Clinical trial NCT02167737: The Emergency Department Stopping Elderly Accidents, Deaths and Injuries Program
Official title: "ED-STEADI:" The Emergency Department Stopping Elderly Accidents, Deaths and Injuries Program (A Pilot Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Falls
Falling Injury
Other and Unspecified Fall on Same Level
Keywords: Accident Prevention
Accidental Falls
Geriatric Health Services
Gender Differences
Lead sponsor: Lehigh Valley Hospital
Sponsor class: OTHER
First posted: 2014-06-19
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.).

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)

Primary outcomes:
measure: Efficacy of the bedside decision tool/worksheet
timeFrame: 12 months
Secondary outcomes:
measure: Gender differences in use of the decision tool
timeFrame: 12 months
Other outcomes:
measure: Gender differences in fall management choices
timeFrame: 12 months
Locations:
city: Bethlehem
country: United States
facility: Lehigh Valley Hospital, Emergency Medicine Research
state: Pennsylvania
Study officials:
affiliation: Lehigh Valley Hospital
name: Marna R. Greenberg, DO, MPH
role: PRINCIPAL_INVESTIGATOR
References: