The Emergency Department Stopping Elderly Accidents, Deaths and Injuries Program
Status: | Active, not recruiting |
---|---|
Conditions: | Hospital, Hospital |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 65 - Any |
Updated: | 10/1/2017 |
Start Date: | May 2014 |
End Date: | September 2018 |
"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.
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.
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.).
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.).
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)
We found this trial at
1
site
2545 Schoenersville Road
Bethlehem, Pennsylvania 18017
Bethlehem, Pennsylvania 18017
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