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✪ Feasibility and Implementation of INTERVAL-GAP4: A Global Randomised Controlled Trial of Intense Hybrid-supervised/Self-managed Versus Self-directed Exercise for Metastatic Prostate Cancer

Authors:

Stacey A Kenfield, Nicolas H Hart, Kerry S Courneya, Rosemary Greenwood , June M Chan, Jennette Sison, Li Zhang, Sarah RudmaN, Leah Ung, Moritz Schumann, Erin L Van Blarigan, Sam McKeown, Charles J Ryan, James Catto, Daniel A Galvão, Robert U Newton, Fred Saad; INTERVAL-GAP4 Site Investigators and INTERVAL-GAP4 Steering and Management Committees (Stephen R. Plymate, Committee Member

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: December 2025

Read the full text in the open access journal European Urology Open Science

Abstract:

Background and objective

Physical activity is associated with a lower risk of mortality in men with prostate cancer (PC); yet, randomised controlled trials with survival endpoints are nonexistent. INTense ExeRcise for surviVAL-Global Action Plan 4 (INTERVAL-GAP4) was a global phase 3 trial designed to test whether structured, hybrid-supervised/self-managed exercise improves survival in men with metastatic PC. The trial was stopped early due to poor accrual. This paper reports feasibility and implementation outcomes.

Methods

Men with metastatic PC were randomised (1:1) to a supervised/self-managed moderate- to high-intensity resistance and aerobic programme (three sessions per week for 2 yr) or to self-directed exercise. We evaluated site activation, recruitment, year 1 adherence, adverse events, and barriers to global trial feasibility. Efficacy outcomes—including survival, physical fitness, and biomarker results—will be reported separately.

Key findings and limitations

Of 21 activated sites across seven countries, 13 (62%) randomised patients. Of 938 patients approached, 232 (25%) consented and 145 (15%) were randomised (75 in the intervention and 70 in the control group) between April 2016 and February 2023. The median age was 70 yr (range: 44–89 yr). The study closed early after reaching 17% of the intended target. The median adherence in the intervention arm was 84% (interquartile range: 61–95%), with no difference between metastatic castrate-resistant and hormone-sensitive PC. At 12 mo, 58% of intervention participants met exercise guidelines versus 24% of controls. In year 1, 162 adverse events occurred in the intervention group and 109 in the control group; 19 adverse events were study related, all in the intervention arm. The major feasibility challenges included administrative burden, infrastructure limitations, logistics of supervised exercise delivery, and coronavirus disease 2019 disruptions.

Conclusions and clinical implications

While high adherence to a demanding exercise programme was achieved in selected metastatic PC patients, global recruitment proved difficult. Future large-scale exercise-oncology trials require streamlined protocols, realistic timelines, and greater alignment with site resources. Implementation science research is needed to support integration of exercise into routine advanced cancer care. A forthcoming paper will present the trial’s survival and physical fitness efficacy outcomes.

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

✪ HIV Prevention for People Releasing from Incarceration: A Qualitative Pre-implementation Study

Authors:

Emily Callen, Susan M. Graham, Winter Forsyth, Nicola R. Gerbino, Zoë Senter, Brett Hauber, Bryan J. Weiner, Courtney Bagdon-Cox & Helen E. Jack

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: December 2025

Read the full text in the open access journal Journal of General Internal Medicine

Abstract:

Background

Release from prison or jail is a high-risk time for HIV acquisition, yet prior efforts to expand access to pre-exposure prophylaxis (PrEP) and other HIV prevention services for people releasing from jail or prison have faced substantial implementation barriers.

Objective

Characterize the implementation landscape for HIV prevention for people releasing from prison or jail in Washington State, gathering input from staff at carceral institutions and community-based organizations to inform implementation of evidence-based HIV prevention strategies.

Design

Qualitative study.

Participants

Healthcare and reentry staff in prisons and jails (n = 15) and staff at community-based organizations that may serve people releasing from jail or prison (n = 20), selected through chain referral sampling.

Approach

Semi-structured qualitative interviews were conducted to theoretical saturation, then coded using a mixed inductive-deductive approach, based on the Consolidated Framework for Implementation Research.

Key Results

Carceral institutions had few programs aimed specifically at HIV prevention. Carceral institutions had PrEP available but did not offer it widely, focusing on behavioral health or acute medical needs. Some community-based organizations offered PrEP or other forms of HIV prevention, but many focused on meeting basic needs or building community. Five themes characterized the implementation landscape for HIV prevention: 1) primacy of basic needs means HIV prevention is lower priority, 2) adding HIV prevention programming would require new funding, 3) differences in culture and philosophy influence interest in providing PrEP, 4) disconnection between carceral institutions and providers in the community limits linkage to care, 5) organizations balance protecting confidentiality while coordinating care.

Conclusion

Rather than directly focusing on HIV prevention, carceral institutions and community-based organizations often focused on substance use disorder treatment, and there are opportunities to integrate additional HIV prevention education and interventions into substance use care. Closer relationships between carceral institutions and community organizations may improve care coordination but would require staff capacity.

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

✪ Exploring implementation strategies in evidence-based open streets programs for promoting physical activity in the Americas: a scoping review

Authors:

Raúl D. Gierbolini-Rivera, Milena Franco Silva, Milena Franco Silva, Lorna Fabiola Pineda, Bryan J. Weiner, Byron J. Powell, Ross C. Brownson & Diana C. Parra

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: November 2025

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

Abstract:

Background

Chronic diseases are a leading public health concern in the Americas, and physical inactivity contributes significantly to their burden. Open streets program—community initiatives that temporarily close urban streets to vehicles—promote physical activity and community engagement, demonstrating positive health and social impacts. Effective implementation depends on identifying suitable strategies and frameworks. The Expert Recommendations for Implementing Change (ERIC) taxonomy, developed for clinical/healthcare contexts, has not been widely assessed for community-based interventions such as Open Streets. Implementation strategies could lead to specific outcomes (e.g., adoption, sustainability) that differ from program outcomes (e.g., PA levels, chronic disease prevalence). This scoping review focuses on the strategies that influence implementation outcomes. The primary aims of this review were to (1) identify implementation strategies for Open Streets programs and (2) identify opportunities for Open Streets programs to promote chronic disease prevention and physical activity, specifically in the Americas.

Methods

A scoping review was conducted using Joanna Briggs Institute methodology and PRISMA-ScR guidelines. Six databases (PubMed, Scopus, Scielo, Web of Science, TRIS, and LILACS) were searched for studies on Open Streets programs in the Americas (January 2004–April 2024). Three reviewers independently screened studies in Rayyan. Strategies were extracted and coded according to the 73 ERIC taxonomy strategies. Quality appraisal used MMAT for empirical studies, AMSTAR-2 for reviews, and AACODS for gray literature.

Results

Fifty-nine studies met the inclusion criteria, yielding 63 distinct implementation strategies for Open Streets programs. All 63 strategies were classified within the ERIC taxonomy. Frequently aligned ERIC strategies included building coalitions, capturing local knowledge, conducting needs assessments, and fostering stakeholder engagement. Open Streets strategies emphasized multisectoral collaboration, cultural adaptation, equity, and sustainability.

Discussion

Among the 63 identified Open Streets strategies, many aligned with ERIC, providing a foundation in stakeholder engagement, coalition building, and flexible, context-sensitive implementation. However, several ERIC strategies were not relevant to Open Streets, underscoring that while many ERIC strategies were applicable, not all suited this setting. Open Streets programs may require supplemental approaches to address equity, cultural competence, and multisectoral collaboration. Findings present opportunities to tailor, test, and scale strategies that maximize the population health impact of Open Streets and similar community-based programs.

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

✪ Protocol for the process evaluation of a randomised clinical trial of incremental-start versus conventional haemodialysis: the TwoPlus study

Authors:

Mariana Murea, Kristie L Foley, Samir C Gautam, Jennifer E Flythe , Jochen G Raimann, Emaad Abdel-Rahman, Alaa S Awad, Vandana Dua Niyyar, Cassandra Kovach, Glenda V Roberts, Nicole M Jefferson, Paul T Conway, Laura M Rosales, Jobira Woldemichael, Hiba I Sheikh, Gaurav Raman, Anne M Huml, Daphne H Knicely, Irtiza Hasan, Bhaktidevi Makadia , Janice Lea, John T Daugirdas, Nihan Gencerliler, Jasmin Divers, Peter Kotanko, TwoPlus Research Consortium & Ucheoma C Nwaozuru

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: November 2025

Read the full text in the open access journal BMJ Open

Abstract:

Introduction

Process evaluation provides insight into how interventions are delivered across varying contexts and why interventions work in some contexts and not in others. This manuscript outlines the protocol for a process evaluation embedded in a hybrid type 1 effectiveness-implementation randomised clinical trial of incremental-start haemodialysis (HD) versus conventional HD delivered to patients starting chronic dialysis (the TwoPlus Study). The trial will simultaneously assess the effectiveness of incremental-start HD in real-world settings and the implementation strategies needed to successfully integrate this intervention into routine practice. This manuscript describes the rationale and methods used to capture how incremental-start HD is implemented across settings and the factors influencing its implementation success or failure within this trial.

Methods and analysis

We will use the Consolidated Framework for Implementation Research (CFIR) and the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) frameworks to inform process evaluation. Mixed methods include surveys conducted with treating providers (physicians) and dialysis personnel (nurses and dialysis administrators); semi-structured interviews with patient participants, caregivers of patient participants, treating providers (physicians and advanced practice practitioners), dialysis personnel (nurses, dieticians and social workers); and focus group meetings with study investigators and stakeholder partners. Data will be collected on the following implementation determinants: (a) organisational readiness to change, intervention acceptability and appropriateness; (b) inner setting characteristics underlying barriers and facilitators to the adoption of HD intervention at the enrollment centres; (c) external factors that mediate implementation; (d) adoption; (e) reach; (f) fidelity, to assess adherence to serial timed urine collection and HD treatment schedule; and (g) sustainability, to assess barriers and facilitators to maintaining intervention. Qualitative and quantitative data will be analysed iteratively and triangulated following a convergent parallel and pragmatic approach. Mixed methods analysis will use qualitative data to lend insight to quantitative findings. Process evaluation is important to understand factors influencing trial outcomes and identify potential contextual barriers and facilitators for the potential implementation of incremental-start HD into usual workflows in varied outpatient dialysis clinics and clinical practices. The process evaluation will help interpret and contextualise the trial clinical outcomes’ findings.

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

✪ Pilot randomized controlled trial to assess the effectiveness of a heat risk reduction decision support platform and barriers and facilitators of its implementation

Authors:

Jeremy Hess, Marci Burden, Tania M. Busch Isaksen, Kristie L. Ebi, Nicole A. Errett, Chelsea Gridley-Smith, C. Bradley Kramer, Clare McCarthy, Oma McLaughlin, Resham Patel, Anna Reed, Mary Hannah Smith, Stefan Wheat & Kenneth Sherr

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: November 2025

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

Abstract:

Background

Climate-sensitive hazards such as extreme heat are increasing in frequency and severity. Protecting population health requires hazard-specific risk assessment, selection of potential interventions, and support for intervention implementation. This process typically takes several years, constraining health adaptation to climate-sensitive hazards. The investigators have developed an online decision support platform, CHaRT, that links evidence-based, location-specific heat-health risk assessment with transparent analyses of risk drivers and evidence-based risk reduction guidance for use in local health departments (LHDs). CHaRT’s effectiveness in supporting delivery of effective health interventions has not been evaluated.

Methods

LHDs are the organizational unit being studied. In this pilot randomized controlled trial, LHDs from the conterminous US will be recruited in coordination with the National Association of City and County Health Officials (NACCHO). Thirty LHDs will be selected at random from interested participants. Fifteen will be randomized to receive the intervention, a facilitated engagement with CHaRT, and 15 will receive the control, a package with information on heat vulnerability assessment and potential interventions. Intervention and control packages will be delivered simultaneously. Facilitated engagement will include an introduction to the tool, user exploration of the tool, elective inclusion of site-specific data into the tool, follow-up sessions to address additional questions, and discussion with investigators regarding planning and implementation needs. Pre- and post-study surveys will be used to assess CHaRT’s effectiveness using the RE-AIM (Reach, Effectiveness, Acceptability, Implementation, Maintenance) framework and by comparing each site’s intentions to implement specific interventions. After the trial, barriers and facilitators of the CHaRT platform’s implementation will be assessed through key informant interviews with the intervention group and analyzed using the Consolidated Framework for Implementation Research (CFIR).

Discussion

This study will allow investigators to evaluate the public health impact of a decision support platform and to identify barriers and facilitators of its implementation. The results will guide future research into strategies for increasing public health adaptation to climate change at the speed and breadth required.

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

✪ Exploring Factors Across Levels Impacting Educators’ Selection of Evidence-Based Practices for Autistic Students

Authors:

Maria L. Hugh, Olivia G. Michael, Mahima M. Joshi, Alyssa M. Hernandez & Jill J. Locke

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: November 2025

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

Abstract:

Introduction

Front-line implementers report that selecting an evidence-based practice is the most challenging aspect of supporting Autistic students, which may contribute to the long-standing implementation gap. There is a need to understand educators’ (special education teachers’, general education teachers’, and paraeducators’) decision-making and determinants of their evidence-based practice (EBP) selection.

Method

This study aimed to identify educators’ decision-making factors, focusing on (a) information sources and (b) factors within the student, intervention, educator, and classroom levels. Eighty-one educators (general education teachers, special education teachers, and paraeducators) participated in semistructured interviews regarding their EBP selection for a specific student they served in inclusive classrooms.

Results

General and special education teachers cited EBP sources from their teacher preparation and colleagues with autism expertise, while paraeducators relied on existing classroom practices and guidance from other educators. EBP decision-making frequently revolved around student and intervention characteristics, focusing less on educator, environment, and resource determinants. Educators made individualized EBP decisions for each student, selecting EBPs that served all students. They also shared that their decision-making was most supported through collaboration, despite limited opportunity.

Conclusion

The study provides insights into key team members’ EBP selection for Autistic students to aid in the development of implementation supports.

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

✪ Increasing access without compromising quality: optimizing telemedicine care in pediatric rheumatology

Authors:

S Jones, M Toth, A B Liu, E M Morgan, J Leal, Y I Goh & K Hayward

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: November 2025

Read the full text in the open access journal Frontiers in Pediatrics

Abstract:

Juvenile idiopathic arthritis (JIA) is a chronic immune-mediated condition affecting approximately 1 in 1,000 children in the United States. Without appropriate treatment, JIA can lead to permanent disability, chronic pain, and impaired quality of life. Targeted treatment strategies have enabled some patients to achieve sustained inactive disease and improved outcomes. However, the ongoing workforce shortage of pediatric rheumatologists poses a barrier to accessing effective care for many patients and families. Telemedicine is a potential solution to improving access to care for patients who travel significant distances to obtain pediatric rheumatology healthcare. During the COVID-19 pandemic, telemedicine saw rapid adoption with exponential uptake in use during unprecedented circumstances and resulted in inconsistent implementation of this emerging healthcare modality. While virtual visits offer many benefits, they often fail in gathering critical data elements required for measuring and tracking health outcomes, engaging in data-driven shared decision making, population health management and secondary research. In response to these challenges, the Pediatric Rheumatology Care and Outcomes Improvement Network (PR-COIN) Digital Health Workgroup conducted a needs assessment among its members to identify opportunities and barriers for optimizing telemedicine visits for patients with JIA. Based on this assessment, potential interventions and instructional materials were developed and compiled into a “change package” to assist rheumatology teams in planning, implementing and evaluating improvements to telemedicine visits at their centers. This change package is publicly available on the PR-COIN website for adoption and use (https://www.pr-coin.org/center-tools-resources). Continuous evaluation and adaptation of these tools are essential as telemedicine practices continue to evolve.

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

✪ Strategies to improve healthcare team communication structure and quality in resource-variable childhood cancer hospitals (TeamTalk): a study protocol

Authors:

Asya Agulnik, Dylan E. Graetz, Bobbi J. Carothers, Jocelyn Rivera, Erin Abu-Rish Blakeney, Samantha Hayes, Veronica L. Chaitan, Leopoldo Cabassa, Charles W. Goss, Douglas A. Luke & Sara Malone

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: November 2025

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

Abstract:

Background

Healthcare team communication is essential to high-quality childhood cancer care, especially during high-acuity events such as clinical deterioration and in resource-variable settings, where supportive interventions to resolve deterioration are less available. Communication quality has traditionally been understudied in these settings, and there is a notable lack of communication interventions that are appropriate and feasible in settings across resource levels. We propose addressing this challenge in this study protocol, which will co-develop and pilot a multi-level intervention to improve communication and outcomes for children receiving cancer treatment.

Methods/design

This study leverages systems and implementation science methodologies to evaluate and improve communication quality in the care of hospitalized children with cancer. We will use a newly developed reliable and multilingual measure of communication quality during clinical deterioration (CritCom). In this study, we will: 1) evaluate the relationship between healthcare team communication structures (using social network analysis) and quality (using CritCom) in the care of children with cancer, with a specific focus on the impact of hierarchy and modifiable communication determinants. We will then: 2) co-develop a multilevel intervention to address challenges in communication quality across variably resourced settings, using semi-structured interviews among clinicians working in these settings and intervention mapping with a global expert panel. Finally, we will 3) test the feasibility, acceptability, appropriateness, and preliminary efficacy of this novel intervention using a cluster-randomized wait list control pilot trial in eight resource-variable hospitals providing childhood cancer care with poor team communication quality.

Discussion

This project identifies modifiable determinants of communication before co-developing and testing interventions with clinicians. When completed, this study will produce an evidence-informed, multilevel intervention to improve healthcare team communication during clinical deterioration, advancing the science of team communication during cancer care, and ultimately improving survival for children with cancer.

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

✪ Assessing ‘connective tissue’ in public-private partnerships: a stakeholder survey on multisectoral collaboration in global health

Authors:

Gavin Allman, Sumithra Krishnamurthy Reddiar, Carrie Ngongo, Meritxell Mallafré-Larrosa, Cristina Parsons Perez, Helen McGuire, Roberto F. Iunes, Andrea Vassalotti, Kyle Peterson & Rachel Nugent

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: November 2025

Read the full text in the open access journal Global Health

Abstract:

Background

Public-private partnerships have the potential to advance solutions to complex dilemmas such as the prevention and control of noncommunicable diseases. Knowledge creation, trust, and social capital among partners – encapsulated in the term “connective tissue” – are key considerations for the cohesion and sustainability of multisectoral collaborative efforts in global health.

Methods

A survey was conducted with 23 stakeholders of projects in four countries supported by Access Accelerated, a collective of biopharmaceutical and life sciences companies. The survey elicited perspectives on the factors that strengthen collaboration and develop knowledge creation, trust, and social capital within the multisectoral partner network.

Results

Survey respondents related how connective tissue was cultivated through implementation of multiple projects with shared goals. Identified barriers to effective collaboration included resource constraints, while facilitators included shared objectives and overlapping activities. Qualitative responses provide deeper understanding of how multisectoral collaboration contributed to the sustainability of the Access Accelerated initiative.

Conclusion

Measurement of connective tissue enhances understanding of project performance by addressing dynamic and previously overlooked outcomes of multisectoral collaboration. Multisectoral health initiatives can incorporate implementation science methods into measurement approaches to strengthen connective tissue among partners and stakeholders.

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

✪ Perceptions and practices of long-acting injectable antipsychotic administration in community pharmacies within Washington state: A qualitative implementation science study

Authors:

Clayton English, Christian Helfrich, Jennifer L. Bacci, Julia Fox & Ashley C. Mog

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: November 2025

Read the full text in the open access journal Journal of the American Pharmacy Association

Abstract:

Background

Use of long-acting injectable antipsychotics (LAIAs) for schizophrenia are associated with improved medication adherence and reduce relapse and hospitalizations compared to oral antipsychotics; however, despite these advantages LAIAs remain underutilized. Community pharmacies could improve access and reduce logistical barriers to LAIA administration; however, relatively few deliver this service, and we do not yet fully understand why.

Objective

To assess the contextual fit of administering LAIAs in community pharmacies, identify determinants influencing implementation, and inform implementation strategies to optimize and increase LAIA delivery across Washington State.

Methods

Key informant interviews were conducted with community pharmacy staff in Washington State using a hybrid deductive–inductive qualitative approach to explore determinants and compatibility of LAIA administration. Interviews were conducted using a semi-structured guide informed by Proctor's Implementation Outcomes Framework. Using rapid analysis, transcripts were summarized in a structured matrix and coded into a priori domains. Barriers and facilitators were inductively categorized and then deductively-mapped to the Consolidated Framework for Implementation Research domains; recommendations were identified to inform future implementation strategies.

Results

Ten interviews were conducted with 9 community pharmacists and one pharmacy technician. Current practices varied across participants administering LAIAs in community pharmacies. Reimbursement and payment for LAIA administration emerged as the top barrier. Appointment-based models were seen as facilitators by improving predictability for staffing and medication inventory. Participants recommended streamlining reimbursement and turnkey toolkits for training, care coordination, and communication between prescribers.

Conclusion

For community pharmacies within Washington State, payment models and reimbursement present a critical barrier to LAIA administration. Optimizing billing processes, improving funding and contracting mechanisms, and engaging payers may expand LAIA services. These represent both outer-setting and inner-setting factors, meaning that optimizing LAIA administration in community pharmacies will require system-level, multistakeholder involvement and research.

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