Authors:
Lisa V. Ibañez, Sabine Scott, Wendy L. Stone
University of Washington affiliated authors are displayed in bold.
Subscription Required for Full Text Access
Published: May 2021
Keywords: Stepped Wedge Design
Targeted Assessment and Context-Tailored Implementation of Change Strategies (TACTICS) to increase evidence based psychotherapy in military behavioral health clinics: Design of a cluster-randomized stepped-wedge implementation study
Authors:
Craig S. Rosen
C. Adrian Davis, David Riggs, Jeffery Cook, Alan L. Peterson, Stacey Young-McCaughan, Katherine Anne Comtois, Christopher K. Haddock, Elisa V. Borah, Katherine A. Dondanville, Erin P. Finley, Sara A. Jahnke, Walker S.C. Poston, Shannon Wiltsey-Stirman, Andrea Neitzer, Capt Rachel Broussard, MAJ Amy Brzuchalski, Maj Spencer P. Clayton, LT Allison M. Conforte, Araceli Flores, Jessica Hein, Capt Felicia Keith, Capt Jeremy Jinkerson, Margaret Letendre, Debra Nofziger, Kirsten Pollick, Capt Kyra Santiago, Lt Col John Waggoner, Craig Woodworth, and Carmen P. McLean for the STRONG STAR Consortium andthe TACTICS Research Group
University of Washington affiliated authors are displayed in bold.
Subscription Required for Full Text Access
Published: April 2020
Read the full text in the subscription access journal Contemporary Clinical Trials
✪ Advancing successful implementation of task-shifted mental health care in low-resource settings (BASIC): Protocol for a stepped wedge cluster randomized trial
Authors:
Shannon Dorsey, Christine L. Gray, Augustine I. Wasonga, Cyrilla Amanya, Bryan J. Weiner, C. Micha Belden, Prerna Martin, Rosemary D. Meza, Andrew K. Weinhold, Caroline Soi, Laura K. Murray, Leah Lucid, Elizabeth L. Turner, Robyn Mildon & Kathryn Whetten
University of Washington affiliated authors are displayed in bold.
✪ Open Access
Published: January 2020
Read the full text in the open access journal BMC Psychiatry
Abstract:
Background
The mental health treatment gap—the difference between those with mental health need and those who receive treatment—is high in low- and middle-income countries. Task-shifting has been used to address the shortage of mental health professionals, with a growing body of research demonstrating the effectiveness of mental health interventions delivered through task-shifting. However, very little research has focused on how to embed, support, and sustain task-shifting in government-funded systems with potential for scale up. The goal of the Building and Sustaining Interventions for Children (BASIC) study is to examine implementation policies and practices that predict adoption, fidelity, and sustainment of a mental health intervention in the education sector via teacher delivery and the health sector via community health volunteer delivery.
Methods
BASIC is a Hybrid Type II Implementation-Effectiveness trial. The study design is a stepped wedge, cluster randomized trial involving 7 sequences of 40 schools and 40 communities surrounding the schools. Enrollment consists of 120 teachers, 120 community health volunteers, up to 80 site leaders, and up to 1280 youth and one of their primary guardians. The evidence-based mental health intervention is a locally adapted version of Trauma-focused Cognitive Behavioral Therapy, called Pamoja Tunaweza. Lay counselors are trained and supervised in Pamoja Tunaweza by local trainers who are experienced in delivering the intervention and who participated in a Train-the-Trainer model of skills transfer. After the first sequence completes implementation, in-depth interviews are conducted with initial implementing sites’ counselors and leaders. Findings are used to inform delivery of implementation facilitation for subsequent sequences’ sites. We use a mixed methods approach including qualitative comparative analysis to identify necessary and sufficient implementation policies and practices that predict 3 implementation outcomes of interest: adoption, fidelity, and sustainment. We also examine child mental health outcomes and cost of the intervention in both the education and health sectors.
Discussion
The BASIC study will provide knowledge about how implementation of task-shifted mental health care can be supported in government systems that already serve children and adolescents. Knowledge about implementation policies and practices from BASIC can advance the science of implementation in low-resource contexts.
Trial registration
ClinicalTrials.gov Identifier: NCT03243396. Registered 9th August 2017
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
✪ Scaling-up the Systems Analysis and Improvement Approach for prevention of mother-to-child HIV transmission in Mozambique (SAIA-SCALE): a stepped-wedge cluster randomized trial
Authors:
Kenneth Sherr, Kristjana Ásbjörnsdóttir, Jonny Crocker, Joana Coutinho, Maria de Fatima Cuembelo, Esperança Tavede, Nélia Manaca, Keshet Ronen, Felipe Murgorgo, Ruanne Barnabas, Grace John-Stewart, Sarah Holte, Bryan J. Weiner, James Pfeiffer & Sarah Gimbel
University of Washington affiliated authors are displayed in bold.
✪ Open Access
Published: April 2019
Read the full text in the open access journal Implementation Science
Abstract:
Background
The introduction of option B+ — rapid initiation of lifelong antiretroviral therapy regardless of disease status for HIV-infected pregnant and breastfeeding women — can dramatically reduce HIV transmission during pregnancy, birth, and breastfeeding. Despite significant investments to scale-up Option B+, results have been mixed, with high rates of loss to follow-up, sub-optimal viral suppression, continued pediatric HIV transmission, and HIV-associated maternal morbidity. The Systems Analysis and Improvement Approach (SAIA) cluster randomized trial demonstrated that a package of systems engineering tools improved flow through the prevention of mother-to-child HIV transmission (PMTCT) cascade. This five-step, facility-level intervention is designed to improve understanding of gaps (cascade analysis), guide identification and prioritization of low-cost workflow modifications (process mapping), and iteratively test and redesign these modifications (continuous quality improvement). This protocol describes a novel model for SAIA delivery (SAIA-SCALE) led by district nurse supervisors (rather than research nurses), and evaluation procedures, to serve as a foundation for national scale-up.
Methods
The SAIA-SCALE stepped wedge trial includes three implementation waves, each 12 months in duration. Districts are the unit of assignment, with four districts randomly assigned per wave, covering all 12 districts in Manica province, Mozambique. In each district, the three highest volume health facilities will receive the SAIA-SCALE intervention (totaling 36 intervention facilities). The RE-AIM framework will guide SAIA-SCALE’s evaluation. Reach describes the proportion of clinics and population in Manica province reached, and sub-groups not reached. Effectiveness assesses impact on PMTCT process measures and patient-level outcomes. Adoption describes the proportion of districts/clinics adopting SAIA-SCALE, and determinants of adoption using the Organizational Readiness for Implementing Change (ORIC) tool. Implementation will identify SAIA-SCALE core elements and determinants of successful implementation using the Consolidated Framework for Implementation Research (CFIR). Maintenance describes the proportion of districts sustaining the intervention. We will also estimate the budget and program impact from the payer perspective for national scale-up.
Discussion
SAIA packages user-friendly systems engineering tools to guide decision-making by frontline health workers, and to identify low-cost, contextually appropriate PMTCT improvement strategies. By integrating SAIA delivery into routine management structures, this pragmatic trial is designed to test a model for national intervention scale-up.
Trial Registration
ClinicalTrials.gov NCT03425136 (registered 02/06/2018).
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
✪ Using implementation facilitation to implement primary care mental health integration via clinical video telehealth in rural clinics: protocol for a hybrid type 2 cluster randomized stepped-wedge design
Authors:
Richard R. Owen, Eva N. Woodward, Karen L. Drummond, Tisha L. Deen, Karen Anderson Oliver, Nancy J. Petersen, Scott S. Meit, John C. Fortney, & JoAnn E. Kirchner
University of Washington affiliated authors are displayed in bold.
✪ Open Access
Published: March 2019
Read the full text in the open access journal Implementation Science
Abstract:
Background
Integrating mental health providers into primary care clinics improves access to and outcomes of mental health care. In the Veterans Health Administration (VA) Primary Care Mental Health Integration (PCMHI) program, mental health providers are co-located in primary care clinics, but the implementation of this model is challenging outside large VA medical centers, especially for rural clinics without full mental health staffing. Long wait times for mental health care, little collaboration between mental health and primary care providers, and sub-optimal outcomes for rural veterans could result. Telehealth could be used to provide PCMHI to rural clinics; however, the clinical effectiveness of the tele-PCMHI model has not been tested. Based on evidence that implementation facilitation is an effective implementation strategy to increase uptake of PCMHI when delivered on-site at larger VA clinics, it is hypothesized that this strategy may also be effective with regard to ensuring adequate uptake of the tele-PCMHI model at rural VA clinics.
Methods
This study is a hybrid type 2 pragmatic effectiveness-implementation trial of tele-PCMHI in six sites over 24 months. Tele-PCMHI, which will be delivered by clinical staff available in routine care settings, will be compared to usual care. Fidelity to the care model will be monitored but not controlled. We will use the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework to evaluate the patient-level clinical effectiveness of tele-PCMHI in rural VA clinics and also to evaluate the fidelity to and outcomes of the implementation strategy, implementation facilitation. The proposed study will employ a stepped-wedge design in which study sites sequentially begin implementation in three steps at 6-month intervals. Each step will include (1) a 6-month period of implementation planning, followed by (2) a 6-month period of active implementation, and (3) a final period of stepped-down implementation facilitation.
Discussion
This study will evaluate the effectiveness of PCMHI in a novel setting and via a novel method (clinical video telehealth). We will test the feasibility of using implementation facilitation as an implementation strategy to deploy tele-PCMHI in rural VA clinics.
Trial registration
ClinicalTrials.gov registration number NCT02713217. Registered on 18 March 2016.
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
✪ Scale up of PrEP integrated in public health HIV care clinics: a protocol for a stepped-wedge cluster-randomized rollout in Kenya
Authors:
Kenneth K. Mugwanya, Elizabeth Irungu, Elizabeth Bukusi, Nelly R. Mugo, Josephine Odoyo, Elizabeth Wamoni, Kenneth Ngure, Jennifer F. Morton, Kathryn Peebles, Sarah Masyuko, Gena Barnabee, Deborah Donnell, Ruanne Barnabas, Jessica Haberer, Gabrielle O’Malley, and Jared M. Baeten, for the Partners Scale Up Team
University of Washington affiliated authors are displayed in bold.
✪ Open Access
Published: September 2018
Read the full text in the open access journal Implementation Science
Abstract:
Background
Antiretroviral therapy (ART) for HIV-infected persons and pre-exposure prophylaxis (PrEP) for uninfected persons are extraordinarily effective strategies for HIV prevention. In Africa, the region which shoulders the highest HIV burden, HIV care is principally delivered through public health HIV care clinics, offering an existing platform to incorporate PrEP delivery and maximize ART and PrEP synergies. However, successfully bringing this integrated approach to scale requires an implementation science evaluation in public health settings.
Methods
The Partners Scale Up Project is a prospective, pragmatic implementation evaluation, designed as a stepped-wedge, cluster-randomized trial, operating at 24 clinics in Kenya. In collaboration with the Kenya Ministry of Health, we are catalyzing scaled implementation of PrEP delivery integrated in HIV care clinics. The intervention package includes staff training, clinic streamlined access to PrEP commodity from the Kenya Medical Supply Authority, and ongoing intensive technical assistance to rigorously assess how PrEP delivery is implemented. PrEP service delivery including retention efforts are conducted by the clinic staff with no additional resources from the project. Guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework and Consolidated Framework for Implementation Science Research, project progress and learning are documented through ongoing monitoring and process evaluations, including chart abstraction and individual and key informant interviews, to evaluate pragmatic rollout and understand barriers and facilitators for successful PrEP delivery in this setting. In this staged rollout design, each step provides data for both pre-implementation (baseline) and implementation periods, and we will compare time points across steps in the baseline versus implementation periods.
Discussion
Cost-effective delivery models are urgently needed to maximize the public health impact of PrEP and ART. The Partners Scale Up Project will set the stage for full-scale PrEP implementation fully run and owned by the Kenya Ministry of Health. The work combines nationally sponsored PrEP delivery with technical support and implementation science from academic partners, defining a new but sustainable paradigm for public health collaboration.
Trial registration
Registered with ClinicalTrials.gov on February 14, 2017:NCT03052010.
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
✪ Stepped-Wedge Cluster Randomized Controlled Trial to Promote Option B+ Retention in Central Mozambique
Authors:
James T. Pfeiffer; Manuel Napúa; Bradley H. Wagenaar; Falume Chale; Roxanne Hoek; Mark Micek; João Manuel; Cathy Michel; Jessica Greenberg Cowan; James F. Cowan; Sarah Gimbel; Kenneth Sherr; Stephen Gloyd; Rachel R. Chapman
University of Washington affiliated authors are displayed in bold.
✪ Open Access
Published: November 2017
Read the full text in the subscription access JAIDS: Journal of Acquired Immune Deficiency Syndromes
An effectiveness-implementation hybrid trial study protocol targeting post-traumatic stress disorder and comorbidity
Authors:
Douglas F. Zatzick, Joan Russo, Doyanne Darnell, David A. Chambers, Lawrence Palinkas, Erik Van Eaton,
Jin Wang, Leah M. Ingraham, Roxanne Guiney, Patrick Heagerty, Bryan Comstock, Lauren K. Whiteside, and Gregory Jurkovich
University of Washington affiliated authors are displayed in bold.
✪ Open Access
Published: April 2016
Read the full text in the open access journal Implementation Science
Abstract:
Background
Each year in the USA, 1.5–2.5 million Americans are so severely injured that they require inpatient hospitalization. Multiple conditions including posttraumatic stress disorder (PTSD), alcohol and drug use problems, depression, and chronic medical conditions are endemic among physical trauma survivors with and without traumatic brain injuries.
Methods/Design
The trauma survivors outcomes and support (TSOS) effectiveness-implementation hybrid trial is designed to test the delivery of high-quality screening and intervention for PTSD and comorbidities across 24 US level I trauma center sites. The pragmatic trial aims to recruit 960 patients. The TSOS investigation employs a stepped wedge cluster randomized design in which sites are randomized sequentially to initiate the intervention. Patients identified by a 10-domain electronic health record screen as high risk for PTSD are formally assessed with the PTSD Checklist for study entry. Patients randomized to the intervention condition will receive stepped collaborative care, while patients randomized to the control condition will receive enhanced usual care. The intervention training begins with a 1-day on-site workshop in the collaborative care intervention core elements that include care management, medication, cognitive behavioral therapy, and motivational-interviewing elements targeting PTSD and comorbidity. The training is followed by site supervision from the study team. The investigation aims to determine if intervention patients demonstrate significant reductions in PTSD and depressive symptoms, suicidal ideation, alcohol consumption, and improvements in physical function when compared to control patients. The study uses implementation science conceptual frameworks to evaluate the uptake of the intervention model. At the completion of the pragmatic trial, results will be presented at an American College of Surgeons’ policy summit. Twenty-four representative US level I trauma centers have been selected for the study, and the protocol is being rolled out nationally.
Discussion
The TSOS pragmatic trial simultaneously aims to establish the effectiveness of the collaborative care intervention targeting PTSD and comorbidity while also addressing sustainable implementation through American College of Surgeons’ regulatory policy. The TSOS effectiveness-implementation hybrid design highlights the importance of partnerships with professional societies that can provide regulatory mandates targeting enhanced health care system sustainability of pragmatic trial results.
Trial registration
ClinicalTrials.gov NCT02655354. Registered 27 July 2015.
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**