A hybrid type I randomized effectiveness-implementation trial of patient navigation to improve access to services for children with autism spectrum disorder.

TitleA hybrid type I randomized effectiveness-implementation trial of patient navigation to improve access to services for children with autism spectrum disorder.
Publication TypeJournal Article
Year of Publication2018
AuthorsBroder-Fingert, S, Walls, M, Augustyn, M, Beidas, R, Mandell, D, Wiltsey-Stirman, S, Silverstein, M, Feinberg, E
JournalBMC Psychiatry
Volume18
Issue1
Pagination79
Date Published2018 03 27
ISSN1471-244X
KeywordsAutism Spectrum Disorder, Child, Child, Preschool, Comparative Effectiveness Research, Connecticut, Ethnic Groups, Female, Health Services Accessibility, Healthcare Disparities, Humans, Male, Massachusetts, Patient Navigation, Pennsylvania, Primary Health Care, Research Design
Abstract

BACKGROUND: Significant racial, ethnic, and socioeconomic disparities exist in access to evidence-based treatment services for children with autism spectrum disorder (ASD). Patient Navigation (PN) is a theory-based care management strategy designed to reduce disparities in access to care. The purpose of this study is to test the effectiveness of PN a strategy to reduce disparities in access to evidence-based services for vulnerable children with ASD, as well as to explore factors that impact implementation.

METHODS: This study uses a hybrid type I randomized effectiveness/implementation design to test effectiveness and collect data on implementation concurrently. It is a two-arm comparative effectiveness trial with a target of 125 participants per arm. Participants are families of children age 15-27 months who receive a positive screen for ASD at a primary care visit at urban clinics in Massachusetts (n = 6 clinics), Connecticut (n = 1), and Pennsylvania (n = 2). The trial measures diagnostic interval (number of days from positive screen to diagnostic determination) and time to receipt of evidence-based ASD services/recommended services (number of days from date of diagnosis to receipt of services) in those with PN compared to and activated control -Conventional Care Management - which is similar to care management received in a high quality medical home. At the same time, a mixed-method implementation evaluation is being carried out.

DISCUSSION: This study will examine the effectiveness of PN to reduce the time to and receipt of evidence-based services for vulnerable children with ASD, as well as factors that influence implementation. Findings will tell us both if PN is an effective approach for improving access to evidence-based care for children with ASD, and inform future strategies for dissemination.

TRIAL REGISTRATION: NCT02359084 Registered February 1, 2015.

DOI10.1186/s12888-018-1661-7
Alternate JournalBMC Psychiatry
PubMed ID29587698
PubMed Central IDPMC5870193
Grant ListR01 MH104355 / MH / NIMH NIH HHS / United States
K23MH109673 / MH / NIMH NIH HHS / United States
R01MH104355 / MH / NIMH NIH HHS / United States
K24HD081057 / MH / NIMH NIH HHS / United States
K24 HD081057 / HD / NICHD NIH HHS / United States
K23 MH109673 / MH / NIMH NIH HHS / United States