Pragmatic trial evaluating the effectiveness of a patient navigator to decrease emergency room utilisation in transition age youth with chronic conditions: the Transition Navigator Trial protocol.


Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
10 12 2019
Historique:
entrez: 13 12 2019
pubmed: 13 12 2019
medline: 1 12 2020
Statut: epublish

Résumé

Transition to adult care is a challenging and complex process for youth with special healthcare needs. We aim to compare effectiveness of a patient navigator service in reducing emergency room (ER) use among adolescents with chronic health conditions transitioning to adult care. Pragmatic randomised controlled trial parallel group design comparing ER visit rates between patients with access to a personalised navigator intervention compared with usual care. Unit of randomisation is the patient. Treatment assignment will not be blinded. Embedded qualitative study to understand navigator's role and cost analysis attributable to the intervention will be performed. Patients aged 16-21 years, followed within a chronic disease clinic, expected to be transferred to adult care within 12 months and residing in Alberta during study period will be recruited from three tertiary care paediatric hospitals. Sample size will be 300 in each arm. Navigator intervention over 24 months is designed to assist participants in four domains: transition preparation, health system brokering, socioeconomic determinants of health and self-management. Primary outcome is ER visit rate during observation period. Secondary outcomes are ambulatory and inpatient care utilisation measures, as well as Transition Readiness Assessment Questionnaire score, and Short-Form Health Survey 12 (SF-12) score at 6 and 18 months post-randomisation. Poisson regression will compare rates of ER/urgent care visits between navigator and control participants, using intention to treat principle. Cost analysis of the intervention will be conducted. Thematic analysis will be used to identify perceptions of stakeholders regarding the role of navigators. Ethics approval was obtained from the University of Calgary Conjoint Health Research Ethics Board (REB #162561) and the University of Alberta Health Research Ethics Board (Pro00077325). Our team is composed of diverse stakeholders who are committed to improving transition of care who will assist with dissemination of results. NCT03342495.

Identifiants

pubmed: 31826899
pii: bmjopen-2019-034309
doi: 10.1136/bmjopen-2019-034309
pmc: PMC6924868
doi:

Banques de données

ClinicalTrials.gov
['NCT03342495']

Types de publication

Clinical Trial Protocol Comparative Study Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e034309

Subventions

Organisme : CIHR
ID : 388256-CHI-CBBA-161557
Pays : Canada

Informations de copyright

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: None declared.

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Auteurs

Susan Samuel (S)

Section of Nephrology, Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada susan.samuel@ahs.ca.

Gina Dimitropoulos (G)

Faculty of Social Work, University of Calgary, Calgary, Alberta, Canada.

Kyleigh Schraeder (K)

Alberta Children's Hospital Research Institute, Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada.

Scott Klarenbach (S)

Division of Nephrology, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.

Alberto Nettel-Aguirre (A)

Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada.

Greg Guilcher (G)

Section of Pediatric Oncology and Blood and Marrow Transplant, Alberta Children's Hospital, University of Calgary, Calgary, Alberta, Canada.

Daniele Pacaud (D)

Section of Endocrinology, Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada.

Jorge Pinzon (J)

Section of Adolescent Medicine, Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada.

Eddy Lang (E)

Department of Emergency Medicine, University of Calgary, Calgary, Alberta, Canada.

Gail Andrew (G)

Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada.

Lonnie Zwaigenbaum (L)

Department of Pediatrics, Autism Research Centre, University of Alberta, Edmonton, Alberta, Canada.

Shannon Scott (S)

Faculty of Nursing, University of Alberta, Edmonton, Alberta, Canada.

Kerry McBrien (K)

Department of Family Medicine, Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada.

Lorraine Hamiwka (L)

Section of Nephrology, Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada.

Andrew Mackie (A)

Division of Cardiology, Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada.

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