Study protocol for the antidepressant advisor (ADeSS): a decision support system for antidepressant treatment for depression in UK primary care: a feasibility study.


Journal

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

Informations de publication

Date de publication:
24 05 2020
Historique:
entrez: 26 5 2020
pubmed: 26 5 2020
medline: 18 2 2021
Statut: epublish

Résumé

The Antidepressant Advisor Study is a feasibility trial of a computerised decision-support tool which uses an algorithm to provide antidepressant treatment guidance for general practitioners (GPs) in the UK primary care service. The tool is the first in the UK to implement national guidelines on antidepressant treatment guidance into a computerised decision-support tool. The study is a parallel group, cluster-randomised controlled feasibility trial where participants are blind to treatment allocation. GPs were assigned to two treatment arms: (1) treatment-as-usual (TAU) and (2) computerised decision-support tool to assist with antidepressant choices. The study will assess recruitment and lost to follow-up rates, GP satisfaction with the tool and impact on health service use. A meaningful long-term roll-out unit cost will be calculated for the tool, and service use data will be collected at baseline and follow-up to inform a full economic evaluation of a future trial. The study has received National Health Service ethical approval from the London-Camberwell St Giles Research Ethics Committee (ref: 17/LO/2074). The trial was pre-registered in the Clinical Trials.gov registry. The results of the study will be published in a pre-publication archive within 1 year of completion of the last follow-up assessment. NCT03628027.

Identifiants

pubmed: 32448796
pii: bmjopen-2019-035905
doi: 10.1136/bmjopen-2019-035905
pmc: PMC7252992
doi:

Substances chimiques

Antidepressive Agents 0

Banques de données

ClinicalTrials.gov
['NCT03628027']

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e035905

Subventions

Organisme : CIHR
Pays : Canada
Organisme : Medical Research Council
Pays : United Kingdom
Organisme : Wellcome Trust
Pays : United Kingdom

Informations de copyright

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: AHY is employed by King’s College London as an honorary consultant in the South London and Maudsley Trust (NHS UK) and is a consultant to Johnson & Johnson and Livanova. AHY has given paid lectures and sat on advisory boards for the following companies with drugs used in affective and related disorders: Astrazenaca, Eli Lilly, Lundbeck, Sunovion, Servier, Livanova, Janssen, Allegan, Bionomics, Sumitomo Dainippon Pharma. AHY has received honoraria for attending advisory boards and presenting talks at meetings organised by LivaNova. AHY is the Principal Investigator of the following studies: Restore-Life VNS registry study funded by LivaNova, ESKETINTRD3004: ‘An Open-label, Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression’, ‘The Effects of Psilocybin on Cognitive Function in Healthy Participants’and ‘The Safety and Efficacy of Psilocybin in Participants with Treatment-Resistant Depression (P-TRD)’. AHY has received grant funding (past and present) from the following: NIMH (USA); CIHR (Canada); NARSAD (USA); Stanley Medical Research Institute (USA); MRC (UK); Wellcome Trust (UK); Royal College of Physicians (Edin); BMA (UK); UBC-VGH Foundation (Canada); WEDC (Canada); CCS Depression Research Fund (Canada); MSFHR (Canada); NIHR (UK); Janssen (UK). AHY has no shareholdings in pharmaceutical companies. RZ is a private psychiatrist service provider at The London Depression Institute and co-investigator on a Livanova-funded observational study of Vagus Nerve Stimulation for Depression. RZ has received honorarium for talks at three medical symposia sponsored by Lundbeck as well as a talk funded by Janssen whom he collaborates with on an MRC-funded grant. KG reports grants from NIHR, Stroke association, National Institutes of Health (US) and Juvenile Diabetes Research Foundation (US) during the conduct of the study. EC reports personal fees from NIHR during the conduct of the study. BB reports grants from NIHR Research for Patient Benefit during the conduct of the study.

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Auteurs

Phillippa Harrison (P)

Centre for Affective Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.

Ewan Carr (E)

Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.

Kimberley Goldsmith (K)

Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.

Allan H Young (AH)

Centre for Affective Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.

Mark Ashworth (M)

Department of Population Health Sciences, King's College London, London, UK.

Diede Fennema (D)

Centre for Affective Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.

Barbara Barrett (B)

Department of Health Services & Population Research, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.

Roland Zahn (R)

Centre for Affective Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK Roland.zahn@kcl.ac.uk.

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