Title: General practitioner led medication review of older people with polypharmacy (GP-POLY): a large cluster randomised stepped-wedge trial of a complex intervention to incentivise and facilitate medication review in older people with multimorbidity.
Funder: Chief Scientist Office (Scotland)

Abstract: Background. Ageing populations pose one of the greatest challenges to health systems worldwide with increasing numbers of multimorbid older people living in the community where they are often prescribed large numbers of medications (polypharmacy). Adverse drug events are common in the elderly and those with polypharmacy and account for 5-6% of all emergency hospital admissions and a higher proportion in older people. There is NHS interest in targeting medication review at older people with polypharmacy with some evidence that incentivising GPs to do this improves prescribing outcomes but no evidence of impact on longer term or patient centred outcomes. This study aims to deliver high-quality evidence for or against such an intervention.Design. The study will be a cluster randomised trial of a complex intervention to improve prescribing quality and safety in older people with multiple conditions through the delivery of medication review by their general practitioner. To avoid contamination and to measure population effectiveness randomisation will be at the level of the General Practice with outcomes measured at individual patient level. The trial will use a stepped wedge design in which all participating practices receive the intervention but are randomised to different start dates. Stepped wedge designs are particularly suitable when interventions are expected to do more good than harm where policymakers or health service organisations intend to implement the intervention anyway and where delivery of the intervention has to be spread over time for feasibility reasons. All of these conditions apply in this case. We will also conduct a parallel mixed methods parallel process evaluation to ensure that the way the intervention works in practice is understood in order to inform interpretation of the main trial results and any future implementation. Health technologies being assessed. The technology being assessed is a medication review programme that incentivises and supports practices to provide GP-led medication review of patients at high risk of adverse events. This highly pragmatic intervention will combine a) educational outreach and written guidelines; b) informatics to support the review process and; c) a financial incentive to review specific patients. Educational outreach will be delivered by a pharmacist during a practice visit supplemented by written and web-based guidance. The informatics will use existing enhanced services software to identify patients for review to structure and record the review and manage payment. The financial incentive will be modelled on existing General Practice Enhanced Services contracts. The comparison is existing/usual care in the period before practices implement the intervention which we will describe and document in the parallel process evaluation. Setting and target population. General practices in two Primary Care Organisations (PCOs - Scottish Health Boards or English Clinical Commissioning Groups). The target population of practices is those choosing to participate in an enhanced service offered by thePCO (typically 85-95%; our sample size of 80 practices assumes 70% practice participation). The target population of patients is those aged 80 and over with selected chronic conditions where effectiveness and safety trade offs are common (dementia OR diabetes and at least 1 other chronic condition OR 3 or more chronic conditions). We will recruit 80 practices and ~6400 patients will be eligible for review. Measurements of costs and outcomes. Primary and secondary outcomes will be measured using data extracted from GP electronic medical records and linked to routine NHS datasets. The primary outcome will be emergency admission to an acute hospital measured by linkage to hospital admissions data. Secondary outcomes include acute hospital occupied bed days A&E attendance nursing home admission mortality and prescribing quality and safety. Data extraction linkage and anonymisation will be securely carried out in the University of Dundee Health Informatics Centre (HIC) using NHS REC and Caldicott Guardian approved procedures and the research team will only have access to the data inside the HIC Safe Haven secure environment. For each practice a quarterly time series will be created where the target population of patients is defined at the beginning of each 13 week block and primary and secondary outcomes assessed for that population over the subsequent 13 weeks. In each practice there will be 8 timepoints (2 years) before and 5 timepoints (1.25 years) after the intervention. The primary analysis will be intention to treat at the patient level using Generalised Linear Mixed Models to account for repeated measures on patients clustered within practices. An economic evaluation from the perspective of the NHS and PSS will be performed to estimate the cost-effectiveness of the intervention. The parallel process evaluation will use both quantitative and qualitative methods to understand how the practice-level intervention was actually implemented and how and why practices responded to it (or not). The findings will inform interpretation of the main trial and implementation of trial findings in the future if appropriate. Dissemination. As well as academic dissemination via conference presentations and peer reviewed publication we will work with Age UK to ensure dissemination to policy professional and lay audiences and provide intervention documentation and other materials to support any NHS implementation.


Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: GENERIC HEALTH RELEVANCE