title: The CARE Plus study - a whole-system intervention to improve quality of life of primary care patients with multimorbidity in areas of high socioeconomic deprivation: exploratory cluster randomised controlled trial and cost-utility analysis.
abstract: Multimorbidity is common in deprived communities and reduces quality of life. Our aim was to evaluate a whole-system primary care-based complex intervention, called CARE Plus, to improve quality of life in multimorbid patients living in areas of very high deprivation.
  
  
  
  We used a phase 2 exploratory cluster randomised controlled trial with eight general practices in Glasgow in very deprived areas that involved multimorbid patients aged 30-65 years. The intervention comprised structured longer consultations, relationship continuity, practitioner support, and self-management support. Control practices continued treatment as usual. Primary outcomes were quality of life (EQ-5D-5L utility scores) and well-being (W-BQ12; 3 domains). Cost-effectiveness from a health service perspective, engagement, and retention were assessed. Recruitment and baseline measurements occurred prior to randomisation. Blinding post-randomisation was not possible but outcome measurement and analysis were masked. Analyses were by intention to treat.
  
  
  
  Of 76 eligible practices contacted, 12 accepted, and eight were selected, randomised and participated for the duration of the trial. Of 225 eligible patients, 152 (68 %) participated and 67/76 (88 %) in each arm completed the 12-month assessment. Two patients died in the control group. CARE Plus significantly improved one domain of well-being (negative well-being), with an effect size of 0.33 (95 % confidence interval [CI] 0.11-0.55) at 12 months (p = 0.0036). Positive well-being, energy, and general well-being (the combined score of the three components) were not significantly influenced by the intervention at 12 months. EQ-5D-5L area under the curve over the 12 months was higher in the CARE Plus group (p = 0.002). The incremental cost in the CARE Plus group was £929 (95 % CI: £86-£1788) per participant with a gain in quality-adjusted life years of 0.076 (95 % CI: 0.028-0.124) over the 12 months of the trial, resulting in a cost-effectiveness ratio of £12,224 per quality-adjusted life year gained. Modelling suggested that cost-effectiveness would continue.
  
  
  
  It is feasible to conduct a high-quality cluster randomised control trial of a complex intervention with multimorbid patients in primary care in areas of very high deprivation. Enhancing primary care through a whole-system approach may be a cost-effective way to protect quality of life for multimorbid patients in deprived areas.
  
  
  
  
  
  
  
  ISRCTN 34092919 , assigned 14/1/2013.
authors.affiliation: Institute of Health and Wellbeing, General Practice and Primary Care, University of Glasgow, 1 Horselethill Road, Glasgow, G12 9LX, UK. stewart.mercer@glasgow.ac.uk.
authors.forename: Stewart W
authors.initials: SW
authors.lastname: Mercer
authors.affiliation: Institute of Health and Wellbeing, General Practice and Primary Care, University of Glasgow, 1 Horselethill Road, Glasgow, G12 9LX, UK.
authors.forename: Bridie
authors.initials: B
authors.lastname: Fitzpatrick
authors.affiliation: Population Health Sciences Division, University of Dundee, Mackenzie Building, Kirsty Semple Way, Dundee, DD2 4BF, UK.
authors.forename: Bruce
authors.initials: B
authors.lastname: Guthrie
authors.affiliation: Health Economics and Health Technology Assessment, Institute of Health & Wellbeing, University of Glasgow, 1 Lilybank Gardens, Glasgow, G12 8RZ, UK.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Fenwick
authors.affiliation: Health Economics and Health Technology Assessment, Institute of Health & Wellbeing, University of Glasgow, 1 Lilybank Gardens, Glasgow, G12 8RZ, UK.
authors.forename: Eleanor
authors.initials: E
authors.lastname: Grieve
authors.affiliation: Health Economics and Health Technology Assessment, Institute of Health & Wellbeing, University of Glasgow, 1 Lilybank Gardens, Glasgow, G12 8RZ, UK.
authors.forename: Kenny
authors.initials: K
authors.lastname: Lawson
authors.affiliation: Health Economics and Health Technology Assessment, Institute of Health & Wellbeing, University of Glasgow, 1 Lilybank Gardens, Glasgow, G12 8RZ, UK.
authors.forename: Nicki
authors.initials: N
authors.lastname: Boyer
authors.affiliation: Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, G12 8QQ, UK.
authors.forename: Alex
authors.initials: A
authors.lastname: McConnachie
authors.affiliation: Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, G12 8QQ, UK.
authors.forename: Suzanne M
authors.initials: SM
authors.lastname: Lloyd
authors.affiliation: Institute of Applied Health, Glasgow Caledonian University, 4th Floor George Moore Building, Cowcaddens Road, Glasgow, Lanarkshire, G4 0BA, UK.
authors.forename: Rosaleen
authors.initials: R
authors.lastname: O'Brien
authors.affiliation: Institute of Health and Wellbeing, General Practice and Primary Care, University of Glasgow, 1 Horselethill Road, Glasgow, G12 9LX, UK.
authors.forename: Graham C M
authors.initials: GC
authors.lastname: Watt
authors.affiliation: Institute of Health and Wellbeing, University of Glasgow, 27 Bute Gardens, Glasgow, G12 8RS, UK.
authors.forename: Sally
authors.initials: S
authors.lastname: Wyke
mesh_terms: D000368:Aged; D015897:Comorbidity; D003362:Cost-Benefit Analysis / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011320:Primary Health Care / Q000379:methods*; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D012959:Socioeconomic Factors
keywords: Care plan; Complex intervention; Deprivation; Empathy; General practice; Longer consultations; Mindfulness; Multimorbidity; Primary care; Socioeconomic