Team Approach to Polypharmacy Evaluation and Reduction Randomized Controlled Trial
概览
- 阶段
- 不适用
- 干预措施
- Medication reduction
- 疾病 / 适应症
- Multi-morbidity
- 发起方
- McMaster University
- 入组人数
- 345
- 试验地点
- 1
- 主要终点
- Successful discontinuation (mean difference in number of medications)
- 状态
- 已完成
- 最后更新
- 3个月前
概览
简要总结
In an aging population, most seniors suffer from multiple chronic conditions. When the number of medications taken is ≥5 (polypharmacy), the burden of taking multiple concurrent medications can do more harm than good. Seniors take an average of 7 regular medications and studies link polypharmacy with adverse effects on morbidity, function and health service use. However, it is not clear to what extent these are reversible if medication burden is reduced.
This trial will test the effects on medication numbers and patient health outcomes of an intervention to polypharmacy. This study will test a program focused on medication reduction number and dose. Prioritizing medications according to the patient's preference as reducing the dose also reduces the risk of drug side effects.
Patients, aged 70 years of age or older and are taking ≥5 medications, will randomly receive the program immediately or at 6 months. The program involves information gathering from the patient, including systematically seeking patients priorities and preferences medication review with the pharmacist and then a consultation with the family doctor. The intervention is focused on discontinuing/reducing the dose of medications where possible using a 'pause and monitor' framework to assess the need for restart. An electronic program that detects drug adverse effects and flags potentially inappropriate medications will be integrated into an electronic clinical pathway incorporating monitoring and follow up systems.
This study will examine effects on patient and health relevant outcome measures as well as qualitative research exploring patients' and clinicians' experiences of reducing medication burden. The results will be used to determine whether this system can be implemented as part of routine preventative care in primary care for older adults.
详细描述
Patients will be randomized 1:1 to receive the intervention at study start or delayed appointment 6 months later. Initial baseline data collection from the patient include data on demographics, medications, and illness characteristics. The patient will then attend an appointment with a pharmacist to review medications appropriate for discontinuation/dose reduction, after which the patient will meet with their family physician to discuss patient preferences for discontinuation/dose reduction. Both health care providers will have access to TaperMD, a web based program linked to evidence and tools to support reduction in polypharmacy. Follow-up research assessments will take place at one week, 3 months and 6 months (study end). Outcome assessments and a semi-structured interview will take place at the 6 month appointment.
研究者
入排标准
入选标准
- •Aged 70 years of age or older
- •Patient must have a family doctor
- •Participating family doctor as most responsible provider
- •Currently taking more 5 or more long-term medications
- •Have not had a recent (past 12 months) comprehensive medication review
- •Patient willing to try discontinuation
排除标准
- •English language or cognitive skills inadequate to understand and respond to rating scales
- •Terminal illness or other circumstance precluding 6 month study period
研究组 & 干预措施
TAPER
The intervention is medication reduction. This arm is comprised of: 1. Medication reconciliation 2. Identification of patient priorities for care 3. Identification of medications that are potentially appropriate for discontinuation/dose reduction 4. Linked pharmacist/family physician consultations with patient to discuss medication with intention to reduce 5. Identification of medications for trial of discontinuation/dose reduction (shared decision making) 6. Pause of medication and clinical monitoring
干预措施: Medication reduction
Control
Standard of Care as wait list control. Control group will be offered intervention as part of usual clinical care at 6 months.
结局指标
主要结局
Successful discontinuation (mean difference in number of medications)
时间窗: Baseline, 6 months
Difference in mean number of medications
次要结局
- Patient enablement(Baseline, 6 months)
- Quality of life (EQ5D-5L)(Baseline, 6 months)
- Patient experience of pain(Baseline, 6 months)
- Cognition(Baseline, 6 months)
- Quality of life (SF36v2)(Baseline, 6 months)
- Sleep(Baseline, 6 months)
- Disease burden(Baseline, 6 months)
- Nutritional status(Baseline, 6 months)
- Treatment burden(Baseline, 6 months)
- Falls(Baseline, 6 months)
- Physical functional capacity and ability(Baseline, 6 months)
- Physical function capacity and ability (timed-up-and-go)(Baseline, 6 months)
- Physical function capacity and ability (strength)(Baseline, 6 month)
- Physical function capacity and ability (balance)(Baseline, 6 months)
- Fatigue(Baseline, 6 months)
- Healthcare resource utilization (hospital admissions)(Baseline, 6 months)
- Healthcare resource utilization (ED/urgent care visits)(Baseline, 6 months)
- Healthcare resource utilization (primary care visits)(baseline, 6 months)
- Successful discontinuation or dose reduction(6 months)
- Successful discontinuation or dose reduction (proportion)(6 months)
- Changes in medication side effects and symptoms (adverse)(1 week, 3 month, 6 month)
- Changes in medication side effects and symptoms (positive)(1 week, 3 month, 6 month)
- Serious adverse events(3 months, 6 months)
- Medication self-efficacy(Baseline, 6 months)