GAPcare II: The Geriatric Acute & Post-acute Care Coordination Program for Fall Prevention in the Emergency Department
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 197
- Locations
- 6
- Primary Endpoint
- Rate of study activity completion
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
Participants will be randomly assigned (by the REDCap program) 1:1 to the intervention or usual care arm.
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Rate of study activity completion
Time Frame: 12 months
Rate of participants who completed all study activities, including initial enrollment and multiple follow up visits over a 12 month period
Secondary Outcomes
- Number of recurrent falls(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)
- Change in activity level(12 months)