Clinical trial NCT04304495: The Geriatric Acute & Post-acute Care Coordination Program for Fall Prevention in the Emergency Department II
Official title: GAPcare II: The Geriatric Acute & Post-acute Care Coordination Program for Fall Prevention in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall
Keywords: prevention
emergency department
digital health
Apple Watch
physical therapy
pharmacy
GAPcare
Geriatric
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Apple Inc.
First posted: 2020-03-11
Enrollment: 197
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of study activity completion
timeFrame: 12 months
Secondary outcomes:
measure: Change in gait speed
timeFrame: 12 months
measure: Change in activity level
timeFrame: 12 months
measure: Number of recurrent falls
timeFrame: 12 months
measure: Number of ED re-visits
timeFrame: 12 months
measure: Rate of hospitalization
timeFrame: 12 months
measure: Rate of permanent moves to nursing homes
timeFrame: 12 months
measure: Mortality rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: University of Colorado, Denver
name: Elizabeth M Goldberg, MD, ScM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Strauss DH, Davoodi NM, Healy M, Metts CL, Merchant RC, Banskota S, Goldberg EM. The Geriatric Acute and Post-Acute Fall Prevention Intervention (GAPcare) II to Assess the Use of the Apple Watch in Older Emergency Department Patients With Falls: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2021 Apr 1;10(4):e24455. doi: 10.2196/24455.