N/A N=430 Randomized Double-blind Supportive Care

Trauma Medical Home for Older Injured Patients

Injuries

Bottom Line

View on ClinicalTrials.gov: NCT03108820 ↗

Enrolled (actual)

430

Serious AEs

0.0%

Results posted

Jun 2024

Primary outcome: Primary: Change in Self Reported Physical Recovery — 40.42; 39.18 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: TMH Intervention (Behavioral); Usual Care (Other)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Indiana University
Primary completion: Mar 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Self Reported Physical Recovery	36.86; 38.04	—
PRIMARY Change in Physical Recovery	7.02; 7.66	—
PRIMARY Change in Self Reported Psychological Recovery	53.72; 53.01	—
PRIMARY Healthcare Utilization	70; 71; 146; 142	—
PRIMARY Change in Self Reported Physical Recovery	36.86; 38.04	—
PRIMARY Change in Physical Recovery	7.02; 7.66	—
PRIMARY Change in Self Reported Psychological Recovery	53.72; 53.01	—
SECONDARY Change in Depression Symptoms	4.73; 4.31	—
SECONDARY Change in Anxiety Symptoms	3.64; 3.60	—
SECONDARY Cost Effectiveness	—	—
SECONDARY Change in Depression Symptoms	4.73; 4.31	—
SECONDARY Change in Anxiety Symptoms	3.64; 3.60	—

Summary

This proposal aims to conduct a randomized controlled trial to evaluate the efficacy of a 6-month collaborative care intervention in improving the functional and psychological recovery of 430 injury survivors 50 and older. The trial has the following specific aims: 1) Evaluate the ability of the TMH intervention to improve the physical recovery of older injury survivors; and 2) Evaluate the ability of the TMH intervention to improve the psychological recovery of older injury survivors; and 3) Evaluate the ability of the TMH intervention to reduce healthcare costs of older injury survivors and evaluate the cost of effectiveness of the TMH intervention.

Eligibility Criteria

Inclusion Criteria

English-speaking adult age 50 years and older;
admitted to Indiana University Health - Methodist or Eskenazi Health hospitals;
able to provide consent or has a legally authorized representative to provide consent;
access to a telephone;
and an injury severity score (ISS) of 9 or greater.

Exclusion Criteria

have a self-reported diagnosis of cancer with short life expectancy;
have a history of dementing illnesses and other neurodegenerative disease such as Alzheimer disease, Parkinson disease, or vascular dementia;
have a significant traumatic brain injury (defined as the presence of any intracranial blood on Computed Tomography scan of the head or best Glasgow Coma Scale Score of less than 13 at the time of study enrollment);
have any spinal cord injury with persistent neurologic deficit at the time of study enrollment;
are pregnant women (assessed by a urine pregnancy test);
have a primary residence outside the state of Indiana;
are incarcerated at the time of study enrollment;
have an acute stroke upon admission or develop a stroke as a new event during the course of hospitalization;
unable to complete study questionnaire due to severe hearing loss;
recent history of alcohol or substance abuse;
discharged to a permanent care facility;
admitted with a burn affecting >10% total body surface area.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03108820). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.