Trial Outcomes & Findings for Piloting Acute Care to Primary Care Linkage of Safety Net Patients (NCT NCT01347541)
NCT ID: NCT01347541
Last Updated: 2021-03-10
Results Overview
The investigators will use the Alcohol Use Disorders Identification Test (AUDIT) as a continuous measure. The 10-item scale score ranges from 0-40, with higher values indicating a worse outcome.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
4 participants
Primary outcome timeframe
Baseline, Up to 12 months after injury
Results posted on
2021-03-10
Participant Flow
Participant milestones
| Measure |
Stepped Care
Combination of behavioral therapy and drug therapy
Cognitive Behavioral Therapy: Behavioral therapy includes standard cognitive behavioral therapy, with an emphasis on behavioral activation. Treatment is administered on the basis of the participants' individual needs and may continue for up to 12 months.
Motivational Interviewing: Motivational interviewing is designed to address alcohol and drug use.
FDA-Approved Anti-Anxiety Medications: Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine, sertraline, paroxetine, buspirone, propranolol, trazodone, and any of the benzodiazepines. Participants may begin receiving medication immediately or anytime within the 12 months post-injury. Form, dosage, frequency, and duration depend on patient need, but all are prescribed in accordance with standards of care.
|
Standard Care Provided to Injured Trauma Survivors
Standard Care Control: Standard care control includes the usual treatment for injured trauma survivors
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
1
|
|
Overall Study
COMPLETED
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Piloting Acute Care to Primary Care Linkage of Safety Net Patients
Baseline characteristics by cohort
| Measure |
Stepped Care
n=3 Participants
Combination of behavioral therapy and drug therapy
Cognitive Behavioral Therapy: Behavioral therapy includes standard cognitive behavioral therapy, with an emphasis on behavioral activation. Treatment is administered on the basis of the participants' individual needs and may continue for up to 12 months.
Motivational Interviewing: Motivational interviewing is designed to address alcohol and drug use.
FDA-Approved Anti-Anxiety Medications: Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine, sertraline, paroxetine, buspirone, propranolol, trazodone, and any of the benzodiazepines. Participants may begin receiving medication immediately or anytime within the 12 months post-injury. Form, dosage, frequency, and duration depend on patient need, but all are prescribed in accordance with standards of care.
|
Standard Care Provided to Injured Trauma Survivors
n=1 Participants
Standard Care Control: Standard care control includes the usual treatment for injured trauma survivors
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.33 years
STANDARD_DEVIATION 18.01 • n=5 Participants
|
31 years
STANDARD_DEVIATION NA • n=7 Participants
|
35.75 years
STANDARD_DEVIATION 15.04 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Up to 12 months after injuryThe investigators will use the Alcohol Use Disorders Identification Test (AUDIT) as a continuous measure. The 10-item scale score ranges from 0-40, with higher values indicating a worse outcome.
Outcome measures
| Measure |
Stepped Care
n=3 Participants
Combination of behavioral therapy and drug therapy
Cognitive Behavioral Therapy: Behavioral therapy includes standard cognitive behavioral therapy, with an emphasis on behavioral activation. Treatment is administered on the basis of the participants' individual needs and may continue for up to 12 months.
Motivational Interviewing: Motivational interviewing is designed to address alcohol and drug use.
FDA-Approved Anti-Anxiety Medications: Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine, sertraline, paroxetine, buspirone, propranolol, trazodone, and any of the benzodiazepines. Participants may begin receiving medication immediately or anytime within the 12 months post-injury. Form, dosage, frequency, and duration depend on patient need, but all are prescribed in accordance with standards of care.
|
Standard Care Provided to Injured Trauma Survivors
n=1 Participants
Standard Care Control: Standard care control includes the usual treatment for injured trauma survivors
|
|---|---|---|
|
Change From Baseline Alcohol Use Disorders Identification at 1 Month
|
-1.7 score on a scale
Interval -7.9 to 4.6
|
-2.0 score on a scale
Only one participant was recruited for the standard care arm of this pilot, so no confidence interval can be calculated.
|
PRIMARY outcome
Timeframe: Baseline, Up to 12 months after injuryThe investigators will use the PTSD Checklist - Civilian (PCL-C). The scoring of the scale ranges from a minimum of 17 to a maximum of 85, with higher scores indicating a worse outcome. The measure can also provide a rating of symptoms consistent with a diagnosis of PTSD.
Outcome measures
| Measure |
Stepped Care
n=3 Participants
Combination of behavioral therapy and drug therapy
Cognitive Behavioral Therapy: Behavioral therapy includes standard cognitive behavioral therapy, with an emphasis on behavioral activation. Treatment is administered on the basis of the participants' individual needs and may continue for up to 12 months.
Motivational Interviewing: Motivational interviewing is designed to address alcohol and drug use.
FDA-Approved Anti-Anxiety Medications: Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine, sertraline, paroxetine, buspirone, propranolol, trazodone, and any of the benzodiazepines. Participants may begin receiving medication immediately or anytime within the 12 months post-injury. Form, dosage, frequency, and duration depend on patient need, but all are prescribed in accordance with standards of care.
|
Standard Care Provided to Injured Trauma Survivors
n=1 Participants
Standard Care Control: Standard care control includes the usual treatment for injured trauma survivors
|
|---|---|---|
|
Change From Baseline PTSD Checklist Civilian (PCL-C) at 1 Month
|
-4.0 score on a scale
Interval -55.3 to 47.3
|
-14.0 score on a scale
Only one participant was recruited for the standard care arm of this pilot, so no confidence interval can be calculated.
|
PRIMARY outcome
Timeframe: Baseline, Up to 12 months after injuryThe investigators will use the Medical Outcomes Study Short Form healthy survey (MOS SF-12/36) physical components summary to assess physical function. The minimum and maximum scores are 0-100 with higher scores representing a better outcome.
Outcome measures
| Measure |
Stepped Care
n=3 Participants
Combination of behavioral therapy and drug therapy
Cognitive Behavioral Therapy: Behavioral therapy includes standard cognitive behavioral therapy, with an emphasis on behavioral activation. Treatment is administered on the basis of the participants' individual needs and may continue for up to 12 months.
Motivational Interviewing: Motivational interviewing is designed to address alcohol and drug use.
FDA-Approved Anti-Anxiety Medications: Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine, sertraline, paroxetine, buspirone, propranolol, trazodone, and any of the benzodiazepines. Participants may begin receiving medication immediately or anytime within the 12 months post-injury. Form, dosage, frequency, and duration depend on patient need, but all are prescribed in accordance with standards of care.
|
Standard Care Provided to Injured Trauma Survivors
n=1 Participants
Standard Care Control: Standard care control includes the usual treatment for injured trauma survivors
|
|---|---|---|
|
Change in Functional Status at 1 Month
|
-1.9 score on a scale
Interval -11.5 to 7.8
|
4.0 score on a scale
Only one participant was recruited for the standard care arm of this pilot, so no confidence interval can be calculated.
|
SECONDARY outcome
Timeframe: Up to 12 months after injuryPopulation: Data were not collected
Assessed using the Posttraumatic Growth Inventory (PTGI) and Satisfaction with Care (NSCOT)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 years after injuryPopulation: Data were not collected
Assessed using Healthcare Utilization Questions (NSCOT)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 months after injuryPopulation: Data were not collected
Assessed using Work, Disability and Legal (NSCOT) and Sheehan Disability Scale (SDS)
Outcome measures
Outcome data not reported
Adverse Events
Stepped Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Care Provided to Injured Trauma Survivors
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr, Douglas Zatzick
University of Washington School of Medicine
Phone: 206-744-6701
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place