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The Emergency Department Stopping Elderly Accidents, Deaths and Injuries Program (ED-STEADI)

Primary Purpose

Accidental Falls, Falling Injury, Other and Unspecified Fall on Same Level

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bedside Decision Aid
Control Arm
Sponsored by
Lehigh Valley Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Accidental Falls focused on measuring Accident Prevention, Accidental Falls, Geriatric Health Services, Gender Differences

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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)

Sites / Locations

  • Lehigh Valley Hospital, Emergency Medicine Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bedside Decision Aid Group

Control Arm

Arm Description

This 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.).

Participants 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 14, 2014
Last Updated
August 12, 2019
Sponsor
Lehigh Valley Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02167737
Brief Title
The Emergency Department Stopping Elderly Accidents, Deaths and Injuries Program
Acronym
ED-STEADI
Official Title
"ED-STEADI:" The Emergency Department Stopping Elderly Accidents, Deaths and Injuries Program (A Pilot Study)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lehigh Valley Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.
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.).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Accidental Falls, Falling Injury, Other and Unspecified Fall on Same Level
Keywords
Accident Prevention, Accidental Falls, Geriatric Health Services, Gender Differences

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bedside Decision Aid Group
Arm Type
Experimental
Arm Description
This 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.).
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
Participants 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.
Intervention Type
Behavioral
Intervention Name(s)
Bedside Decision Aid
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control Arm
Intervention Description
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.
Primary Outcome Measure Information:
Title
Efficacy of the bedside decision tool/worksheet
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Gender differences in use of the decision tool
Description
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.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Gender differences in fall management choices
Description
Participants in *both* study arms will have phone follow-ups at the same time intervals to determine if men and women have different management option preferences and/or different patterns in completing them.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marna R. Greenberg, DO, MPH
Organizational Affiliation
Lehigh Valley Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lehigh Valley Hospital, Emergency Medicine Research
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share IPD, just publish the study's results.

Learn more about this trial

The Emergency Department Stopping Elderly Accidents, Deaths and Injuries Program

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