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


BACKGROUND
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.


BACKGROUND
ISRCTN06180958; Pre-results.
Centre for Academic Primary Care, School of Social and Community Medicine, University of Bristol, Bristol, UK.
Mei-See
http://orcid.org/0000-0003-4948-5670
MS
Man
Centre for Academic Primary Care, School of Social and Community Medicine, University of Bristol, Bristol, UK.
Katherine
K
Chaplin
Centre for Academic Primary Care, School of Social and Community Medicine, University of Bristol, Bristol, UK.
Cindy
http://orcid.org/0000-0002-1256-1820
C
Mann
Centre for Primary Care, Institute of Population Health, University of Manchester, Manchester, UK.
Peter
P
Bower
Centre for Academic Primary Care, School of Social and Community Medicine, University of Bristol, Bristol, UK.
Sara
S
Brookes
Institute of Health and Wellbeing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.
Bridie
B
Fitzpatrick
Quality, Safety and Informatics Research Group, University of Dundee, Dundee, UK.
Bruce
B
Guthrie
Centre for Academic Primary Care, School of Social and Community Medicine, University of Bristol, Bristol, UK.
Alison
A
Shaw
Centre for Academic Primary Care, School of Social and Community Medicine, University of Bristol, Bristol, UK.
Sandra
http://orcid.org/0000-0003-0782-3117
S
Hollinghurst
Institute of Health and Wellbeing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.
Stewart
S
Mercer
Clinical Innovation and Research, Royal College of General Practitioners, London, UK.
Imran
I
Rafi
Centre for Academic Primary Care, School of Social and Community Medicine, University of Bristol, Bristol, UK.
Joanna
J
Thorn
Centre for Academic Primary Care, School of Social and Community Medicine, University of Bristol, Bristol, UK.
Chris
http://orcid.org/0000-0002-4378-3960
C
Salisbury
D000293:Adolescent; D000328:Adult; D002908:Chronic Disease; D002985:Clinical Protocols; D015897:Comorbidity; D017281:Cost of Illness; D003362:Cost-Benefit Analysis; D019468:Disease Management; D005260:Female; D058006:General Practice; D006801:Humans; D008297:Male; D018802:Patient-Centered Care; D011788:Quality of Life; D012107:Research Design; D006113:United Kingdom
Chronic disease; Family Practice; Multimorbidity; Patient centred care; co-morbidity