MODIFY or Medication Review in Primary Care Study

NCT05705284 | Recruiting DMC

• 1 other identifier: ERGO ID 71720
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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. 1.Review literature to identify what makes a successful medication review and how to safely deprescribe.
2. 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. 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. 4.Feasibility study for staff in four GP practices to be trained and to implement the intervention.(this will be subject to further amendment).

Conditions

Aging

Keywords

polypharmacy

Outcome Measures

Primary Outcomes (15)

• Feasibility of recruitment

  proportion of staff recruited and trained in each GP practice

  Baseline

• Number of medications

  Total number of medications taken by each patient

  change in scores between baseline and 3 months follow up

• 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

• Rates of hospitalisation

  rates of hospitalisation 3 months post intervention

  3 months

• Mortality rates

  mortality rates 3 months post intervention

  3 months

• frailty status

  Frailty score using the electronic frailty index (e-FI)

  changes between baseline and 3 months

• rates of falls

  number of falls reported and proportion of fallers (self-reported)

  changes between baseline and 3 months

• Rates of fractures

  number of fractures and proportion of people sustained fractures (self-reported)

  changes between baseline and 3 months

• function

  Activity of daily living using Barthel

  changes between baseline and 3 months

• cognition

  \- cognition using the abbreviated mental test (AMT)

  changes between baseline and 3 months

• depression

  \- depression using the geriatric depression scale (GDS)

  changes between baseline and 3 months

• healthcare utilisation

  number of visits to GP/specialists and number of unplanned hospitalisations

  at 3 months follow up

• 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

• Feasibility of deprescribing

  number of recommendations in the medication reviews made to each patient (stop, reduce, switch or start).

  3 months follow up

• 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

Study Arms (1)

Patients participating in structured multidisciplinary medication review

EXPERIMENTAL

Patients participating in structured multidisciplinary medication review

Other: Structured multidisciplinary medication review

Interventions

Structured multidisciplinary medication review OTHER

Multidisciplinary process for medication review/deprescribing: The intervention will be a structured process for performing a shared-decision, person-centred medication review among those living with frailty involving GPs, PCN-pharmacist and ANPs.

Patients participating in structured multidisciplinary medication review

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Aged under 65
• Severe cognitive impairment, as judged by their health care professional
• Informal carers/ relatives eligibility 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.

Sponsors & Collaborators

• University of Southampton: lead
• University of Portsmouth: collaborator

Study Sites (1)

Clinical Research Network in Primary Care

Southampton, United Kingdom

RECRUITING

Related Links

• The development and iMplementation Of a multidisciplinary medication review and Deprescribing Intervention among Frail older people in primarY care

Study Officials

• Kinda Ibrahim, PhD

  University of Southampton

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eloise Radcliffe, PhD

CONTACT

(023) 8120 4656; e.radcliffe@soton.ac.uk

Kinda Ibrahim, PhD

CONTACT

(023) 8120 4656; k.ibrahim@soton.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multidisciplinary process for medication review/deprescribing: The intervention will be a structured process for performing a shared-decision, person-centred medication review among those living with frailty involving GPs, PCN-pharmacist and ANPs.

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: January 30, 2023
• Study Start: January 1, 2022
• Primary Completion: April 30, 2024
• Study Completion: September 30, 2024
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)