Evidence map›Paper›PMID 27328975›Full record

Trial reportBMC medicine2016

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.

Stewart W Mercer, Bridie Fitzpatrick, Bruce Guthrie, Elisabeth Fenwick, Eleanor Grieve, Kenny Lawson, Nicki Boyer, Alex McConnachie, Suzanne M Lloyd, Rosaleen O'Brien and 2 more

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 93 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
93citing papers in PubMed, 12 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

93 citing papers in PubMed, 12 syntheses or guidelines pooled it.

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  20. Patient-centred innovation for multimorbidity care: a mixed-methods, randomised trial and qualitative study of the patients' experience.The British journal of general practice : the journal of the Royal College of General Practitioners · 2021
    Trial

33 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Stewart W MercerInstitute of Health and Wellbeing, General Practice and Primary Care, University of Glasgow, 1 Horselethill Road, Glasgow, G12 9LX, UK. stewart.mercer@glasgow.ac.uk.
Bridie FitzpatrickInstitute of Health and Wellbeing, General Practice and Primary Care, University of Glasgow, 1 Horselethill Road, Glasgow, G12 9LX, UK.
Bruce GuthriePopulation Health Sciences Division, University of Dundee, Mackenzie Building, Kirsty Semple Way, Dundee, DD2 4BF, UK.
Elisabeth FenwickHealth Economics and Health Technology Assessment, Institute of Health & Wellbeing, University of Glasgow, 1 Lilybank Gardens, Glasgow, G12 8RZ, UK.
Eleanor GrieveHealth Economics and Health Technology Assessment, Institute of Health & Wellbeing, University of Glasgow, 1 Lilybank Gardens, Glasgow, G12 8RZ, UK.
Kenny LawsonHealth Economics and Health Technology Assessment, Institute of Health & Wellbeing, University of Glasgow, 1 Lilybank Gardens, Glasgow, G12 8RZ, UK.
Nicki BoyerHealth Economics and Health Technology Assessment, Institute of Health & Wellbeing, University of Glasgow, 1 Lilybank Gardens, Glasgow, G12 8RZ, UK.
Alex McConnachieRobertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, G12 8QQ, UK.
Suzanne M LloydRobertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, G12 8QQ, UK.
Rosaleen O'BrienInstitute of Applied Health, Glasgow Caledonian University, 4th Floor George Moore Building, Cowcaddens Road, Glasgow, Lanarkshire, G4 0BA, UK.
Graham C M WattInstitute of Health and Wellbeing, General Practice and Primary Care, University of Glasgow, 1 Horselethill Road, Glasgow, G12 9LX, UK.
Sally WykeInstitute of Health and Wellbeing, University of Glasgow, 27 Bute Gardens, Glasgow, G12 8RS, UK.

Funding

Chief Scientist Office ARPG/07/01
6 · The paper itself

Abstract

backgroundMultimorbidity 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.

methodsWe 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.

resultsOf 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.

conclusionsIt 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.

trial registration

trial registrationISRCTN 34092919 , assigned 14/1/2013.

Indexed as

Quality of LifeAgedComorbidityCost-Benefit AnalysisFemaleHumansMaleMiddle AgedPrimary Health CareQuality-Adjusted Life YearsSocioeconomic FactorsCare planComplex interventionDeprivationEmpathyGeneral practiceLonger consultationsMindfulnessMultimorbidityPrimary careSocioeconomic

Identifiers

PMID27328975
PMCPMC4916534

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.