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

February 13, 2024 updated by: University of Colorado, Denver

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

197

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • The Miriam Hospital
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.

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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in gait speed
Time Frame: 12 months
Apple watch determined; average change in gait speed over 12-month follow-up
12 months
Change in activity level
Time Frame: 12 months
Apple watch determined; average change in proportion of time spent active per day (e.g. walking, running, not driving or sedentary)
12 months
Number of recurrent falls
Time Frame: 12 months
Number of falls in person months
12 months
Number of ED re-visits
Time Frame: 12 months
Any visit to the ED in the 12-month follow-up
12 months
Rate of hospitalization
Time Frame: 12 months
Any hospital admission in the 12-month follow-up
12 months
Rate of permanent moves to nursing homes
Time Frame: 12 months
Any move to a nursing home for >30 days
12 months
Mortality rate
Time Frame: 12 months
All cause patient mortality in follow-up
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Elizabeth M Goldberg, MD, ScM, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2021

Primary Completion (Estimated)

August 2, 2024

Study Completion (Estimated)

August 2, 2025

Study Registration Dates

First Submitted

December 6, 2019

First Submitted That Met QC Criteria

March 9, 2020

First Posted (Actual)

March 11, 2020

Study Record Updates

Last Update Posted (Actual)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-2089
  • K76AG059983 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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