Injuries
Conditions
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.
Interventions
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.
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self Reported Physical Recovery | 12 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 is between baseline and 12 months. |
| Change in Physical Recovery | 12 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 12 months. |
| Change in Self Reported Psychological Recovery | 12 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 12 months. |
| Healthcare Utilization | 12 months | As determined by hospital readmission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Anxiety Symptoms | 12 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. |
| Cost Effectiveness | 6 and 12 months | As determined using the cost-effectiveness ratio |
| Change in Depression Symptoms | 12 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 12 months. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 216 |
| 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. | 213 |
| Total | 429 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 6 | 11 |
| Overall Study | Lost to Follow-up | 30 | 28 |
| Overall Study | Withdrawal by Subject | 32 | 24 |
Baseline characteristics
| Characteristic | Usual Care | Total | TMH Intervention |
|---|---|---|---|
| Age, Continuous | 68.9 years STANDARD_DEVIATION 10.6 | 69.3 years STANDARD_DEVIATION 10.8 | 69.6 years STANDARD_DEVIATION 10.9 |
| Hospital Length of Stay | 6 days | 7 days | 7 days |
| Injury Severity Score | 12.5 score STANDARD_DEVIATION 5.1 | 12.3 score STANDARD_DEVIATION 4.6 | 12 score STANDARD_DEVIATION 3.9 |
| Mechanism of Injury Fall | 122 Participants | 243 Participants | 121 Participants |
| Mechanism of Injury Motor Vehicle Crash | 66 Participants | 132 Participants | 66 Participants |
| Mechanism of Injury Other | 25 Participants | 54 Participants | 29 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic | 1 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Ethnicity Non-Hispanic | 212 Participants | 426 Participants | 214 Participants |
| Race/Ethnicity, Customized Race Black | 18 Participants | 37 Participants | 19 Participants |
| Race/Ethnicity, Customized Race Other | 2 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized Race White | 193 Participants | 388 Participants | 195 Participants |
| Region of Enrollment United States | 213 participants | 429 participants | 216 participants |
| Sex: Female, Male Female | 114 Participants | 228 Participants | 114 Participants |
| Sex: Female, Male Male | 99 Participants | 201 Participants | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 216 | 11 / 213 |
| other Total, other adverse events | 0 / 216 | 0 / 213 |
| serious Total, serious adverse events | 0 / 216 | 0 / 213 |
Outcome results
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMH Intervention | Change in Physical Recovery | 7.02 score on a scale | Standard Deviation 4.39 |
| Usual Care | Change in Physical Recovery | 7.66 score on a scale | Standard Deviation 3.91 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMH Intervention | Change in Physical Recovery | 8.28 score on a scale | Standard Deviation 3.88 |
| Usual Care | Change in Physical Recovery | 8.00 score on a scale | Standard Deviation 3.6 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMH Intervention | Change in Self Reported Physical Recovery | 36.86 score on a scale | Standard Deviation 12.53 |
| Usual Care | Change in Self Reported Physical Recovery | 38.04 score on a scale | Standard Deviation 12.09 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMH Intervention | Change in Self Reported Physical Recovery | 40.42 score on a scale | Standard Deviation 12.82 |
| Usual Care | Change in Self Reported Physical Recovery | 39.18 score on a scale | Standard Deviation 12.43 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMH Intervention | Change in Self Reported Psychological Recovery | 53.72 score on a scale | Standard Deviation 10.22 |
| Usual Care | Change in Self Reported Psychological Recovery | 53.01 score on a scale | Standard Deviation 10.64 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMH Intervention | Change in Self Reported Psychological Recovery | 53.92 score on a scale | Standard Deviation 10.02 |
| Usual Care | Change in Self Reported Psychological Recovery | 53.21 score on a scale | Standard Deviation 10.82 |
Healthcare Utilization
As determined by hospital readmission
Time frame: 12 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TMH Intervention | Healthcare Utilization | Readmission within 1 year | 70 Participants |
| TMH Intervention | Healthcare Utilization | No readmission | 146 Participants |
| Usual Care | Healthcare Utilization | Readmission within 1 year | 71 Participants |
| Usual Care | Healthcare Utilization | No readmission | 142 Participants |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMH Intervention | Change in Anxiety Symptoms | 3.39 score on a scale | Standard Deviation 4.36 |
| Usual Care | Change in Anxiety Symptoms | 3.61 score on a scale | Standard Deviation 4.8 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMH Intervention | Change in Anxiety Symptoms | 3.64 score on a scale | Standard Deviation 4.36 |
| Usual Care | Change in Anxiety Symptoms | 3.60 score on a scale | Standard Deviation 4.31 |
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
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| TMH Intervention | Change in Depression Symptoms | 4.73 score on a scale | Standard Deviation 5 |
| Usual Care | Change in Depression Symptoms | 4.31 score on a scale | Standard Deviation 4.62 |
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
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| TMH Intervention | Change in Depression Symptoms | 4.31 score on a scale | Standard Deviation 4.79 |
| Usual Care | Change in Depression Symptoms | 4.44 score on a scale | Standard Deviation 5.58 |
Cost Effectiveness
As determined using the cost-effectiveness ratio
Time frame: 6 and 12 months
Population: Financial data were not collected so we have not done this analysis.