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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG052493-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Northwestern University | OTHER |
| University of Missouri, Kansas City | OTHER |
| National Institute on Aging (NIA) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMH Intervention | Behavioral | Home visits and close interaction with injured patient to assure plan for care is being followed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Change in Anxiety Symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ben Zarzaur, MD, MPH | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eskenazi Hospital | Indianapolis | Indiana | 46202 | United States | ||
| IU Health Methodist Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38717762 | Derived | 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. | |
| 32678026 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. TMH Intervention: Home visits and close interaction with injured patient to assure plan for care is being followed. |
| FG001 | 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. Usual Care: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. TMH Intervention: Home visits and close interaction with injured patient to assure plan for care is being followed. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. TMH Intervention: Home visits and close interaction with injured patient to assure plan for care is being followed. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ben Zarzaur | University of Wisconsin School of Medicine and Public Health | (608) 265-9574 | zarzaur@surgery.wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 27, 2021 | Feb 15, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| NIH |
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| 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. |
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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 |
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. |
| 12 months |
| Cost Effectiveness | As determined using the cost-effectiveness ratio | 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. | 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. | 6 months |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| St. Vincent Indianapolis | Indianapolis | Indiana | 46260 | United States |
| UW Health - University Hospital | Madison | Wisconsin | 53792 | United States |
| Death |
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| BG001 | 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. Usual Care: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Mechanism of Injury | Count of Participants | Participants |
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| Injury Severity Score | The Injury Severity Score (ISS) is measured on a scale of 1-75 with higher scores associated with an increased probability of mortality. Scores of more than 9 are considered moderate to severe injury. | Mean | Standard Deviation | score |
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| Hospital Length of Stay | Median | Inter-Quartile Range | days |
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| OG001 | 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. Usual Care: 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. |
|
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| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
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| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
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| Primary | Healthcare Utilization | As determined by hospital readmission | Posted | Count of Participants | Participants | 12 months |
|
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| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
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| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| Secondary | 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. | Posted | Median | Standard Deviation | score on a scale | 12 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
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| Secondary | Cost Effectiveness | As determined using the cost-effectiveness ratio | Financial data were not collected so we have not done this analysis. | Posted | 6 and 12 months |
|
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| Secondary | 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. | Posted | Median | Standard Deviation | score on a scale | 6 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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|
| 6 |
| 216 |
| 0 |
| 216 |
| 0 |
| 216 |
| EG001 | 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. Usual Care: 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. | 11 | 213 | 0 | 213 | 0 | 213 |
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