The NAVIGATE program was developed for the Recovery After Initial Schizophrenia Episode-Early Treatment Program (RAISE-ETP) study, which compared NAVIGATE to usual Community Care in a cluster randomized design involving 34 sites and 404 patients. This article describes the approach to training and implementing the NAVIGATE program at the 17 sites (including 134 practitioners) randomized to provide it, and to evaluating the fidelity of service delivery to the NAVIGATE model. Fidelity was evaluated to five different components of the program, all of which were standardized in manuals in advance of implementation. The components included four interventions (Individualized Resiliency Training, Family Education Program, Supported Employment and Education, Personalized Medication Management) and the overall organization (staffing and structure) of the NAVIGATE team. Most of the sites demonstrated acceptable or higher levels of fidelity in their implementation of the four interventions and the organization of the program, with all 17 sites demonstrating at least acceptable overall fidelity to the NAVIGATE program. The results indicate that the NAVIGATE program can be implemented with good fidelity to the treatment model in a diverse array of community mental health care settings serving persons with a first episode psychosis.
Trial registration: ClinicalTrials.gov NCT01321177.
Keywords: Coordinated specialty care; Fidelity; Implementation; Training.
Copyright © 2018 Elsevier B.V. All rights reserved.
Conflict of interest statement
CONFLICTS OF INTEREST:
The authors and their associates provide training and consultation regarding implementation of NAVIGATE treatment that can include compensation. These activities started only after data collection for the article was completed. At the time of publication, Dr. Robinson, Dr. Meyer-Kalos, Dr. Mueser, Ms. Gingerich, Mr. Lynde, Dr. Glynn and Dr. Cather have received compensation for these activities.
Dr. Kane has been a consultant to or received honoraria from Alkermes, Bristol Myers Squibb, Eli Lilly, Forrest Labs, Genentech, Intracellular Therapeutics, Janssen, Johnson and Johnson, Lundbeck, Merck, Neurocrine, Novartis, Otsuka, Proteus, Reviva, Roche, Sumitomo Dainippon, Sunovion and Teva. He is a shareholder in MedAvante, LB Pharmaceuticals and The Vanguard Research group. Constance R. Klein, RN, MPA owns shares in Bristol-Myers Squibb, GlaxoSmithKline, and Merck.
Dr. Meyer-Kalos has consulted for Sumitomo Dainippon Pharma Co., Ltd.
Dr. Robinson has been a consultant to 3D Communications, Asubio, Costello Medical, Innovative Science Solutions, Janssen and Otsuka.
Dr. Schooler has served on advisory boards or as a consultant for Alkermes, Allergan, Eli Lilly, Forum (formerly EnVivo), Roche, and Sunovion, and she has received grant/research support from Otsuka.
All other authors declare that they have no conflicts of interest (Addington, Estroff, Gottlieb, Penn, Potretzke, Rosenheck, and Wiseman).
The NAVIGATE Program for First-Episode Psychosis: Rationale, Overview, and Description of Psychosocial ComponentsKT Mueser et al. Psychiatr Serv 66 (7), 680-90. PMID 25772766.Comprehensive coordinated specialty care programs for first-episode psychosis have been widely implemented in other countries but not in the United States. The National I …
Comprehensive Versus Usual Community Care for First-Episode Psychosis: 2-Year Outcomes From the NIMH RAISE Early Treatment ProgramJM Kane et al. Am J Psychiatry 173 (4), 362-72. PMID 26481174. - Randomized Controlled TrialComprehensive care for first-episode psychosis can be implemented in U.S. community clinics and improves functional and clinical outcomes. Effects are more pronounced for …
Psychopharmacological Treatment in the RAISE-ETP Study: Outcomes of a Manual and Computer Decision Support System Based InterventionDG Robinson et al. Am J Psychiatry 175 (2), 169-179. PMID 28945118. - Randomized Controlled TrialAs part of comprehensive care services, medication prescription can be optimized for first-episode psychosis, contributing to better outcomes with a lower side effect bur …
[What Support of Young Presenting a First Psychotic Episode, When Schooling Is Being Challenged?]MN Vacheron et al. Encephale 43 (6), 570-576. PMID 29128195. - ReviewPsychiatric disorders (more specifically mood disorders and psychosis) represent the 1st cause of disability among young people. Unemployment rate between 75 to 95% for t …
Fidelity Scales and Performance Measures to Support Implementation and Quality Assurance for First Episode Psychosis ServicesD Addington et al. Early Interv Psychiatry 12 (6), 1235-1242. PMID 29882236. - ReviewFidelity scales and outcome measure are valuable resources to support widespread implementation and quality assurance for first episode psychosis services.
Cited by 3 PubMed Central articles
Impact of First Episode Psychosis Treatment on Heavy Cannabis Use: Secondary Analysis on RAISE-ETP StudyKC Alcover et al. Schizophr Res 211, 86-87. PMID 31378555.
The Therapeutic Alliance in Individual Resiliency Training for First Episode Psychosis: Relationship With Treatment Outcomes and Therapy ParticipationJ Browne et al. J Consult Clin Psychol 87 (8), 734-744. PMID 31219276.A stronger alliance was related to improved treatment outcomes in FEP. Future work should consider examining mediators of the alliance-outcome relationship as well as how …
Community Interventions to Promote Mental Health and Social EquityEG Castillo et al. Curr Psychiatry Rep 21 (5), 35. PMID 30927093. - ReviewThere are recent examples of effective interventions in each topic area. The majority of interventions focus on individual, family/interpersonal, and program/institutiona …