Appropriate Polypharmacy in Older People in Primary Care

NCT04181879 | Unknown

• 1 other identifier: B19/20
• Study Type: interventional
• Target: 68
• Locations: 2 countries
• Sites: 2

Brief Summary

In the past, prescribing many medicines (polypharmacy) was seen in a negative light. However, because people are living longer and have several medical conditions at the same time, views on polypharmacy have changed. The challenge is to have the correct balance between enough medicines and too many medicines. Members of the research team have developed a new approach to achieving this balance. This approach has been tested in two general practices in Northern Ireland (NI). The approach (intervention package) currently consists of two parts: (1) a video showing how general practitioners (GPs) can prescribe appropriate polypharmacy for older patients, and (2) an appointment system for patients to visit a GP to have their medicines reviewed. As the intervention package was developed and tested in NI, further testing needs to be carried out in NI and the six border counties of the Republic of Ireland (ROI; Cavan, Donegal, Leitrim, Louth, Monaghan, and Sligo). This will be done in three stages or phases. In phase 1, which is now complete, 13 GPs were interviewed across 12 practices in the six border counties in the ROI; shown the video, asked about this new approach and asked if any changes are needed before doing more testing. In the next two phases (Phase 2 \& 3) a small study will be carried out involving 12 practices: six practices in NI and six practices in the six border counties in the ROI and approximately 10 patients per practice. GP practices will either receive the intervention package and conduct medication reviews with recruited patients (intervention group) or continue to treat recruited patients as usual (control group). Interviews with up to 10 GPs and six members of practice staff (i.e. those involved in implementing the intervention within each practice) respectively in the six intervention group practices will also be conducted at the end of the intervention. Patients from the six intervention group practices will be asked to complete a feedback questionnaire after the delivery of the intervention (i.e. after completion of their final follow-up questionnaires).

Conditions

Polypharmacy

Keywords

Older people; Primary care; General Practitioners; Behaviour Change Techniques

Outcome Measures

Primary Outcomes (7)

• The number of patients contacted and recruited

  Through study completion, an average of 1 year

• The number of GP practices contacted and recruited

  Through study completion, an average of 1 year

• The retention rate of patients

  The number of patients retained over the study period

  Through study completion, an average of 1 year

• The retention rate of GP practices

  The number of GP practices retained over the study period

  Through study completion, an average of 1 year

• Medication appropriateness

  Assessed using STOPP/START criteria

  Baseline

• Medication appropriateness

  Assessed using STOPP/START criteria

  Six months' post-initial medication review in the intervention arm and the equivalent time points in the control arm

• Medication appropriateness

  Assessed using STOPP/START criteria

  Nine months' post-initial medication review in the intervention arm and the equivalent time points in the control arm

Secondary Outcomes (11)

• The number of video view counts per GP participant for the online video

  Through study completion, an average of 1 year

• The numbers of appointments scheduled

  Through study completion, an average of 1 year

• The number of medication review appointments attended (first and second reviews)

  Through study completion, an average of 1 year

• The length of the medication reviews

  Through study completion, an average of 1 year

• The number of scheduled weekly meetings within each practice at which explicit plans were made to recall patients for medication reviews

  Through study completion, an average of 1 year

Study Arms (2)

Intervention

EXPERIMENTAL

GPs will receive the intervention package and conduct medication reviews with recruited patients

Behavioral: Intervention

Usual care

NO INTERVENTION

GPs will continue to treat recruited patients as usual

Interventions

Intervention BEHAVIORAL

* GPs allocated to the intervention will be given access to the intervention package and asked to perform medication reviews with approximately 10 patients on two occasions (initial and 6-months follow-up). * The intervention package consists of two components: (a) an online video demonstrating how GPs can improve appropriate polypharmacy during typical consultations with older patients; (b) a patient recall process (appointment with the GP for a medication review). * GPs will be asked to schedule appointments with consenting patients (telephone or online consultations where a face-to-face consultation is not possible). During these appointments, GPs will undertake medication reviews ('a structured, critical examination of a person's medicines with the objective of reaching an agreement with the person about treatment, optimising the impact of medicines, minimising the number of medication-related problems and reducing waste').

Also known as: PolyPrime

Intervention

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients must be ≥70 years
• Patients must be receiving four or more regular medicines
• Patients must be resident in the community
• Patients must be in receipt of a valid general medical services (GMS) card in the Republic of Ireland, or in the case of Northern Ireland patients, registered for NHS primary care services
• Patients must be registered with and/or regularly attending the practice for a minimum of 12 months

You may not qualify if:

• Care home residents
• Patients who are cognitively impaired
• Patients with a terminal illness
• Involved in other Investigational Medicinal Product (IMP) or medicines management studies

Sponsors & Collaborators

• Queen's University, Belfast: lead
• University of Dublin, Trinity College: collaborator
• Royal College of Surgeons, Ireland: collaborator
• National University of Ireland, Galway, Ireland: collaborator
• Belfast Health and Social Care Trust: collaborator

Study Sites (2)

Trinity College Dublin

Dublin, D02PN40, Ireland

Location

Queen's University Belfast

Belfast, Antrim, BT9 7BL, United Kingdom

Location

Related Publications (5)

• Cadogan CA, Ryan C, Gormley GJ, Francis JJ, Passmore P, Kerse N, Hughes CM. A feasibility study of a theory-based intervention to improve appropriate polypharmacy for older people in primary care. Pilot Feasibility Stud. 2017 Jul 20;4:23. doi: 10.1186/s40814-017-0166-3. eCollection 2018.

  PMID: 28748106 BACKGROUND

• Cadogan CA, Ryan C, Francis JJ, Gormley GJ, Passmore P, Kerse N, Hughes CM. Development of an intervention to improve appropriate polypharmacy in older people in primary care using a theory-based method. BMC Health Serv Res. 2016 Nov 16;16(1):661. doi: 10.1186/s12913-016-1907-3.

  PMID: 27852287 BACKGROUND

• Rankin A, Cadogan CA, Barry HE, Gardner E, Agus A, Molloy GJ, Gorman A, Ryan C, Leathem C, Maxwell M, Gormley GJ, Ferrett A, McCarthy P, Fahey T, Hughes CM; PolyPrime team. An external pilot cluster randomised controlled trial of a theory-based intervention to improve appropriate polypharmacy in older people in primary care (PolyPrime): study protocol. Pilot Feasibility Stud. 2021 Mar 19;7(1):77. doi: 10.1186/s40814-021-00822-2.

  PMID: 33741071 BACKGROUND

• Rankin A, Molloy GJ, Cadogan CA, Barry HE, Gorman A, Ryan C, Ferrett A, McCarthy P, Gormley GJ, Fahey T, Hughes CM; PolyPrime team. Protocol for a process evaluation of an external pilot cluster randomised controlled trial of a theory-based intervention to improve appropriate polypharmacy in older people in primary care: the PolyPrime study. Trials. 2021 Jul 14;22(1):449. doi: 10.1186/s13063-021-05410-6.

  PMID: 34261527 BACKGROUND

• Rankin A, Gorman A, Cole J, Cadogan CA, Barry HE, Agus A, Logan D, McDowell C, Molloy GJ, Ryan C, Leathem C, Maxwell M, Brennan C, Gormley GJ, Ferrett A, McCarthy P, Fahey T, Hughes CM; PolyPrime team. An external pilot cluster randomised controlled trial of a theory-based intervention to improve appropriate polypharmacy in older people in primary care (PolyPrime). Pilot Feasibility Stud. 2022 Sep 10;8(1):203. doi: 10.1186/s40814-022-01161-6.

  PMID: 36088445 DERIVED

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Carmel Hughes, PhD

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Members of the research team who are pharmacists will undertake an assessment of medication appropriateness following medication review by GPs and will be blind to the allocation of patients to either arm. Due to the nature of the intervention package (i.e. access to the video and patient recall), we will be unable to blind the GPs or patients.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A pilot cluster randomised controlled trial (cRCT). Eligible GP practices will be allocated to intervention or control (usual care) arm by a Northern Ireland Clinical Trials Unit (NICTU) statistician using an automated randomisation system. Practices will be randomised on a 1:1 allocation ratio stratified by country (i.e. Northern Ireland or the Republic of Ireland).

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: December 2, 2019
• Study Start: September 1, 2019
• Primary Completion: October 21, 2021
• Study Completion: December 1, 2021
• Last Updated: December 2, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1); GB (1)