Methods: Phase 2 exploratory cluster randomised controlled trial with 8 general practices in Glasgow in very deprived areas involving 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 wellbeing (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; outcome measurement and analysis were masked. Analyses were by intention to treat.
Results: Of 76 eligible practices contacted, 12 accepted, and 8 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 12-month assessment. Two patients died in the control group. CARE Plus significantly improved one domain of well-being (negative wellbeing); effect size 0·33 (95% CI 0·11 to 0·55) at 12 months (p=0·0036). Positive wellbeing, energy, and general wellbeing (the combined score of the three components) were not significantly influenced by the intervention at 12 months. EQ-5D-5L area under the curve (AUC) 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% CIs: £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 QALY gained. Modelling suggested that cost-effectiveness would continue.
Conclusions: It is feasible to conduct a high quality cluster RCT 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 multimorbid patients in deprived areas.
Trial Registration: Trial registration: ISRCTN 34092919, assigned 14/1/2013.
- Primary care
- General practice
- Longer consultations
- Care plan
- Complex intervention