Clinical trial NCT05705284: MODIFY or Medication Review in Primary Care Study
Official title: The Development and iMplementation Of a Multidisciplinary Medication Review and Deprescribing Intervention Among Frail Older People in primarY Care (MODIFY Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aging
Keywords: polypharmacy
Lead sponsor: University of Southampton
Sponsor class: OTHER
Collaborators: name: University of Portsmouth
First posted: 2023-01-30
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of recruitment
timeFrame: Baseline
measure: Number of medications
timeFrame: change in scores between baseline and 3 months follow up
measure: Rates of adverse events
timeFrame: at 3 months
measure: Rates of hospitalisation
timeFrame: 3 months
measure: Mortality rates
timeFrame: 3 months
measure: frailty status
timeFrame: changes between baseline and 3 months
measure: rates of falls
timeFrame: changes between baseline and 3 months
measure: Rates of fractures
timeFrame: changes between baseline and 3 months
measure: function
timeFrame: changes between baseline and 3 months
measure: cognition
timeFrame: changes between baseline and 3 months
measure: depression
timeFrame: changes between baseline and 3 months
measure: healthcare utilisation
timeFrame: at 3 months follow up
measure: Acceptability
timeFrame: at 3 months follow up
measure: Feasibility of deprescribing
timeFrame: 3 months follow up
measure: number of potentially inappropriate medications
timeFrame: Change between baseline and 3 months follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: Clinical Research Network in Primary Care
Study officials:
affiliation: University of Southampton
name: Kinda Ibrahim, PhD
role: PRINCIPAL_INVESTIGATOR
References: