TSOS III: Piloting Acute Care to Primary Care Linkage of Safety Net Patients

• Sponsor: University of Washington (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01347541
• Collaborator: (none)
• Enrollment: 4
• Location: 1
• Arms: 2
• Actual Duration (Months): 10
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

This pilot study will evaluate the implementation of a stepped care intervention that combines Cognitive-Behavioral Therapy, Motivational Interviewing, psychotropic medications, and information technology innovations at a level 1 trauma center to community linkage components to reduce the symptoms of posttraumatic stress disorder and related comorbidities in injured trauma survivors treated in the emergency department and surgical inpatient settings.

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorder	Behavioral: Cognitive Behavioral Therapy; Behavioral: Motivational Interviewing; Drug: FDA-Approved Anti-Anxiety Medications; Behavioral: Standard Care Control	Phase 1

Detailed Description

The investigators plan to implement a pilot linkage program in which trauma center based care facilitators will use a population-based recruitment strategy to facilitate outpatient follow-up for acutely injured trauma center inpatients and emergency department patients. All patients recruited into the trial will be low income patients with one or more of the following characteristics: being uninsured, low income older adults, low income mothers, and other high risk individuals who lack health insurance. Patients will be linked for care to one of the community health centers participating in Washington State.

In phase I, patients will be recruited from the trauma center inpatient trauma surgery service and emergency departments. In phase one, no randomization will occur; patients will be linked to one of the community health centers. Patients who consent to the protocol will be assessed in the surgical inpatient units or emergency department. After the baseline assessment, all patients will be immediately assigned a bachelor's, MSW, or RN level care manager. The care managers will elicit and address posttraumatic concerns, and attempt linkage of patients to community programs. Care managers may also deliver motivational interviewing and cognitive behavioral therapy interventions. Patient may also be linked to psychopharmacologic interventions targeting PTSD. Follow-up assessments will occur in the weeks and months after the injury and will assess patterns of health service utilization and symptomatic outcomes. Phase I will establish the feasibility of recruitment and follow-up, acceptability of care management for patients, as well as the pragmatics of linkage to community programs.

Piloting in phase II will depend on the results of phase I; the phase II pilot will build and extend upon phase I. In phase II, patients will be randomized to either intervention or control conditions. Patients randomized to the intervention condition will be met by a care manager who may address patients' initial needs and concerns. Care managers may also deliver Motivational Interviewing and Cognitive Behavioral Therapy interventions. Patients may also be linked to psychopharmacologic interventions targeting PTSD. The care manager will attempt to link patients to participating community health centers. Linkages may occur by the telephone, or through web-based clinical registry tools that are under development by the intervention team. Some linkages may occur in person. To determine if intervention patients are successfully linked more frequently than controls, all patients will be followed from the time of designation at hospital admission to outpatient primary care appointments. Follow-up outcome assessments will occur in the weeks and months post-injury and will includes assessments of patterns of health service utilization, function, and symptomatic outcomes.

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Piloting Acute Care to Primary Care Linkage of Safety Net Patients
• Actual Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stepped care Combination of behavioral therapy and drug therapy	Behavioral: 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.; Other Names: CBT ; Behavioral: Motivational Interviewing; Motivational interviewing is designed to address alcohol and drug use.; Other Names: MI ; Drug: 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.
Active Comparator: Standard care provided to injured trauma survivors	Behavioral: Standard Care Control; Standard care control includes the usual treatment for injured trauma survivors; Other Names: BA

Outcome Measures

Primary Outcome Measures

1. Change From Baseline Alcohol Use Disorders Identification at 1 Month [Baseline, Up to 12 months after injury]

   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.

2. Change From Baseline PTSD Checklist Civilian (PCL-C) at 1 Month [Baseline, Up to 12 months after injury]

   The 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.

3. Change in Functional Status at 1 Month [Baseline, Up to 12 months after injury]

   The 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.

Secondary Outcome Measures

1. Increased Satisfaction With Global Care [Up to 12 months after injury]

   Assessed using the Posttraumatic Growth Inventory (PTGI) and Satisfaction with Care (NSCOT)

2. Injury Relapse [Up to 5 years after injury]

   Assessed using Healthcare Utilization Questions (NSCOT)

3. Work, Disability, and Legal Outcomes [Up to 12 months after injury]

   Assessed using Work, Disability and Legal (NSCOT) and Sheehan Disability Scale (SDS)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• English-speaking

• Admitted to Harborview Medical Center with injuries sufficiently severe enough to require inpatient admission

• Experienced a traumatic injury

• Exhibits symptoms of PTSD while in the hospital ward

• Low-income

Exclusion Criteria:

• History of head, spinal, or other injury that may prevent participation in the ward interview

• Requires immediate intervention due to conditions such as self-inflicted injury, active psychosis, or active mania

• Currently incarcerated

• Likely to face criminal charges

• Lives outside of the state of Washington

• Not low-income

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harborview Medical Center	Seattle	Washington	United States	98104

Sponsors and Collaborators

• University of Washington

Investigators

• Principal Investigator: Douglas Zatzick, MD, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

• Zatzick D, Roy-Byrne P, Russo J, Rivara F, Droesch R, Wagner A, Dunn C, Jurkovich G, Uehara E, Katon W. A randomized effectiveness trial of stepped collaborative care for acutely injured trauma survivors. Arch Gen Psychiatry. 2004 May;61(5):498-506.
• Zatzick DF, Roy-Byrne P, Russo JE, Rivara FP, Koike A, Jurkovich GJ, Katon W. Collaborative interventions for physically injured trauma survivors: a pilot randomized effectiveness trial. Gen Hosp Psychiatry. 2001 May-Jun;23(3):114-23.

• Responsible Party: Douglas Zatzick, Professor, University of Washington
• ClinicalTrials.gov Identifier: NCT01347541
• Other Study ID Numbers: 40069
• First Posted: May 4, 2011
• Last Update Posted: Mar 10, 2021
• Last Verified: Feb 1, 2021

• Keywords provided by Douglas Zatzick, Professor, University of Washington: PTSD
• Additional relevant MeSH terms: Stress Disorders, Post-Traumatic

Study Results

Participant Flow

Arm/Group Title	Stepped Care	Standard Care Provided to Injured Trauma Survivors
Arm/Group Description	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 Control: Standard care control includes the usual treatment for injured trauma survivors
Period Title: Overall Study
STARTED	3	1
COMPLETED	3	1
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Stepped Care	Standard Care Provided to Injured Trauma Survivors	Total
Arm/Group Description	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 Control: Standard care control includes the usual treatment for injured trauma survivors	Total of all reporting groups
Overall Participants	3	1	4
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.33 (18.01)	31 (NA)	35.75 (15.04)
Sex: Female, Male (Count of Participants)
Female	2 66.7%	0 0%	2 50%
Male	1 33.3%	1 100%	2 50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 33.3%	0 0%	1 25%
Not Hispanic or Latino	2 66.7%	1 100%	3 75%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	1 33.3%	0 0%	1 25%
More than one race	1 33.3%	1 100%	2 50%
Unknown or Not Reported	1 33.3%	0 0%	1 25%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline Alcohol Use Disorders Identification at 1 Month
Description	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.
Time Frame	Baseline, Up to 12 months after injury

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stepped Care	Standard Care Provided to Injured Trauma Survivors
Arm/Group Description	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 Control: Standard care control includes the usual treatment for injured trauma survivors
Measure Participants	3	1
Mean (95% Confidence Interval) [score on a scale]	-1.7	-2.0

2. Primary Outcome

Title	Change From Baseline PTSD Checklist Civilian (PCL-C) at 1 Month
Description	The 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.
Time Frame	Baseline, Up to 12 months after injury

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stepped Care	Standard Care Provided to Injured Trauma Survivors
Arm/Group Description	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 Control: Standard care control includes the usual treatment for injured trauma survivors
Measure Participants	3	1
Mean (95% Confidence Interval) [score on a scale]	-4.0	-14.0

3. Primary Outcome

Title	Change in Functional Status at 1 Month
Description	The 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.
Time Frame	Baseline, Up to 12 months after injury

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stepped Care	Standard Care Provided to Injured Trauma Survivors
Arm/Group Description	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 Control: Standard care control includes the usual treatment for injured trauma survivors
Measure Participants	3	1
Mean (95% Confidence Interval) [score on a scale]	-1.9	4.0

4. Secondary Outcome

Title	Increased Satisfaction With Global Care
Description	Assessed using the Posttraumatic Growth Inventory (PTGI) and Satisfaction with Care (NSCOT)
Time Frame	Up to 12 months after injury

Outcome Measure Data

Analysis Population Description

Data were not collected

Arm/Group Title	Stepped Care	Standard Care Provided to Injured Trauma Survivors
Arm/Group Description	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 Control: Standard care control includes the usual treatment for injured trauma survivors
Measure Participants	0	0

5. Secondary Outcome

Title	Injury Relapse
Description	Assessed using Healthcare Utilization Questions (NSCOT)
Time Frame	Up to 5 years after injury

Outcome Measure Data

Analysis Population Description

Data were not collected

Arm/Group Title	Stepped Care	Standard Care Provided to Injured Trauma Survivors
Arm/Group Description	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 Control: Standard care control includes the usual treatment for injured trauma survivors
Measure Participants	0	0

6. Secondary Outcome

Title	Work, Disability, and Legal Outcomes
Description	Assessed using Work, Disability and Legal (NSCOT) and Sheehan Disability Scale (SDS)
Time Frame	Up to 12 months after injury

Outcome Measure Data

Analysis Population Description

Data were not collected

Arm/Group Title	Stepped Care	Standard Care Provided to Injured Trauma Survivors
Arm/Group Description	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 Control: Standard care control includes the usual treatment for injured trauma survivors
Measure Participants	0	0

Adverse Events

Arm/Group Title	Stepped Care		Standard Care Provided to Injured Trauma Survivors
Arm/Group Description	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 Control: Standard care control includes the usual treatment for injured trauma survivors
All Cause Mortality
	Stepped Care		Standard Care Provided to Injured Trauma Survivors
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Stepped Care		Standard Care Provided to Injured Trauma Survivors
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/1 (0%)
Other (Not Including Serious) Adverse Events
	Stepped Care		Standard Care Provided to Injured Trauma Survivors
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/1 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.