A Pilot Cluster Randomised Controlled Trial of a Theory-based Intervention to Improve Appropriate Polypharmacy in Older People in Primary Care
试验速览
- 阶段
- 不适用
- 入组人数
- 68
- 试验地点
- 4
- 主要终点
- Medication appropriateness
研究概览
简要总结
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).
详细描述
Design: We will perform a pilot cluster randomised controlled trial where 12 GP practices will be randomly assigned (6 GP practices per arm) to the intervention group versus usual care. Randomisation will be stratified according to location (Northern Ireland /Republic of Ireland - Cavan, Donegal, Leitrim, Louth, Monaghan and Sligo). GP practices will be randomly allocated to the intervention or usual care arm after patient screening and recruitment. A total of 120 patients (60 per study arm, approximately 10 patients, randomly selected, per GP practice) will be enrolled into the study.
Design: Pilot cluster randomized controlled trial
Unit of randomization: GP practice.
Unit of analysis: Patient and GP practice.
Setting: Practices located in Northern Ireland will be recruited via Research Nurse(s) from the Northern Ireland Clinical Research Network (NICRN - Primary Care). In the Republic of Ireland a Research Nurse(s) from Trinity College Dublin will recruit GP practices located in the border counties of Cavan, Donegal, Leitrim, Louth, Monaghan and Sligo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Care home residents
- •Patients who are cognitively impaired
- •Patients with a terminal illness
- •Involved in other Investigational Medicinal Product (IMP) or medicines management studies
结局指标
主要结局
Medication appropriateness
时间窗: Nine months' post-initial medication review in the intervention arm and the equivalent time points in the control arm
Assessed using STOPP/START criteria
The number of GP practices contacted and recruited
时间窗: Through study completion, an average of 1 year
The retention rate of patients
时间窗: Through study completion, an average of 1 year
The number of patients retained over the study period
The number of patients contacted and recruited
时间窗: Through study completion, an average of 1 year
The retention rate of GP practices
时间窗: Through study completion, an average of 1 year
The number of GP practices retained over the study period
次要结局
- The number of medication review appointments attended (first and second reviews)(Through study completion, an average of 1 year)
- Participant health and social care 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)
- The number of video view counts per GP participant for the online video(Through study completion, an average of 1 year)
- Estimates of effect size between groups, cluster size and intraclass correlation coefficients (ICCs)(Through study completion, an average of 1 year)
- The numbers of appointments scheduled(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)
- The number of prompts made by reception staff(Through study completion, an average of 1 year)
- 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)
- Health-related quality of life(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)
- Medication-Related Burden Quality of Life(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)
研究者
Carmel Hughes
Professor
Queen's University, Belfast