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Appropriate Polypharmacy in Older People in Primary Care (PolyPrime)

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ClinicalTrials.gov Identifier: NCT04181879
Recruitment Status : Recruiting
First Posted : December 2, 2019
Last Update Posted : December 7, 2020
Sponsor:
Collaborators:
University of Dublin, Trinity College
Royal College of Surgeons, Ireland
National University of Ireland, Galway, Ireland
Belfast Health and Social Care Trust
Information provided by (Responsible Party):
Carmel Hughes, Queen's University, Belfast

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).

Condition or disease Intervention/treatment Phase
Polypharmacy Behavioral: Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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).
Masking: Single (Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Health Services Research
Official Title: A Pilot Cluster Randomised Controlled Trial of a Theory-based Intervention to Improve Appropriate Polypharmacy in Older People in Primary Care
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Arm Intervention/treatment
Experimental: Intervention
GPs will receive the intervention package and conduct medication reviews with recruited patients
Behavioral: Intervention
  • 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').
Other Name: PolyPrime

No Intervention: Usual care
GPs will continue to treat recruited patients as usual



Primary Outcome Measures :
  1. The number of patients contacted and recruited [ Time Frame: Through study completion, an average of 1 year ]
  2. The number of GP practices contacted and recruited [ Time Frame: Through study completion, an average of 1 year ]
  3. The retention rate of patients [ Time Frame: Through study completion, an average of 1 year ]
    The number of patients retained over the study period

  4. The retention rate of GP practices [ Time Frame: Through study completion, an average of 1 year ]
    The number of GP practices retained over the study period

  5. Medication appropriateness [ Time Frame: Baseline ]
    Assessed using STOPP/START criteria

  6. Medication appropriateness [ Time Frame: Six months' post-initial medication review in the intervention arm and the equivalent time points in the control arm ]
    Assessed using STOPP/START criteria

  7. Medication appropriateness [ Time Frame: Nine months' post-initial medication review in the intervention arm and the equivalent time points in the control arm ]
    Assessed using STOPP/START criteria


Secondary Outcome Measures :
  1. The number of video view counts per GP participant for the online video [ Time Frame: Through study completion, an average of 1 year ]
    The number of times the GPs watched the online video; taken from the hosting website

  2. The numbers of appointments scheduled [ Time Frame: Through study completion, an average of 1 year ]
    Collected on study-specific data collection forms

  3. The number of medication review appointments attended (first and second reviews) [ Time Frame: Through study completion, an average of 1 year ]
    Collected on study-specific data collection forms

  4. The length of the medication reviews [ Time Frame: Through study completion, an average of 1 year ]
    The length of the medication reviews will be based on audio-recordings of a selection of patient medication reviews

  5. The number of scheduled weekly meetings within each practice at which explicit plans were made to recall patients for medication reviews [ Time Frame: Through study completion, an average of 1 year ]
    Recorded on GP practice staff data collection form

  6. The number of prompts made by reception staff [ Time Frame: Through study completion, an average of 1 year ]
    The number of prompts made by reception staff will be recorded on a GP practice staff data collection form

  7. The resource use and associated costs of the intervention [ Time Frame: Baseline, six months' post-initial medication review in the intervention arm and the equivalent time points in the control arm and nine months' post-initial medication review in the intervention arm and the equivalent time points in the control arm ]
  8. Participant health and social care service use [ Time Frame: Baseline, six months' post-initial medication review in the intervention arm and the equivalent time points in the control arm and 12 months' post--initial medication review in the intervention arm and the equivalent time points in the control arm ]
    As reported in GP notes and compared with self-reported health service use

  9. Health-related quality of life [ Time Frame: Baseline, six months' post-initial medication review in the intervention arm and the equivalent time points in the control arm and nine months' post-initial medication review in the intervention arm and the equivalent time points in the control arm ]
    Measured using the EQ-5D-5L

  10. Medication-Related Burden Quality of Life [ Time Frame: Baseline, six months' post-initial medication review in the intervention arm and the equivalent time points in the control arm and nine months' post-initial medication review in the intervention arm and the equivalent time points in the control arm ]
    Measured using the Medication-Related Burden Quality of Life (MRB-QoL) tool

  11. Estimates of effect size between groups, cluster size and intraclass correlation coefficients (ICCs) [ Time Frame: Through study completion, an average of 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04181879


Contacts
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Contact: Carmel Hughes, PhD 02890972147 c.hughes@qub.ac.uk
Contact: Audrey Rankin, PhD 02890972348 a.rankin@qub.ac.uk

Locations
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Ireland
Trinity College Dublin Recruiting
Dublin, Ireland, D02PN40
Contact: Cristín Ryan, PhD    +35318968452    cristin.ryan@tcd.ie   
Contact: Ashleigh Gorman, MSc    +35318962943    gormanas@tcd.ie   
Principal Investigator: Cristín Ryan, PhD         
United Kingdom
Queen's University Belfast Recruiting
Belfast, Antrim, United Kingdom, BT9 7BL
Contact: Carmel Hughes, PhD    02890972147    c.hughes@qub.ac.uk   
Contact: Audrey Rankin, PhD    02890972348    a.rankin@qub.ac.uk   
Principal Investigator: Carmel Hughes, PhD         
Sponsors and Collaborators
Queen's University, Belfast
University of Dublin, Trinity College
Royal College of Surgeons, Ireland
National University of Ireland, Galway, Ireland
Belfast Health and Social Care Trust
Investigators
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Principal Investigator: Carmel Hughes, PhD Queen's University, Belfast
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Carmel Hughes, Professor, Queen's University, Belfast
ClinicalTrials.gov Identifier: NCT04181879    
Other Study ID Numbers: B19/20
First Posted: December 2, 2019    Key Record Dates
Last Update Posted: December 7, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The current data sharing plans for this study are unknown and will be available at a later date

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carmel Hughes, Queen's University, Belfast:
Older people
Primary care
General Practitioners
Behaviour Change Techniques