Alerting on Adverse Drug Reactions: Falls Prevention Improvement Through Developing a Computerized Clinical Support System: Effectiveness of Individualized medicaTion Withdrawal
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 20
- 主要终点
- Time to first injurious fall
研究概览
简要总结
Falls in older adults represents a growing public health challenge. The use of certain medication is recognized as an important modifiable risk factor for falls. Research indicates fall-risk increasing drug (FRID) deprescribing is effective in reducing falls but difficult to initiate and to sustain over longer periods of follow-up. A clinical decision support system (CDSS) and patient portal for communicating medication-related fall risk to fall clinic patients may improve joint medication management between patients and physicians and consequently reduce the incidence of injurious falls.
详细描述
This study investigates the effectiveness and cost-effectiveness of the concurrent use of a CDSS and a patient portal for personalized FRID deprescribing, and will be assessed through a multicenter cluster-randomized controlled trial among new fall clinic patients, aged 65 years or older. The main study parameter is the time to first injurious fall. The primary objective of the ADFICE_IT study is to investigate the effects of a CDSS and accompanying patient portal for optimizing FRID deprescribing on injurious falls. This study has three secondary objectives. First, the effect of the CDSS and patient portal on a number of secondary outcomes will be investigated. Second, a process evaluation to evaluate the implementation of the CDSS and patient portal will be conducted. Third, the cost-effectiveness of the CDSS and patient portal will be investigated.
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 (Participant)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •History of at least one fall in the past year;
- •A Mini-Mental State Examination (MMSE) score of 21 points or higher or equivalently a Montreal Cognitive Assessment (MOCA) Dutch score of 16 points or higher;
- •Use of at least one fall-risk increasing drug (FRID); and
- •Sufficient command of the Dutch language in speech and writing.
排除标准
- •Active participation in another study;
- •Life expectancy of less than one year: and/or
- •Suffering from severe mobility impairment (i.e. bedridden, e.g. inability to walk short distances with assistance of a walking aid).
结局指标
主要结局
Time to first injurious fall
时间窗: 12 months
This concerns the time to the first injurious fall. An injurious fall is defined as a fall resulting in wounds, bruises, sprains, cuts, medically recorded fractures, head or internal injury, requiring medical/health professional examination, accident and emergency treatment, or inpatient treatment.
次要结局
- Number of injurious falls(12 months)
- Total number of falls resulting in any injuries(12 months)
- Total number of falls(12 months)
- The Older Persons and Informal Caregivers Minimum Data Set-Short Form (TOPICS-SF)(at baseline and 12 months)
- iMTA Productivity Cost Questionnaire (iPCQ)(at baseline, 3 months, 6 months, and 12 months)
- Time to first fall resulting in any injuries(12 months)
- Time to first non-injurious fall(12 months)
- EuroQol-5D-5L (EQ-5D-5L)(at baseline, 3 months, 6 months, and 12 months)
- iMTA Medical Consumption Questionnaire (iMCQ)(at baseline, 3 months, 6 months, and 12 months)
研究者
Prof. dr. Nathalie van der Velde
Full Professor Geriatric medicine (internal medicine)
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)