The Geriatric Acute & Post-acute Care Coordination Program for Fall Prevention in the Emergency Department II

NCT04304495 | Completed DMC

• 2 other identifiers: 22-2089K76AG059983
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 3

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.

Conditions

Fall

Keywords

prevention; emergency department; digital health; Apple Watch; physical therapy; pharmacy; GAPcare; Geriatric

Outcome Measures

Primary Outcomes (1)

• Rate of study activity completion

  Rate of participants who completed all study activities, including initial enrollment and multiple follow up visits over a 12 month period

  12 months

Secondary Outcomes (7)

• Change in gait speed

  12 months

• Change in activity level

  12 months

• Number of recurrent falls

  12 months

• Number of ED re-visits

  12 months

• Rate of hospitalization

  12 months

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Other: Fall Prevention

Usual care arm

NO INTERVENTION

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.

Interventions

Fall Prevention OTHER

The intervention arm participants will receive a physical therapy and pharmacy consults as well as Apple Watch training and an Apple Watch device to test memory and mobility during the ED visit and during our home visits.

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute on Aging (NIA): collaborator
• Apple Inc.: collaborator

Study Sites (3)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (1)

• 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.

  PMID: 33792553 BACKGROUND

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Elizabeth M Goldberg, MD, ScM

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will be randomly assigned (by the REDCap program) 1:1 to the intervention or usual care arm.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: March 11, 2020
• Study Start: January 6, 2021
• Primary Completion: February 2, 2025
• Study Completion: May 2, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Locations

US (3)