Trauma Medical Home for Older Injured Patients

NCT03108820 | Completed Results DMC

• 2 other identifiers: 16126908521R01AG052493-01A1
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Injuries

Outcome Measures

Primary Outcomes (7)

• Change in Self Reported Physical Recovery

  As determined using the Physical Component Score of Short form (SF) SF-36. Score range: 0-100, higher scores indicate a better health state. The change is between baseline and 12 months.

  12 months

• Change in Physical Recovery

  As determined using the Short Physical Performance Battery (SPPB). SPPB total score ranges from 0 (worst performance) to 12 points (best performance). The change was determined between baseline and 12 months.

  12 months

• Change in Self Reported Psychological Recovery

  As determined using the Mental Component Score of SF-36. Score range: 0-100, higher scores indicate a better health state. The change was determined between baseline and 12 months.

  12 months

• Healthcare Utilization

  As determined by hospital readmission

  12 months

• Change in Self Reported Physical Recovery

  As determined using the Physical Component Score of Short form (SF) SF-36. Score range: 0-100, higher scores indicate a better health state. The change was determined between baseline and 6 months.

  6 months

• Change in Physical Recovery

  As determined using the Short Physical Performance Battery (SPPB). SPPB total score ranges from 0 (worst performance) to 12 points (best performance). The change was determined between baseline and 6 months.

  6 months

• Change in Self Reported Psychological Recovery

  As determined using the Mental Component Score of SF-36. Score range: 0-100, higher scores indicate a better health state. The change was determined between baseline and 6 months.

  6 months

Secondary Outcomes (5)

• Change in Depression Symptoms

  12 months

• Change in Anxiety Symptoms

  12 months

• Cost Effectiveness

  6 and 12 months

• Change in Depression Symptoms

  6 months

• Change in Anxiety Symptoms

  6 months

Study Arms (2)

TMH Intervention

EXPERIMENTAL

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.

Behavioral: TMH Intervention

Usual Care

ACTIVE COMPARATOR

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.

Other: Usual Care

Interventions

TMH Intervention BEHAVIORAL

Home visits and close interaction with injured patient to assure plan for care is being followed.

TMH Intervention

Usual Care OTHER

Review hospital discharge and rehabilitation plan, identification of primary care provider, provision of educational materials on communication skills, caregiver coping skills, and legal and financial advice.

Usual Care

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead
• National Institutes of Health (NIH): collaborator
• Northwestern University: collaborator
• University of Missouri, Kansas City: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (4)

Eskenazi Hospital

Indianapolis, Indiana, 46202, United States

Location

IU Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

St. Vincent Indianapolis

Indianapolis, Indiana, 46260, United States

Location

UW Health - University Hospital

Madison, Wisconsin, 53792, United States

Location

Related Publications (2)

• 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.

  PMID: 38717762 DERIVED

• 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.

  PMID: 32678026 DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Limitations and Caveats

One outcome measure, the SPPB, was only validated in face-to-face assessments but it had to be adapted for telehealth evaluation during the pandemic. Care coordinator visits switched from a combination of in person and remote to fully remote after the pandemic started.

Results Point of Contact

• Title: Dr. Ben Zarzaur
• Organization: University of Wisconsin School of Medicine and Public Health

zarzaur@surgery.wisc.edu

(608) 265-9574

Study Officials

• Ben Zarzaur, MD, MPH

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 11, 2017
• Study Start: October 1, 2017
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: June 24, 2024
• Results First Posted: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)