Discontinuing Inappropriate Medication in Nursing Home Residents (the DIM NHR Study): a Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 992
- 试验地点
- 1
- 主要终点
- Successful medication discontinuation
研究概览
简要总结
Nursing home residents are among the frailest patient groups with a high number of co-morbidities and a high use of medicines. Inappropriate polypharmacy (i.e. often overprescribing) is one of the major problems in the nursing home population increasing the number of adverse drug reactions, falls, hospital admissions, mortality as well as having an impact on health care utilization. Multidisciplinary medication reviews have a great potential to reduce inappropriate medication use. The purpose of this study is to determine the efficacy of a multidisciplinary medication review model focussing on discontinuing inappropriate medication in a cluster randomized controlled trial in 600 nursing home residents. The primary outcome measure is the difference in proportion of residents who successfully discontinued medication between intervention and control group after four months. Secondary outcome measures will be the drug burden index, adverse drug withdrawal events related to the discontinued medication, death, referral to hospitals and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Nursing Home Wards:
- •Inclusion criteria:
- •Long stay ward
- •Capability and commitment to perform a multidisciplinary multistep medication review.
排除标准
- •Short stay, revalidation or observation wards
- •Specialized ward where patients with an atypical etiology are cared for.
- •Elderly care physicians who have recently received or who are to receive recertification at short notice with regard to systematic medication review methodology.
- •Participation in other studies aimed at improving the quality of drug prescription (in the past 12 months).
- •Nursing Home Residents:
- •Inclusion criteria:
- •A life expectancy of >4 weeks as judged by the treating elderly care physician.
- •IC provided by patients themselves or provided by a legal representative for incapacitated patients.
- •Exclusion criteria:
- •Refusal of treatment with medicines.
- •Having received a multidisciplinary systematic medication review in the past 6 months.
- •Being terminally ill and having a life expectancy ≤ 4 weeks as judged by the treating elderly care physician.
- •Other reasons at the discretion of the elderly care physician / nursing staff
研究组 & 干预措施
Multidisciplinary medication review
The multidisciplinary medication review consists of 5 steps:
Step #1: Assessing patients' experiences and preferences regarding medicine use en assessing their medical history, allergies and lab results Step #2: Drug reviewing to assess contra-indicated medication and duplicate medication using consensus criteria e.g. START STOPP Beers criteria Step #3: Reflecting on results of drug reviewing Step #4: Setting up a pharmacotherapeutical action plan Step #5: Execution of pharmacotherapeutical action plan
干预措施: Multidisciplinary medication review (Procedure)
usual care
Includes medication safety monitoring and ad hoc medication reviews on clinical indication that differ in quality and frequency, but no standardized multidisciplinary multistep medication reviews in the way as described for the intervention arm
结局指标
主要结局
Successful medication discontinuation
时间窗: 4 months
The number of residents for whom ≥1 inappropriate medication(s) are succesfully discontinued i.e. without relapse or severe withdrawal effects
次要结局
- Hospital admission(4 months)
- Falling(4 months)
- number of visits to outpatient clinics / emergency rooms / by medical consultants(4 months)
- Dose adjustment(4 months)
- Death(4 months)
- Safer alternative medication(4 months)
- Bone fractures(4 months)
- Drug burden index(4 months)
- Quality of Life(4 months)
- adverse drug withdrawal events(4 months)
- Medication initiation(4 months)
研究者
Katja Taxis
Professor of Pharmacotherapy and Clinical Pharmacy
University of Groningen