Medication Use and Quality of Life Among Older People
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- HEALTH-RELATED QUALITY OF LIFE
研究概览
简要总结
This project will provide new evidence on how to optimize medication use among older people with limited life expectancy. This will be done by testing whether a patient-centered deprescribing intervention, focused on aligning medical treatment with patients' preferences, can improve quality of life among older people with limited life expectancy.
详细描述
In a pragmatic randomized controlled trial, this project will test whether a comprehensive and patient-centered deprescribing intervention can improve quality of life among older people with limited life expectancy. The intervention will comprise a series of consultations between the patient and general practitioner (GP) (at least three) to continuously adjust the patient's medication according to the patient's goals, needs, and preferences, thereby ensuring alignment with the patient's priorities. Thus, the purpose of this intervention is to initiate and facilitate a continued deprescribing process.
The process can be summarized in eight steps: During an initial consultation (1: Consultation 0), the GP assesses patient eligibility. If the patient would like to participate, a project nurse subsequently visits the patient at home (2: Home visit) for retrieval of informed consent as well as baseline measurements. After retrieval of informed consent, patients are randomized. Patients randomized to the control group continue with usual care (consultations with their GP when needed). Patients in the intervention group receive the intervention, comprising a series of consultations between the patient and GP (at least three). During the first intervention consultation (3: Consultation 1), the patient and GP discuss how the patient feels about their medical treatment, and the GP provides the patient with written material for the patient to prepare prior to the next consultation. The patients prepare (4: Preparation) by considering and verbalizing their goals of care and treatment preferences. Simultaneously, a clinical pharmacist examines the patient's medication list and provides suggestions to the GP on which drugs can be continued and deprescribed, respectively. During the next intervention consultation (5: Consultation 2), the patient and GP discuss the patient's preferences and initiate deprescribing initiatives aligned with the patient's priorities. During a new intervention consultation (6: Consultation 3), the patient and GP follow up on the changes initiated and initiate new deprescribing initiatives if such can be identified. If needed, subsequent intervention consultations (7: Consultation X) are planned until the patient and GP consider the patient's medical treatment optimal. A project nurse visits all patients (both patients randomized to the control and intervention group, respectively) at home 3 and 6 months after first home visit to retrieve follow-up measurements (8: Follow-ups). A project nurse retrieves medication lists at 3 months, 6 months, and 12 months.
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)
入排标准
- 年龄范围
- 80 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 80 years
- •Take ≥ 8 different medications
- •Have a life expectancy of <2 years, estimated via the Surprise Question ("Would you be surprised if this patient died within 1-2 years?") by the general practitioner
- •have a Mini-Mental State Exam (MMSE) score of ≥18
- •Are able to provide informed consent
排除标准
- •Not able to communicate
- •Does not speak and understand Danish
研究组 & 干预措施
Control group
The control group will not receive a series of consultations with their general practitioner. Controls will receive baseline measurements and follow-up measurements 3 months and 6 months following baseline measurements.
Intervention group
The intervention will comprise a series of consultations between the patient and general practitioner (at least three), where the patient and general practitioner will continuously adjust the patient's medication according to the patient's goals, needs, and preferences. Interventions will receive baseline measurements and follow-up measurements 3 months and 6 months following baseline measurements.
干预措施: Deprescribing intervention (Behavioral)
结局指标
主要结局
HEALTH-RELATED QUALITY OF LIFE
时间窗: Baseline
Health-related quality of life will be measured using the Danish version of the Short Form 12 Health Survey Version 2 (SF-12v2).
HEALTH-RELATED QUALITY OF LIFE (DEPRESSION)
时间窗: Baseline
Health-related quality of life will be measured using the Danish version of the Depression List (DL).
CHANGE FROM BASLINE HEALTH-RELATED QUALITY OF LIFE AT 3 MONTHS
时间窗: 3 months
Health-related quality of life will be measured using the Danish version of the Short Form 12 Health Survey Version 2 (SF-12v2).
CHANGE FROM BASLINE HEALTH-RELATED QUALITY OF LIFE AT 6 MONTHS
时间窗: 6 months
Health-related quality of life will be measured using the Danish version of the Short Form 12 Health Survey Version 2 (SF-12v2).
CHANGE FROM BASLINE HEALTH-RELATED QUALITY OF LIFE (DEPRESSION) AT 3 MONTHS
时间窗: 3 months
Health-related quality of life will be measured using the Danish version of the Depression List (DL).
MORTALITY
时间窗: 12 months
Mortality will be assessed through the nationwide Danish Central Person Registry (CPR).
CHANGE FROM BASLINE HEALTH-RELATED QUALITY OF LIFE (DEPRESSION) AT 6 MONTHS
时间窗: 6 months
Health-related quality of life will be measured using the Danish version of the Depression List (DL).
MORTALITY
时间窗: 3 months
Mortality will be assessed through the nationwide Danish Central Person Registry (CPR).
MORTALITY
时间窗: 6 months
Mortality will be assessed through the nationwide Danish Central Person Registry (CPR).
次要结局
- NUMBER OF MEDICATION DISCONTINUED(3 months, 6 months and 12 months)
- COGNITIVE FUNCTION(Baseline, 3 months and 6 months)
- FUNCTIONAL LEVEL(Baseline, 3 months and 6 months)
- HAND-GRIP STRENGTH(Baseline, 3 months and 6 months)
- NUMBER OF MEDICATION CHANGES(3 months, 6 months and 12 months)
- HOSPITAL ADMISSIONS(3 months, 6 months and 12 months)
- HEALTH CARE COSTS(3 months, 6 months and 12 months)
- SUCCESS RATE OF THE INTERVENTION(3 months, 6 months and 12 months)
研究者
Carina Lundby
Postdoctoral Researcher
Odense University Hospital
