Skip to content

✪ Harnessing Human-Centered Design for Evidence-Based Psychosocial Interventions and Implementation Strategies in Community Settings: Protocol for Redesign to Improve Usability, Engagement, and Appropriateness

Authors:

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.

✪ Open Access

Published: January 2025

Read the full text in the open access journal JMIR Research Protocols

Abstract:

Background

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.

Objective

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.

Methods

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.

Results

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.

Conclusions

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.

International Registered Report Identifier (IRRID)

PRR1-10.2196/65446

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

✪ Sustainability of an evidence-based intervention supporting transition to independent care for youth living with HIV in Kenya

Authors:

Alina Metje, Sarah Shaw, Cyrus Mugo, Mercy Awuor, Annabell Dollah, Hellen Moraa, Christine Kundu, Dalton Wamalwa, Grace John-Stewart, Kristin Beima-Sofie, and Irene Njuguna

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: January 2025

Read the full text in the open access journal PLOS Global Public Health

Abstract:

Integrating and sustaining evidence-based interventions (EBIs) in routine care is crucial to improving HIV treatment outcomes among youth living with HIV (YLH). However, EBIs are often not sustained post clinical trial. An Adolescent Transition Package (ATP) delivered by health care workers (HCWs) and tested in Kenya in 2021 significantly improved YLH readiness to transition to independent care. Post-trial, participating clinics could continue using the ATP. We conducted 30 in-depth interviews with health care workers to evaluate determinants of continued ATP implementation one-year post-trial. Interviews used semi-structured guides, informed by the Consolidated Framework for Implementation Research version 2.0 (CFIR v2.0). Transcripts were analyzed thematically to identify key influences of ATP sustainment and fidelity post-trial. Effective training during and after the trial, and continued internal and external support for implementation, were crucial for sustained acceptability and feasibility. In contrast, staff shortages and high turnover, lack of integration into the existing electronic medical system, and maintaining staff motivation were barriers to ATP sustainment. Implementation fidelity was limited by workforce constraints and HCW beliefs about the importance of individualizing content and delivery to be responsive to individual client needs. ATP adaptability afforded optimization of delivery to overcome workforce constraints and meet client needs, increasing HCW perceptions of feasibility and motivating continued use. Alignment between observed impact and care provision goals further motivated ongoing ATP utilization. Strategies to ensure continued training and integration of tools into existing systems have the potential to further enhance ATP sustainability.

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

✪ Systems analysis and improvement to optimize opioid use disorder care quality and continuity for patients exiting jail (SAIA-MOUD)

Authors:

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.

✪ Open Access

Published: December 2024

Read the full text in the open access journal Implementation Science

Abstract:

Background

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.

Methods

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.

Discussion

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.

Trial registration

ClinicalTrials.gov NCT06593353 (registered 09/06/2024).

Contributions to the literature
  • Our study examines whether the introduction of an evidence-based, user-friendly, low-cost package of systems engineering tools can optimize investments in providing medications for opioid use disorder for individuals during the high-risk period immediately after exiting jail.
  • This is the first application of the Systems Analysis and Improvement Approach (SAIA) across health system levels to optimize both care delivery and continuity of care.
  • Our study is designed to provide decision-makers with evidence they need to decide whether to invest in systems engineering approaches during the expansion of MOUD in jail settings, including information on acceptability, feasibility, effectiveness and cost.

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

Peer Review reports

✪ Formative evaluation of the implementation of digital therapeutics for opioids and other substance use disorders in primary care (DIGITS trial)

Authors:

Lorella Palazzo, Caitlin N Dorsey, Jess Mogk, Tara Beatty, Deborah King, Kelsey Stefanik-Guizlo, Dustin Key, Tessa E Matson, Mary Shea, Ryan M Caldeiro, Angela Garza McWethy, Edwin S Wong, Abisola E Idu, and Joseph E Glass

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: December 2024

Read the full text in the open access journal Implementation Research and Practice

Abstract:

Background

Substance use disorders (SUDs) result in individual and societal burden. However, most individuals with SUD receive no treatment. Implementing SUD interventions in primary care could address this population's treatment needs. In the USA, reSET® and reSET-O® were the first prescription digital therapeutics (PDTs) for SUDs and opioid use disorder (OUD), respectively. The Digital Treatments for Substance Use Disorder (DIGITS) study tested the effectiveness of practice facilitation and health coaching strategies to support reSET and reSET-O implementation into primary care. A formative evaluation was conducted to monitor implementation, inform adaptations, and learn what promotes PDT sustainment.

Method

The Dynamic Sustainability Framework and the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies guided the evaluation. Using rapid qualitative methods, we collected and analyzed observational fieldnotes, key informant interviews, and document sources (e.g., meeting minutes) for synthesis and dissemination to clinical partners and the study team via formative reports. We analyzed the reports to generate evaluation results.

Results

Twenty-four primary care clinics participated. Evaluation data included 98 observational fieldnotes, 16 interviews, and 253 document sources. We produced nine formative reports. The study encountered barriers and facilitators in each DSF domain (ecological system, practice setting, and intervention). In the ecological system, the PDT vendor enabled the study, but the COVID-19 pandemic, laws, regulations, and contracting delayed implementation. In the practice setting, staff shortages and low clinic capacity were implementation challenges, while electronic health record capabilities were both barriers and facilitators. At the intervention level, non-routine workflows, clinician burden, and low patient engagement were barriers despite clinicians’ efforts.

Conclusions

Digital therapeutics are promising SUD and OUD treatments, but integration into primary care requires conducive laws and regulations, organizational capacity, and patient and clinician engagement. Formative evaluation identified important lessons for future PDT implementation.

Plain Language Summary

Evaluation of the integration of digital treatments for opioid and other substance use disorders in primary care

Most people with substance use disorders (SUDs) receive no treatment. In the USA, two smartphone app-based digital treatments for SUD and opioid use disorders (OUDs) became available by prescription. The Digital Treatments for Substance Use Disorder (DIGITS) study, a randomized implementation trial, tested how best to integrate these digital treatments for SUD and OUD into primary care. Throughout the study, we conducted a formative evaluation to observe progress, recommend implementation improvements, and understand how digital treatments could be offered to patients after the study ended. For this evaluation, we collected qualitative data through observing study meetings and interviewing primary care leaders, clinicians, and clinical and study staff. The data were regularly summarized and reported to our clinical partners and the study team. We used two implementation frameworks to interpret the data: the Dynamic Sustainability Framework and the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies. The evaluation revealed factors that helped and hindered implementation. Obstacles from outside the health care system included the COVID-19 pandemic, laws, regulations, and delays in setting up contractual agreements, whereas a partnership with the digital treatment vendor proved helpful. Clinics had difficulties with clinician burden, staff shortages, lack of time and available appointments, and performing new and unfamiliar tasks. The electronic health record system both supported and impended implementation. Last, few patients accepted the offered digital treatment, or used it persistently. Formative evaluation results suggest that digital treatments for SUD and OUD in primary care are promising, however their successful use requires supportive laws and regulations, health system resources, and increased patient and clinician engagement.

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

✪ Community partner coauthorship for increased implementation science impact: Strengthening capacity and engagement

Authors:

Rebekka M. Lee, Cristina Huebner Torres, James G. Daly, Annette Thomas, Peggy A. Hannon, Sonja Likumahuwa-Ackman and Karen M. Emmons

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: September 2024

Read the full text open access in the journal Hepatology Communications

Abstract:

Engaging diverse partners in each phase of the research process is the gold standard of community-engaged research and adds value to the impact of implementation science. However, partner engagement in dissemination, particularly meaningful involvement in developing peer-reviewed manuscripts, is lacking. The Implementation Science Centers in Cancer Control are using the Translational Science Benefits Model to demonstrate the impact of our work beyond traditional metrics, including building capacity and promoting community engagement. This paper presents a case example of one center that has developed a policy for including community partners as coauthors. Standard practices are used to foster clear communications and bidirectional collaboration. Of published papers focused on center infrastructure and implementation research pilots, 92% have community partner coauthors. This includes 21 individuals in roles ranging from physician assistant to medical director to quality manager. Through this intentional experience of co-creation, community partners have strengthened implementation science expertise. Community coauthors have also ensured that data interpretation and dissemination reflect real-world practice environments and offer sustainable strategies for rapid translation to practice improvements. Funders, academic journals, and researchers all have important roles to play in supporting community coauthors as critical thought partners who can help to narrow the gap between research and practice.

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

✪ Reimagining policy implementation science in a global context: a theoretical discussion

Authors:

Kellie List, Peter Agamile, Didier Yélognissè Alia, Peter Cherutich, Kristen Danforth, John Kinuthia, Arianna Rubin Means, Irene Mukui, Nancy Ngumbau, Yanfang Su, Anjuli Dawn Wagner, Bryan J Weiner, and Sarah Masyuko

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: September 2024

Read the full text in the open access journal Frontiers in Health Services

Abstract:

Introduction

Policy implementation science (IS) is defined here as generating knowledge and deploying implementation strategies to effectively adopt and integrate evidence-based interventions (EBIs) into policy designs and improve policy implementation and effectiveness (1–3). Most existing policy IS scholarly works originate from the Global North (United States, Canada, and Western Europe) and describe or evaluate strategies to increase the uptake of EBIs (4). The existing Global North-generated frameworks focus less on the critical resources needed to formulate and implement a policy in diverse settings. Current approaches to policy IS lack sufficient contextual nuance to be applicable to...[read more].

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

✪ Using FRAME to characterize provider-identified adaptations to a stepped care intervention for adolescents and youth living with HIV in Kenya: a mixed methods approach

Authors:

Nok Chhun, Dorothy Oketch, Kawango Agot, Dorothy I. Mangale, Jacinta Badia, James Kibugi, Wenwen Jiang, Mary Kirk, Barbra A. Richardson, Pamela K. Kohler, Grace John-Stewart & Kristin Beima-Sofie

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: July 2024

Read the full text in the open access journal Journal of the International AIDS Society

Abstract:

Introduction

The Data-informed Stepped Care (DiSC) study is a cluster-randomized trial implemented in 24 HIV care clinics in Kenya, aimed at improving retention in care for adolescents and youth living with HIV (AYLHIV). DiSC is a multi-component intervention that assigns AYLHIV to different intensity (steps) of services according to risk. We used the Framework for Reporting Adaptations and Modifications-Expanded (FRAME) to characterize provider-identified adaptations to the implementation of DiSC to optimize uptake and delivery, and determine the influence on implementation outcomes.

Methods

Between May and December 2022, we conducted continuous quality improvement (CQI) meetings with providers to optimize DiSC implementation at 12 intervention sites. The meetings were guided by plan-do-study-act processes to identify challenges during early phase implementation and propose targeted adaptations. Meetings were audio-recorded and analysed using FRAME to categorize the level, context and content of planned adaptations and determine if adaptations were fidelity consistent. Providers completed surveys to quantify perceptions of DiSC acceptability, appropriateness and feasibility. Mixed effects linear regression models were used to evaluate these implementation outcomes over time.

Results

Providers participated in eight CQI meetings per facility over a 6-month period. A total of 65 adaptations were included in the analysis. The majority focused on optimizing the integration of DiSC within the clinic (83%, n = 54), and consisted of improving documentation, addressing scheduling challenges and improving clinic workflow. Primary reasons for adaptation were to align delivery with AYLHIV needs and preferences and to increase reach among AYLHIV: with reminder calls to AYLHIV, collaborating with schools to ensure AYLHIV attended clinic appointments and addressing transportation challenges. All adaptations to optimize DiSC implementation were fidelity-consistent. Provider perceptions of implementation were consistently high throughout the process, and on average, slightly improved each month for intervention acceptability (β = 0.011, 95% CI: 0.002, 0.020, p = 0.016), appropriateness (β = 0.012, 95% CI: 0.007, 0.027, p<0.001) and feasibility (β = 0.013, 95% CI: 0.004, 0.022, p = 0.005).

Conclusions

Provider-identified adaptations targeted improved integration into routine clinic practices and aimed to reduce barriers to service access unique to AYLHIV. Characterizing types of adaptations and adaptation rationale may enrich our understanding of the implementation context and improve abilities to tailor implementation strategies when scaling to new settings.

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

A tailored decision aid improves understanding of lung cancer screening in people with HIV

Authors:

Nicholas R. Murphy, Kristina Crothers, Madison Snidarich, Jehan Z. Budak, Meagan C. Brown, Bryan J. Weiner, Nicholas Giustini, Tanner Caverly, Katherine Durette, Katie DeCell, and Matthew Triplette

University of Washington affiliated authors are displayed in bold.

Subscription Required for Full Text Access

Published: July 2024

Read the full text in the subscription access CHEST Journal

✪ Use of concept mapping to inform a participatory engagement approach for implementation of evidence-based HPV vaccination strategies in safety-net clinics

Authors:

Jennifer Tsui, Michelle Shin, Kylie Sloan, Thomas I. Mackie, Samantha Garcia, Anne E. Fehrenbacher, Benjamin F. Crabtree & Lawrence A. Palinkas

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: June 2024

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

Abstract:

Background

Multiple evidence-based strategies (EBS) for promoting HPV vaccination exist. However, adolescent HPV vaccination rates remain below target levels in communities at high risk for HPV-associated cancers and served by safety-net clinics. Participatory engaged approaches are needed to leverage the expertise of community and clinical partners in selecting EBS relevant to their local context. We engaged concept mapping as a method to inform the adoption and adaptation of EBS that seeks to empower implementation partners to prioritize, select, and ultimately implement context-relevant EBS for HPV vaccination.

Methods

Using 38 EBS statements generated from qualitative interviews and national HPV vaccine advocacy sources, we conducted a modified concept mapping activity with partners internal to safety-net clinics and external community members in two study sites of a larger implementation study (Greater Los Angeles and New Jersey), to sort EBS into clusters and rate each EBS by importance and feasibility for increasing HPV vaccination within safety-net clinics. Concept mapping findings (EBS statement ratings, ladder graphs and go-zones) were shared with leaders from a large federally qualified health center (FQHC) system (focusing on three clinic sites), to select and implement EBS over 12 months.

Results

Concept mapping participants (n=23) sorted and rated statements, resulting in an eight-cluster solution: 1) Community education and outreach; 2) Advocacy and policy; 3) Data access/quality improvement monitoring; 4) Provider tracking/audit and feedback; 5) Provider recommendation/communication; 6) Expanding vaccine access; 7) Reducing missed opportunities; and 8) Nurse/staff workflow and training. The FQHC partner then selected to intervene on eight of 17 EBS statements in the “go-zone” for action, with three from “reducing missed opportunities,” two from “nurse/staff workflow and training,” and one each from “provider tracking/audit and feedback,” “provider recommendation/communication,” and “expanding vaccine access,” which the research team addressed through the implementation of three multi-level intervention strategies (e.g., physician communication training, staff training and workflow assessment, audit and feedback of clinic processes).

Conclusions

Concept mapping provided a powerful participatory approach to identify multilevel EBS for HPV vaccination relevant to the local safety-net clinic context, particularly when several strategies exist, and prioritization is necessary. This study demonstrates how a clinic system benefited directly from the ratings and prioritization of EBS by multilevel clinic and community partners within the broader safety-net clinic context to identify and adapt prioritized solutions needed to advance HPV vaccine equity.

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

✪ Development of a method for Making Optimal Decisions for Intervention Flexibility during Implementation (MODIFI): a modified Delphi study

Authors:

Stephanie K. Brewer, Catherine M. Corbin, Ana A. Baumann, Shannon Wiltsey Stirman, Janine M. Jones, Michael D. Pullmann, Aaron R. Lyon & MODIFI Expert Panel

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: June 2024

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

Abstract:

Background

Intervention adaptation is often necessary to improve the fit between evidence-based practices/programs and implementation contexts. Existing frameworks describe intervention adaptation processes but do not provide detailed steps for prospectively designing adaptations, are designed for researchers, and require substantial time and resources to complete. A pragmatic approach to guide implementers through developing and assessing adaptations in local contexts is needed. The goal of this project was to develop Making Optimal Decisions for Intervention Flexibility during Implementation (MODIFI), a method for intervention adaptation that leverages human centered design methods and is tailored to the needs of intervention implementers working in applied settings with limited time and resources.

Method

MODIFI was iteratively developed via a mixed-methods modified Delphi process. Feedback was collected from 43 implementation research and practice experts. Two rounds of data collection gathered quantitative ratings of acceptability and inclusion (Round 1) and feasibility (Round 2), as well as qualitative feedback regarding MODIFI revisions analyzed using conventional content analysis.

Results

In Round 1, most participants rated all proposed components as essential but identified important avenues for revision which were incorporated into MODIFI prior to Round 2. Round 2 emphasized feasibility, where ratings were generally high and fewer substantive revisions were recommended. Round 2 changes largely surrounded operationalization of terms/processes and sequencing of content. Results include a detailed presentation of the final version of the three-step MODIFI method (Step 1: Learn about the users, local context, and intervention; Step 2: Adapt the intervention; Step 3: Evaluate the adaptation) along with a case example of its application.

Discussion

MODIFI is a pragmatic method that was developed to extend the contributions of other research-based adaptation theories, models, and frameworks while integrating methods that are tailored to the needs of intervention implementers. Guiding teams to tailor evidence-based interventions to their local context may extend for whom, where, and under what conditions an intervention can be effective.

Contributions to the literature
  • Adaptation of evidence-based practices, programs, and treatments is often needed to ensure successful implementation. However, existing theories/models/frameworks do not outline concrete adaptation steps that are feasible for real-world settings.
  • We created a resource-efficient method (MODIFI) for developing and assessing intervention adaptations in local settings. This method was iteratively developed through a mixed-methods modified Delphi process, which resulted in consensus among experts in implementation science and practice.
  • MODIFI leverages human centered design techniques and is tailored to the needs of intervention implementers in applied settings, filling a crucial gap in the research to practice pipeline.

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