Polypharmacy Clinical Trial
— PolyPrimeOfficial title:
A Pilot Cluster Randomised Controlled Trial of a Theory-based Intervention to Improve Appropriate Polypharmacy in Older People in Primary Care
Verified date | November 2021 |
Source | Queen's University, Belfast |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Active, not recruiting |
Enrollment | 68 |
Est. completion date | December 2021 |
Est. primary completion date | October 21, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 70 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Ireland | Trinity College Dublin | Dublin | |
United Kingdom | Queen's University Belfast | Belfast | Antrim |
Lead Sponsor | Collaborator |
---|---|
Queen's University, Belfast | Belfast Health and Social Care Trust, National University of Ireland, Galway, Ireland, Royal College of Surgeons, Ireland, University of Dublin, Trinity College |
Ireland, United Kingdom,
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. — View Citation
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. Erratum in: Pilot Feasibility Stud. 2017 Oct 24;3:48. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The number of patients contacted and recruited | Through study completion, an average of 1 year | ||
Primary | The number of GP practices contacted and recruited | Through study completion, an average of 1 year | ||
Primary | The retention rate of patients | The number of patients retained over the study period | Through study completion, an average of 1 year | |
Primary | The retention rate of GP practices | The number of GP practices retained over the study period | Through study completion, an average of 1 year | |
Primary | Medication appropriateness | Assessed using STOPP/START criteria | Baseline | |
Primary | 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 | |
Primary | 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 | The number of video view counts per GP participant for the online video | The number of times the GPs watched the online video; taken from the hosting website | Through study completion, an average of 1 year | |
Secondary | The numbers of appointments scheduled | Collected on study-specific data collection forms | Through study completion, an average of 1 year | |
Secondary | The number of medication review appointments attended (first and second reviews) | Collected on study-specific data collection forms | Through study completion, an average of 1 year | |
Secondary | The length of the medication reviews | The length of the medication reviews will be based on audio-recordings of a selection of patient medication reviews | Through study completion, an average of 1 year | |
Secondary | The number of scheduled weekly meetings within each practice at which explicit plans were made to recall patients for medication reviews | Recorded on GP practice staff data collection form | Through study completion, an average of 1 year | |
Secondary | The number of prompts made by reception staff | The number of prompts made by reception staff will be recorded on a GP practice staff data collection form | Through study completion, an average of 1 year | |
Secondary | The resource use and associated costs of the intervention | 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 | ||
Secondary | Participant health and social care service use | As reported in GP notes and compared with self-reported health service use | 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 | |
Secondary | Health-related quality of life | Measured using the EQ-5D-5L | 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 | |
Secondary | Medication-Related Burden Quality of Life | Measured using the Medication-Related Burden Quality of Life (MRB-QoL) tool | 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 | |
Secondary | Estimates of effect size between groups, cluster size and intraclass correlation coefficients (ICCs) | Through study completion, an average of 1 year |
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