Trial Outcomes & Findings for Trauma Medical Home for Older Injured Patients (NCT NCT03108820)

NCT ID: NCT03108820

Last Updated: 2024-06-24

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 430 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2024-06-24

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	216	214
Overall Study 6 Month Assessment	158	166
Overall Study COMPLETED	148	151
Overall Study NOT COMPLETED	68	63

Reasons for withdrawal

Measure	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.	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.
Overall Study Lost to Follow-up	30	28
Overall Study Withdrawal by Subject	32	24
Overall Study Death	6	11

Baseline Characteristics

Trauma Medical Home for Older Injured Patients

Baseline characteristics by cohort

Measure	TMH Intervention n=216 Participants 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.	Usual Care n=213 Participants 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.	Total n=429 Participants Total of all reporting groups
Age, Continuous	69.6 years STANDARD_DEVIATION 10.9 • n=5 Participants	68.9 years STANDARD_DEVIATION 10.6 • n=7 Participants	69.3 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	114 Participants n=5 Participants	114 Participants n=7 Participants	228 Participants n=5 Participants
Sex: Female, Male Male	102 Participants n=5 Participants	99 Participants n=7 Participants	201 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	195 Participants n=5 Participants	193 Participants n=7 Participants	388 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Non-Hispanic	214 Participants n=5 Participants	212 Participants n=7 Participants	426 Participants n=5 Participants
Region of Enrollment United States	216 participants n=5 Participants	213 participants n=7 Participants	429 participants n=5 Participants
Mechanism of Injury Fall	121 Participants n=5 Participants	122 Participants n=7 Participants	243 Participants n=5 Participants
Mechanism of Injury Motor Vehicle Crash	66 Participants n=5 Participants	66 Participants n=7 Participants	132 Participants n=5 Participants
Mechanism of Injury Other	29 Participants n=5 Participants	25 Participants n=7 Participants	54 Participants n=5 Participants
Injury Severity Score	12 score STANDARD_DEVIATION 3.9 • n=5 Participants	12.5 score STANDARD_DEVIATION 5.1 • n=7 Participants	12.3 score STANDARD_DEVIATION 4.6 • n=5 Participants
Hospital Length of Stay	7 days n=5 Participants	6 days n=7 Participants	7 days n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	TMH Intervention n=148 Participants 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.	Usual Care n=151 Participants 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.
Change in Self Reported Physical Recovery	40.42 score on a scale Standard Deviation 12.82	39.18 score on a scale Standard Deviation 12.43

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	TMH Intervention n=71 Participants 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.	Usual Care n=65 Participants 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.
Change in Physical Recovery	8.28 score on a scale Standard Deviation 3.88	8.00 score on a scale Standard Deviation 3.60

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	TMH Intervention n=148 Participants 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.	Usual Care n=151 Participants 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.
Change in Self Reported Psychological Recovery	53.92 score on a scale Standard Deviation 10.02	53.21 score on a scale Standard Deviation 10.82

PRIMARY outcome

Timeframe: 12 months

As determined by hospital readmission

Outcome measures

Measure	TMH Intervention n=216 Participants 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.	Usual Care n=213 Participants 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.
Healthcare Utilization Readmission within 1 year	70 Participants	71 Participants
Healthcare Utilization No readmission	146 Participants	142 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	TMH Intervention n=158 Participants 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.	Usual Care n=165 Participants 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.
Change in Self Reported Physical Recovery	36.86 score on a scale Standard Deviation 12.53	38.04 score on a scale Standard Deviation 12.09

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	TMH Intervention n=84 Participants 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.	Usual Care n=92 Participants 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.
Change in Physical Recovery	7.02 score on a scale Standard Deviation 4.39	7.66 score on a scale Standard Deviation 3.91

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	TMH Intervention n=158 Participants 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.	Usual Care n=165 Participants 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.
Change in Self Reported Psychological Recovery	53.72 score on a scale Standard Deviation 10.22	53.01 score on a scale Standard Deviation 10.64

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	TMH Intervention n=148 Participants 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.	Usual Care n=150 Participants 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.
Change in Depression Symptoms	4.31 score on a scale Standard Deviation 4.79	4.44 score on a scale Standard Deviation 5.58

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	TMH Intervention n=148 Participants 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.	Usual Care n=151 Participants 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.
Change in Anxiety Symptoms	3.39 score on a scale Standard Deviation 4.36	3.61 score on a scale Standard Deviation 4.80

SECONDARY outcome

Timeframe: 6 and 12 months

Population: Financial data were not collected so we have not done this analysis.

As determined using the cost-effectiveness ratio

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 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 6 months.

Outcome measures

Measure	TMH Intervention n=158 Participants 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.	Usual Care n=165 Participants 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.
Change in Depression Symptoms	4.73 score on a scale Standard Deviation 5	4.31 score on a scale Standard Deviation 4.62

SECONDARY outcome

Timeframe: 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 6 months.

Outcome measures

Measure	TMH Intervention n=157 Participants 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.	Usual Care n=166 Participants 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.
Change in Anxiety Symptoms	3.64 score on a scale Standard Deviation 4.36	3.60 score on a scale Standard Deviation 4.31

Adverse Events

TMH Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 6 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 11 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ben Zarzaur

University of Wisconsin School of Medicine and Public Health

Phone: (608) 265-9574

Email: zarzaur@surgery.wisc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place