Randomised feasibility trial and embedded qualitative process evaluation of a new intervention to facilitate the involvement of older patients with multimorbidity in decision-making about their healthcare during general practice consultations: the VOLITION study protocol

Abstract

Background The number of older people with multiple health problems is increasing worldwide. This creates a strain on clinicians and the health service when delivering clinical care to this patient group, who themselves carry a large treatment burden. Despite shared decision-making being acknowledged by healthcare organisations as a priority feature of clinical care, older patients with multimorbidity are less often involved in decision-making when compared with younger patients, with some evidence suggesting associated health inequalities. Interventions aimed at facilitating shared decision-making between doctors and patients are outdated in their assessments of today’s older patient population who need support in prioritising complex care needs in order to maximise quality of life and day-to-day function. Aims To undertake feasibility testing of an intervention (‘VOLITION’) aimed at facilitating the involvement of older patients with more than one long-term health problem in shared decision-making about their healthcare during GP consultations. To inform the design of a fully powered trial to assess intervention effectiveness. Methods This study is a cluster randomised controlled feasibility trial with qualitative process evaluation interviews. Participants are patients, aged 65 years and above with more than one long-term health problem (multimorbidity), and the GPs that they consult with. This study aims to recruit 6 GP practices, 18 GPs and 180 patients. The intervention comprises two components: (i) a half-day training workshop for GPs in shared decision-making; and (ii) a leaflet for patients that facilitate their engagement with shared decision-making. Intervention implementation will take 2 weeks (to complete delivery of both patient and GP components), and follow-up duration will be 12 weeks (from index consultation and commencement of data collection to final case note review and process evaluation interview). The trial will run from 01/01/20 to 31/01/21; 1 year 31 days. Discussion Shared decision-making for older people with multimorbidity in general practice is under-researched. Emerging clinical guidelines advise a patient-centred approach, to reduce treatment burden and focus on quality of life alongside disease control. The systematic development, testing and evaluation of an intervention is warranted and timely. This study will test the feasibility of implementing a new intervention in UK general practice for future evaluation as a part of routine care. Trial registration CLINICAL TRIALS.GOV registration number NCT03786315, registered 24/12/18