Clinical trial NCT03108820: Trauma Medical Home for Older Injured Patients
Official title: Collaborative Care for the Older Injured Patient: A Trauma Medical Home
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injuries
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Northwestern University
name: University of Missouri, Kansas City
name: National Institute on Aging (NIA)
First posted: 2017-04-11
Enrollment: 430
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Despite the potential for full recovery surprisingly few older injury survivors are able to realize maximal recovery of function and quality of life after injury due to fragmentation of care delivery and lack of focus on psychological symptoms in the early post-injury period. Older injured adults are at particular risk of death and disability after injury. Thus, a fundamental gap in knowledge exists regarding the best way to enhance the recovery of injury survivors. The continued existence of this gap is an important problem because unless it is filled, injury survivors will continue to suffer from potentially reversible impairments of health and well-being. The long-term goal of this line of research is to improve the health and quality of care for injured patients. Indiana University School of Medicine researchers have over 20 years of experience developing innovative and effective collaborative care models that integrate with primary care and specialty physicians to address the complex biopsychosocial needs of patients with chronic disease states, such as dementia and depression. Based on these successes, an interdisciplinary team of clinical investigators at Indiana University revised the collaborative care model to meet the needs of injury survivors who are in an active recovery state. This injury specific collaborative care model is called the Trauma Medical Home (TMH). 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. The research proposed in this application is innovative, in our opinion, because it represents a new and substantive departure from the status quo. Previous collaborative care models focused on chronic care management and they lack rapid adaptability. Because the recovery trajectory of injured patients is dynamic and changes quickly, the innovations in this proposal have to do with providing real-time feedback to a care coordinator that will allow the care coordinator to adjust an injury specific collaborative care protocol to meet the needs of the injured as they move through the dynamic recovery period after injury. This contribution will be significant as broad application of the Trauma Medical Home in trauma centers and trauma systems nationwide could result in better health and improved quality of post-injury care for older injured patients. Improved physical health and fewer psychological symptoms, will likely result in better overall functional ability, the increased ability to return to work and less reliance on family, social, and health care resources.

Eligibility criteria: Inclusion Criteria:

1. English-speaking adult age 50 years and older;
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:

1. have a self-reported diagnosis of cancer with short life expectancy;
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.

Primary outcomes:
measure: Change in Self Reported Physical Recovery
timeFrame: 12 months
measure: Change in Physical Recovery
timeFrame: 12 months
measure: Change in Self Reported Psychological Recovery
timeFrame: 12 months
measure: Healthcare Utilization
timeFrame: 12 months
measure: Change in Self Reported Physical Recovery
timeFrame: 6 months
measure: Change in Physical Recovery
timeFrame: 6 months
measure: Change in Self Reported Psychological Recovery
timeFrame: 6 months
Secondary outcomes:
measure: Change in Depression Symptoms
timeFrame: 12 months
measure: Change in Anxiety Symptoms
timeFrame: 12 months
measure: Cost Effectiveness
timeFrame: 6 and 12 months
measure: Change in Depression Symptoms
timeFrame: 6 months
measure: Change in Anxiety Symptoms
timeFrame: 6 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Eskenazi Hospital
state: Indiana
city: Indianapolis
country: United States
facility: IU Health Methodist Hospital
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Indianapolis
state: Indiana
city: Madison
country: United States
facility: UW Health - University Hospital
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Ben Zarzaur, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.