Study Results
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View full resultsBasic Information
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COMPLETED
NA
430 participants
INTERVENTIONAL
2017-10-01
2023-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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TMH Intervention
The multidisciplinary team which develops and carries out the intervention includes a care coordinator who will organize and align recovery resources, a Trauma Surgeon (Dr. Zarzaur), a critical care physician (Dr. Khan), a geriatrician with expertise in collaborative care (Dr. Boustani), and an ICU collaborative care nurse (Dr. Lasiter). Using the Healthy Aging Brain Care monitor, care protocols, specialized software, and specific care protocols, the multidisciplinary team will modulate the intensity and the type of intervention the patient's receive based on the patient's needs. The intervention will last from the time of discharge to 6 months after injury.
TMH Intervention
Home visits and close interaction with injured patient to assure plan for care is being followed.
Usual Care
Review hospital discharge and rehabilitation plan, identify the primary care physician responsible for the patient care. Patients will receive education on communication skills; caregiver coping skills; and legal and financial advice. Patients randomized to usual care will receive no further interventions.
Usual Care
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Interventions
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TMH Intervention
Home visits and close interaction with injured patient to assure plan for care is being followed.
Usual Care
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Eligibility Criteria
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Inclusion Criteria
2. admitted to Indiana University Health - Methodist or Eskenazi Health hospitals;
3. able to provide consent or has a legally authorized representative to provide consent;
4. access to a telephone;
5. and an injury severity score (ISS) of 9 or greater.
Exclusion Criteria
2. have a history of dementing illnesses and other neurodegenerative disease such as Alzheimer disease, Parkinson disease, or vascular dementia;
3. 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);
4. have any spinal cord injury with persistent neurologic deficit at the time of study enrollment;
5. are pregnant women (assessed by a urine pregnancy test);
6. have a primary residence outside the state of Indiana;
7. are incarcerated at the time of study enrollment;
8. have an acute stroke upon admission or develop a stroke as a new event during the course of hospitalization;
9. unable to complete study questionnaire due to severe hearing loss;
10. recent history of alcohol or substance abuse;
11. discharged to a permanent care facility;
12. admitted with a burn affecting \>10% total body surface area.
50 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
Northwestern University
OTHER
University of Missouri, Kansas City
OTHER
National Institute on Aging (NIA)
NIH
Indiana University
OTHER
Responsible Party
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Ben Zarzaur, MD, MPH
Associate Professor of Surgery
Principal Investigators
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Ben Zarzaur, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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Eskenazi Hospital
Indianapolis, Indiana, United States
IU Health Methodist Hospital
Indianapolis, Indiana, United States
St. Vincent Indianapolis
Indianapolis, Indiana, United States
UW Health - University Hospital
Madison, Wisconsin, United States
Countries
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References
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Zarzaur BL, Holler E, Ortiz D, Perkins A, Lasiter S, Gao S, French DD, Khan B, Boustani M. Collaborative Care for Injured Older Adults: The Trauma Medical Home Randomized Clinical Trial. JAMA Surg. 2024 Jul 1;159(7):756-764. doi: 10.1001/jamasurg.2024.1043.
Ortiz D, Meagher AD, Lindroth H, Holler E, Gao S, Khan B, Lasiter S, Boustani M, Zarzaur B. A trauma medical home, evaluating collaborative care for the older injured patient: study protocol for a randomized controlled trial. Trials. 2020 Jul 16;21(1):655. doi: 10.1186/s13063-020-04582-x.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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1612690852
Identifier Type: -
Identifier Source: org_study_id
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