MODIFY or Medication Review in Primary Care Study
- Conditions
- Aging
- Interventions
- Other: Structured multidisciplinary medication review
- Registration Number
- NCT05705284
- Lead Sponsor
- University of Southampton
- Brief Summary
A third of older people take five or more regular medications (polypharmacy) potentially increasing the risk of side-effects, hospital admission and death, with higher risk among people living with frailty. National recommendations suggest that medications taken by frail older people should be reviewed annually by GPs to identify and reduce/ stop inappropriate medications (deprescribing). Yet this does not happen routinely due to GPs' lack of time, increased workloads and worries about stopping medicines. Recent recommendations suggest involving other non-medical prescribers such as practice-pharmacists and advanced nurse practitioners (ANPs) in reviewing medications. However, it is unknown how staff could work together most effectively and whether they have any training needs.
This research will investigate how practice-pharmacists, ANPs and GPs could best work together with patients living with frailty to perform regular medication reviews. There are four work packages (WPs).
1. Review literature to identify what makes a successful medication review and how to safely deprescribe.
2. Interviews with GPs, practice-pharmacists, ANPs, frail older patients and carers will investigate where medication review should take place, the role of involved parties, type of medications that could be deprescribed, staff training needs, barriers and facilitators for implementation, and strategies to address them.
3. Information from WP1\&2 will be used to develop the intervention: a structured medication review process using pharmacists, ANPs and GPs and involving frail patients and their families in decisions about medications. This will be refined through workshops with service users, clinicians and commissioners. A training programme to implement the intervention and increase staff confidence in deprescribing will be developed alongside the intervention.
4. Feasibility study for staff in four GP practices to be trained and to implement the intervention.(this will be subject to further amendment).
- Detailed Description
Background A third of older people take five or more regular medications (polypharmacy) potentially increasing the risk of side-effects, hospital admission and death. These effects are higher among people living with frailty who lose their in-built reserves and become vulnerable to changes triggered by small events such as a change in medication. National recommendations suggest that medications taken by frail older people should be reviewed annually by their GPs to identify and reduce/ stop inappropriate medications (deprescribing). Yet this does not happen routinely due to GPs' lack of time, increased workloads and worries about stopping medicines.
Recent recommendations suggest involving other non-medical prescribers such as practice-pharmacists and advanced nurse practitioners (ANPs) in reviewing medications. However, it is unknown how staff could work together most effectively and whether they have any training needs.
Aim This research will investigate how practice-pharmacists, ANPs and GPs could best work together with patients living with frailty to perform regular medication review.
Methods The study involves four work packages (WPs). The research team will review previous literature to identify what makes a successful medication review and how to safely reduce/ stop inappropriate medications (WP1).
Interviews with GPs, practice-pharmacists, ANPs, frail older patients and carers will be conducted (WP2). These will discover views about where medication review should take place, the role of each of the involved parties in the process, type of medications that could be deprescribed, staff development and training needs, barriers and facilitators for implementation, and strategies to address these barriers.
Information gathered from WP1\&2 will be used to develop the intervention: a structured medication review process using pharmacists, ANPs and GPs most effectively and involving frail patients and their families in decisions about medications (WP3). The intervention will be refined further through a series of workshops with service users, clinicians and commissioners. A training programme to implement the intervention and increase staff confidence in reducing/ stopping medications safely will be developed and delivered to GPs, practice-pharmacists and ANPs based on the Polypharmacy Action Learning Sets approach adopted by the Wessex Academic Health Science Network (AHSN) .
Finally, the feasibility and acceptability of the intervention to staff and patients in four GP practices will be assessed (WP4).
Patient and Public Involvement (PPI) Three PPI members have been involved in protocol development and refinement and will continue to contribute to the research study by for example being involved in developing research instruments and monitoring recruitment.
Dissemination and impact Working with colleagues in the Wessex AHSN and local clinical commissioners, the research team will be able to share our findings and training programme to the wider research and clinical community in Wessex and potentially influence practices and policies both locally and nationally.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients participating in structured multidisciplinary medication review Structured multidisciplinary medication review Patients participating in structured multidisciplinary medication review
- Primary Outcome Measures
Name Time Method Number of medications change in scores between baseline and 3 months follow up Total number of medications taken by each patient
Mortality rates 3 months mortality rates 3 months post intervention
Feasibility of recruitment Baseline proportion of staff recruited and trained in each GP practice
Rates of fractures changes between baseline and 3 months number of fractures and proportion of people sustained fractures (self-reported)
Feasibility of deprescribing 3 months follow up number of recommendations in the medication reviews made to each patient (stop, reduce, switch or start).
number of potentially inappropriate medications Change between baseline and 3 months follow up total number of potentially inappropriate medications months using the STOPP/START criteria.
frailty status changes between baseline and 3 months Frailty score using the electronic frailty index (e-FI)
rates of falls changes between baseline and 3 months number of falls reported and proportion of fallers (self-reported)
function changes between baseline and 3 months Activity of daily living using Barthel
Rates of adverse events at 3 months rates of adverse drug events due to deprescribing (including self-reported dizziness, falls, drowsiness, confusion, hallucinations, blurred vision, constipation, diarrhoea, dry mouth or other) during 3 months follow up.
Rates of hospitalisation 3 months rates of hospitalisation 3 months post intervention
cognition changes between baseline and 3 months - cognition using the abbreviated mental test (AMT)
depression changes between baseline and 3 months - depression using the geriatric depression scale (GDS)
healthcare utilisation at 3 months follow up number of visits to GP/specialists and number of unplanned hospitalisations
Acceptability at 3 months follow up Interviews or focus groups will be conducted at the end of the feasibility study with a purposive sample of (n=6-8) GPs, pharmacists, ANPs in the four GP practices who received the training and implemented the intervention, and 8-10 patients and carers who received the intervention
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinical Research Network in Primary Care
🇬🇧Southampton, United Kingdom