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✪ A cross-consortium, stakeholder-driven model for implementing a modern electronic data capture and submission system across the Alzheimer’s Disease Research Centers Program

Authors:

Sarah Biber, Sarah Gothard, Charles F Murchison, Laura McLeod, Kathryn Gauthreaux, Chandima HewaNadungodage, Emily Cheng, Jessica Welsch, Jessica E. Culhane, Sarah Yasuda, Hannah Stockwell, Shilpa Allimatti, Mark Bauer, Jonathan M. Reader, Walter Kukull, Meredith Zozus & Sudeshna Das

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: March 2026

Read the full text in the open access Alzheimer's & Dementia: The Journal of the Alzheimer's Association

Abstract:

INTRODUCTION

The National Alzheimer's Coordinating Center (NACC) and Alzheimer's Disease Research Center (ADRC) Program advances dementia research by collecting and sharing standardized, longitudinal data, including the Uniform Data Set with the global research community. To modernize workflow and accelerate the availability of analyzable data, we co-developed a consortium-wide Electronic Data Capture and Submission system.

METHODS

A cross-disciplinary workgroup of ADRC and NACC members co-developed the system using a stakeholder-centered sociotechnical implementation model. Subgroups focused on requirements, development, and training. Surveys and pilot testing across centers guided design and priorities.

RESULTS

Research Electronic Data Capture was selected as the foundational platform. Deliverables included modular UDS version 4 instruments, embedded logic and automated quality checks, dynamic training resources, and an API-based submission pipeline to NACC. The platform was adopted across all 36 ADRCs and surveys indicated high user satisfaction.

DISCUSSION

Beyond infrastructure, this initiative provides a scalable, stakeholder-driven implementation model that supports higher-quality, more timely multicenter data submission, accelerating biomarker validation, early detection studies, and precision-medicine analyses.

Highlights
  • A cross-disciplinary workgroup of ADRC and NACC members designed a stakeholder-centric sociotechnical implementation model.
  • The workgroup drove the adoption of a modernized data infrastructure across a national consortium.
  • Deployed a modern electronic data capture and submission system for the ADRC program.
  • Leveraged REDCap as a flexible, scalable tool for a large-scale EDCS system.

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

✪ Optimizing healthcare for blood donors at risk of transfusion-transmissible infections: pre-implementation mixed methods protocol

Authors:

Juan Macalupu, Elsa González-Lagos, Sarah Gimbel, & Eduardo Gotuzzo

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: August 2025

Read the full text in the open access journal Global Health Action

Abstract:

In the Peruvian Amazon, a significant proportion of replacement blood donors test reactive for HIV, HTLV-1/2, and other transfusion-transmissible infections but often receive no subsequent care. Optimizing healthcare for these individuals can mitigate adverse outcomes by enabling early diagnosis and management. Effective coordination between Blood Bank and Infectious Diseases services is essential to provide comprehensive care. To address this challenge, this study applies an Implementation Science approach to design and assess an innovation that enhances healthcare for blood donors affected by transfusion-transmissible infections. A pre-implementation mixed methods study will be conducted at two hospitals in the Peruvian Amazon, employing the Consolidated Framework for Implementation Research (CFIR) and a systems engineering tool (mapping). The study will focus on the inner setting domain of CFIR and map the care continuum to identify contextual determinants that may influence implementation. It has three specific aims planned for the future: first, to use a convergent mixed methods approach to examine the care continuum of blood donors and the inner settings; second, to co-design an innovation through qualitative and participatory methods, integrating Blood Bank and Infectious Diseases services via the hospital information management system; and third, to evaluate the feasibility, appropriateness, and acceptability of the co-designed innovation through a pilot. Replacement blood donation and fragmented healthcare systems are common challenges in other low- and middle-income countries. The findings of this study can inform future implementation research and policy in similar settings.

Paper context

Main findings: This study will co-design and pilot an innovation to improve how blood donors at risk of transfusion-transmissible infections receive screening results, confirmatory testing, and care, by integrating Blood Bank and Infectious Diseases services through digital tools.

Added knowledge: This study employs a participatory, mixed-methods implementation science approach to systematically assess and address gaps in blood donor healthcare, providing a scalable methodology while ensuring context-specific, actionable interventions for resource-limited settings.

Global health impact for policy and action: This study will drive digital innovations in blood donor healthcare to strengthen blood safety and infectious disease control, while framing a pragmatic, adaptable approach for integrating fragmented healthcare systems in resource-limited settings.

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

✪ Evaluating behavioral intervention technologies: Integrating human-centered design and implementation science outcomes

Authors:

Shumenghui Zhai, Weichao Yuwen, Tiffany L. Zyniewicz, Jennifer Sonney, Jonika Hash, Maida Chen, & Teresa M Ward

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: June 2025

Read the full text in the open access journal Digital Health

Abstract:

Background

Behavioral intervention technologies (BITs) offer scalable, cost-effective healthcare solutions but often show reduced impacts in community settings and are rarely sustained. Human-centered design (HCD) enhances usability by tailoring BITs to stakeholder needs, while implementation science (IS) identifies contextual barriers and strategies to promote uptake and sustainability. Both HCD and IS aim to improve BIT usability and implementation through iterative, user-focused processes but are rarely integrated.

Objective

We introduced the user-centered and sustainable implementation science (USIS) model, a novel and systematic framework that combines HCD and IS principles to enhance BIT effectiveness and sustainability. We aimed to (1) synthesize the HCD and IS outcomes and integrate them into a USIS framework; (2) apply USIS to a case study: the sleep shared-management intervention for children with juvenile idiopathic arthritis and their parents (SLEEPSMART).

Methods

We conducted a narrative literature review on HCD and IS outcomes for BITs from the PubMed, CINAHL, and Web of Science databases. Articles were selected based on their focus on usability, implementation outcomes, and evidence-based healthcare practices. This synthesis informed the development of the USIS model.

Results

The USIS model incorporates five domains: (1) user-centeredness (empathy, engagement, and equity), (2) efficiency (cost, timeliness, and rapidity), (3) feasibility (learnability, memorability, error reduction, and low cognitive load), (4) satisfaction (acceptability and appropriateness), and (5) fidelity (adoption, penetration, and sustainability). We applied the USIS model to evaluate the SLEEPSMART project to demonstrate the application of the USIS model in guiding BIT design and refinement. Insights from the review informed the design principles applied during the development and testing stages of SLEEPSMART.

Conclusion

The USIS model serves as a practical and theoretical guide to improve BIT design and evaluation. By emphasizing implementation considerations early and centering user needs, USIS provides a pathway to bridge HCD and IS approaches to enhance the real-world impact and sustainability of digital health innovations.

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

✪ Advancing implementation of single session interventions in schools: a protocol for a qualitative study

Authors:

Katherine A. Cohen, Eric Bruns, Aaron Lyon, Tali Raviv, Sara Becker & Jessica L. Schleider

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: May 2025

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

Abstract:

Background

Schools are one of the most common settings in which youth seek mental health services, yet existing school-based mental health interventions are often difficult to implement due to time, cost, and staffing limitations. Digital, self-administered Single Session Interventions (SSIs) are evidence-based supports that are intentionally structured to deliver a clinically-meaningful dosage of evidence-based content within one session. Although multiple studies have demonstrated the clinical effectiveness of school-based SSIs, there have been no systemic efforts to understand how SSIs can be practically implemented in schools. The goal of this project is to partner with students, parents, and school staff to identify factors that impact the implementation of SSIs and understand how SSIs can be sustainably integrated as mental health supports into school mental health infrastructure.

Methods

We will conduct focus groups (five groups, total n = 35–45) among community members (i.e., students, parents/caregivers, teachers, school administrators, and school mental health providers) to assess perceived facilitators and barriers to the effective implementation of evidence-based SSIs in schools (Aim 1). We will then work in partnership with community members (n = 10–15) to co-design multi-level implementation strategies (i.e., student-directed, staff-directed, system-directed) for increasing uptake and promoting sustainability of school-based SSIs (Aim 2). We will use inductive coding to thematically analyze qualitative data from group sessions. This study is being conducted within the Lake Washington School District in the Seattle, Washington region.

Discussion

The proposed project will be the first to investigate facilitators and barriers to real-world implementation of SSIs in schools and strategies to improve implementation. Future studies may test the effectiveness of the generated implementation strategies on outcomes such as SSI uptake over time.

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

✪ School-Partnered Collaborative Care (SPACE) for Pediatric Type 1 Diabetes: Development and Usability Study of a Virtual Intervention With Multisystem Community Partners

Authors:

Christine A March, Elissa Naame, Ingrid Libman, Chelsea N Proulx, Linda Siminerio, Elizabeth Miller, & Aaron R Lyon

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: March 2025

Read the full text in the open access journal JMIR Diabetes

Abstract:

Background

School-partnered interventions may improve health outcomes for children with type 1 diabetes, though there is limited evidence to support their effectiveness and sustainability. Family, school, or health system factors may interfere with intervention usability and implementation.

Objective

To identify and address potential implementation barriers during intervention development, we combined methods in user-centered design and implementation science to adapt an evidence-based psychosocial intervention, the collaborative care model, to a virtual school-partnered collaborative care (SPACE) model for type 1 diabetes between schools and diabetes medical teams.

Methods

We recruited patient, family, school, and health system partners (n=20) to cocreate SPACE through iterative, web-based design sessions using a digital whiteboard (phase 1). User-centered design methods included independent and group activities for idea generation, visual voting, and structured critique of the evolving SPACE prototype. In phase 2, the prototype was evaluated with the usability evaluation for evidence-based psychosocial interventions methods. School nurses reviewed the prototype and tasks in cognitive walkthroughs and completed the Intervention Usability Scale (IUS). Two members of the research team independently identified and prioritized (1-3 rating) discrete usability concerns. We evaluated the relationship between prioritization and the percentage of nurses reporting each usability issue with Spearman correlation. Differences in IUS scores by school nurse characteristics were assessed with ANOVA.

Results

In the design phase, the partners generated over 90 unique ideas for SPACE, prioritizing elements pertaining to intervention adaptability, team-based communication, and multidimensional outcome tracking. Following three iterations of prototype development, cognitive walkthroughs were completed with 10 school nurses (n=10, 100% female; mean age 48.5, SD 9.5 years) representing different districts and years of experience. Nurses identified 16 discrete usability issues (each reported by 10%-60% of participants). Two issues receiving the highest priority (3.0): ability to access a virtual platform (n=3, 30% of participants) and data-sharing mechanisms between nurses and providers (n=6, 60% of participants). There was a moderate correlation between priority rating and the percentage of nurses reporting each issue (ρ=0.63; P=.01). Average IUS ratings (77.8, SD 11.1; 100-point scale) indicated appropriate usability. There was no difference in IUS ratings by school nurse experience (P=.54), student caseload (P=.12), number of schools covered (P=.90), or prior experience with type 1 diabetes (P=.83), suggesting that other factors may influence usability. The design team recommended strategies for SPACE implementation to overcome high-priority issues, including training users on videoconferencing applications, establishing secure forms for school data reporting, and sharing glucose data in real-time during SPACE meetings.

Conclusions

Cross-sector interventions are complex, and perceived usability is a potential barrier to implementation. Using web-based cocreation methods with community partners promoted high-quality intervention design that is aligned with end-user priorities. Quantitative and qualitative assessments indicated appropriate degree of usability to move forward with pilot-testing.

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

✪ Human-Centered Design of an mHealth Tool for Optimizing HIV Index Testing in Wartime Ukraine: Formative Research Case Study

Authors:

Nancy Puttkammer, Elizabeth Dunbar, Myroslava Germanovych, Mariia Rosol, Matthew Golden, Anna Hubashova, Vladyslav Fedorchenko, Larisa Hetman, Liudmyla Legkostup, Jan Flowers, and Olena Nesterova

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: January 2025

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

Abstract:

Background

Assisted partner services (APSs; sometimes called index testing) are now being brought to scale as a high-yield HIV testing strategy in many nations. However, the success of APSs is often hampered by low levels of partner elicitation. The Computer-Assisted Self-Interview (CASI)–Plus study sought to develop and test a mobile health (mHealth) tool to increase the elicitation of sexual and needle-sharing partners among persons with newly diagnosed HIV. CASI-Plus provides client-facing information on APS methods and uses a standardized, self-guided questionnaire with nonjudgmental language for clients to list partners who would benefit from HIV testing. The tool also enables health care workers (HCWs) to see summarized data to facilitate partner tracking.

Objective

The formative research phase of the CASI-Plus study aimed to gather client and HCW input on the design of the CASI-Plus tool to ensure its acceptability, feasibility, and usability.

Methods

This study gathered input to prioritize features and tested the usability of CASI-Plus with HCWs and clients receiving HIV services in public health clinics in wartime Ukraine. The CASI-Plus study’s formative phase, carried out from May 2023 to July 2024, adapted human-centered design (HCD) methods grounded in principles of empathy, iteration, and creative ideation. The study involved 3 steps: formative HCD, including in-depth individual interviews with clients, such as men who have sex with men and people who inject drugs, and internet-based design workshops with HCWs from rural and urban HIV clinics in Chernihiv and Dnipro; software platform assessment and heuristic evaluation, including assessment of open-source mHealth platforms against CASI-Plus requirements, prototype development, and testing of the REDCap (Research Electronic Data Capture) prototype based on usability heuristics; and usability walk-throughs, including simulated cases with HCWs and clients.

Results:

The formative phase of the CASI-Plus study included in-depth individual interviews with 10 clients and 3 workshops with 22 HCWs. This study demonstrated how simplified HCD methods, adapted to the wartime context, gathered rich input on prioritized features and tool design. The CASI-Plus design reflected features that are both culturally sensitive and in alignment with the constraints of Ukraine’s wartime setting. Prioritized features included information about the benefits of HIV index testing; a nonjudgmental, self-guided questionnaire to report partners; client stories; and bright images to accompany the text. Two-way SMS text messaging between clients and HCWs was deemed impractical based on risks of privacy breaches, national patient privacy regulations, and HCW workload./p>

Conclusions

It was feasible to conduct HCD research in Ukraine in a wartime setting. The CASI-Plus mHealth tool was acceptable to both HCWs and clients. The next step for this research is a randomized clinical trial of the effect of the REDCap-based CASI-Plus tool on the number of partners named and the rate of partners completing HIV testing.

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

✪ 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**

✪ Applying the Cognitive Walkthrough for Implementation Strategies methodology to inform the redesign of a selection-quality implementation toolkit for use in schools

Authors:

Kelsey S. Dickson, Olivia G. Michael, Amy Drahota, Aksheya Sridhar, Jessica E. Tschida, & Jill Locke

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: November 2024

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

Abstract:

Background

Implementation strategies are key to enhancing the translation of new innovations but there is a need to systematically design and tailor strategies to match the targeted implementation context and address determinants. There are increasing methods to inform the development and tailoring of implementation strategies to maximize their usability, feasibility, and appropriateness in new settings such as the Cognitive Walkthrough for Implementation Strategies (CWIS) approach. The aim of the current project is to apply the CWIS approach to inform the redesign of a multifaceted selection-quality implementation toolkit entitled Adoption of Curricular supports Toolkit: Systematic Measurement of Appropriateness and Readiness for Translation in Schools (ACT SMARTS) for use in middle and high schools.

Methods

We systematically applied CWIS as the second part of a community-partnered iterative redesign of ACT SMARTS for schools to evaluate the usability and inform further toolkit redesign areas. We conducted three CWIS user testing sessions with key end users of school district administrators (n = 3), school principals (n = 6), and educators (n = 6).

Results

Our CWIS application revealed that end users found ACT SMARTS acceptable and relevant but anticipate usability issues engaging in the ACT SMARTS process. Results informed the identification of eleven usability issues and corresponding redesign solutions to enhance the usability of ACT SMARTS for use in middle and high schools.

Conclusions

Results indicated the utility of CWIS in assessing implementation strategy usability in service of informing strategy modification as part of our broader redesign to improve alignment with end user, end recipient, and setting needs. Recommendations regarding the use of this participatory approach are discussed.

Contributions to the literature

  • The current case study adds to the nascent literature applying the Cognitive Walkthrough for Implementation Strategies (CWIS) method as part of a larger implementation project, including one of the first independent applications outside of the CWIS method developers.
  • The current case study illustrates the impact and utility of the CWIS method for designing and tailoring implementation strategies.
  • This case study provides further guidance and recommendations for the application of CWIS to future implementation projects.

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

Employing user-centered design to develop a remote technology kit for studying young children’s social communication skills

Authors:

Marisa Petruccelli, Mya Howard, Andres Morelos, Allison Wainer, Sarabeth Broder-Fingert, Brooke Ingersoll, Wendy L Stone & Alice S Carter

University of Washington affiliated authors are displayed in bold.

Subscription Required for Full Text Access

Published: August 2024

Read the full text in the subscription access journal Journal of Pediatric Psychology