Study «Mercer SW, Fitzpatrick B, Guthrie B ym. The CARE P...»1
Design
12 months phase 2 exploratory cluster randomised controlled trial with eight general practices in Glasgow in very deprived areas.
Population
Patients were eligible if they were aged between 30 and 65 years and had two or more long-term conditions (intervention group n = 76, control group n = 76). Participating patients had a mean age of 52 years with a mean of five long-term conditions each.
Exclusion criteria were (a) unable to give informed consent including those with severe learning disability, severe active mental health problems (active psychosis, schizophrenia, bipolar illness, psychotic depression, severe depression including active suicidal ideation), severe dementia, or other severe cognitive impairments; (b) terminally ill or considered by their GP as likely to die within next 12 months; and (c) unable to understand spoken and written English.
Intervention
Development and optimisation of the CARE Plus intervention included qualitative interviews with GPs and practice nurses working in, and multimorbid patients living in, deprived areas of Glasgow to understand how primary care might better respond. From these, and the available evidence, we drew up an outline of a whole-system intervention which included longer consultations, a structured patient-centred empathic approach, relational continuity, practitioner training and support, and patient self-management support.
The final CARE Plus intervention involved:
1. Changes to practice systems to allow longer consultations (30–45 minutes) and relational continuity with eligible multimorbid patients.
2. Group-based practitioner support and training to use the longer CARE Plus structured consultations to carry out a holistic assessment, including identification of patient concerns and priorities, a focus on self-management, and agreeing on a care plan.
3. Additional patient self-management support materials (mindfulness-based stress management CDs, a cognitive behavioural therapy-derived self-help booklet) and written material (also supplied on a CD) about the intervention and the self-help material.
Control
Control practices continued treatment as usual.
Outcome
The primary patient-reported outcome measures were health-related quality of life, The 5-level EQ-5D version (EQ-5D-5L) and wellbeing, Well-being Questionnaire (W-BQ12).
– 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
– quality of life (EQ-5D-5L) area under the curve over the 12 months was higher in the CARE Plus group (p=0.002)