An interventional study of TMH Intervention and Usual Care in Injuries, sponsored by Indiana University. Completed at 4 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-06-24.
Sponsored by Indiana University · Not applicable, Interventional, and Supportive care
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.
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.
Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.
Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Home visits and close interaction with injured patient to assure plan for care is being followed.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Healthcare Utilization
As determined by hospital readmission
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Change in Depression Symptoms
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 12 months.
Time frame: 12 months
Change in Anxiety Symptoms
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 12 months.
Time frame: 12 months
Cost Effectiveness
As determined using the cost-effectiveness ratio
Time frame: 6 and 12 months
Change in Depression Symptoms
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.
Time frame: 6 months
Change in Anxiety Symptoms
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.
Time frame: 6 months
| Milestone | TMH Intervention | Usual Care |
|---|---|---|
| Started | 216 | 214 |
| 6 month assessment | 158 | 166 |
| Completed | 148 | 151 |
| Not completed | 68 | 63 |
| Withdrew: Lost to follow-up | 30 | 28 |
| Withdrew: Withdrawal by subject | 32 | 24 |
| Withdrew: Death | 6 | 11 |
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.
| score on a scale | TMH Intervention | Usual Care |
|---|---|---|
| Change in Self Reported Physical Recovery | 40.42 ± 12.82 | 39.18 ± 12.43 |
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.
| score on a scale | TMH Intervention | Usual Care |
|---|---|---|
| Change in Physical Recovery | 8.28 ± 3.88 | 8.00 ± 3.60 |
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.
| score on a scale | TMH Intervention | Usual Care |
|---|---|---|
| Change in Self Reported Psychological Recovery | 53.92 ± 10.02 | 53.21 ± 10.82 |
As determined by hospital readmission
| Participants | TMH Intervention | Usual Care |
|---|---|---|
| Readmission within 1 year | 70 | 71 |
| No readmission | 146 | 142 |
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.
| score on a scale | TMH Intervention | Usual Care |
|---|---|---|
| Change in Self Reported Physical Recovery | 36.86 ± 12.53 | 38.04 ± 12.09 |
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.
| score on a scale | TMH Intervention | Usual Care |
|---|---|---|
| Change in Physical Recovery | 7.02 ± 4.39 | 7.66 ± 3.91 |
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.
| score on a scale | TMH Intervention | Usual Care |
|---|---|---|
| Change in Self Reported Psychological Recovery | 53.72 ± 10.22 | 53.01 ± 10.64 |
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 12 months.
| score on a scale | TMH Intervention | Usual Care |
|---|---|---|
| Change in Depression Symptoms | 4.31 ± 4.79 | 4.44 ± 5.58 |
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 12 months.
| score on a scale | TMH Intervention | Usual Care |
|---|---|---|
| Change in Anxiety Symptoms | 3.39 ± 4.36 | 3.61 ± 4.80 |
As determined using the cost-effectiveness ratio
No measurements were reported for this outcome.
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.
| score on a scale | TMH Intervention | Usual Care |
|---|---|---|
| Change in Depression Symptoms | 4.73 ± 5 | 4.31 ± 4.62 |
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.
| score on a scale | TMH Intervention | Usual Care |
|---|---|---|
| Change in Anxiety Symptoms | 3.64 ± 4.36 | 3.60 ± 4.31 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TMH Intervention | 6/216 (2.8%) | 0/216 (0%) | 0/216 (0%) |
| Usual Care | 11/213 (5.2%) | 0/213 (0%) | 0/213 (0%) |
| Age, Continuous(years) | TMH Intervention | Usual Care | Total |
|---|---|---|---|
| Mean | 69.6 ± 10.9 | 68.9 ± 10.6 | 69.3 ± 10.8 |
| Sex: Female, Male(Participants) | TMH Intervention | Usual Care | Total |
|---|---|---|---|
| Female | 114 | 114 | 228 |
| Male | 102 | 99 | 201 |
| Race/Ethnicity, Customized(Participants) | TMH Intervention | Usual Care | Total |
|---|---|---|---|
| Race — Black | 19 | 18 | 37 |
| Race — Other | 2 | 2 | 4 |
| Race — White | 195 | 193 | 388 |
| Race/Ethnicity, Customized(Participants) | TMH Intervention | Usual Care | Total |
|---|---|---|---|
| Ethnicity — Hispanic | 2 | 1 | 3 |
| Ethnicity — Non-Hispanic | 214 | 212 | 426 |
| Region of Enrollment(participants) | TMH Intervention | Usual Care | Total |
|---|---|---|---|
| United States | 216 | 213 | 429 |
| Mechanism of Injury(Participants) | TMH Intervention | Usual Care | Total |
|---|---|---|---|
| Fall | 121 | 122 | 243 |
| Motor Vehicle Crash | 66 | 66 | 132 |
| Other | 29 | 25 | 54 |
| Injury Severity Score(score) | TMH Intervention | Usual Care | Total |
|---|---|---|---|
| Mean | 12 ± 3.9 | 12.5 ± 5.1 | 12.3 ± 4.6 |
| Hospital Length of Stay(days) | TMH Intervention | Usual Care | Total |
|---|---|---|---|
| Median | 7 (4 to 10) | 6 (4 to 10) | 7 (4 to 10) |
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