Trauma Medical Home for Older Injured Patients

Not Applicable

Completed

• Conditions: Injuries
• Interventions: Other: Usual Care; Behavioral: TMH Intervention

• Registration Number: NCT03108820
• Lead Sponsor: Indiana University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-04-06
• Study First Submitted QC: 2017-04-06
• Study First Posted: 2017-04-11
• Study Start: 2017-10-01
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-01
• Results First Submitted: 2024-02-19
• Status Verified: 2024-06
• Results First Submitted QC: 2024-06-20
• Last Update Submitted: 2024-06-20
• Results First Posted: 2024-06-24
• Last Update Posted: 2024-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 430

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	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.
TMH Intervention	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.

Primary Outcome Measures

Name	Time	Method
Change in Physical Recovery	6 months	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.
Healthcare Utilization	12 months	As determined by hospital readmission
Change in Self Reported Physical Recovery	6 months	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.
Change in Self Reported Psychological Recovery	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Cost Effectiveness	6 and 12 months	As determined using the cost-effectiveness ratio
Change in Depression Symptoms	6 months	As determined using the (Patient Health Questionnaire) PHQ-9. The scale is from 1 - 27 with higher scores related to worse depression severity. The change was determined between baseline and 6 months.
Change in Anxiety Symptoms	6 months	As determined using the (Generalized Anxiety Disorder) GAD-7. Scores range from 0-21, with higher scores indicating worse symptoms. The change was determined between baseline and 6 months.

Trial Locations

Locations (4)

UW Health - University Hospital; 🇺🇸 Madison, Wisconsin, United States

St. Vincent Indianapolis; 🇺🇸 Indianapolis, Indiana, United States

Eskenazi Hospital; 🇺🇸 Indianapolis, Indiana, United States

IU Health Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States