Polypharmacy Outpatient Clinic as a Randomized Intervention: Effect on Quality of Life, Admissions and Mortality
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 408
- 试验地点
- 2
- 主要终点
- EQ5D-5L index, 4 months, including death
研究概览
简要总结
To investigate the effect of physician-initiated, medication reviews in geriatric patients on self-reported health-related quality of life, admissions, mortality and falls.
详细描述
Aim: To investigate the effect of physician-initiated, medication reviews in geriatric patients on self-reported health-related quality of life, admissions and mortality.
Trial design: Randomized trial with polypharmacy intervention in addition to standard geriatric care. After referral to the geriatric outpatient clinic (but before the first visit), a medical secretary screens the patient's medication on the electronic medication list. If the patient is taking more than 8 different drugs, the patient is randomized to either standard geriatric care or standard geriatric care plus polypharmacy intervention. During the first visit, the patient is informed of the project and asked for written, informed consent. If given, we collect data regarding the patient's medication and any medication changes during the intervention, demographics, frailty (FRAIL Scale), Charlson Comorbidity Index, self-reported history of falls, recent admissions, self-reported, health-related quality of life (EQ-5D-5L) and death. Data is collected at baseline, 4 months follow-up and 13 months follow-up.
Participants: All randomized, polymedicated (>8 drugs) patients referred to the geriatric outpatient clinic.
Outcomes: The primary outcome is the between-group difference in the EQ-5D-5L difference (self-reported, health-related quality of life) between baseline and 13 month follow-up.
The secondary outcomes are number of medications, number of successful medication discontinuations, number of admissions and visits to the emergency department, self-reported low-energy falls, and death.
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
The outcome assessor of the 13 months follow-up EQ5D data is blinded to participant allocation.
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
- •New referral to the geriatric outpatient clinic
- •More than > 8 different substances in drugs on the electronic medication list before the first visit. Regular and PRN drugs count. Excluding topical treatment (eye drops, ear drops, creams etc) but including inhalation, excluding antibiotics with limited duration, excluding multivitamins, and excluding protein drinks.
排除标准
- •Inability (or refuses) to give informed consent (e.g. because of lack of interest, inability to understand the intervention or language barriers).
- •Inability to understand the consent form and/or the intervention.
- •Patients referred to the dementia diagnostics unit.
结局指标
主要结局
EQ5D-5L index, 4 months, including death
时间窗: EQ5D-5L index values at baseline (inclusion) and at 4 months followup
Comparison of changes in EQ5D-5L index from baseline to 4 months follow-up between the control and intervention group (including death). EQ-5D is an abbreviation for "European Quality of life - 5 Dimensions" and measures Quality of Life. The scale has five subcomponents with scores from 1 (best) to 5 (worst). The five subcomponents consitute a health state that is translated into an index value using the Danish EQ-5D-5L Value Set from 2021 (see Jensen et al. The Danish EQ-5D-5L Value Set: A Hybrid Model Using cTTO and DCE Data. Appl Health Econ Health Policy. 2021 Feb 2. doi: 10.1007/s40258-021-00639-3. PMID: 33527304). The index value is anchored at 0 = death and 1 = full health and the range in the Danish population ranges from -0.758 (worse than death) to 1.0 (full health). Higher values / increases in index value is better than lower values / decreases in index value.
次要结局
- EQ5D-5L index, 13 months, including death(EQ5D-5L index values at baseline (inclusion) and at 13 months follow-up)
- Mortality(Baseline to 13 months follow-up.)
- Admissions (number)(From baseline to 4 month follow-up and from 4 month follow-up to 13 month-followup comparison between the control and intervention group.)
- Admissions (days)(From baseline to 4 month follow-up and from 4 month follow-up to 13 month-followup comparison between the control and intervention group.)
- Number of drugs(At 4 month follow-up and 13 month follow-up.)
- Falls(Comparison between groups at 4 month follow-up and 13 month follow-up.)
- EQ5D-5L index, 4 months, excluding death(EQ5D-5L index values at baseline (inclusion) and at 4 months followup)
- EQ5D-5L index, 13 months, excluding death(EQ5D-5L index values at baseline (inclusion) and at 13 months followup)
- EQ5D-5L VAS, 13 months, including death(EQ5D-5L VAS values at baseline (inclusion) and at 13 months followup)
- EQ5D-5L VAS, 4 months, including death(EQ5D-5L VAS values at baseline (inclusion) and at 4 months followup)
- EQ5D-5L VAS, 13 months, excluding death(EQ5D-5L VAS values at baseline (inclusion) and at 13 months followup)
- EQ5D-5L VAS, 4 months, excluding death(EQ5D-5L VAS values at baseline (inclusion) and at 4 months followup)
研究者
Jonatan Kornholt
MD, clinical assistent
Bispebjerg Hospital