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Additional follow up study results tables (baseline characteristics, clinical and psychological outcomes, and lifetime economic evaluation). (DOCX 103 kb)

Economic evaluation supplementary tables. (DOCX 57 kb)

Background: Multimorbidity is common in deprived communities and reduces quality of life quality. Our aim was to evaluate a whole system primary care-based complex intervention to improve quality of life in multimorbid patients living in areas of very high deprivation.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.

METHODS\ud 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.\ud \ud RESULTS\ud 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.\ud \ud CONCLUSIONS\ud 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.

Baseline measures and additional data. (DOCX 221 kb)

Economic analysis. (DOCX 27 kb)