Aging Clinical Trial
— MODIFYOfficial title:
The Development and iMplementation Of a Multidisciplinary Medication Review and Deprescribing Intervention Among Frail Older People in primarY Care (MODIFY Study)
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).
Status | Recruiting |
Enrollment | 90 |
Est. completion date | September 30, 2024 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | Eligibility criteria for WP2 Patients: Inclusion criteria - Aged 65 and over - Frail, (as judged by their health care professional, if applicable) - Prescribed multiple medications (10+), as determined by their health care professional - Able to give informed consent Exclusion criteria - Aged under 65 - Severe cognitive impairment, as judged by their health care professional Informal carers/ relatives eligibility criteria Inclusion criteria - An informal carer/ relative of a frail patient (aged 65 and over) who is taking multiple medications, as identified by a health care professional - An informal carer/ relative of a patient (aged 65 and over) living with severe dementia who is taking multiple medications, as identified by a health care professional - Able to consent Health care professional eligibility criteria • A health care professional based in GP surgeries in Wessex (eg. GPs, practice-pharmacists, advanced nurse prescriber (ANPs) who works with older people living with frailty, who are prescribed multiple medications. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Clinical Research Network in Primary Care | Southampton |
Lead Sponsor | Collaborator |
---|---|
University of Southampton | University of Portsmouth |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of recruitment | proportion of staff recruited and trained in each GP practice | Baseline | |
Primary | Number of medications | Total number of medications taken by each patient | change in scores between baseline and 3 months follow up | |
Primary | Rates of adverse events | 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. | at 3 months | |
Primary | Rates of hospitalisation | rates of hospitalisation 3 months post intervention | 3 months | |
Primary | Mortality rates | mortality rates 3 months post intervention | 3 months | |
Primary | frailty status | Frailty score using the electronic frailty index (e-FI) | changes between baseline and 3 months | |
Primary | rates of falls | number of falls reported and proportion of fallers (self-reported) | changes between baseline and 3 months | |
Primary | Rates of fractures | number of fractures and proportion of people sustained fractures (self-reported) | changes between baseline and 3 months | |
Primary | function | Activity of daily living using Barthel | changes between baseline and 3 months | |
Primary | cognition | - cognition using the abbreviated mental test (AMT) | changes between baseline and 3 months | |
Primary | depression | - depression using the geriatric depression scale (GDS) | changes between baseline and 3 months | |
Primary | healthcare utilisation | number of visits to GP/specialists and number of unplanned hospitalisations | at 3 months follow up | |
Primary | Acceptability | 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 | at 3 months follow up | |
Primary | Feasibility of deprescribing | number of recommendations in the medication reviews made to each patient (stop, reduce, switch or start). | 3 months follow up | |
Primary | number of potentially inappropriate medications | total number of potentially inappropriate medications months using the STOPP/START criteria. | Change between baseline and 3 months follow up |
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