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)
4
Enrollment
1
Location
2
Arms
10
Actual Duration (Months)
0.4
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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

    SiteCityStateCountryPostal Code
    1Harborview Medical CenterSeattleWashingtonUnited States98104

    Sponsors and Collaborators

    • University of Washington

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    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
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleStepped CareStandard Care Provided to Injured Trauma Survivors
    Arm/Group DescriptionCombination 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
    STARTED31
    COMPLETED31
    NOT COMPLETED00

    Baseline Characteristics

    Arm/Group TitleStepped CareStandard Care Provided to Injured Trauma SurvivorsTotal
    Arm/Group DescriptionCombination 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 survivorsTotal of all reporting groups
    Overall Participants314
    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
    TitleChange From Baseline Alcohol Use Disorders Identification at 1 Month
    DescriptionThe 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 FrameBaseline, Up to 12 months after injury

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleStepped CareStandard Care Provided to Injured Trauma Survivors
    Arm/Group DescriptionCombination 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 Participants31
    Mean (95% Confidence Interval) [score on a scale]
    -1.7
    -2.0
    2. Primary Outcome
    TitleChange From Baseline PTSD Checklist Civilian (PCL-C) at 1 Month
    DescriptionThe 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 FrameBaseline, Up to 12 months after injury

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleStepped CareStandard Care Provided to Injured Trauma Survivors
    Arm/Group DescriptionCombination 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 Participants31
    Mean (95% Confidence Interval) [score on a scale]
    -4.0
    -14.0
    3. Primary Outcome
    TitleChange in Functional Status at 1 Month
    DescriptionThe 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 FrameBaseline, Up to 12 months after injury

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleStepped CareStandard Care Provided to Injured Trauma Survivors
    Arm/Group DescriptionCombination 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 Participants31
    Mean (95% Confidence Interval) [score on a scale]
    -1.9
    4.0
    4. Secondary Outcome
    TitleIncreased Satisfaction With Global Care
    DescriptionAssessed using the Posttraumatic Growth Inventory (PTGI) and Satisfaction with Care (NSCOT)
    Time FrameUp to 12 months after injury

    Outcome Measure Data

    Analysis Population Description
    Data were not collected
    Arm/Group TitleStepped CareStandard Care Provided to Injured Trauma Survivors
    Arm/Group DescriptionCombination 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 Participants00
    5. Secondary Outcome
    TitleInjury Relapse
    DescriptionAssessed using Healthcare Utilization Questions (NSCOT)
    Time FrameUp to 5 years after injury

    Outcome Measure Data

    Analysis Population Description
    Data were not collected
    Arm/Group TitleStepped CareStandard Care Provided to Injured Trauma Survivors
    Arm/Group DescriptionCombination 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 Participants00
    6. Secondary Outcome
    TitleWork, Disability, and Legal Outcomes
    DescriptionAssessed using Work, Disability and Legal (NSCOT) and Sheehan Disability Scale (SDS)
    Time FrameUp to 12 months after injury

    Outcome Measure Data

    Analysis Population Description
    Data were not collected
    Arm/Group TitleStepped CareStandard Care Provided to Injured Trauma Survivors
    Arm/Group DescriptionCombination 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 Participants00

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group TitleStepped CareStandard Care Provided to Injured Trauma Survivors
    Arm/Group DescriptionCombination 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 CareStandard Care Provided to Injured Trauma Survivors
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total/ (NaN) / (NaN)
    Serious Adverse Events
    Stepped CareStandard Care Provided to Injured Trauma Survivors
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/3 (0%) 0/1 (0%)
    Other (Not Including Serious) Adverse Events
    Stepped CareStandard Care Provided to Injured Trauma Survivors
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/3 (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.

    Results Point of Contact

    Name/TitleDr, Douglas Zatzick
    OrganizationUniversity of Washington School of Medicine
    Phone206-744-6701
    Emaildzatzick@uw.edu
    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