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Trauma Medical Home for Older Injured Patients

Collaborative Care for the Older Injured Patient: A Trauma Medical Home

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03108820
Enrollment
430
Registered
2017-04-11
Start date
2017-10-01
Completion date
2023-03-01
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Injuries

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

BEHAVIORALTMH Intervention

Home visits and close interaction with injured patient to assure plan for care is being followed.

OTHERUsual 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.

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
Northwestern University
CollaboratorOTHER
University of Missouri, Kansas City
CollaboratorOTHER
National Institute on Aging (NIA)
CollaboratorNIH
Indiana University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Change in Self Reported Physical Recovery12 monthsAs 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 Recovery12 monthsAs 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 Recovery12 monthsAs 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 Utilization12 monthsAs determined by hospital readmission

Secondary

MeasureTime frameDescription
Change in Anxiety Symptoms12 monthsAs 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 Effectiveness6 and 12 monthsAs determined using the cost-effectiveness ratio
Change in Depression Symptoms12 monthsAs 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

ArmCount
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
Total429

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath611
Overall StudyLost to Follow-up3028
Overall StudyWithdrawal by Subject3224

Baseline characteristics

CharacteristicUsual CareTotalTMH Intervention
Age, Continuous68.9 years
STANDARD_DEVIATION 10.6
69.3 years
STANDARD_DEVIATION 10.8
69.6 years
STANDARD_DEVIATION 10.9
Hospital Length of Stay6 days7 days7 days
Injury Severity Score12.5 score
STANDARD_DEVIATION 5.1
12.3 score
STANDARD_DEVIATION 4.6
12 score
STANDARD_DEVIATION 3.9
Mechanism of Injury
Fall
122 Participants243 Participants121 Participants
Mechanism of Injury
Motor Vehicle Crash
66 Participants132 Participants66 Participants
Mechanism of Injury
Other
25 Participants54 Participants29 Participants
Race/Ethnicity, Customized
Ethnicity
Hispanic
1 Participants3 Participants2 Participants
Race/Ethnicity, Customized
Ethnicity
Non-Hispanic
212 Participants426 Participants214 Participants
Race/Ethnicity, Customized
Race
Black
18 Participants37 Participants19 Participants
Race/Ethnicity, Customized
Race
Other
2 Participants4 Participants2 Participants
Race/Ethnicity, Customized
Race
White
193 Participants388 Participants195 Participants
Region of Enrollment
United States
213 participants429 participants216 participants
Sex: Female, Male
Female
114 Participants228 Participants114 Participants
Sex: Female, Male
Male
99 Participants201 Participants102 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
6 / 21611 / 213
other
Total, other adverse events
0 / 2160 / 213
serious
Total, serious adverse events
0 / 2160 / 213

Outcome results

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.

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
TMH InterventionChange in Physical Recovery7.02 score on a scaleStandard Deviation 4.39
Usual CareChange in Physical Recovery7.66 score on a scaleStandard Deviation 3.91
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.

Time frame: 12 months

ArmMeasureValue (MEAN)Dispersion
TMH InterventionChange in Physical Recovery8.28 score on a scaleStandard Deviation 3.88
Usual CareChange in Physical Recovery8.00 score on a scaleStandard Deviation 3.6
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.

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
TMH InterventionChange in Self Reported Physical Recovery36.86 score on a scaleStandard Deviation 12.53
Usual CareChange in Self Reported Physical Recovery38.04 score on a scaleStandard Deviation 12.09
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.

Time frame: 12 months

ArmMeasureValue (MEAN)Dispersion
TMH InterventionChange in Self Reported Physical Recovery40.42 score on a scaleStandard Deviation 12.82
Usual CareChange in Self Reported Physical Recovery39.18 score on a scaleStandard Deviation 12.43
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.

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
TMH InterventionChange in Self Reported Psychological Recovery53.72 score on a scaleStandard Deviation 10.22
Usual CareChange in Self Reported Psychological Recovery53.01 score on a scaleStandard Deviation 10.64
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.

Time frame: 12 months

ArmMeasureValue (MEAN)Dispersion
TMH InterventionChange in Self Reported Psychological Recovery53.92 score on a scaleStandard Deviation 10.02
Usual CareChange in Self Reported Psychological Recovery53.21 score on a scaleStandard Deviation 10.82
Primary

Healthcare Utilization

As determined by hospital readmission

Time frame: 12 months

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
TMH InterventionHealthcare UtilizationReadmission within 1 year70 Participants
TMH InterventionHealthcare UtilizationNo readmission146 Participants
Usual CareHealthcare UtilizationReadmission within 1 year71 Participants
Usual CareHealthcare UtilizationNo readmission142 Participants
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.

Time frame: 12 months

ArmMeasureValue (MEAN)Dispersion
TMH InterventionChange in Anxiety Symptoms3.39 score on a scaleStandard Deviation 4.36
Usual CareChange in Anxiety Symptoms3.61 score on a scaleStandard Deviation 4.8
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.

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
TMH InterventionChange in Anxiety Symptoms3.64 score on a scaleStandard Deviation 4.36
Usual CareChange in Anxiety Symptoms3.60 score on a scaleStandard Deviation 4.31
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.

Time frame: 6 months

ArmMeasureValue (MEDIAN)Dispersion
TMH InterventionChange in Depression Symptoms4.73 score on a scaleStandard Deviation 5
Usual CareChange in Depression Symptoms4.31 score on a scaleStandard Deviation 4.62
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.

Time frame: 12 months

ArmMeasureValue (MEDIAN)Dispersion
TMH InterventionChange in Depression Symptoms4.31 score on a scaleStandard Deviation 4.79
Usual CareChange in Depression Symptoms4.44 score on a scaleStandard Deviation 5.58
Secondary

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.

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026