Patient-centred Deprescribing of Psychotropic, Sedative and Anticholinergic Medication in Elderly Patients With Polypharmacy: a Cluster-randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 352
- 试验地点
- 6
- 主要终点
- Reduction in the PSA-PIM Drug Burden Index (DBI) by ≥ 0.15 points
研究概览
简要总结
The PARTNER study is a multicentre, two-arm, pragmatic cluster-randomised trial evaluating the impact of a focused and patient-centred cooperation between general practitioners (GPs) and community pharmacists (PARTNER intervention) on reductions in the use of psychotropic, sedative and anticholinergic potentially inappropriate medication (PSA-PIM) compared to a control intervention. The PARTNER intervention comprises (1) education for health care professionals, (2) an interprofessional workshop and case conference, (3) a pharmacy visit with brown bag/medication review and patient empowerment, (4) GP practice visit with shared decision making. The control intervention only comprises a pharmacy visit with brown bag review.
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
- Double (Participant, Care Provider)
盲法说明
To avoid selection bias and Hawthorne bias, the collaborating units (GP practice and community pharmacy) in the intervention group are blinded to the target drugs (PSA-PIM) until the time of randomisation, and in the control group until the end of the study. The same applies to patient participants.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 65 years or older
- •Patient is capable of giving consent
- •GP contact in the quarter prior to inclusion
- •Current use of ≥ 5 drugs, including ≥ 1 PSA-PIM (hypnotics, opioids, gabapentinoids, antipsychotics, antidepressants, anticholinergic urospasmolytics) with a treatment duration of ≥ 6 months
- •Willingness to select a regular pharmacy for the study period
- •Consent to data exchange between GP and community pharmacy
排除标准
- •Terminal illness (life expectancy < 6 months)
- •Current treatment of pain associated with cancer
- •Other serious physical illness or mental distress (e.g. bereavement) that makes participation in the study impossible (according to the GP's assessment)
- •Psychiatric illness or addiction that makes participation in the study impossible (according to the GP's assessment)
- •Unable to meet the requirements of the study (participation in telephone or written questionnaires, visits to the GP practice or community pharmacy, alone or with the help of caregivers for physical infirmity)
- •Current participation in research projects on medication safety or geriatric medicine
结局指标
主要结局
Reduction in the PSA-PIM Drug Burden Index (DBI) by ≥ 0.15 points
时间窗: 6 months
Clinically relevant reduction in PSA-PIM exposure at patient level after 6 months follow-up, as measured by the Drug Burden Index method. The primary endpoint is defined as a responder endpoint at patient level, where response is defined as a reduction in the Drug Burden Index (DBI) by ≥ 0.15 points (Primary endpoint: T2 vs T0)
次要结局
- Frequency of taking other potentially inappropriate medication (PIM) (Validated PIM lists, e.g. PRISCUS list, START/STOPP, Anticholinergic Burden)(12 months)
- Quality of life (EQ5-D-5L)(12 months)
- Total exposure with PSA-PIM(12 months)
- Frequency of new PSA-PIM prescriptions(12 months)
- Number of falls and hospitalisations due to fall events (Falls diary, Hospitalisation diary according to FIMA)(12 months)
- Reduction in the PSA-PIM Drug Burden Index (DBI) by ≥ 0.15 points(12 months)
- Total exposure to PSA-PIM stratified by PSA-PIM subgroups(12 months)
- Frequency of deprescribing PSA-PIM stratified by PSA-PIM subgroups(12 months)
- Cognition (Verbal Fluency Test)(12 months)
- Adverse drug reactions (ADRs)(12 months)
- Insomnia (Regensburg Insomnia Scale; RIS)(12 months)
研究者
Tobias Dreischulte
Professor of Clinical Health Services Research
Ludwig-Maximilians - University of Munich