AIM: The aim is to optimise, implement and evaluate an intervention to improve the management of patients with multimorbidity in general practice
Design: Pragmatic cluster randomised controlled trial with nested process evaluation and economic analysis of cost effectiveness.
Setting: 4 practices (2 in Bristol and 2 in Glasgow) will participate in a pilot phase followed by approximately 32 GP practices in Bristol, Glasgow and Manchester. Only practices with a minimum of 3 GP partners and minimum practice list size of 4,500 patients will be approached in order to ensure an adequate number of participants per practice.
A target of 1383 participants from 32 GPs will be recruited to the study. Eligible participants will be 18 or over with multimorbidity, defined as having three or more long term conditions (LTC) from a predefined list of conditions.
GP practices will be randomised to the intervention or usual care groups.
A. Intervention group:
This is also described as the ‘new approach’ group. The intervention is designed to address the problems of illness burden (poor quality of life, depression) treatment burden (multiple unco-ordinated appointments, polypharmacy, poor primary/secondary care co-ordination) and lack of patient-centred care (low continuity, disregard of patients’ priorities) experienced by patients with multimorbidity.
B. Control group:
Practices in the care as usual group, will continue their usual practice following disease specific computerised protocols focussing on data related to QOF targets.
Outcomes will be collected at baseline, 6 months and 12 month post-randomisation.
The primary outcome will be Health Related Quality of Life as measured by the EQ-5D-5L at 12 months post randomisation.
An increasing proportion of the population have long term health conditions. The current approach to managing patients with long term conditions is based on guidelines and treatment for each specific condition. Patients are regularly called to clinics in general practice (eg. diabetes clinics) to see a nurse who follows guidelines on managing that particular disease. However, there is an increasing awareness that many patients have multiple long term health conditions. This is known as multimorbidity. Patients with multimorbidity often have to attend several clinics which can be repetitive, inconvenient and inefficient. They see different nurses and doctors who may give conflicting advice. These patients may have to take a large number of drugs which can be confusing, difficult to remember and some combinations could be potentially dangerous. These patients frequently get depressed and they also sometimes complain that no-one treats them as a ‘whole person’ or takes their views into account.
To address this problem, this study aims to develop and test a new approach to how GP practices manage patients with multimorbidity. Instead of focussing on each disease in isolation, the aim is to treat the whole patient in a consistent, joined-up manner in order to improve their overall quality of life. GP practices testing this new management system (intervention group) will be compared with GP practices following the current treatment system (usual care or control group).
Specifically, patients in general practices allocated to the intervention group will be identified and flagged on their GP computer systems. A named nurse and doctor will be allocated to them to manage their care. These patients will be given a card to identify them to reception staff who will offer longer appointment times. Patients will also be invited for a comprehensive ‘3D’ health review every 6 months designed to cover all of their health issues. The patient will first see their named nurse who will identify the patients’ concerns and priorities (Dimensions of health), as well as perform any routine checks required by each of the patients’ conditions. The patients’ Drugs will be reviewed to check they are being correctly prescribed (without dangerous interactions), taken properly and where possible, to try to simplify the patients prescriptions e.g. by arranging for all of them to be taken once a day. The named GP will check for and treat symptoms of Depression. The practice will also have a linked ‘general physician’ at the local hospital whom they can contact easily for advice about patients with complex problems.
Patients in general practices allocated to the usual care group will continue having their care managed by their GPs and practice nurses using current management practices of multiple appointments and clinics for each separate condition.
We will first try out the new approach in four practices and use this experience to improve it. Then we aim to recruit 32 GP practices from in and around Bristol, Manchester and Glasgow to take part in the main study. These practices will be randomly assigned to the intervention or usual care group. A target of 1382 multimorbid patients from these practices will be followed up over a period of 12 months.
Before the practice randomisation and at 6 and 12 months into the study, participants from both groups will be asked to fill in questionnaires about their wellbeing, illnesses and treatments, their experience of their care, and what health resources they use. The research team will review the notes of patients in both groups to record the number, type, duration and quality of consultations within general practice as well as their use of other health and social services.
We will compare the cost of the old and new approaches (both the cost to the NHS and the cost to the patient) and relate this to the benefit in a cost-effectiveness analysis.
We will check whether the care provided in the intervention practices actually changed the way intended. Through interviews with patients and care staff, and by direct observation, we will explore how well the approach was implemented and how it could be improved.