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

Phase 2
Active, not recruiting
Conditions
Fall
Interventions
Other: Fall Prevention
Registration Number
NCT04304495
Lead Sponsor
University of Colorado, Denver
Brief Summary

In brief, this K76 study consists of a small open trial to refine the study protocol and train study personnel on study procedures (Aim 1.b.). In Aim 2, we will recruit older adults into a multidisciplinary fall prevention pilot study. Participants will be randomly assigned to usual care with a traditional fall evaluation by an ED clinician (i.e., ED medical staff member) or an intervention. In the intervention, participants will receive an in-ED consultation by a physical therapist and pharmacist to determine reasons for the fall and offer additional education and training. Participants will be provided an Apple Watch to record measures of fitness and falls, if possible, in the following 12 months. Recurrent falls will be measured in twelve-month follow-up.

Detailed Description

In order to determine whether a multifactorial fall prevention intervention is feasible, acceptable and may reduce recurrent falls in older adults presenting to the ED after a fall, we will randomize patients to usual care with a traditional fall evaluation by an ED clinician or an intervention. Patients in the intervention arm receive a fall risk assessment and recommendations by a physical therapist. They are also evaluated by a pharmacist and participate in a medication therapy management session with the aim to reduce fall risk increasing medication.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
197
Inclusion Criteria
  • Community-dwelling adult (non-institutionalized) 65 years-old or older presenting to ED after a fall
  • 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/rehabilitation at completion of ED visit (i.e., not admitted)
  • Legally authorized representative able to give informed consent if patient has cognitive impairment on Six Item Screener (score of less than four) either over the phone with witness present or in person
  • Must screen or test negative for COVID-19
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Exclusion Criteria
  • 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)
  • Allergies to any wearable device component
  • Unable or unwilling to wear Apple Watch at home (only for periodic study visits)
  • Patient has advanced cancer and/or is on hospice care
  • Pts coming from SNF or nursing home
  • Previously enrolled in GAPcare II Aim1.b
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
InterventionFall PreventionIn addition to the usual care arm, the Intervention arm will receive a physical therapy and pharmacy consultation in the ED. PTs will perform a fall risk assessment and provide recommendations on the safety of discharge. Pharmacists will perform medication review, recommend cessation or tapering of medication that increase fall risk using motivational interviewing (MTM) techniques. The participants will also receive Apple Watch training and an Apple Watch to perform tasks that test their memory and mobility during their ED visit and during our home visits at 1,3, 6, and 12 month after enrollment.
Primary Outcome Measures
NameTimeMethod
Rate of study activity completion12 months

Rate of participants who completed all study activities, including initial enrollment and multiple follow up visits over a 12 month period

Secondary Outcome Measures
NameTimeMethod
Number of recurrent falls12 months

Number of falls in person months

Mortality rate12 months

All cause patient mortality in follow-up

Change in gait speed12 months

Apple watch determined; average change in gait speed over 12-month follow-up

Rate of permanent moves to nursing homes12 months

Any move to a nursing home for \>30 days

Number of ED re-visits12 months

Any visit to the ED in the 12-month follow-up

Rate of hospitalization12 months

Any hospital admission in the 12-month follow-up

Change in activity level12 months

Apple watch determined; average change in proportion of time spent active per day (e.g. walking, running, not driving or sedentary)

Trial Locations

Locations (3)

The Miriam Hospital

🇺🇸

Providence, Rhode Island, United States

University of Colorado Hospital

🇺🇸

Aurora, Colorado, United States

Rhode Island Hospital

🇺🇸

Providence, Rhode Island, United States

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