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Accidental FallsED-STEADINCT02167737

The Emergency Department Stopping Elderly Accidents, Deaths and Injuries Program

A study testing Bedside Decision Aid in people with Accidental Falls and Falling Injury, run by Lehigh Valley Hospital at 1 site 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

This study aims to determine if a bedside decision aid used in the ED for mechanical fall prevention can increase patient participation in management options that decrease their fall risk. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Bedside Decision Aid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteUnited States
Study dates
May 2014to Sep 2018
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

  • Patients must:
  • Be 65 years of age or older
  • Be discharged home from the ED
  • Be able to speak English.
  • Be competent and able to give consent (not in critical condition, intoxicated or otherwise incapacitated)
  • Have a mechanical fall risk as defined by one of the following:
  • Reports to have fallen in the last year Reports worrying about falling Admits they feel unsteady when standing or walking

Who cannot join

  • Patients must not:
  • Be younger than 65 years old
  • Be discharged from the ED to anywhere, but home (i.e., must not be discharged to family member's home, personal care facility, nursing home, group home, etc.)
  • Be unable to speak English
  • Be incompetent and unable to give consent (in critical condition, intoxicated or otherwise incapacitated)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Lehigh Valley Hospital, Emergency Medicine Research

    Bethlehem, Pennsylvania, 18017

Other trials in United States

About this study

Official title: "ED-STEADI:" The Emergency Department Stopping Elderly Accidents, Deaths and Injuries Program (A Pilot Study)

This study aims to determine if a bedside decision aid used in the ED for mechanical fall prevention can increase patient participation in management options that decrease their fall risk. Additionally, the investigators aim to determine if there are gender differences in patient choices in management options and accomplished goals inspired by the decision tool.

Read the detailed description

This prospective, randomized controlled study will be conducted when there is a member of the research team available to consent patients at a Level I Trauma Center with approximately 90,000 annual ED visits across all age groups. Each potentially eligible patient will be identified by the research team and approached in the ED. Consented and enrolled patients will be assigned a study identification number and the enrollment documented by a member of the research team in the ED's electronic medical record after subjects are confirmed to meet inclusion and exclusion criteria. Subjects will be assigned randomly (by using a computer generated sequence) to either the control or intervention study arms.

Subjects in the control arm will have demographic data collected, a baseline Falls Efficacy Scale (FES) and Vulnerable Elders Survey (VES) screening completed and two STEADI Tool Kit mobility tests administered (the "TUG" [Timed Up and GO] and the 30-Second Chair Stand test). The FES and VES are validated surveys measuring fall concern and functional decline. The research team will advise them that they have a risk of falling as identified by inclusion criteria and that we are advising them to take action to prevent future falls. They will be given the brochure, "What YOU Can Do to Prevent Falls," that is standardized information recommended in the STEADI Tool Kit for Health Care Providers by the Centers for Disease Control (CDC).

Subjects in the active arm will also have demographic data collected, a baseline FES and VES screening completed, and two STEADI Tool Kit mobility tests administered (the "TUG" [Timed Up and GO] and the 30-Second Chair Stand test). Their risk of falling will be reviewed with them using a bedside decision aid indicating what they can do to decrease their risk. Particular attention will be given to personalizing their fall risk. The fall prevention management options will be presented in a value neutral fashion, along with the advantages and disadvantages of each option. They will have an opportunity to discuss what outcomes are the most important to them and choose the management options from the list provided that are the most valuable to them. Study and treatment team members will then work with this agreed upon selection to provide reliable intervention and outpatient follow up to improve the gains that can be realized in an integrated healthcare system. If the participant chooses to do their own home safety evaluation, they will be provided with a checklist to guide them in looking for hazards in their home and how to fix them. The patient will keep the original copy of their decision aid with their agreed-upon selected treatment options, and a copy of it will be placed in the subject's study file. All actions that are in response to the subject's selected plan (prescriptions, appointments, etc.) will also be documented in the study file.

Both groups will have phone follow-up at 6 weeks post ED visit, and then again at 3, 6, 9 and 12 months to collect self-reported data about goal completion and fall history. The last phone follow-up will include an exit FES and VES reassessment. All participants in both arms will have data collected about their inpatient and outpatient visits throughout the network during the study period to corroborate their self-report (e.g., occupational therapy, physical therapy visits, hospital admissions or ER visits for injuries related to a fall, etc.).

Being tested
Bedside Decision Aid, Control Arm
Keywords
Accident Prevention, Accidental Falls, Geriatric Health Services, Gender Differences

What participants receive

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

  • Bedside Decision AidBehavioural

    This group will have an initial FES and VES screening completed in the ED, the TUG test and Chair 30-Second Stand test, and the participant's risk of falling evaluated using our Bedside Decision worksheets. A study team member explains what subjects can do to decrease their risk of falling and discuss what mobility goals are the most important to them.

    Participants will receive a follow-up telephone call approximately six weeks after their discharge from the ED to collect self-reported data about goal completion, and then at four additional times--three, six, nine and 12 months--over the course of a year to collect self-reported data such as fall history.

  • Control ArmBehavioural

    This group will also have an initial FES and VES screening completed in the ED and the same two mobility tests (TUG and Chair 30-Second Stand). Study staff will advise subjects on how to take action to prevent falls and give them a brochure, "What YOU Can Do to Prevent Falls," from the CDC's "STEADI Tool Kit for Health Care Providers."

    Participants will receive a telephone call approximately six weeks after their discharge from the ED to collect self-reported data about goal completion, and then at four additional times--three, six, nine and 12 months--over the course of a year to collect self-reported data such as fall history.

Study groups in NCT02167737
Study groupRoleWhat they receive
Bedside Decision Aid GroupExperimentalThis arm will include study participants who are randomized to the group utilizing the bedside decision aid, which has hospital staff arrange fall-risk reduction interventions (e.g., home safety checks, exercise programs, vision checks, etc.).
Receives: Behavioral: Bedside Decision Aid
Control ArmActive comparatorParticipants in the control/comparator arm will experience the same study procedures with the exception of not using the Bedside Decision Aid and instead being given the Centers for Disease Control (CDC) brochure, "What You Can Do to Prevent Falls," and arranging for their own fall prevention strategies.
Receives: Behavioral: Control Arm

What is being measured

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

  1. Efficacy of the bedside decision tool/worksheet

    A single sheet bedside decision aid form/worksheet will be used to engage the patient in a discussion about fall prevention, the aim of which is to increase patient interest and participation in different management options that decrease fall risk. Patients will be followed up via phone calls re: their management option choices and how thorough/successful they were in completing them.

    Measured: 12 months

Secondary outcomes (1)
  1. Gender differences in use of the decision tool

    Responses from the bedside decision tool choices will be grouped by gender to determine if men and women select different management options and/or have different patterns in completing them.

    Measured: 12 months

Timeline

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

  1. First posted19 Jun 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionSep 2018
  4. Study completionSep 2018

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
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02167737
Sponsor's protocol ID
#PRO-00001450
Acronym
ED-STEADI
Status last verified
Aug 2019
First submitted
14 Jun 2014
Last updated
13 Aug 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No: No plan to share IPD, just publish the study's results.

Questions about this trial

What is this clinical trial studying?

A study testing Bedside Decision Aid in people with Accidental Falls and Falling Injury, run by Lehigh Valley Hospital at 1 site 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 7 inclusion and 5 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 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Efficacy of the bedside decision tool/worksheet (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 13 Aug 2019.

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