Title: Development and feasibility testing of an intervention: To facilitate the inVolvement of OLder patients with muLtimorbidITy in decisION-making about their healthcare during general practice consultations (VOLITION)
Funder: Department of Health and Social Care

Abstract: Development and feasibility testing of an intervention: To facilitate the involvement of older patients with multimorbidity in decision-making about their healthcare during GP consultationsBackgroundIt is estimated that by 2032 there will be 13.5 million people in the UK aged 65 years or over, compared with 9 million in 2012. Patients in this age group account for over a third of spending in primary care and these older patients consult with increased frequency. The prevalence of long-term conditions increases with age, whilst quality of care for older patients in England is worsening. The burden on primary healthcare, from the care of this important and vulnerable section of the population, is increasing considerably.Patient centred care is associated with improved health outcomes including patient adherence with treatment advice, increased satisfaction with, and enhanced experience of primary healthcare, and enhanced trust in the doctor. Shared decision-making has been identified as a key feature of good clinical care by the World Health Organisation and in NHS policy. Older patients report being less frequently involved in decisions about their healthcare when compared with younger patients. Interventions to facilitate this process for older patients are outdated, and there is some evidence to suggest that there may be associated health inequalities. Our previous research found that, in general, older patients value shared decision-making, with patient perceptions varying regarding what it means to be involved in decisions.AimsTo undertake the development and refinement of an intervention aimed at supporting older patients with multimorbidity in shared decision-making when visiting a GP. To undertaking feasibility testing of the intervention, with a view to informing the design of a future definitive randomised controlled trial. Plan of investigationThe study design will follow a structured approach as set out in the MRC Framework for developing and evaluating complex interventions.WP1. To identify relevant theory, and to use our recent Cochrane review of existing interventions, to outline the core components of a new intervention aimed at supporting older patients with multimorbidity in shared decision-making when consulting with a general practitioner (GP).WP2. Qualitative work in the form of a focus group study will identify views of key stakeholders (older patients and GPs) in order to refine the proposed intervention and to anticipate its facilitation into everyday practice.WP3. A feasibility cluster randomised controlled trial with parallel qualitative process evaluation.We aim to recruit six practices, five GPs per practice and 15 patients per GP. Cluster randomisation to the intervention or to usual care will be at practice level. Feasibility objectives will be finalised during intervention development, but are likely to include assessing the suitability of research procedures, the burdens associated with collecting processes, resource use and potential outcome measures for use in a future, definitive RCT.Semi-structured qualitative interviews with patients and GPs will be conducted across all practices to establish the acceptability of the trial and the intervention. We will use normalisation process theory to plan future integration of the intervention into routine practice.Potential benefits to patients and to the NHSLife expectancy is predicted to continue to rise. Further research is needed to inform future policy aimed at improving GPs' care of older patients with multimorbidity; through making adjustments to GP and system-related factors whilst taking account of the needs and characteristics of individual patients. The development of a complex intervention to facilitate shared decision-making between older patients with multimorbidity and the GP may go some way towards addressing inequalities in healthcare outcomes for this patient group.

Lay abstract: Development of an intervention (VOLITION): To support older patients with multiple health problems in joint decision-making about their healthcare with a GP.Aim To develop an intervention aimed at supporting older patients, who have more than one health problem, in joint decision-making about their healthcare when visiting a GP. To feasibility test the intervention, with a view to informing the design of a fully-powered clinical trial to assess its effectiveness in routine clinical care. BackgroundIn the UK, the number of people aged over 65 years is increasing, with a predicted population in excess of 13.5 million by 2032 compared with 9 million in 2012. Over a third of spending in general practice goes towards care for older patients. Older people see a General Practitioner (GP) more often than younger patients. They are likely to have more than one long-term health problem. This is multimorbidity. It makes a patient's healthcare needs more complex. Older patients with a greater burden of multimorbidity tend to have a poorer quality of life.Patient-centred care, such as sharing in decision-making with a doctor, has positive health outcomes for patients. Outcomes include taking the doctors' advice about treatments, feeling happier about the care received, and having greater trust in the doctor. Both the World Health Organisation and the National Health Service agree that shared decision-making is important. Older patients with multimorbidity prefer sharing in decision-making about their healthcare. However, older patients are currently less often involved in such interactions when compared with younger patients, and this may have negative health effects.Design and methodsThe study design will consist of three work packages (WP):WP1. We will identify current evidence and relevant theory to outline the core components of a new intervention aimed at supporting older patients with multimorbidity in shared decision-making when consulting with a GP.WP2. A focus group (group discussion) will establish the views of older patients with multimorbidity and the views of GPs to refine the proposed intervention, ahead of testing it.WP3. A feasibility (test) study of the intervention will be carried out. We aim to recruit a sample of six GP practices, with five GPs per practice and fifteen patients per GP recruited. Practices will be randomly allocated to either the new intervention or to usual care. The feasibility study will assess any resource, cost, and recruitment issues for a future larger study, and assess ways to measure the effect of the intervention. Interviews with patients and staff will aim to work out how acceptable the future trial would be and whether they think the intervention would be feasible. Patient and public involvement (PPI)A PPI group has been established, consisting of eight members of the public, aged over 65 years, with varying health care needs and experiences. A PPI workshop helped to inform this application and changes were made to the background section to better describe why this study is needed.PPI members will be involved in project meetings every three months. The group will help in the design of the intervention. They will help develop patient information leaflets and support ethics applications. We plan to train a PPI member to run a patient focus group, allowing the researcher to watch and make notes with less influence on the conversation. The PPI member will be offered free training for this process. The group will discuss findings from the feasibility study and assist in writing summaries of results. They will help with presentations to professionals, providing a powerful way of conveying a patient-centred message. The group will be regularly debriefed and supported. They will review the PPI setup ahead of the future trial.DisseminationFindings will be circulated to patient groups, charities, clinicians, service managers, research funders and relevant royal colleges. We will use national and international conferences, the NIHR research networks and local clinical networks. Public events will be held with GP surgeries, working with our PPI members as well as other interested groups. We will publish academic papers in high quality scientific journals. A key output of this work will be the drafting of a funding bid. We will propose a full-scale, fully-powered clinical trial. The trial will examine the health outcomes, cost-effectiveness and acceptability of the intervention. Any dissemination will describe how to use the intervention to positively impact on patient experiences. We will seek to ensure direct NHS service benefit within a 5 year window.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;7.2 END OF LIFE CARE
Health categories: GENERIC HEALTH RELEVANCE