Abstract
Introduction
An increasing number of people are living with multimorbidity. The evidence base for how best to manage these patients is weak. Current clinical guidelines generally focus on single conditions, which may not reflect the needs of patients with multimorbidity. The aim of the 3D study is to develop, implement and evaluate an intervention to improve the management of patients with multimorbidity in general practice.
Methods and analysis
This is a pragmatic two-arm cluster randomised controlled trial. 32 general practices around Bristol, Greater Manchester and Glasgow will be randomised to receive either the ‘3D intervention’ or usual care. 3D is a complex intervention including components affecting practice organisation, the conduct of patient reviews, integration with secondary care and measures to promote change in practice organisation. Changes include improving continuity of care and replacing reviews of each disease with patient-centred reviews with a focus on patients' quality of life, mental health and polypharmacy. We aim to recruit 1383 patients who have 3 or more chronic conditions. This provides 90% power at 5% significance level to detect an effect size of 0.27 SDs in the primary outcome, which is health-related quality of life at 15 months using the EQ-5D-5L. Secondary outcome measures assess patient centredness, illness burden and treatment burden. The primary analysis will be a multilevel regression model adjusted for baseline, stratification/minimisation, clustering and important co-variables. Nested process evaluation will assess implementation, mechanisms of effectiveness and interaction of the intervention with local context. Economic analysis of cost-consequences and cost-effectiveness will be based on quality-adjusted life years.
Ethics and dissemination
This study has approval from South-West (Frenchay) National Health Service (NHS) Research Ethics Committee (14/SW/0011). Findings will be disseminated via final report, peer-reviewed publications and guidance to healthcare professionals, commissioners and policymakers.
Citation: Mei-See Man, Katherine Chaplin, Cindy Mann, Peter Bower, Sara Brookes, Bridie Fitzpatrick Improving the management of multimorbidity in general practice: protocol of a cluster randomised controlled trial (The 3D Study)
BMJ Open 2016;6:e011261 doi:10.1136/bmjopen-2016-011261
Received: 22 January 2016 Revised: 26 February 2016 Accepted: 10 March 2016 Published: 25 April 2016
Copyright: This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/
Contributors
CS conceived the original study. CS, PB, SM, BG, IR, SB, AS, SH and CM are co-applicants on the funding application. M-SM led the writing of the first draft of the paper with contribution from SB (statistical analyses), SH and JT (questionnaire outcomes and economic analyses), KC and CM (intervention development and optimisation). All authors contributed to the development of the protocol and to the editing of this manuscript.
Funding
This project was funded by the National Institute for Health Research Health Services and Delivery Research Programme (project number 12/130/15). The trial sponsor is the University of Bristol, (Senate House, Tyndall Avenue, Bristol BS8 1TH, UK).
Disclaimer
The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HS&DR Programme, NIHR, NHS or the Department of Health.
Competing interests None declared.
