Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2026-01-10 @ 4:18 AM
Study NCT ID:
NCT03108820
Status:
COMPLETED
Last Update Posted:
2024-06-24
First Post:
2017-04-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trauma Medical Home for Older Injured Patients
Sponsor:
Indiana University
Organization:
Study Overview
Official Title:
Collaborative Care for the Older Injured Patient: A Trauma Medical Home
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R01AG052493-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |