Assessment Archives - Implementation Science at UW

✪ 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

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

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**}

✪ “Though there are some challenges, we try our best to follow the guidelines”: a qualitative study exploring determinants of providing guideline-adherent care to hospitalized children in Kenya

Abstract:

Background

Clinical treatment guidelines are designed to improve quality of care by offering clear recommendations for health workers; however, across many settings, implementing guidelines is a challenge. For over 20 years, comprehensive World Health Organization guidelines for care of hospitalized children have provided guidance for treating the primary causes of childhood death. These recommendations were adapted in Kenya and codified in the Basic Paediatric Protocol; however, adherence to these evidence-based interventions remains suboptimal.

Methods

This qualitative study identified the barriers and facilitators of providing guideline-adherent care to children admitted to two hospitals in Kenya. The semi-structured question guide was informed by the Theoretical Domains Framework (TDF). Three focus group discussions and 16 in-depth interviews were conducted with 35 health workers. Participants were nurses, doctors, clinical officers, or nutritionists (including in-charges and clinical supervisors). Interviews were audio recorded and transcribed. Transcripts were coded using a TDF-based codebook, validated, and analyzed for themes.

Results

TDF domains with the greatest influence on the thematic findings were environmental context and resources, social influences, beliefs about consequences, and beliefs about capabilities. Health workers were knowledgeable about guidelines and felt strongly that adherence to them was beneficial; however, they also faced barriers implementing them. Challenges related to the environmental context were pervasive, including shortages of staff and supplies. Participants praised the simplicity of guidelines but also noted that simplified diagnostic criteria don’t align with complex patient presentations. While guidelines empowered some nurses to make clinical decisions, respondents reported that strict professional roles sometimes delayed diagnosis and treatment. Further, health workers reported some deviations were intentional (ex. when guidelines were not aligned to their beliefs) and other times they were unintentional (ex. when complex patient presentations make guideline adherence difficult).

Conclusions

Knowledge of guidelines and motivation to use them were not major determinants in this analysis. Rather, human and material resource shortages presented the greatest barrier to guideline adherence in this setting. Improving guidelines by involving health workers in participatory development of guidelines would improve both clarity and feasibility. Health workers are well-versed in guideline recommendations, so educational strategies should focus on knowledge gaps or changes in the latest version of guidelines.

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

Tailored strategies to increase the use of an evidence-based psychotherapy for posttraumatic stress disorder: A stepped-wedge randomized trial in military clinics

Authors:

Craig S Rosen, Alan L Peterson, David S Riggs, Christopher K Haddock, Chunki Fong, Stacey Young-McCaughan, Jeffrey Cook, Katherine Anne Comtois, Elisa V Borah, C Adrian Davis, Katherine A Dondanville, Erin P Finley, Sara A Jahnke, Melissa Mistretta, Andrea Neitzer, Shannon Wiltsey-Stirman, Erin R Frick, Olivia Hayes, Spencer Clayton, Allison M Conforte, Araceli Flores, Jeremy Jinkerson , Zachary K Jones, Hana J Kim, Margaret Letendre, Jared S Link, Debra Nofziger, Erik N Ringdahl, John W Waggoner, Craig Woodworth, Emily Ho, Carmen P McLean & TACTICS Research Group

^{University of Washington affiliated authors are displayed in bold.}

Subscription Required for Full Text Access

Published: October 2025

Read the full text in the subscription access journal Journal of Anxiety Disorders

✪ Predictors of skill trajectories in the implementation of cognitive behavioral therapy

Abstract:

Background

Cognitive behavioral therapy (CBT), an umbrella term for therapeutic techniques guided by cognitive behavioral theory, is an evidence-based approach for many psychiatric conditions in youth. A stronger dose of CBT delivery is thought to improve youth clinical outcomes. While a critical indicator of care quality, measuring the use of CBT techniques feasibly and affordably is challenging. Certain CBT techniques (e.g., more concrete and observable) may be easier to measure than others using low-cost methods, such as clinician self-report; however, this has not been studied.

Method

To assess the concordance of three methods of measuring CBT technique use with direct observation (DO), clinicians from 27 community agencies (n = 126; Mage = 37.7 years, SD = 12.8; 76% female) were randomized 1:1:1 to a self-report, chart-stimulated recall (CSR; semistructured interviews with the chart available), or behavioral rehearsal (BR; simulated role-plays) condition. In previous work using a global score aggregating 12 CBT techniques, only BR produced scores that did not differ from DO. This secondary analysis examined the concordance of these alternate methods with DO for each discrete CBT technique, testing for differential concordance across cognitive techniques (e.g., cognitive education) compared to behavioral techniques (e.g., behavioral activation).

Results

Results of three-level mixed effects regression models indicated that BR scores did not differ significantly from DO for any techniques, and for nine techniques, neither did CSR (all ps > .05). Contrastingly, self-report scores differed from DO for all but one technique, with greater concordance for behavioral than cognitive techniques (z = −3.29, p < .001).

Conclusions

Unlike previous findings using an aggregate score, we found that both BR and CSR did not differ significantly from DO for most techniques tested. These findings have implications within implementation research and usual care settings; they support multiple viable measurement methods that are less resource-intensive than DO.

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

✪ “Going above and beyond” for implementation in the education sector: extension and validation of the School Implementation Citizenship Behavior Scale (SICBS)

Abstract:

Background

Employee behaviors that strategically support implementation (i.e., implementation citizenship behavior [ICB]) theoretically promote the adoption and high-fidelity use of evidence-based practices (EBPs). ICB (e.g., helping colleagues overcome implementation barriers) may vary across contexts, including schools where children are most likely to access and receive mental and behavioral health services. Pragmatic measures are needed to advance nascent research on school-based ICB and inform how these behaviors can be used to support successful implementation. The current study expanded the Implementation Citizenship Behavior Scale (ICBS) to create and validate the School Implementation Citizenship Behavior Scale (SICBS) in a sample of elementary school teachers implementing evidence-based prevention programs to support children’s mental and behavioral health.

Methods

Based on subject matter expert feedback, items were refined from the original ICBS and items for two new subscales (taking initiative, advocacy) were created for the SICBS. A sample of 441 public school teachers from 52 elementary schools in the Midwest and Western United States of America completed a survey that included the SICBS and additional measures to assess convergent and divergent validity. SICBS was refined and validated via examination of item characteristics curves to reduce items and develop a pragmatic instrument, confirmatory factor analyses to evaluate the hypothesized measurement structure, and assessment of convergent and divergent validity.

Results

The original two ICBS subscales (helping others, keeping informed) were retained, and two new three-item subscales resulted from item reduction analyses (taking initiative, advocacy). The hypothesized second-order factor model was generally well fit to the data (CFI = .99, TLI = .99, RMSEA = .09), all first- (λs = .85-.96) and second-order factor loadings (λs = .93-.95) were high. All SICBS subscales demonstrated acceptable reliability (αs = .88-.92). Convergent validity was evidenced by moderate correlations with organizational citizenship behavior items (rs = .42-.49). Divergent validity was demonstrated by weak correlations with teachers’ beliefs about teaching (rs = .31-.38) and null correlations with most school demographics.

Conclusion

Results support the structural, convergent, and divergent validity of the 12-item, 4-factor SICBS. The SICBS provides a deeper understanding of individual implementer actions that may serve as implementation mechanisms or outcomes.

^{**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

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**}

✪ Integrating behavioral health care into a low-barrier HIV clinic using the Collaborative Care Model: a mixed methods evaluation of patient care cascade outcomes and determinants

Abstract:

Background

Low-barrier HIV care is an evidence-based intervention to improve HIV outcomes among those who have complex barriers to care, but the walk-in model poses challenges to integrating behavioral health services. We evaluated the acceptability and feasibility of a Collaborative Care Model (CoCM) for treatment of depression and opioid use disorder in a low-barrier clinic.

Methods

In a sequential explanatory mixed methods pilot study, we accessed data from patient records to generate a care cascade for the number of patients enrolled in the first six months of the program and conducted individual interviews with patients and staff to interpret the care cascade findings.

Results

Among 175 patients who visited the clinic, 36% were screened for, 24% were referred to, 15% completed an intake for, and 9% engaged in CoCM. The interviews revealed that screening was limited by a lack of clarity among staff about services offered in CoCM, staff forgetting the screening process, and limited time during patent visits. Referrals were limited by low buy-in among staff and patient complexity. Intakes were limited by time and space constraints in the care setting and competing acute patient needs. The care manager’s ability to embody the clinic’s culture facilitated engagement among patients who completed intakes.

Conclusions

Staff perceived CoCM to be acceptable and feasible to implement, but only in the context of multiple barriers to implementation and challenges to systematic screening and measurement-based care.

Trial registration

Not applicable.

Contributions to the literature

We evaluated implementation of the Collaborative Care Model, an evidence-based model for integrating behavioral healthcare into primary care settings, for treating depression and opioid-use disorder in a low-barrier HIV clinic. To our knowledge, this is the first implementation of the Collaborative Care Model in a low-barrier HIV clinic.
By specifying a multi-component implementation strategy, our evaluation provides a foundation for selecting and tailoring implementation strategies for use with integrated behavioral healthcare interventions.
Through use of a joint visual display showing a care cascade with illustrative quotes, our evaluation demonstrates a novel approach to using explanatory mixed methods in implementation science.

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

Authors:

✪ Open Access

Read the full text in the open access journal BMJ Open

Abstract:

Introduction

Methods and analysis

Authors:

✪ Open Access

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

Abstract:

Background

Methods/design

Discussion

Authors:

✪ Open Access

Read the full text in the open access journal Global Health

Abstract:

Background

Methods

Results

Conclusion

Authors:

✪ Open Access

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

Abstract:

Background

Methods

Results

Conclusions

Authors:

Subscription Required for Full Text Access

Read the full text in the subscription access journal Journal of Anxiety Disorders

Authors:

✪ Open Access

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

Abstract:

Background

Method

Results

Conclusions

Authors:

✪ Open Access

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

Abstract:

Background

Methods

Results

Conclusion

Authors:

✪ Open Access

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

Abstract:

Background

Methods

Results

Conclusions

Trial registration

Authors:

✪ Open Access

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

Abstract:

Background

Methods

Results

Conclusions

Trial registration

Contributions to the literature

Authors:

Subscription Required for Full Text Access

Read the full text in the subscription access journal Annals of Emergency Medicine