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✪ 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**

✪ Looking under the hood of a hybrid two-way texting intervention to improve early retention on antiretroviral therapy in Malawi: an implementation fidelity evaluation

Authors:

Robin E. Klabbers, Caryl Feldacker, Jacqueline Huwa, Christine Kiruthu-Kamamia, Agness Thawani, & Hannock Tweya

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: Janurary 2025

Read the full text in the open access journal Implementation Science

Abstract:

Background

While key to interpreting findings and assessing generalizability, implementation fidelity is underreported in mobile health (mHealth) literature. We evaluated implementation fidelity of an opt-in, hybrid, two-way texting (2wT) intervention previously demonstrated to improve 12-month retention on antiretroviral therapy (ART) among people living with HIV (PLHIV) in a quasi-experimental study in Lilongwe, Malawi.

Methods

Short message service (SMS) data and ART refill visit records were used to evaluate adherence to 2wT content, frequency and duration through the lens of the Conceptual Framework for Implementation Fidelity. Message delivery and 2wT participant interactions were considered across four core 2wT components: 1) weekly motivational SMS messages; 2) proactive SMS appointment reminders; 3) SMS reminders after missed appointments; and 4) interactive messaging with 2wT staff about transfers and appointment rescheduling. Using mixed-effects logistic regression models adjusted for participant demographics, we examined the effect of core 2wT component fidelity on a) on-time appointment attendance and b) timely return to care after a missed appointment, presenting adjusted odds ratios (aORs) and 95% confidence intervals (CIs).

Results

The 468 2wT participants had a median of 52 study weeks (interquartile range [IQR] 34 – 52) with 6 ART appointments (IQR 4—7) of which 2 (IQR 1 – 3) were missed. On average, participants received a motivation message for 75% (IQR 56%—83%) of enrolled weeks, a reminder before 83% (IQR 67%—100%) of appointments, and after 67% (IQR 0%—100%) of missed appointments. Participants reported 9 transfers and rescheduled 46 appointments through 2wT prompts; 196 appointments were changed via unprompted interaction. Participants with 10% higher expected motivation message delivery were more likely to attend clinic appointments on time (aOR: 1.08; 95%CI: 1.01 – 1.16, p = 0.03). Receiving and responding to an appointment reminder in any way were also associated with increased on-time appointment attendance (aOR: 1.35; 95%CI: 1.03 – 1.79, p = 0.03 and aOR: 1.47, 95%CI: 1.16 – 1.87, p = 0.001, respectively). No associations were found for 2wT messages and timely return to care following a missed appointment.

Conclusion

Greater 2wT implementation fidelity was associated with improved care outcomes. Although implementation fidelity monitoring of mHealth interventions is complex, it should be integrated into study design.

Contributions to the literature
  • Despite the recognized importance of implementation fidelity in digital health research, few studies evaluate and transparently report the extent to which mHealth interventions were implemented as intended.
  • This study presents a framework-based evaluation of the implementation fidelity of a two-way texting intervention for HIV retention in a routine care setting in Malawi. Findings demonstrate how fidelity assessment not only facilitates replication of findings and generalizability assessment, but uncovers implementation challenges and generates hypotheses about intervention mechanisms of action.
  • The benefits and complexity of implementation fidelity evaluation underscore the need to consider fidelity early and integrate monitoring mechanisms into study design.

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

✪ Healthcare provider perspectives on integrating HIV care into cancer centers in Malawi, South Africa, Uganda, and Zimbabwe

Authors:

Michalina A Montaño, Alfred Jatho, Cecilia Nassolo, Noleb Mugisha, Agatha Bula, Maganizo B Chagomerana, Margaret Borok, Takudzwa J Mtisi, Maureen Joffe, Rachel A. Bender Ignacio, and Ntokozo Ndlovu

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: January 2025

Read the full text open access in the journal Translational Oncology

Abstract:

Background

In East and Southern Africa, treatment of people with concomitant cancer and HIV is complicated by siloed service delivery pathways, which exacerbate barriers to care and impact clinical decision-making. Integrating HIV care into cancer treatment centers may improve service delivery and overall patient outcomes.

Methods

We administered a questionnaire to clinicians and support staff at tertiary cancer referral centers in Malawi, Zimbabwe, Uganda, and South Africa to assess level of concern about clinical management of people with HIV (PWH) and cancer, barriers to integrating HIV service delivery into cancer treatment delivery, and beliefs related to HIV, antiretroviral therapy (ART), and integrated care.

Results

Of 195 clinician and support staff participants, 165 (85 %) were direct providers of cancer-associated care. Over 50 % indicated that they held concerns about survival, treatment complications, co-morbidities, and drug-drug interactions in PWH compared to patients without HIV. Over 80 % agreed that knowing cancer patients’ HIV status, ART status, and ART regimen would facilitate better care and should be considered in cancer care decision-making. Overall, respondents were optimistic that HIV-related care could be easily integrated into cancer care provision. The most-frequently endorsed barriers to integrated care were workspace limitations, disruptions to workflow, availability of staff, and cost to the hospital and to patients.

Conclusions

Cancer clinicians and support staff report overall positive attitudes toward integrating HIV and cancer service delivery. Research to elucidate service delivery pathways and contextualize system-based barriers to integrating care are critical next steps to optimize linked HIV and cancer care delivery.

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

✪ Training and Support Practices and Insights in the Sustainability of mHealth Implementations in Sub-Saharan Africa

Authors:

Diana Babirye & Richard Anderson

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: January 2025

Read the full text in the open access ACM Journal on Computing and Sustainable Societies

Abstract:

We conducted an interview-based study to understand the training and support practices and insights that influence sustainable implementations of mHealth projects of varying mHealth technologies. The qualitative assessment was inspired by the Consolidated Framework for Implementation Research adapted with the recommended questions for guiding the implementation of training programs. Participants in the study (N = 16) were both international and in-country researchers managing projects in sub-Saharan Africa. We chose to focus on training and support, as it is often the interface between international and in-country components of these projects. Participants agreed on the central role of training in the implementation of mHealth projects and are following best practices. There was often a division in the responsibility of training between international and in-country researchers reflecting the distinction between project management and local implementation adaptions. One of the main findings is the importance of individualized continuous retraining to make deployments robust with respect to changing conditions with technology and personnel, an aspect that has been managed a bit differently with varying mHealth technologies as presented in this article.

**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**

✪ Study protocol for a hybrid type 3 effectiveness-implementation trial of a team-based implementation strategy to support educators’ use of a social engagement intervention

Authors:

Jill Locke, Aksheya Sridhar, Wendy Shih, Stephanie Shire, Andria B. Eisman, Emily Kim, Adora Du, Christine Espeland, & Connie Kasari

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: January 2025

Read the full text in the open access journal Implementation Science

Abstract:

Background

Remaking Recess (RR) is a school-based evidence-based peer social engagement intervention for autistic students. RR involves direct training and coaching with educators; however, educators face several barriers to implementation at both the individual- and organizational-levels. This protocol paper describes a multi-site study that will test whether an educator-level implementation strategy, coaching, with or without a school-level implementation strategy, school-based teams, will maximize educators’ use (fidelity and sustainment) of RR for autistic students and their peers who are socially-isolated, rejected, or peripheral and may need additional support during recess.

Methods

This study will employ a hybrid type-3 effectiveness-implementation trial. Fifty-five elementary schools will be recruited as well as 121 educators (e.g., classroom assistants, aides), 55 general and special educator teachers, and 83–138 other school personnel (e.g., administrators). Additionally, at least 118 autistic students and allistic or non-autistic classmates will be recruited as RR recipients. Participants will complete baseline assessments at the beginning of the year, and all schools will be provided RR training. Schools will be randomized to coaching with or without school-based teams. This study will measure RR fidelity (primary outcome), RR sustainment, as well as peer engagement, social network inclusion, and social skills (secondary outcomes). It is expected that coaching with school-based teams will improve both RR fidelity and social network inclusion, while coaching with and without school-based teams will result in improved peer engagement and social skills.

Discussion

Previous research has documented barriers to RR implementation at both the individual- (provider) and organization-level (school). Using multi-level implementation strategies such as coaching with school-based teams may address these barriers and support RR implementation in schools. Findings from this study may guide future efforts to scale up tailored implementation strategies for use in public school districts, with the ultimate goal of increasing intervention access and improving student outcomes.

Trial registration

Name of the Registry: clinicaltrials.gov.
Trial Registration: Clinical Trials ID: NCT06559267.
Date of Registration: August 15, 2024. Prospectively registered.

Contributions to the literature

Remaking Recess (RR) is an intervention that improves peer engagement and classroom inclusion in autistic students. Educators, who play an important role in supporting autistic youth and their peers who are socially-isolated, rejected, or peripheral during the school day and at recess, can deliver RR.
Schools face many challenges, at both the individual- (i.e., educator) and organizational-levels (i.e., school), when implementing new interventions.
This study will evaluate the impact of two implementation strategies on the fidelity and sustainment of RR: (a) individual direct coaching for educators (coaching), and (b) supporting a team of school personnel (school-based teams) in addition to coaching.

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

✪ Implementation research logic model in the design and execution of eHealth innovations for maternal and newborn healthcare in Ethiopia

Authors:

Dabere Nigatu, Muluken Azage, Eyaya Misgan, Daniel A. Enquobahrie, Tegegn Kebebaw, Enyew Abate, Esubalew Alemneh, Mirkuzie Woldie & Tsinuel Girma

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: January 2025

Read the full text open access in the journal Health Research Policy and Systems

Abstract:

Background

The use of eHealth innovations is becoming increasingly important in improving health outcomes, especially for maternal and newborn health. However, planning and executing these innovations can be challenging due to their complex nature. To provide guidance and clarity on implementation approaches, researchers need to use implementation research (IR) tools. We conducted IR to recognize the challenges in implementing eHealth innovations in the context of maternal and newborn healthcare using the implementation research logic model (IRLM). Therefore, this paper aims to describe the practical application of IRLM to design, execute and evaluate eHealth innovations that improve maternal and newborn care in public facilities in Ethiopia.

Methods

We employed rapid review, formative assessment and process evaluation of an eHealth innovation in selected healthcare facilities serving maternal and newborn care. The eHealth innovation we developed and deployed was named ‘ADHERE’ (Antenatal Care, ChilDbirtH CarE and Postnatal CaRE), representing the continuum of maternal care. The rapid review was conducted as an initial step using the Consolidated Framework for Implementation Research (CFIR). We employed a mix of data collection methods: interview/discussion, eHealth system or document review and direct observation. Furthermore, we executed various stakeholder engagement activities: two co-creation workshops and on-site iterative discussions. We applied the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS) to capture ongoing implementation learnings.

Results

We developed IRLM of the eHealth innovation implementation for three contexts: urban, peri-urban and remote public healthcare facilities. The model depicted the mechanism of interaction between implementation determinants and implementation strategies to produce the intended implementation outcomes. The IRLM helped to identify more than 35 implementation barriers or facilitators for eHealth interventions and to develop over 17 mitigation strategies for the study contexts. The initial IRLM was refined through ongoing implementation learnings and the mitigation strategies that were executed.

Conclusions

The IRLM is a comprehensive and effective guiding tool for the development, implementation and evaluation of innovations in various low- and middle-income contexts. Researchers and implementing partners should adapt and use it.

**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

✪ A Team Coaching Intervention for Dementia Care: Acceptability and Feasibility Study in Care Communities

Authors:

Jessica Welsch, Boeun Kim, Lorna Prophater, Basia Belza, & Sam Fazio

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: December 2024

Read the full text open access in the Journal of the American Medical Directors Association

Abstract:

Objectives

In 2018, the Alzheimer's Association published the Dementia Care Practice Recommendations (DCPR) to provide guidance on quality care for professionals. This study aimed to examine the feasibility and acceptability of a consultative coaching program to increase adoption of the DCPR.

Design

A single-group pre-post design was employed. A 6-month team coaching intervention was implemented to make organization-wide and measurable changes in the areas of (1) policies and procedures, (2) education and training, or (3) care practices to increase person-centered care practices.

Setting and Participants

A total of 36 care communities in Washington and Montana states were enrolled in this program.

Methods

Focus groups were conducted with participants to explore the acceptability and feasibility of the program. A 35-item employees satisfaction survey was administered both before and after the program.

Results

The findings offer preliminary evidence that implementing a coaching program is desired by care community staff and has a positive impact on staff job satisfaction and the use of person-centered care. The coaching model was received by staff as a supportive and affirming program.

Conclusions and Implications

The team coaching intervention, designed to improve person-centered care and employee satisfaction, is acceptable. However, its efficacy needs to be tested with a larger sample using a randomized controlled design.

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

✪ Organization Theory for Implementation Science (OTIS): Reflections and recommendations

Authors:

Sarah A Birken, Jure Baloh, Michelle C Kegler, Terry T-K Huang, Matthew Lee, Prajakta Adsul, Grace Ryan, Alexandra Peluso, Cheyenne Wagi, Aliza Randazzo, Megan A Mullins, Kristin E Morrill, & Linda K Ko

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: December 2024

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

Abstract:

Organizations exert influence on the implementation of evidence-based practices and other innovations that are independent of the influence of organizations' individual constituents. Despite their influence, nuanced explanations of organizations' influence remain limited in implementation science. Organization theories are uniquely suited to offer insights and explain organizational influences on implementation. In this paper, we describe the efforts of the Cancer Prevention and Control Research Network's (CPCRN) Organization Theory for Implementation Science (OTIS) workgroup to equip implementation scientists with theory-guided understanding of organizational influences on implementation. We provide a set of recommendations for future efforts to enhance implementation through the use of organization theories and OTIS tools.

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