MODIFY or Medication Review in Primary Care Study (MODIFY)

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).

Study Overview

• Status: Recruiting
• Conditions: Aging
• Intervention / Treatment: Other: Structured multidisciplinary medication review

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eloise Radcliffe, PhD; Phone Number: (023) 8120 4656; Email: e.radcliffe@soton.ac.uk
• Study Contact Backup: Name: Kinda Ibrahim, PhD; Phone Number: (023) 8120 4656; Email: k.ibrahim@soton.ac.uk

Study Locations

• United Kingdom
  • Southampton, United Kingdom
    • Recruiting
    • Clinical Research Network in Primary Care
    • Contact: Eloise Radcliff, PhD
    • Contact: Kinda Ibrahim, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients participating in structured multidisciplinary medication review	Other: Structured multidisciplinary medication review; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Southampton
• Collaborators: University of Portsmouth
• Investigators: Principal Investigator: Kinda Ibrahim, PhD, University of Southampton

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: March 22, 2022
• First Submitted That Met QC Criteria: January 26, 2023
• First Posted (Actual): January 30, 2023

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: polypharmacy
• Other Study ID Numbers: ERGO ID 71720

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No