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.
Published: February 2025
Aaron R Lyon, Sean A Munson, Michael D Pullmann, Brittany Mosser, Tricia Aung , John Fortney, Alex Dopp, Katie P Osterhage, Helen G Haile, Kathryn E Bruzios, Brittany E Blanchard, Ryan Allred, Macey R Fuller, Patrick J Raue, Ian Bennett, Jill Locke, Karen Bearss, Denise Walker, Elizabeth Connors, Eric J Bruns, Jenna Van Draanen, Doyanne Darnell, Patricia A Areán
University of Washington affiliated authors are displayed in bold.
Published: January 2025
Although substantial progress has been made in establishing evidence-based psychosocial clinical interventions and implementation strategies for mental health, translating research into practice—particularly in more accessible, community settings—has been slow.
This protocol outlines the renewal of the National Institute of Mental Health–funded University of Washington Advanced Laboratories for Accelerating the Reach and Impact of Treatments for Youth and Adults with Mental Illness Center, which draws from human-centered design (HCD) and implementation science to improve clinical interventions and implementation strategies. The Center’s second round of funding (2023-2028) focuses on using the Discover, Design and Build, and Test (DDBT) framework to address 3 priority clinical intervention and implementation strategy mechanisms (ie, usability, engagement, and appropriateness), which we identified as challenges to implementation and scalability during the first iteration of the center. Local redesign teams work collaboratively and share decision-making to carry out DDBT.
All 4 core studies received institutional review board approval by June 2024, and each pilot project will pursue institutional review board approval when awarded. We will provide research infrastructure to 1 large effectiveness study and 3 exploratory pilot studies as part of the center grant. At least 4 additional small pilot studies will be solicited and funded by the center. All studies will explore the use of DDBT for clinical interventions and implementation strategies to identify modification targets to improve usability, engagement, and appropriateness in accessible nonspecialty settings (Discover phase); develop redesign solutions with local teams to address modification targets (Design and Build phase); and determine if redesign improves usability, engagement, and appropriateness (Test phase), as well as implementation outcomes. Center staff will collaborate with local redesign teams to develop and test clinical interventions and implementation strategies for community settings. We will collaborate with teams to use methods and centerwide measures that facilitate cross-project analysis of the effects of DDBT-driven redesign on outcomes of interest.
As of January 2025, three of the 4 core studies are underway. We will generate additional evidence on the robustness of DDBT and whether combining HCD and implementation science is an asset for improving clinical interventions and implementation strategies.
During the first round of the center, we established that DDBT is a useful approach to systematically identify and address chronic challenges of implementing clinical interventions and implementation strategies. In this subsequent grant, we expect to increase evidence of DDBT’s impact on clinical interventions and implementation strategies by expanding a list of common challenges that could benefit from modification, a list of exemplary solutions to address these challenges, and guidance on using the DDBT framework. These resources will contribute to broader discourse on how to enhance implementation of clinical interventions and implementation strategies that integrate HCD and implementation science.
PRR1-10.2196/65446
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
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.
Published: January 2025
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.
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.
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.
Name of the Registry: clinicaltrials.gov.
Trial Registration: Clinical Trials ID: NCT06559267.
Date of Registration: August 15, 2024. Prospectively registered.
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**
Sarah Gimbel, Anirban Basu, Emily Callen, Abraham D. Flaxman, Omeid Heidari, Julia E. Hood, Anna Kellogg, Eli Kern, Judith I. Tsui, Ericka Turley, and Kenneth Sherr
University of Washington affiliated authors are displayed in bold.
Published: December 2024
Between 2012–2022 opioid-related overdose deaths in the United States, including Washington State, have risen dramatically. Opioid use disorder (OUD) is a complex, chronic, and criminalized illness with biological, environmental, and social causes. One-fifth of people with OUD have recent criminal-legal system involvement; > 50% pass through WA jails annually.
Medications for Opioid Use Disorder (MOUD) can effectively treat OUD. WA has prioritized improving access to MOUD, including for those in jails. As patients in jail settings are systematically marginalized due to incarceration, it is critical to foster connections to MOUD services upon release, an acknowledged period of high overdose risk. Currently, there is insufficient focus on developing strategies to foster linkages between jail-based MOUD and referral services.
The Systems Analysis and Improvement Approach (SAIA), an evidence-based implementation strategy, may optimize complex care cascades like MOUD provision and improve linkages between jail- and community-based providers. SAIA bundles systems engineering tools into an iterative process to guide care teams to visualize cascade drop-offs and prioritize steps for improvement; identify modifiable organization-level bottlenecks; and propose, implement, and evaluate modifications to overall cascade performance. The SAIA-MOUD study aims to strengthen the quality and continuity of MOUD care across jail and referral clinics in King County, WA, and ultimately reduce recidivism and mortality.
We will conduct a quasi-experimental evaluation of SAIA effectiveness on improving MOUD care cascade quality and continuity for patients receiving care in jail and exiting to referral clinics; examine determinants of SAIA-MOUD adoption, implementation, and sustainment; and determine SAIA-MOUD’s cost and cost-effectiveness. Clinic teams with study team support will deliver the SAIA-MOUD intervention at the jail-based MOUD program and three referral clinics over a two-year intensive phase, followed by a one-year sustainment phase where SAIA implementation will be led by King County Jail MOUD staff without study support to enable pragmatic evaluation of sustained implementation.
SAIA packages user-friendly systems engineering tools to guide decision-making by front-line care providers to identify low-cost, contextually appropriate health care improvement strategies. By integrating SAIA into MOUD care provision in jail and linked services, this pragmatic trial is designed to test a model for national scale-up.
ClinicalTrials.gov NCT06593353 (registered 09/06/2024).
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
Peer Review reports
Keshet Ronen, Lincoln C. Pothan, Violet Apondi, Felix A. Otieno, Daniel Mwakanema, Felix O. Otieno, Lusi Osborn, Julia C. Dettinger, Priyanka Shrestha, Helena Manguerra, Ferdinand Mukumbang, Millicent Masinde, Evelyn Waweru, Mercy Amulele, Christine Were, Beatrice Wasunna, Grace John-Stewart, Bryan Weiner, Arianna Rubin Means, Barbra A. Richardson, Anna B. Hedstrom, Jennifer A. Unger & John Kinuthia
University of Washington affiliated authors are displayed in bold.
Published: October 2024
Provision of essential newborn care at home, rapid identification of illness, and care-seeking by caregivers can prevent neonatal mortality. Mobile technology can connect caregivers with information and healthcare worker advice more rapidly and frequently than healthcare visits. Community health workers (CHWs) are well-suited to deliver such interventions. We developed an interactive short message service (SMS) intervention for neonatal health in Kenya, named CHV-NEO. CHV-NEO sends automated, theory-based, actionable, messages throughout the peripartum period that guide mothers to evaluate maternal and neonatal danger signs and facilitate real-time dialogue with a CHW via SMS. We integrated this intervention into Kenya’s national electronic community health information system (eCHIS), which is currently used at scale to support CHW workflow.
The effect of CHV-NEO on clinical and implementation outcomes will be evaluated through a non-blinded cluster randomized controlled trial. Twenty sites across Kisumu County in Western Kenya were randomized 1:1 to provide either the national eCHIS with integrated CHV-NEO messaging (intervention) or standard of care using eCHIS without CHV-NEO (control). We will compare neonatal mortality between arms based on abstracted eCHIS data from 7200 pregnant women. Secondary outcomes include self-reported provision of essential newborn care (appropriate cord care, thermal care, and timely initiation of breastfeeding), knowledge of neonatal danger signs, and care-seeking for neonatal illness, compared between arms based on questionnaires with a subgroup of 2000 women attending study visits at enrollment in pregnancy and 6 weeks postpartum. We will also determine CHV-NEO’s effect on CHW workflows and evaluate determinants of intervention acceptability, adoption, and fidelity of use through questionnaires, individual interviews, and messaging data.
We hypothesize that the CHV-NEO direct-to-client communication strategy can be successfully integrated within existing CHW workflows and infrastructure, improve the provision of at-home essential newborn care, increase timely referral of neonatal illness to facilities, and reduce neonatal mortality. The intervention’s integration into the national eCHIS tool will facilitate rapid scale-up if it is clinically effective and successfully implemented.
ClinicalTrials.gov, NCT05187897. The CHV-NEO study was registered on January 12, 2022.
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
Jacob T. Painter, Jeffrey Pyne, Geoffrey Curran, Rebecca A. Raciborski, Shane Russell, John Fortney, Allen L. Gifford, Michael Ohl & Eva N. Woodward
University of Washington affiliated authors are displayed in bold.
Published: September 2024
Depression is the most diagnosed mental health condition among people living with HIV. Collaborative care is an effective intervention for depression, typically delivered in primary care settings. The HIV Translating Initiatives for Depression into Effective Solutions (HITIDES) clinical intervention involves a depression care team housed off-site that supports depression care delivery by HIV care providers. In a randomized controlled trial, HITIDES significantly improved depression symptoms for veterans living with HIV and delivered cost savings. However, no HIV clinics in the Veterans Health Administration (VHA) have implemented HITIDES; as such, it is unclear what implementation strategies are necessary to launch and sustain this intervention.
This hybrid type-3 effectiveness-implementation trial examines the implementation and effectiveness of HITIDES in 8 VHA HIV clinics randomly assigned to one of two implementation arms. Each arm uses a different implementation strategy package. Arm 1 includes an intervention operations guide; an on-site clinical champion who, with the help of a peer community of practice, will work with local clinicians and leadership to implement HITIDES at their site; and patient engagement in implementation tools. Arm 2 includes all strategies from Arm 1 with assistance from an external facilitator. The primary implementation outcomes is reach; secondary outcomes include adoption, implementation dose, depressive symptoms, and suicidal ideation. We will conduct a budget impact analysis of the implementation strategy packages. We hypothesize that Arm 2 will be associated with greater reach and adoption and that Arm 1 will be less costly.
Preliminary work identified implementation strategies acceptable to veterans living with HIV and HIV care providers; however, the effectiveness and cost of these strategies are unknown. While the depression care team can deliver services consistently with high quality, the ability of the depression care team to engage with HIV care providers at sites is unknown. Findings from this study will be used to inform selection of implementation strategies for a broad rollout to enhance depression and suicide care for people living with HIV.
ClinicalTrials.gov ID: NCT05901272, Registered 10 May 2023, https://clinicaltrials.gov/study/NCT05901272
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
Kirstine J. Bell, Shannon Brodie, Jennifer J. Couper, Peter Colman, Elizabeth Davis, Gary Deed, William Hagopian, Aveni Haynes, Christel Hendrieckx, Amanda Henry, Adrienne Gordon, Kirsten Howard, Tony Huynh, Bernadette Kerr, Kara Mikler, Natasha Nassar, Sarah Norris, Richard Oram, Dorota Pawlak, Antonia Shand, Richard O. Sinnott, Bethany Wadling, John M. Wentworth, Maria E. Craig & the Type 1 Diabetes National Screening Pilot Study Group
University of Washington affiliated authors are displayed in bold.
Published: August 2024
One third of Australian children diagnosed with type 1 diabetes present with life-threatening diabetic ketoacidosis (DKA) at diagnosis. Screening for early-stage, presymptomatic type 1 diabetes, with ongoing follow-up, can substantially reduce this risk (<5% risk). Several screening models are being trialled internationally, without consensus on the optimal approach. This pilot study aims to assess three models for a routine, population-wide screening programme in Australia.
An implementation science-guided pilot study to evaluate the feasibility, acceptability and costs of three screening models in children will be conducted between July 2022 and June 2024. These models are as follows: (1) Genetic risk-stratified screening using newborn heel prick dried bloodspots, followed by autoantibody testing from 11 months of age; (2) genetic risk-stratified screening of infant (6–12 months) saliva followed by autoantibody testing from 10 months of age; and (3) autoantibody screening using capillary dried bloodspots collected from children aged 2, 6 or 10 years. Cohorts for each model will be recruited from targeted geographic areas across Australia involving ≥2 states per cohort, with a recruitment target of up to 3000 children per cohort (total up to 9000 children). The primary outcome is screening uptake for each cohort. Secondary outcomes include programme feasibility, costs, parental anxiety, risk perception, satisfaction, well-being and quality of life, and health professional attitudes and satisfaction.
This pilot is the first direct comparison of three screening implementation models for general population screening. Findings will provide evidence to inform a potential national screening programme for Australian children.
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
David B. Bekelman, Karleen Giannitrapani, Kristin A. Linn, Paula Langner, Rebecca L. Sudore, Borsika Rabin, Karl A. Lorenz, Marybeth Foglia, Amanda Glickman, Scott Pawlikowski, Marilyn Sloan, Raziel C. Gamboa, Matthew D. McCaa, Anne Hines & Anne M. Walling
University of Washington affiliated authors are displayed in bold.
Published: July 2024
Goals of care conversations explore seriously ill patients' values to guide medical decision making and often inform decisions about life sustaining treatments. Ideally, conversations occur before a health crisis between patients and clinicians in the outpatient setting. In the United States Veterans Affairs (VA) healthcare system, most conversations still occur in the inpatient setting. Strategies are needed to improve implementation of outpatient, primary care goals of care conversations.
We plan a cluster randomized (clinician-level) sequential, multiple assignment randomized trial to evaluate the effectiveness of patient implementation strategies on the outcome of goals of care conversation documentation when delivered in combination with clinician implementation strategies. Across three VA healthcare system sites, we will enroll primary care clinicians with low rates of goals of care conversations and their patients with serious medical illness in the top 10th percentile of risk of hospitalization or death. We will compare the effectiveness of sequences of implementation strategies and explore how patient and site factors modify implementation strategy effects. Finally, we will conduct a mixed-methods evaluation to understand implementation strategy success or failure. The design includes two key innovations: (1) strategies that target both clinicians and patients and (2) sequential strategies with increased intensity for non-responders.
This study aims to determine the effect of different sequences and combinations of implementation strategies on primary care documentation of goals of care conversations. Study partners, including the VA National Center for Ethics in Health Care and Office of Primary Care, can consider policies based on study findings.
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
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.
Published: July 2024
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.
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.
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.
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.
ClinicalTrials.gov, NCT05050643. Registered September 9th, 2021, https://clinicaltrials.gov/study/NCT05050643
This protocol is Version 1.0 which was created on 6/3/2020.
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
Sophia M. Bartels, Huong T. T. Phan, Heidi E. Hutton, Do T. Nhan, Teerada Sripaipan, Jane S. Chen, Sarah L. Rossi, Olivia Ferguson, Ha T. T. Nong, Ngan T. K. Nguyen, Le Minh Giang, Hao T. M. Bui, Geetanjali Chander, Hojoon Sohn, Sol Kim, Ha V. Tran, Minh X. Nguyen, Byron J. Powell, Brian W. Pence, William C. Miller & Vivian F. Go
University of Washington affiliated authors are displayed in bold.
Published: June 2024
Evidence-based interventions (EBIs) often address normative behaviors. If a behavior is also common among clinicians, they may be skeptical about the necessity or effectiveness of an EBI. Alternatively, clinicians’ attitudes and behaviors may be misaligned, or they may lack the knowledge and self-efficacy to deliver the EBI. Several EBIs address unhealthy alcohol use, a common and often culturally acceptable behavior. But unhealthy alcohol use may be particularly harmful to people with HIV (PWH). Here, we present an implementation trial using an experiential implementation strategy to address clinicians’ knowledge, attitudes, and behaviors. Clinicians receive the experiential intervention before they begin delivering an evidence-based brief alcohol intervention (BAI) to PWH with unhealthy alcohol use.
Design: In this hybrid type 3 implementation-effectiveness cluster randomized controlled trial, ART clinics (n = 30) will be randomized 1:1 to facilitation, a flexible strategy to address implementation barriers, or facilitation plus the experiential brief alcohol intervention (EBAI). In the EBAI arm, clinicians, irrespective of their alcohol use, will be offered the BAI as experiential learning. EBAI will address clinicians’ alcohol-related attitudes and behaviors and increase their knowledge and confidence to deliver the BAI.
Participants: ART clinic staff will be enrolled and assessed at pre-BAI training, post-BAI training, 3, 12, and 24 months. All PWH at the ART clinics who screen positive for unhealthy alcohol use will be offered the BAI. A subset of PWH (n = 810) will be enrolled and assessed at baseline, 3, and 12 months.
Outcomes: We will compare implementation outcomes (acceptability, fidelity, penetration, costs, and sustainability) and effectiveness outcomes (viral suppression and alcohol use) between the two arms. We will assess the impact of site-level characteristics on scaling-up the BAI. We will also evaluate how experiencing the BAI affected clinical staff’s alcohol use and clinic-level alcohol expectations in the EBAI arm.
This trial contributes to implementation science by testing a novel strategy to implement a behavior change intervention in a setting in which clinicians themselves may engage in the behavior. Experiential learning may be useful to address normative and difficult to change lifestyle behaviors that contribute to chronic diseases.
NCT06358885 (04/10/2024), https://clinicaltrials.gov/study/NCT06358885.
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**