NCT03360305

Brief Summary

GAPcare (Geriatric Acute \& Post-acute Care Coordination Program for Fall Prevention) is an early stage investigation that enrolls older adults who present to the Emergency Department after a fall to determine the feasibility of an Emergency Department (ED)-based multidisciplinary intervention for preventing recurrent falls in older adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 4, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 25, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

July 9, 2020

Status Verified

July 1, 2020

Enrollment Period

1.2 years

First QC Date

November 27, 2017

Last Update Submit

July 7, 2020

Conditions

Falls (Accidents) in Old Age

Keywords

emergency departmentpreventiontransitions of care

Outcome Measures

Primary Outcomes (1)

  • Feasibility of Implementing Intervention in Emergency Department

    Assess the feasibility of implementing this intervention in an ED setting. We will report enrollment, reasons for accepting or declining enrollment, and drop-out from the study using the CONSORT approach. We will compare the demographic characteristics of the GAPcare participants in both arms using Chi-square or Fisher's exact test for categorical variables and Student's t-test or Wilcoxon's test for continuous variables, as appropriate. We will use Wilcoxon's test to compare the median ED length of stay between participants of both study arms.

    12 Months

Secondary Outcomes (2)

  • Initial efficacy

    12 Months

  • Feedback

    21-24 Months

Study Arms (2)

Usual care

NO INTERVENTION

The ED clinician will perform a standard medical evaluation. This evaluation includes a focused history and exam to identify injuries. Laboratory tests and radiologic imaging may be ordered. If necessary, the patient will receive consultation with specialty services (e.g., orthopedics). The research assistant (RA) will read the CDC STEADI brochure to the patient and provide them with a printed copy at the conclusion of their visit. The RA will solicit feedback from the clinician and the patient at the conclusion of the visit using the post-visit survey.

Intervention

EXPERIMENTAL

1. ED clinician will perform standard medical evaluation, including focused history and exam to identify injuries. RA will solicit feedback from clinician and patient via post-visit survey at conclusion of visit. 2. PT will perform services, including integrative mobility training and lower extremity strength training and recommending outpatient services/referrals. Specific assessments and treatments will be tailored to patient. 3. Pharmacist will perform a medication review using the updated BEERS criteria and CDC's STEADI instrument and recommend changes to potential fall risk increasing medication. Recommendations will be communicated to ED treatment team. 4. Seniors will return home with standardized checklist containing details of their assessment and action plan. The checklist addresses patient's personal risk factors for the fall and required further actions.

Behavioral: GAPcare intervention

Interventions

GAPcare interventionBEHAVIORAL

Subjects will receive PT and pharmacist evaluation. PT will help determine whether subject may benefit from doing exercises to improve strength or balance. PT may also supply subject with an assist device. A pharmacist will ask patient about any medication they are taking and will make recommendations on how their medication could be changed to prevent falls. Pharmacists will communicate this information to subject's doctors. Subjects will receive a fall calendar for home, where they will record any falls they have after their discharge from the ED. They will receive a phone call at home asking about any recent falls and health care interactions. Study personnel will call subjects every 2 weeks for 6 months. Subjects may receive a referral for outpatient or home-based physical and occupational therapy at the end of the visit.

Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Community-dwelling adult (non-institutionalized) 65 years-old or older presenting to ED after a fall
  • Able to communicate in English
  • 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, or rehabilitation at completion of ED visit (i.e., not admitted)
  • Legally authorized representative present to give informed consent if patient has cognitive impairment on Six Item Screener (score of less than four)

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (3)

  • Goldberg EM, Resnik L, Marks SJ, Merchant RC. GAPcare: the Geriatric Acute and Post-acute Fall Prevention Intervention-a pilot investigation of an emergency department-based fall prevention program for community-dwelling older adults. Pilot Feasibility Stud. 2019 Aug 27;5:106. doi: 10.1186/s40814-019-0491-9. eCollection 2019.

    PMID: 31463079BACKGROUND

  • Goldberg EM, Marks SJ, Ilegbusi A, Resnik L, Strauss DH, Merchant RC. GAPcare: The Geriatric Acute and Post-Acute Fall Prevention Intervention in the Emergency Department: Preliminary Data. J Am Geriatr Soc. 2020 Jan;68(1):198-206. doi: 10.1111/jgs.16210. Epub 2019 Oct 17.

    PMID: 31621901RESULT

  • Goldberg EM, Marks SJ, Resnik LJ, Long S, Mellott H, Merchant RC. Can an Emergency Department-Initiated Intervention Prevent Subsequent Falls and Health Care Use in Older Adults? A Randomized Controlled Trial. Ann Emerg Med. 2020 Dec;76(6):739-750. doi: 10.1016/j.annemergmed.2020.07.025. Epub 2020 Aug 25.

    PMID: 32854965DERIVED

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Data extractors will be blinded to the specific study arm each participant has been randomized to.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Emergency Medicine

Study Record Dates

First Submitted

November 27, 2017

First Posted

December 4, 2017

Study Start

January 25, 2018

Primary Completion

March 29, 2019

Study Completion

October 31, 2019

Last Updated

July 9, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(2)