GAPcare II: The Geriatric Acute & Post-acute Care Coordination Program for Fall Prevention in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 197
- 试验地点
- 3
- 主要终点
- Rate of study activity completion
研究概览
简要总结
In brief, this K76 study consists of a small open trial to refine the study protocol and train study personnel on study procedures (Aim 1.b.). In Aim 2, we will recruit older adults into a multidisciplinary fall prevention pilot study. Participants will be randomly assigned to usual care with a traditional fall evaluation by an ED clinician (i.e., ED medical staff member) or an intervention. In the intervention, participants will receive an in-ED consultation by a physical therapist and pharmacist to determine reasons for the fall and offer additional education and training. Participants will be provided an Apple Watch to record measures of fitness and falls, if possible, in the following 12 months. Recurrent falls will be measured in twelve-month follow-up.
详细描述
In order to determine whether a multifactorial fall prevention intervention is feasible, acceptable and may reduce recurrent falls in older adults presenting to the ED after a fall, we will randomize patients to usual care with a traditional fall evaluation by an ED clinician or an intervention. Patients in the intervention arm receive a fall risk assessment and recommendations by a physical therapist. They are also evaluated by a pharmacist and participate in a medication therapy management session with the aim to reduce fall risk increasing medication.
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
Participants will be randomly assigned (by the REDCap program) 1:1 to the intervention or usual care arm.
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
- •Community-dwelling adult (non-institutionalized) 65 years-old or older presenting to ED after a fall
- •Fall not due to syncope or external force (i.e., struck by car or assault)
- •Fall not due to serious illness (i.e., stroke, acute myocardial infarction)
- •Will be discharged to home/assisted living/rehabilitation at completion of ED visit (i.e., not admitted)
- •Legally authorized representative able to give informed consent if patient has cognitive impairment on Six Item Screener (score of less than four) either over the phone with witness present or in person
- •Must screen or test negative for COVID-19
排除标准
- •Unable to give informed consent due to intoxication or altered mental status
- •Presence of injuries that prevent mobilization (i.e., pelvic or lower extremity fractures)
- •Allergies to any wearable device component
- •Unable or unwilling to wear Apple Watch at home (only for periodic study visits)
- •Patient has advanced cancer and/or is on hospice care
- •Pts coming from SNF or nursing home
- •Previously enrolled in GAPcare II Aim1.b
研究组 & 干预措施
Intervention
In addition to the usual care arm, the Intervention arm will receive a physical therapy and pharmacy consultation in the ED. PTs will perform a fall risk assessment and provide recommendations on the safety of discharge. Pharmacists will perform medication review, recommend cessation or tapering of medication that increase fall risk using motivational interviewing (MTM) techniques.
The participants will also receive Apple Watch training and an Apple Watch to perform tasks that test their memory and mobility during their ED visit and during our home visits at 1,3, 6, and 12 month after enrollment.
干预措施: Fall Prevention (Other)
Usual care arm
The ED clinician will perform a standard medical evaluation, including a focused history and exam to identify injuries, laboratory tests and radiologic imaging. If necessary, the patient will receive consultation with specialty services (e.g., orthopedics).
The participants will also receive Apple Watch training and an Apple Watch to perform tasks that test their memory and mobility during their ED visit and during our home visits at 1,3, 6, and 12 month after enrollment.
结局指标
主要结局
Rate of study activity completion
时间窗: 12 months
Rate of participants who completed all study activities, including initial enrollment and multiple follow up visits over a 12 month period
次要结局
- Number of recurrent falls(12 months)
- Change in activity level(12 months)
- Mortality rate(12 months)
- Change in gait speed(12 months)
- Rate of permanent moves to nursing homes(12 months)
- Number of ED re-visits(12 months)
- Rate of hospitalization(12 months)