UW First Author Archives - Page 4 of 23 - Implementation Science at UW

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

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**}

✪ Not getting better but not getting worse: A cluster randomized controlled pilot trial of a leadership implementation strategy

Abstract:

Background

Implementation of evidence-based practices (EBPs) in schools is fraught with challenges. Even when EBPs are initiated, deterioration of implementation efforts often hinders their long-term success. School leadership behaviors can influence teachers’ EBP implementation. Our study tested an implementation strategy called Helping Educational Leaders Mobilize Evidence (HELM), adapted from the Leadership and Organizational Change for Implementation strategy, to enhance EBP implementation through improvements in school leadership teams’ implementation leadership and climate to buffer against the deterioration of implementation efforts. This study explores the impact of HELM on theorized mechanisms of change (i.e., implementation leadership, climate), educator-level factors (i.e., implementation citizenship), and implementation outcomes (i.e., fidelity, initiative stability).

Method

One school district and 10 schools in Washington participated. Five of the schools were randomized to receive the HELM strategy and the remaining five schools received an alternative leadership training as an implementation attention control. Teachers at every school (n = 341) received training for an EBP called Positive Greetings at the Door that has been previously demonstrated to reduce student behavior problems. Principals and Assistant Principals (n = 18) received the HELM strategy or alternative leadership training. Three district Administrators also participated in HELM as part of the Organizational Strategy Development meetings.

Results

HELM significantly slowed the average decline of implementation leadership (perseverant leadership and communication), three dimensions of implementation climate (recognition, rewards, and existing supports) and total implementation climate, and one dimension of implementation citizenship (keeping informed). No significant effects were found with regard to implementation outcomes (i.e., fidelity, initiative stability).

Conclusions

HELM shows promise in buffering the deterioration of EBP implementation efforts in schools. HELM positively influenced implementation leadership and climate, which are the hypothesized mechanisms for promoting successful long-term implementation efforts. An appropriately powered trial is needed to determine the efficacy of HELM in the future.

Trial Registration Information

Name of the registry: clinicaltrials.gov
Trial registration number: NCT06340074
Date of registration: March 29, 2024. Retrospectively registered
URL of trial registry record: https://clinicaltrials.gov/study/NCT06340074?intr=helm&rank=

Plain Language Summary

Using practices that have been proven to work in research to support youth social, emotional, and behavioral well-being in schools is hard. Efforts to use these practices decrease across the school year. School leadership behaviors can influence educators’ use of these practices. Our study tested an implementation strategy or support designed to help educators use a research-backed practice called Helping Educational Leaders Mobilize Evidence (HELM). HELM was adapted from the Leadership and Organizational Change for Implementation (LOCI) strategy, to enhance school leadership teams’ specific leadership behaviors to protect against the decline in implementation effort. This study explores the impact of HELM on outcomes related to practice use. One school district and 10 schools in western Washington State participated. Five of the schools received the HELM strategy and the remaining five schools received an alternative leadership training. Teachers at every school (n = 341) received training in a practice called Positive Greetings at the Door (PGD) that has been shown to reduce student behavior problems. Principals and Assistant Principals (n = 18) received the HELM strategy or alternative leadership training. Three district administrators also participated in HELM. HELM unexpectedly slowed the average decline of implementation leadership (perseverant leadership and communication), three dimensions of implementation climate (recognition, rewards, and existing supports), total implementation climate, and one dimension of implementation citizenship (keeping informed). No significant effects were found with regard to use of the practice. The HELM strategy shows promise in slowing the deterioration of practice in schools and positively influenced implementation leadership behaviors.

^{**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**}

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

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

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**}

Design of a pragmatic trial integrating human papillomavirus (HPV) self-sampling into primary care to reduce cervical cancer screening disparities in Somali American individuals: The Isbaar project

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

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

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**}

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

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

Authors:

✪ Open Access

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

Abstract:

Background

Objective

Methods

Results:

Conclusions

Authors:

✪ Open Access

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

Abstract:

Background

Method

Results

Conclusions

Trial Registration Information

Plain Language Summary

Authors:

✪ Open Access

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

Abstract:

Background

Objective

Methods

Results

Conclusions

International Registered Report Identifier (IRRID)

Authors:

✪ Open Access

Read the full text in the open access journal Implementation Science

Abstract:

Background

Methods

Results

Conclusion

Contributions to the literature

Authors:

✪ Open Access

Read the full text open access in the journal Translational Oncology

Abstract:

Background

Methods

Results

Conclusions

Authors:

Subscription Required for Full Text Access

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

Authors:

✪ Open Access

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

Abstract:

Authors:

✪ Open Access

Read the full text in the open access journal Implementation Science

Abstract:

Background

Methods

Discussion

Trial registration

Contributions to the literature

Authors:

✪ Open Access

Read the full text in the open access journal Implementation Science

Abstract:

Background

Methods

Discussion

Trial registration

Contributions to the literature

Authors:

Subscription Required for Full Text Access

Read the full text in the subscription access journal Annual Review of Public Health