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Implementation Science at UW

Keywords: Mixed Method

✪ 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**

✪ 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**

✪ Impact of adverse events during community-wide mass drug administration for soil-transmitted helminths on subsequent participation–a Theory of Planned Behaviour analysis

Authors:

Kumudha Aruldas, Gideon John Israel, Jabaselvi Johnson, Angelin Titus, Malvika Saxena, Saravanakumar Puthupalayam Kaliappan, Rohan Michael Ramesh, Judd L. Walson, Arianna Rubin Means & Sitara S. R. Ajjampur

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: March 2023

Read the full text in the open access journal PLOS Neglected Tropical Diseases

Abstract:

Background

Experiencing adverse events (AEs) during mass drug administration (MDA) could affect participation in future MDAs. This study aims to understand the potential influence of AEs during a community-wide MDA (cMDA) trial for soil-transmitted helminths (STH) in India on intention to participate in future cMDAs.

Methods

This study was conducted using a multi-method quantitative and qualitative approach among 74 participants who experienced an AE during STH cMDA and the 12 participants who subsequently refused cMDA treatment of the ongoing DeWorm3 trial. Path analysis and thematic analysis guided by the Theory of Planned Behaviour, was used.

Principal findings

Among 74 individuals who reported an AE, 12% refused treatment in the cMDA immediately subsequent to their AE and 4% refused in all subsequent cMDAs. Of these 74 individuals, 59 (80%) completed a survey and eight participated in in-depth interviews. A positive attitude towards deworming and perceived ability to participate in cMDA (perceived behavioural control) were significant predictors of intention to participate in cMDA (p<0.05). A positive attitude towards cMDA was associated with caste (χ2 = 3.83, P = 0.05), particularly among the scheduled caste/scheduled tribe (SC/ST) (62%). Perceived behavioural control in cMDA participation was associated with occupation (χ2 = 5.02, P<0.05), with higher perceived control among those engaged in skilled occupations (78%). Intention to participate in subsequent cMDAs was associated with caste and family type (χ2 = 3.83, P = 0.05 and χ2 = 7.50, P<0.05 respectively) and was higher among SC/ST (62%) and those with extended families (67%). In-depth interviews demonstrated that perceived severe AEs may lead to treatment refusal in future, particularly if children were affected.

Conclusions

Intention to participate in future STH cMDAs was associated with caste (SC/ST) and family type (extended families). Therefore, community mobilization messages about potential AEs and their management may need to intentionally target non-SC/ST households, nuclear families, and those engaged in unskilled occupations to increase cMDA participation given the possibility of AEs occurring.

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

✪ Evaluation of opportunities to implement community-wide mass drug administration for interrupting transmission of soil-transmitted helminths infections in India

Authors:

Kumudha Aruldas, Kim Dawson, Malvika Saxena, Angelin Titus, Jabaselvi Johnson, Marie-Claire Gwayi-Chore, Jayaprakash Muliyil, Gagandeep Kang, Judd L. Walson, Ajay Khera, Sitara S. R. Ajjampur & Arianna Rubin Means

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: March 2023

Read the full text in the open access journal PLOS Neglected Tropical Diseases

Abstract:

Background

The World Health Organization Neglected Tropical Disease (NTD) guidelines recommend control of soil transmitted helminth (STH)-associated morbidity with targeted deworming of preschool and school-aged children who are disproportionately affected by STH-associated morbidity. However, this strategy leaves many adults untreated and reinfection within communities perpetuates transmission even when mass drug administration (MDA) coverage of children is high. Evidence suggests that it may be possible to interrupt STH transmission by expanding MDA to a community-wide MDA (cMDA).

Methods

This multi-methods study of organizational readiness survey, key informant interviews, and program mapping, were conducted with government stakeholders in three Indian states, Goa, Sikkim, and Odisha, to assess readiness of the states for transitioning from school-based MDA to cMDA and identify opportunities to leverage existing infrastructure from other NTD programs like lymphatic filariasis (LF) for STH cMDA.

Principal findings

Overall, all three states indicated a highly favorable policy environment, effective leadership structure, adequate material resources, demonstrated technical capacity, and adequate community infrastructure needed to launch a STH cMDA program. The findings indicated a high-level of health system readiness to implement provided human resources and financial resources to deliver cMDA is strengthened. Areas with a significant overlap between LF and STH MDA platforms, particularly at the community-level, may be best primed for transitioning. Immunization, maternal child health, and non-communicable disease control programs were the other programs for possible integration of cMDA. States indicated having effective leadership structures in place at the state-level, however, engaging local leaders and community groups were considered crucial for successful implementation of cMDA. In-migration was a perceived challenge for estimating drug requirement and preventing possible stockouts.

Conclusions

Findings from this study are intended to proactively support government decision making, prioritization, and program planning across heterogenous implementation contexts in India to speed the translation of research findings into practice.

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