Pilot Study of the OptiMEDs Intervention: a Complex Intervention for Multidisciplinary Medication Review (Including Nurses, Pharmacists, and Physicians) in Nursing Homes, With ICT-support for the Evaluation of the Appropriateness of Prescribing and for Side-effect Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 3
- 主要终点
- functionality problems
研究概览
简要总结
Pilot study of the OptiMEDs intervention: a complex intervention for multidisciplinary medication review (including nurses, pharmacists, and physicians) in nursing homes (NH), with ICT-support for the evaluation of the appropriateness of prescribing and for side-effect monitoring.
详细描述
The interest in improving the pharmacotherapy of older adults in nursing homes is growing. The OptiMEDs interventions intends to support the decision of GPs regarding the pharmacotherapy of older adults through the combination of an electronic decision support tool (for the appraisal of potentially inappropriate medication use, anticholinergic use, or medications that can be de-prescribed in view of limited life expectancy) with focussed nurse observations (guided by a list of potential medication symptoms based on the individual medication chart of the resident), that will serve as the basis for a multidisciplinary medication review with the input of the GP, community pharmacist and nurse.
The aim of the OptiMEDs intervention is to obtain a more appropriate, safer, and more cost-effective pharmacotherapy in nursing home residents (e.g. less medication-related symptoms, less potentially inappropriate prescribing, a better quality of life, less hospitalisations, health care usage, or mortality)
Before investigating the effectiveness of the OptiMEDs intervention in a large pragmatic clinical trial comparing results of the intervention with standard of care, a pilot study will be undertaken. The aim of the pilot study is to test the feasibility and acceptability of all components of the OptiMEDs interventions in 3 nursing homes in Flanders, Belgium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •for nursing homes:
- •located in East Flanders
- •size: > 100 beds
- •mixed population of high care dependent and low care-dependent residents with and without dementia
- •software of Care Solutions or Farmad is used for electronic handling of the medication chart
- •the NH management as well as the responsible CRA and the community pharmacist who delivers the medication in the NH give their written agreement to participate
- •Inclusion criteria for residents:
- •All residents of all wards of the participating nursing homes will be considered for inclusion if they meet the following inclusion criteria:
- •aged 65 years or older
- •mentally fit as well as cognitive impaired NH residents will be included after Informed Consent given by the resident (mentally capable residents) or his representative (cognitive impaired residents, defined as a sumscore of 6 or more on the KATZ items of disorientation in time and place).
排除标准
- •for residents
- •Residents will not be considered for inclusion if:
- •they have a limited life-expectancy (less than 3 months, as judged and documented by the treating GP)
- •they are residing in a short-stay / revalidation bed
- •GP refused to have his NH residents included in this pilot
研究组 & 干预措施
Intervention
The intervention group (i.e. all eligible and consented residents of 2 NHs) will receive the OptiMEDs intervention: the combination of an electronic decision support tool (for the appraisal of potentially inappropriate medication use, anticholinergic use, or medications that can be de-prescribed in view of limited life expectancy) with focused nurse observations (using a list of potential medication-related symptoms based on the individual medication chart of the nursing home residents), that will serve as the basis during a multidisciplinary medication review with the input of GPs, trained community pharmacists and nurses.
干预措施: OptiMEDs (Device)
Control
The control group (i.e. all eligible and consented residents of one control NH) will receive usual care .
结局指标
主要结局
functionality problems
时间窗: 6 months
Number of functionality problems (n)
practical problems
时间窗: 6 months
listing of practical problems for organizing the medication chart review
workload
时间窗: 6 months
Timing of workload for nurses \& pharmacists regarding the use of OptiMEDs (time)
medication chart review
时间窗: 6 months
duration of a medication chart review by GP and nurse (time)
GPs that refuse
时间窗: 6 months
number of GPs that refuse to participate / accept to participate (n)
Optimeds completion
时间窗: 6 months
Number of symptom observations and medication reviews completed (on time) (n)
Software/user problems
时间窗: 6 months
monthly number of interventions for software/user problems (n)
non-consenting eligible residents (n)
时间窗: 6 months
Number of non-consenting eligible residents legally capable to give consent (n)
Non-consenting proxies for eligible residents (n)
时间窗: 6 months
Number of non-consenting proxies for eligible residents legally not capable to give consent
次要结局
- Number of Consultations(4 months)
- number of anticholinergics(4 months)
- patient-related alertness(4 months)
- patient-related falls(4 months)
- number of medications(4 months)
- patient-related QOL(4 months)
- Number of Hospitalization(4 months)
- number of candidates for de-prescribing(4 months)
- patient-related pain(4 months)