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

Primary Purpose

Fall

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fall Prevention
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fall focused on measuring prevention, emergency department, digital health, Apple Watch, physical therapy, pharmacy, GAPcare, Geriatric

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Colorado HospitalRecruiting
  • Rhode Island Hospital
  • The Miriam Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Usual care arm

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 6, 2019
Last Updated
April 24, 2023
Sponsor
University of Colorado, Denver
Collaborators
National Institute on Aging (NIA), Apple Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04304495
Brief Title
The Geriatric Acute & Post-acute Care Coordination Program for Fall Prevention in the Emergency Department II
Acronym
GAPcareII
Official Title
GAPcare II: The Geriatric Acute & Post-acute Care Coordination Program for Fall Prevention in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 6, 2021 (Actual)
Primary Completion Date
August 2, 2024 (Anticipated)
Study Completion Date
August 2, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Institute on Aging (NIA), Apple Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fall
Keywords
prevention, emergency department, digital health, Apple Watch, physical therapy, pharmacy, GAPcare, Geriatric

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Participants will be randomly assigned (by the REDCap program) 1:1 to the intervention or usual care arm.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Fall Prevention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of study activity completion
Description
Rate of participants who completed all study activities, including initial enrollment and multiple follow up visits over a 12 month period
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in gait speed
Description
Apple watch determined; average change in gait speed over 12-month follow-up
Time Frame
12 months
Title
Change in activity level
Description
Apple watch determined; average change in proportion of time spent active per day (e.g. walking, running, not driving or sedentary)
Time Frame
12 months
Title
Number of recurrent falls
Description
Number of falls in person months
Time Frame
12 months
Title
Number of ED re-visits
Description
Any visit to the ED in the 12-month follow-up
Time Frame
12 months
Title
Rate of hospitalization
Description
Any hospital admission in the 12-month follow-up
Time Frame
12 months
Title
Rate of permanent moves to nursing homes
Description
Any move to a nursing home for >30 days
Time Frame
12 months
Title
Mortality rate
Description
All cause patient mortality in follow-up
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katelynn Petrasic, BA
Phone
303-724-4712
Email
katelynn.petrasic@ucdenver.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth M Goldberg, MD, ScM
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katelynn Petrasic
Email
katelynn.petrasic@ucdenver.edu
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Completed
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Individual Site Status
Completed

12. IPD Sharing Statement

Citations:
PubMed Identifier
33792553
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.
Results Reference
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The Geriatric Acute & Post-acute Care Coordination Program for Fall Prevention in the Emergency Department II

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