InjuriesNCT03108820
Trauma Medical Home for Older Injured Patients
A study testing TMH Intervention in people with Injuries, run by Indiana University at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Injuries
- What is being tested?
- TMH Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Oct 2017to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking adult age 50 years and older;
- admitted to Indiana University Health - Methodist or Eskenazi Health hospitals;
- able to provide consent or has a legally authorized representative to provide consent;
- access to a telephone;
- and an injury severity score (ISS) of 9 or greater.
Who cannot join
- have a self-reported diagnosis of cancer with short life expectancy;
- have a history of dementing illnesses and other neurodegenerative disease such as Alzheimer disease, Parkinson disease, or vascular dementia;
- 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);
- have any spinal cord injury with persistent neurologic deficit at the time of study enrollment;
- are pregnant women (assessed by a urine pregnancy test);
- have a primary residence outside the state of Indiana;
Show all 12Show fewer
- are incarcerated at the time of study enrollment;
- have an acute stroke upon admission or develop a stroke as a new event during the course of hospitalization;
- unable to complete study questionnaire due to severe hearing loss;
- recent history of alcohol or substance abuse;
- discharged to a permanent care facility;
- admitted with a burn affecting >10% total body surface area.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Eskenazi Hospital
Indianapolis, Indiana, 46202
IU Health Methodist Hospital
Indianapolis, Indiana, 46202
St. Vincent Indianapolis
Indianapolis, Indiana, 46260
UW Health - University Hospital
Madison, Wisconsin, 53792
About this study
Official title: Collaborative Care for the Older Injured Patient: A Trauma Medical Home
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.
Read the 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.
- Conditions
- Injuries
- Being tested
- TMH Intervention, Usual Care
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMH InterventionBehavioural
Home visits and close interaction with injured patient to assure plan for care is being followed.
Usual CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: TMH Intervention |
| 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 months
Healthcare Utilization
As determined by hospital readmission
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 12 months
Cost Effectiveness
As determined using the cost-effectiveness ratio
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start1 Oct 2017
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InjuriesStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Northwestern University, University of Missouri, Kansas City, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Ben Zarzaur, MD, MPH, Indiana University
- Investigators
- Ben Zarzaur, MD, MPH, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108820
- Sponsor's protocol ID
- 1612690852
- Other IDs
- 1R01AG052493-01A1
- Status last verified
- Jun 2024
- First submitted
- 6 Apr 2017
- Last updated
- 24 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38717762Ortiz 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.
PubMed 32678026
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Care for the Older Injured Patient: A Trauma Medical Home
- ClinicalTrials.gov ID
- NCT03108820
- Acronym / sponsor ID
- 1612690852
- Conditions
- Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Northwestern University, University of Missouri, Kansas City, National Institute on Aging (NIA)
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 11 Apr 2017 (actual)
- Results
- Posted 24 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMH Intervention | Experimental | Behavioral: TMH InterventionThe 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. |
| Usual Care | Active comparator | Other: Usual CareReview 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- English-speaking adult age 50 years and older;
- admitted to Indiana University Health - Methodist or Eskenazi Health hospitals;
- able to provide consent or has a legally authorized representative to provide consent;
- access to a telephone;
- and an injury severity score (ISS) of 9 or greater.
Key exclusion criteria (12 listed)
- have a self-reported diagnosis of cancer with short life expectancy;
- have a history of dementing illnesses and other neurodegenerative disease such as Alzheimer disease, Parkinson disease, or vascular dementia;
- 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);
- have any spinal cord injury with persistent neurologic deficit at the time of study enrollment;
- are pregnant women (assessed by a urine pregnancy test);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMH InterventionHome visits and close interaction with injured patient to assure plan for care is being followed. | Behavioural | TMH Intervention |
| Usual CareReview 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. | Other | Usual Care |
Primary outcome
Change in Self Reported Physical Recovery
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months
As determined by hospital readmission
Change in Self Reported Physical Recovery
Time frame: 6 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 was determined between baseline and 6 months.
Change in Physical Recovery
Time frame: 6 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 6 months.
Change in Self Reported Psychological Recovery
Time frame: 6 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 6 months.
5 secondary outcomes
Change in Depression Symptoms
Time frame: 12 months
Change in Anxiety Symptoms
Time frame: 12 months
Cost Effectiveness
Time frame: 6 and 12 months
Change in Depression Symptoms
Time frame: 6 months
Change in Anxiety Symptoms
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38717762Zarzaur 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.
- Derived from this study: PubMed 32678026Ortiz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben Zarzaur, MD, MPH principal investigator
University of Wisconsin, Madison
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMH Intervention in people with Injuries, run by Indiana University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Self Reported Physical Recovery (time frame: 12 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03108820, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.