africa, guideline application to screen and manage hypertension among PLHIV is inconsistent due to poor service readiness, low health worker motivation, and limited integration of hypertension screening and management within HIV care services. In Mozambique, where the adult HIV prevalence is over 13%, an estimated 39% of adults have hypertension. As the only scaled chronic care service in the county, the HIV treatment platform presents an opportunity to standardize and scale hypertension care services.
Low-cost, multi-component systems-level strategies such as the Systems Analysis and Improvement Approach (SAIA) have been found effective at integrating hypertension and HIV services to improve the effectiveness of hypertension care delivery for PLHIV, reduce drop-offs in care, and improve service quality. To build off lessons learned from a recently completed cluster randomized trial (SAIA-HTN) and establish a robust evidence base on the effectiveness of SAIA at scale, we evaluated a scaled-delivery model of SAIA (SCALE SAIA-HTN) using existing district health management structures to facilitate SAIA across six districts of Maputo Province, Mozambique.

Methods

This study employs a stepped-wedge design with randomization at the district level. The SAIA strategy will be “scaled up” with delivery by district health supervisors (rather than research staff) and will be “scaled out” via expansion to Southern Mozambique, to 18 facilities across six districts in Maputo Province. SCALE SAIA-HTN will be introduced over three, 9-month waves of intensive intervention, where technical support will be provided to facilities and district managers by study team members from the Mozambican National Institute of Health. Our evaluation of SCALE SAIA-HTN will be guided by the RE-AIM framework and will seek to estimate the budget impact from the payer’s perspective.

Discussion

SAIA packages user-friendly systems engineering tools to support decision-making by frontline health workers and to identify low-cost, contextually relevant improvement strategies. By integrating SAIA delivery into routine management structures, this pragmatic trial will determine an effective strategy for national scale-up and inform program planning.

**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**

✪ The Science of Precision Prevention: Research Opportunities and Clinical Applications to Reduce Cardiovascular Health Disparities

Authors:

Thomas A Pearson, Debbie Vitalis, Charlotte Pratt, Rebecca Campo, Antonis A Armoundas, David Au, Bettina Beech, Olga Brazhnik, Christopher G Chute, Karina W Davidson, Ana V Diez-Roux, Lawrence J Fine, Davera Gabriel, Peter Groenveld, Jaclyn Hall, Alison B Hamilton, Hui Hu, Heng Ji, Amy Kind, William E Kraus, Harlan Krumholz, George A Mensah, Raina M Merchant, Dariush Mozaffarian, David M Murray, Dianne Neumark-Sztainer, Maya Petersen & David Goff

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: January 2024

Read the full text in the open access journal JACC: Advances

Abstract:

Precision prevention embraces personalized prevention but includes broader factors such as social determinants of health to improve cardiovascular health. The quality, quantity, precision, and diversity of data relatable to individuals and communities continue to expand. New analytical methods can be applied to these data to create tools to attribute risk, which may allow a better understanding of cardiovascular health disparities. Interventions using these analytic tools should be evaluated to establish feasibility and efficacy for addressing cardiovascular disease disparities in diverse individuals and communities. Training in these approaches is important to create the next generation of scientists and practitioners in precision prevention. This state-of-the-art review is based on a workshop convened to identify current gaps in knowledge and methods used in precision prevention intervention research, discuss opportunities to expand trials of implementation science to close the health equity gaps, and expand the education and training of a diverse precision prevention workforce.

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

✪ A pragmatic approach to identifying implementation barriers and facilitators for a novel pre-exposure prophylaxis (PrEP) delivery model at public facilities in urban Uganda

Authors:

Dorothy Thomas, Andrew Mujugira, Katrina Ortblad, Sylvia Namanda, Joseph Kibuuka, Mai Nakitende, Florence Nambi, Lylianne Nakabugo, Caitlin Scoville, Timothy Muwonge, Renee Heffron

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: January 2022

Read the full text in the open access journal Implementation Science Communications
BACK TO THE ARCHIVE

Abstract:

Background

Scalable HIV pre-exposure prophylaxis (PrEP) delivery models for resource-limited settings are critical for improving PrEP coverage and interrupting HIV transmission. This research uses technical assistance (TA) reports to evaluate implementation barriers and facilitators for a novel delivery model integrating PrEP and antiretroviral therapy (ART) delivery for HIV sero-different couples in public health facilities in Kampala, Uganda.

Methods

We used data from the Partners PrEP Program (PPP)—a stepped-wedge cluster randomized trial that is launching PrEP delivery through an integrated model of oral PrEP and antiretroviral therapy (ART) delivery for HIV sero-different couples at public health facilities in Kampala and Wakiso, Uganda (NCT03586128). Technical assistance teams, comprised of PPP program staff, conducted monthly TA visits to implementing facilities where they identified and addressed implementation challenges in collaboration with health facility staff. Findings were recorded in TA reports, a standardized form structured using the Consolidated Framework for Implementation Research (CFIR). We used a conceptual content analysis approach to evaluate TA reports completed from January to December 2019 and identify implementation barriers and facilitators.

Results

Among 39 reports from the 8 implementing facilities (~ 5 per facility), we identified 11 CFIR constructs. Key implementation facilitators included sensitizing and educating facility staff about PrEP (knowledge and beliefs about the innovation); establishing formal and informal feedback and accountability mechanisms (reflecting and evaluating); and empowering facility staff to address implementation challenges (self-efficacy). Key implementation barriers were related to ineffective recruitment and referral of sero-different couples to and from nearby facilities (cosmopolitanism) as well as stockouts of laboratory resources and testing supplies (available resources).

Conclusions

This analysis featured a robust implementation science framework to assess the relationship between early implementation determinants and outcomes of this innovative PrEP delivery model. Further, we have provided important descriptions of early implementation barriers and facilitators that will inform scale-up efforts for PrEP delivery within and beyond Uganda. Future work will refine the analysis of pragmatic program data, qualitatively investigate the identified key themes, and explore strategies for addressing implementation barriers.

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