Medication Rationalization for Older People Awaiting Long-term Nursing Home Care: a Randomized Controlled Trial Using the STOPPfrail Criteria
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Change in the Number of medications taken by participants from randomization to 3 months post- randomization
研究概览
简要总结
Older people often have several chronic diseases requiring several medications all at once. Taking several medications all at once is called polypharmacy. Polypharmacy is common in nursing home residents. When people take the same medication long term, the original reason for prescribing the medication may no longer be important or a priority. Polypharmacy is associated with an increased risk of harmful side effects.
STOPPfrail is a tool, designed for doctors, that highlights situations where medications may be inappropriate or harmful to frail older people. When these situations are identified, reducing or stopping the inappropriate medication should be considered. The STOPPfrail tool was developed by an expert group specializing in geriatric pharmacotherapy.
In the present research study, the investigators wish to examine whether medications can be safely reduced and stopped using the STOPPfrail tool in hospitalized frail older people who are awaiting transfer to a nursing home. The investigators will assess this method by comparing its effects with those of the current standard practice of medication management.
In the trial, participants are allocated to one of two groups. One group will have their medications evaluated using the STOPPfrail tool (intervention group). The other group will have their medications reviewed in the standard way (control group). The allocation of participants into these two groups will be done randomly to avoid any bias in the study. When participants are allocated to the intervention group, their physician will receive written advice designed to help him/her to adjust medications so as to minimize the risk of withdrawal reactions. The advice will be based on the STOPPfrail tool.
The hospital case notes and discharge summaries of the participants taking part in the trial will be reviewed at the time of discharge from hospital. Three months after recruitment, the participant's nursing home will be contacted. Information about the number and type of medications prescribed will be requested as well as details about hospitalizations, falls and the participant's well general well-being.
The main aim is to examine whether it is possible to significantly reduce the number of medications that an older frail person takes using the STOPPfrail tool. The investigators will also examine whether reducing the number of medications in this way has an effect on quality of life, unscheduled medical care, falls and the cost of medications.
详细描述
STUDY TITLE Medication Rationalization for Older People awaiting long-term nursing home care: a randomized controlled trial using the STOPPfrail criteria.
AIMS Our primary aim is to test the feasibility of applying explicit deprescribing criteria (STOPPfrail) to the medication regimens of a cohort of older, frail hospitalized patients for whom long-term care is considered necessary and compare this intervention with usual care.
Secondary aims are to estimate the effect of medication rationalization on mortality, acute hospital transfers, unscheduled medical reviews, falls and non vertebral fractures, prescription of neuroleptic antipsychotic medications and cost of medications.
BACKGROUND The majority of people transferring to nursing home care are frail and highly dependent. The average survival following admission to a nursing home in Ireland is 1.9 years.1 Despite frailty and shortened life expectancy, these patients are among the highest consumers of prescription medications. The SHELTER study reports the rate of polypharmacy (5-9 drugs) and excessive polypharmacy (≥10 drugs) in nursing home residents to be 48.7 and 24.3%, respectively.2 This is important because the number of drugs that a patient is taking is the most important predictor of adverse drug reactions (ADRs).3 ADRs are associated with ill health,4 hospitalization,5 and higher mortality.6
Transfer to a nursing home is major life event for older people and medication review in hospital prior to transfer is appropriate. Medication rationalization or deprescribing is the process of tapering and stopping medications. The goal is to prevent adverse drug reactions and to appropriately match medications to the goals of care and prognosis of the patient. Deprescribing trials have been promising to date. Garfinkel8 discontinued 332 different drugs in 119 nursing home residents (2.8 per person) and reported successful cessation of all target drugs in 82% of patients. The one-year mortality rate was 45% in the control group and 21% in the intervention group. Overall, deprescribing of medications resulted in a 53% reduction in mortality(p<0.001). Potter et al9 successfully deprescribed 207 medications in 47 residents (4.4 per patient) and while there was a trend towards improved survival in the intervention group, this did not reach statistical significance. Both trials use a similar deprescribing algorithm that requires the user to answer a series of questions about each medication before a deprescribing decision can be made. Expertise in geriatric pharmacotherapy as well as clinical judgement is required, and these factors, along with time constraints, may limit the use of these algorithms in everyday clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The researcher obtaining outcome measurements will be blinded to the group allocation of patient participants.
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Poor one-year survival prognosis as a result of irreversible pathology
- •A senior physician (consultant, registrar, or general practitioner) indicating that he or she "would not be surprised if the participant died in the next year" ('surprise question'(SQ)) and
- •Severe functional impairment (Clinical frailty Scale score ≥ 7)
- •Symptom control is the priority rather than prevention of disease progression (e.g. stringent control of blood pressure or diabetes is not a priority)
- •Prescribed ≥5 long-term medications
排除标准
- •Not taking any regular medication
- •Actively dying
- •Not competent to consent AND their next of kin does not agree to their participation
- •Prescribed <5 long-term medications
研究组 & 干预措施
Control
Patients in the control arm receive usual pharmaceutical care in hospital i.e. daily medication review by the attending physicians and ward-assigned pharmacist.
Intervention
Patients in the intervention arm receive usual pharmaceutical care as per the control group plus application of STOPPFrail deprescribing criteria advice points on their medication list at a single time point i.e. within 24 hours of randomization. The bespoke STOPPFrail advice report is presented to the patient's attending physician who then adjusts the patient's prescriptions according to the STOPPFrail advice points. The attending physician can implement as few or as many STOPPFrail advice points as he/she sees appropriate.
干预措施: STOPPFrail deprescribing criteria (Other)
结局指标
主要结局
Change in the Number of medications taken by participants from randomization to 3 months post- randomization
时间窗: At 3 months post-randomization.
Total whole number
次要结局
- Number of patients transferred to emergency department since randomization(At 3 months post-randomization.)
- Mortality(At 3 months post-randomization.)
- Change in Dementia-specific Quality of life from randomization to 3 months post randomization(At 3 months post randomization)
- Monthly medication cost(At 3 months post-randomization.)
- Change in the number of patients prescribed neuroleptic antipsychotic medications from randomization to 3 months post randomization(At 3 months post-randomization.)
- Change in Quality of life from randomization to 3 months post randomization(At 3 months post randomization)
- Number of patients that have undergone unscheduled medical reviews since randomization(At 3 months post-randomization.)
- Number of patients who have had a fall since randomization(At 3 months post-randomization.)
- Number of patients who have had a non-vertebral fracture since randomization(At 3 months post-randomization)
研究者
Denis O'Mahony
Professor, Department of Medicine
University College Cork