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Falls (Accidents) in Old AgeGAPcareNCT03360305

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

A study testing GAPcare intervention in people with Falls (Accidents) in Old Age, run by Rhode Island Hospital at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Falls (Accidents) in Old Age
What is being tested?
GAPcare intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
2 sitesUnited States
Study dates
25 Jan 2018to 31 Oct 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • The Miriam Hospital

    Providence, Rhode Island, 02906

Other trials in United States

About this study

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.

Read the detailed description

Falls are the leading cause of fatal and non-fatal injury among older adults. EDs frequently evaluate older adults after their falls, but the typical evaluation consists of an injury assessment alone. There is a critical need for an ED-based intervention that addresses reasons for the fall and provides on-the-spot assessment and guidance to prevent subsequent falls. Failure to prevent subsequent falls will result in increased morbidity, mortality, healthcare utilization, loss of independence, and rising health care costs as the population of older adults increases.

Participants in GAPcare will be older adults (≥65 years-old) who present to the ED for a fall. We will pursue the following specific aims to test and further refine the GAPcare intervention: (1) Examine the feasibility of recruitment and retention of eligible patients into the GAPcare intervention, (2) determine the initial efficacy of the GAPcare intervention in reducing subsequent falls and healthcare utilization at 6 months. Our long-term goal is to prevent the early morbidity and mortality of older adults who present to the ED after a fall. The overall objective of this survey is to gather preliminary data on the feasibility of an ED based fall prevention project.

Being tested
GAPcare intervention
Keywords
emergency department, prevention, transitions of care
Medical subject headings
Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GAPcare interventionBehavioural

    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.

Study groups in NCT03360305
Study groupRoleWhat they receive
Usual careNo interventionThe 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.
InterventionExperimental1. 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.
Receives: Behavioral: GAPcare intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 Months

Secondary outcomes (2)

  1. Initial efficacy

    Determine if the GAPcare intervention versus usual care reduces subsequent falls and all-cause and fall-related ED visits and hospital admissions in the six-month follow-up. We will compare the proportion and number of falls, ED visits, and hospital admissions in each group using chi-square (proportions) and Wilcoxon's and Student's t-tests (occurrence). If sample size permits, we will conduct survival analysis to do a time-to-event analysis. Survival time will be defined as the time from randomization to the time of the first recurrent fall, next ED visit, and hospital admission. First, we will use the Kaplan-Meier method to estimate the cumulative probability of fall-free and visit-free survival time. Next, we will use the log-rank test to test differences between survival curves for the intervention vs. usual care arm. Finally, hazard ratios and 95% confidence intervals will be calculated using the Cox Proportional Hazards model.

    Measured: 12 Months

  2. Feedback

    We will gather feedback from clinicians and patients on the utility and barriers of the GAPcare intervention versus usual care. We will assess 1) patient satisfaction with the care delivered, 2) barriers and facilitators of the intervention, 3) suggestions for improvement, and 4) specific feedback from clinicians on the suitability of the intervention to an ED setting. Researchers will review and code each transcript independently. A consensus process will follow, in which the researchers will categorize data into common themes within each of the 4 domains.

    Measured: 21-24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2017
  2. Study start25 Jan 2018
  3. Primary completion29 Mar 2019
  4. Study completion31 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03360305
Sponsor's protocol ID
GAPcare
Other IDs
R03AG056349
Acronym
GAPcare
Status last verified
Jul 2020
First submitted
27 Nov 2017
Last updated
9 Jul 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31463079

  • 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.

    PubMed 31621901

  • 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.

    PubMed 32854965

Questions about this trial

What is this clinical trial studying?

A study testing GAPcare intervention in people with Falls (Accidents) in Old Age, run by Rhode Island Hospital at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Implementing Intervention in Emergency Department (time frame: 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03360305, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020; AzTrials last refreshed its copy on 29 Oct 2026.

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