Improving the management of multimorbidity in general practice: protocol of a cluster randomised controlled trial (The 3D Study)

Mei-See Man, Katherine Chaplin, Cindy Mann, Peter Bower, Sara Brookes, Bridie Fitzpatrick, Bruce Guthrie, Ali Heawood, Sandra Hollinghurst, Stewart W Mercer, Imran Rafi, Joanna Thorn, Chris Salisbury*

*Corresponding author for this work

Research output: Contribution to journalArticle (Academic Journal)

19 Citations (Scopus)
305 Downloads (Pure)

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 three or more chronic conditions. This provides 90% power at 5% significance level to detect an effect size of 0.27 standard deviations 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 multi-level 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) NHS Research Ethics Committee (14/SW/0011). Findings will be disseminated via final report, peer-reviewed publications and guidance to health care professionals, commissioners and policy makers.

Trial Registration: Current Controlled Trials: ISRCTN06180958
Original languageEnglish
Article numbere011261
Number of pages13
JournalBMJ Open
Volume6
Issue number4
Early online date25 Apr 2016
DOIs
Publication statusPublished - Apr 2016

Structured keywords

  • Centre for Surgical Research

Keywords

  • Chronic disease
  • Family practice
  • Multimorbidity
  • Patient centred care
  • Comorbidity

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  • Projects

    ConDuCT-II

    Blazeby, J. M.

    1/04/1431/03/19

    Project: Research

    The 3D Study: Improving the management of patients with multimorbidity in general practice

    Brookes, S. T., Chaplin, K., Febrey, S., Hollinghurst, S. P., Man, M., Mann, C. L., Thorn, J. C. & Salisbury, C.

    1/03/1430/09/17

    Project: Research

  • Cite this

    Man, M-S., Chaplin, K., Mann, C., Bower, P., Brookes, S., Fitzpatrick, B., Guthrie, B., Heawood, A., Hollinghurst, S., Mercer, S. W., Rafi, I., Thorn, J., & Salisbury, C. (2016). Improving the management of multimorbidity in general practice: protocol of a cluster randomised controlled trial (The 3D Study). BMJ Open, 6(4), [e011261]. https://doi.org/10.1136/bmjopen-2016-011261