Skip to content

✪ 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**

✪ Determinants of implementation of a stepped care intervention for adolescents and youth living with HIV in Kenya: a qualitative evaluation

Authors:

Nok Chhun, Dorothy I. Mangale, Kawango Agot, Winnie A. Owade, Julie Kadima, Jacinta Badia, James K. Kibugi, Pamela K. Kohler, Grace John-Stewart & Kristin Beima-Sofie

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: May 2025

Read the full text in the open access journal BMC Health Service Research

Abstract:

Background

Differentiation of HIV services, a client-centered strategy, may improve care outcomes among adolescents and youth living with HIV (AYLHIV). Understanding health provider perceptions of barriers and facilitators that influence implementation can optimize adoption and sustainment of health systems interventions.

Methods

The Data-informed Stepped Care (DiSC) study was a cluster randomized controlled trial of a stepped care intervention in 24 HIV care facilities in Kenya. At each visit, providers used an assessment tool to allocate AYLHIV to services according to level of need. Stable clients were allocated to differentiated service delivery (DSD) with less frequent visits. Intensified services, including behavioral counseling, were provided for those with greater likelihood of loss to follow-up, mental health issues, or viral non-suppression. We conducted focus group discussions (FGDs) with providers across 12 intervention sites between January-February 2023. FGDs used a semi-structured interview guide, grounded in the Consolidated Framework for Implementation Research, which were audio-recorded and transcribed. Transcripts were analyzed using a team-based rapid turnaround approach to characterize key determinants influencing adoption, reach, and fidelity.

Results

Providers were enthusiastic about, and quick to adopt, the DiSC intervention. They found the DiSC tool easy to use and felt it provided a relative advantage by improving service delivery efficiency and prioritizing time with higher need AYLHIV. Providers noted the importance of tool flexibility to align with changing national guidelines. They expressed concerns about compatibility with existing workflows at facilities exclusively using electronic medical record (EMR) systems, suggesting EMR integration will be needed for intervention sustainment. AYLHIV eligible for DSD benefited from clinic visit intervals that aligned with the school calendar, which posed a challenge for reaching AYLHIV in more intensive steps. Provider collective efficacy was important in consistent implementation of DiSC and was facilitated by continuous quality improvement meetings, access to knowledge and information, and perceived intervention effectiveness. Supportive leadership was an important driver of implementation success, through availing space for mental health counseling sessions and time for client-provider interactions outside standard operating hours.

Conclusions

Consideration of alignment with national policy, integration into clinic workflows, school schedules, and leadership engagement, will be important for sustained use of differentiated care interventions.

Trial registration

ClinicalTrials.gov, NCT05007717. Registration date: July 13, 2021.

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

✪ Evaluating spoke facilitation costs of implementing TelePain in the Veterans Health Administration

Authors:

Alexandra L. Rose, Shaina Coogan, Jess Indresano, Steven B. Zeliadt & Jessica A. Chen

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: May 2025

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

Abstract:

Background

The high prevalence and significant morbidity and mortality associated with chronic pain among veterans has made expansion of pain services within the Veterans Health Administration (VHA) a key priority. TelePain, in which services are provided via telehealth from central “hub” sites to patients at decentralized “spoke” sites, is one such model with positive implementation findings to date. However, the staff effort and cost of implementation have yet to be examined when considering TelePain or similar virtual hub-and spoke models of specialty pain care, information that is critical for expansion of services.

Methods

Using an established time-based activity tracker designed for implementation facilitation, study staff tracked minutes spent on implementation activities at 11 spoke sites. Annual salaries were extracted to calculate an average cost per minute for each personnel type. Costs per personnel minute were combined with activity data to calculate costs of implementation activities at spoke sites. Implementation reach outcomes for the first 36 months of implementation were extracted from the electronic health record. Service utilization data was combined with cost data to calculate cost per patient reached and per clinical encounter achieved at each site.

Results

Total facilitation costs (range: $1,746-$7,978) and unique patients reached (range: 2–46) varied considerably across spoke sites and greater staff implementation efforts (measured in time or cost) were not associated with greater numbers of patients reached. Therefore, costs per patient reached also varied widely (range: $120–2,569) across spoke sites. Key challenges included high rurality and small clinic size; insufficient engagement of frontline providers; lack of referral options for high acuity patients; and lack of existing programming within which to situate pain services.

Conclusions

At spoke sites where patients were consistently referred and reached, costs were relatively modest, particularly compared to the high cost of untreated chronic pain, suggesting the potential impact of this model at scale. However, in spoke sites where referrals and encounters were low during initial implementation, cost per patient was high. Findings highlight the need for better methods for tailoring of facilitation interventions to spoke site’s individual needs to maximize impact.

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

✪ Outcome preferences in fidelity-adaptation scenarios across evidence-based parenting programs: A discrete choice experiment

Authors:

Kristoffer Pettersson, Philip Millroth, Fabrizia Giannotta, Pernilla Liedgren, Aaron R. Lyon, Henna Hasson, and Ulrica von Thiele Schwarz

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: February 2025

Read the full text in the open access journal Implementation Science

Abstract:

Background

Implementing evidence-based parenting programs often involves navigating fidelity-adaptation decisions. While research has explored various aspects of this dilemma, little is known about how practitioners’ outcome preferences influence their decisions in real-world scenarios.

Methods

This study employed a discrete choice experiment (DCE) to investigate the relative importance of five outcomes (Relationship Quality, Satisfaction, Workload Strain, Value Conflict, and Reach) in fidelity-adaptation decisions among 209 practitioners delivering evidence-based parenting programs in Sweden. The DCE presented 25 choice sets across five contextual scenarios, analyzed using Bayesian hierarchical logistic regression.

Results

All five outcomes significantly influenced practitioners’ choices, with Relationship Quality emerging as the most impactful (log-odds: 4.56, 95% CI [4.16, 4.91]). Satisfaction and minimizing Value Conflict showed similar importance (log odds: 2.45 and -2.40, respectively), while Workload Strain and Reach had slightly less impact (log odds: -2.10 and 1.96, respectively).

Conclusions

This study offers a novel perspective on the role of outcome preference in navigating fidelity-adaptation decisions. The strong preference for improving parent-child relationships aligns with core parenting program goals, while consideration of other outcomes reflects practitioners’ holistic approach to implementation. These findings can inform the design of interventions and implementation strategies that balance effectiveness with real-world constraints, potentially enhancing parenting programs’ adoption, sustainability, and impact.

Contributions to the literature
  • This study pioneers the application of discrete choice experiments in exploring fidelity-adaptation decisions.
  • Quantifying practitioners’ outcome preferences provides empirical evidence of complex trade-offs in implementing evidence-based parenting programs.
  • The study’s results provide actionable insights for program developers, policymakers, and implementation scientists on designing interventions that resonate with practitioners’ priorities while maintaining program effectiveness.
  • This research bridges theoretical frameworks and real-world decision-making, advancing our understanding of how various factors influence intervention delivery in practice.

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

✪ Defining gaps in pre-exposure prophylaxis delivery for pregnant and post-partum women in high-burden settings using an implementation science framework

Authors:

Jillian Pintye, Dvora L. Joseph Davey, Anjuli D. Wagner, Grace John-Stewart, Rachel Baggaley, Linda-Gail Bekker, Connie Celum, Benjamin H. Chi, Thomas J. Coates, Allison K. Groves, Jessica E. Haberer, Renee Heffron, John Kinuthia, Lynn T. Matthews, James A. McIntyre, Dhayendre Moodley, Lynne M. Mofenson, Nelly Mugo, Andrew Mujugira, Landon Myer, Steven Shoptaw, Lynda Stranix-Chibanda, Jared M. Baeten, for the PrEP in Pregnancy Working Group

University of Washington affiliated authors are displayed in bold.

Subscription Required for Full Text Access

Published: August 2020

Read the full text open access in the subscription access journal The Lancet: HIV

✪ Breast cancer early detection: A phased approach to implementation

Authors:

Ophira Ginsburg, Cheng‐Har Yip, Ari Brooks, Anna Cabanes, Maira Caleffi, Jorge Antonio, Dunstan Yataco, Bishal Gyawali, Valerie McCormack, Myrna McLaughlin de Anderson, Ravi Mehrotra, Alejandro Mohar, Raul Murillo, Lydia E. Pace, Electra D. Paskett, Anya Romanoff, Anne F. Rositch, John R. Scheel, Miriam Schneidman, Karla Unger‐Saldaña, Verna Vanderpuye, Tsu‐Yin Wu, Safina Yuma, Allison Dvaladze, Catherine Duggan, and Benjamin O. Anderson

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: April 2020

Read the full text in the open access journal Cancer

Abstract:

When breast cancer is detected and treated early, the chances of survival are very high. However, women in many settings face complex barriers to early detection, including social, economic, geographic, and other interrelated factors, which can limit their access to timely, affordable, and effective breast health care services. Previously, the Breast Health Global Initiative (BHGI) developed resource‐stratified guidelines for the early detection and diagnosis of breast cancer.

In this consensus article from the sixth BHGI Global Summit held in October 2018, the authors describe phases of early detection program development, beginning with management strategies required for the diagnosis of clinically detectable disease based on awareness education and technical training, history and physical examination, and accurate tissue diagnosis. The core issues address include finance and governance, which pertain to successful planning, implementation, and the iterative process of program improvement and are needed for a breast cancer early detection program to succeed in any resource setting.

Examples are presented of implementation, process, and clinical outcome metrics that assist in program implementation monitoring. Country case examples are presented to highlight the challenges and opportunities of implementing successful breast cancer early detection programs, and the complex interplay of barriers and facilitators to achieving early detection for breast cancer in real‐world settings are considered.

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

The impact of localized implementation: Determining the cost-effectiveness of HIV prevention and care interventions across six United States cities

Authors:

Emanuel Krebs, Xiao Zang, Benjamin Enns, Jeong E. Min, Czarina N. Behrends, Carlos del Rio, Julia C. Dombrowski, Daniel J. Feaster, Kelly A. Gebo, Matthew Golden, Brandon D.L. Marshall, Lisa R. Metsch, Bruce R. Schackman, Steven Shoptaw, Steffanie A. Strathdee, Bohdan Nosyk on behalf of the Localized Economic Modeling Study Group

University of Washington affiliated authors are displayed in bold.

Subscription Required for Full Text Access

Published: March 2020

Read the full text in the subscription access journal AIDS

The Pediatric Guideline Adherence and Outcomes (PEGASUS) programme in severe traumatic brain injury: A single-centre hybrid implementation and effectiveness study

Authors:

Monica S. Vavilala, Mary A. King, Jen-Ting Yang, Scott L. Erickson, Brianna Mills, Rosemary M. Grant, Carolyn Blayney, Qian Qiu, Randall M. Chesnut, Kenneth M. Jaffe, Bryan J. Weiner, & Brian D. Johnston

University of Washington affiliated authors are displayed in bold.

Subscription Required for Full Text Access

Published: November 2018

Read the full text in the subscription access journal Lancet Child and Adolescent Health