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Pilot testing of a new approach to improving the prescribing of many drugs for older people who live in their own home and are cared for by general practitioners

A pilot cluster randomised controlled trial of a theory-based intervention to improve appropriate polypharmacy in older people in primary care

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN41009897
Enrollment
120
Registered
2019-11-19
Start date
2019-08-01
Completion date
Unknown
Last updated
2022-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple medications (polypharmacy) in older adults Not Applicable Multiple medications (polypharmacy) in older adults

Interventions

Current interventions as of 09/12/2020: Twelve GP practices will be recruited from Northern Ireland (NI) and the border counties of the Republic of Ireland (ROI
Cavan, Donegal, Leitrim, Louth, Monaghan and Sligo). The GP practices will be randomly assigned (6 GP practices per arm) to the intervention group or control group (usual care). Eligible GP practices
(b) a patient recall process (appointment with the GP for a medication review). Rather than introducing new tasks for GPs to perform, the video component seeks to enable GPs to use available time more

Sponsors

Queen's University Belfast
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: GP practices: 1. Provide written informed consent and Research Governance sign-off 2. Stable internet service in order to access the video Patients: 1. =70 years of age 2. Receiving four or more regular medicines 3. Resident in the community 4. 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 5. Registered with and/or regularly attending the practice for a minimum of 12 months

Exclusion criteria

Exclusion criteria: GP practices: 1. Participating in other studies related to medicines management in older people Patients: 1. Care home residents 2. Cognitively impaired 3. Terminal illness 4. Involved in other Investigational Medicinal Product (IMP) or medicines management studies

Design outcomes

Primary

MeasureTime frame
Current primary outcome measure as of 09/12/2020: 1. Recruitment: The number of patients and GP practices contacted and recruited. The retention rate of patients and GP practices at the end of the study 2. Health outcomes: Medication appropriateness assessed using STOPP/START criteria at baseline, six months’ and nine months’ post-initial medication review in the intervention arm and the equivalent time points in the control arm _____ Previous primary outcome measure: 1. Recruitment: The number of patients and GP practices contacted and recruited. The retention rate of patients and GP practices at the end of the study 2. Health outcomes: Medication appropriateness assessed using STOPP/START criteria at baseline, six months’ and 12 months’ post-baseline

Secondary

MeasureTime frame
Current secondary outcome measures as of 09/12/2020: 1. Fidelity and mechanism of action (assessed at end of study): 1.1. The number of video view counts per GP participant for the online video 1.2. The numbers of appointments scheduled 1.3. The number of medication review appointments attended (first and second reviews) 1.4. The length of the medication reviews (based on audio-recordings of a selection of reviews with relevant consent) 1.5. The number of scheduled weekly meetings within each practice at which explicit plans were made to recall patients for medication reviews and the number of prompts made by reception staff (based on study-specific data collection forms) 2. Health economics (assessed at end of study): 2.1. The resource use and associated costs of the intervention 2.2. Participant health and social care service use over the study period as reported in GP notes and compared with self-reported health service use 3. Health-related quality of life measured using the EQ-5D-5L at baseline, six and nine months’ post-initial medication review in the intervention arm and the equivalent time points in the control arm 4. Validation of the MRB-QoL tool: Medication-Related Burden Quality of Life measured using the MRB-QoL at baseline, six and nine months’ post-initial medication review in the intervention arm and the equivalent time points in the control arm 5. Data to inform sample size calculation: Estimates of effect size between groups, cluster size and intraclass correlation coefficients (ICCs) _____ Previous secondary outcome measures: 1. Fidelity and mechanism of action (assessed at end of study): 1.1. The number of video view counts per GP participant for the online video 1.2. The nu

Countries

Ireland, Northern Ireland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 23, 2026