Implementation of a De-prescribing Medication Program to Evaluate Falls in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Changes in Opioid and/or BZD use
研究概览
简要总结
Purpose: The proposed study will implement and evaluate the effect of an opioid and benzodiazepine (BZD) de-prescribing intervention on falls risk in older adults.
Participants: Outpatient clinics with older adult patients, healthcare providers, older adult patients
Procedures (methods): In this proposed study, there will be 10 primary care clinics randomly assigned to the intervention arm and 10 primary care clinics randomly assigned to the control arm. In the first phase of this study, patient and provider focus groups will be used to inform the development of the intervention which will be tested during the active trial phase. The intervention has the following components: 1) alerts given to providers to identify patients taking opioids or benzodiazepines (BZD) and therefore at risk for falls; 2) educational materials to inform providers on best practices for de-prescribing opioids and BZDs in patients at risk; and 3) recommendations on de-prescribing provided by a consultant pharmacist. Impact of the intervention will be evaluated using pre-post surveys evaluating changes in providers' knowledge, confidence, and skills as well as information from the electronic health record (EHR) to evaluate impact of the intervention on de-prescribing opioids and BZDs.
详细描述
Falls among older adults is costly and dangerous. Observational studies show consistent associations between falls and certain medications. It is widely accepted that falls-related morbidity and mortality could be reduced if systems were in place to identify falls risks and intervene to reduce the risks identified. In this study, health care professionals (HCPs) within UNC outpatient clinics will be alerted to patients on high-risk medications and provide team-based interventions to maximize the success of falls education and medication deprescribing.
This deprescribing intervention will focus specifically on opioids and benzodiazepines (BZDs) in patients 65 years of age and older since these medications have high susceptibility to negative cognitive effects in older adults and contribute to a higher risk of falls. This study will identify factors affecting the adoption, effective implementation, and maintenance of a deprescribing program focused on opioids and BZDs with the intent of reducing falls.
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
- None
盲法说明
As this is a pragmatic design, there will be no blinding for this study.
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
- •UNC HealthCare clinic providing primary care services
- •age at least 65 years old
- •taking at least one chronic opioid or one chronic benzodiazepine medication
排除标准
- •Clinics that do not provided primary care services
- •Patients who exhibit signs of cognitive impairment or speech/hearing deficits that make obtaining informed consent and completing data collection activities difficult
- •Patients undergoing active cancer treatment, receiving hospice care, or living in a skilled nursing facility
- •Non-English speaking patients will be excluded from participating in the patient focus group.
- •Participants who do not wish to be audio-recorded during focus group
结局指标
主要结局
Changes in Opioid and/or BZD use
时间窗: 1 year pre-intervention, 1 year post intervention
Changes in opioid use will be measured using milligram morphine equivalents per day and benzodiazepine use will be measure using lorazepam or diazepam equivalents per day
次要结局
- Frequency of Falls(1 year pre-intervention, 1 year post intervention)