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Implementation Science at UW

Keywords: Protocol

✪ Evaluating the sustainability, scalability, and replicability of an STH transmission interruption intervention: The DeWorm3 implementation science protocol

Authors:

Arianna Rubin Means, Sitara S. R. Ajjampur, Robin Bailey, Katya Galactionova, Marie-Claire Gwayi-Chore, Katherine Halliday, Moudachirou Ibikounle, Sanjay Juvekar, Khumbo Kalua, Gagandeep Kang, Pallavi Lele, Adrian J. F. Luty, Rachel Pullan, Rajiv Sarkar, Fabian Schär, Fabrizio Tediosi, Bryan J. Weiner, Elodie Yard, & Judd Walson, on behalf of the DeWorm3 Implementation Science Team

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: January 2018

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

Abstract:

[SECTION NAME]

[ABSTRACT TEXT]

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

✪ An individually tailored family-centered intervention for pediatric obesity in primary care: study protocol of a randomized type II hybrid effectiveness–implementation trial (Raising Healthy Children study)

Authors:

Justin D. Smith, Cady Berkel, Neil Jordan, David C. Atkins, Shrikanth S. Narayanan, Carlos Gallo, Kevin J. Grimm, Thomas J. Dishion, Anne M. Mauricio, Jenna Rudo-Stern, Mariah K. Meachum, Emily Winslow and Meg M. Bruening

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: January 2018

Read the full text in the open access journal Implementation Science

Abstract:

Background

Pediatric obesity is a multi-faceted public health concern that can lead to cardiovascular diseases, cancers, and early mortality. Small changes in diet, physical activity, or BMI can significantly reduce the possibility of developing cardiometabolic risk factors. Family-based behavioral interventions are an underutilized, evidence-based approach that have been found to significantly prevent excess weight gain and obesity in children and adolescents. Poor program availability, low participation rates, and non-adherence are noted barriers to positive outcomes. Effective interventions for pediatric obesity in primary care are hampered by low family functioning, motivation, and adherence to recommendations.

Methods

This (type II) hybrid effectiveness–implementation randomized trial tests the Family Check-Up 4 Health (FCU4Health) program, which was designed to target health behavior change in children by improving family management practices and parenting skills, with the goal of preventing obesity and excess weight gain. The FCU4Health is assessment driven to tailor services and increase parent motivation. A sample of 350 families with children aged 6 to 12 years who are identified as overweight or obese (BMI ≥ 85th percentile for age and gender) will be enrolled at three primary care clinics [two Federally Qualified Healthcare Centers (FQHCs) and a children’s hospital]. All clinics serve predominantly Medicaid patients and a large ethnic minority population, including Latinos, African Americans, and American Indians who face disparities in obesity, cardiometabolic risk, and access to care. The FCU4Health will be coordinated with usual care, using two different delivery strategies: an embedded approach for the two FQHCs and a referral model for the hospital-based clinic. To assess program effectiveness (BMI, body composition, child health behaviors, parenting, and utilization of support services) and implementation outcomes (such outcomes as acceptability, adoption, feasibility, appropriateness, fidelity, and cost), we use a multi-method and multi-informant assessment strategy including electronic health record data, behavioral observation, questionnaires, interviews, and cost capture methods.

Discussion

This study has the potential to prevent excess weight gain, obesity, and health disparities in children by establishing the effectiveness of the FCU4Health and collecting information critical for healthcare decision makers to support sustainable implementation of family-based programs in primary care.

Trial registration

NCT03013309 ClinicalTrials.gov
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

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**