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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Washington.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Douglas Zatzick, University of Washington
ClinicalTrials.gov Identifier:
NCT01347541
First received: April 29, 2011
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Posttraumatic Stress Disorder
Behavioral: Cognitive Behavioral Therapy
Behavioral: Motivational Interviewing
Drug: FDA-Approved Anti-Anxiety Medications
Behavioral: Standard Care Control
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Piloting Acute Care to Primary Care Linkage of Safety Net Patients

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Substance use [ Time Frame: Up to 12 months after injury ] [ Designated as safety issue: No ]
    Assessed using the Alcohol Use Disorders Identification Test (AUDIT), the Munich-Composite Diagnostic Interview (M-CIDI), and The Drug Abuse Screening Test (DAST)

  • PTSD ratings [ Time Frame: Up to 12 months after injury ] [ Designated as safety issue: No ]
    Assessed using the Posttraumatic Stress Disorder Checklist (PCL-C) and the Posttraumatic Growth Inventory (PTGI)

  • General functioning reports [ Time Frame: Up to 12 months after injury ] [ Designated as safety issue: No ]
    Assessed using the SF-36 Health Survey, Sheehan Disability Scale (SDS), and Functional Capacity Index (FCI)


Secondary Outcome Measures:
  • Increased satisfaction with global care [ Time Frame: Up to 12 months after injury ] [ Designated as safety issue: No ]
    Assessed using the Posttraumatic Growth Inventory (PTGI) and Satisfaction with Care(NSCOT)

  • Injury relapse [ Time Frame: Up to 5 years after injury ] [ Designated as safety issue: No ]
    Assessed using Healthcare Utilization Questions (NSCOT)

  • Work, disability, and legal outcomes [ Time Frame: Up to 12 months after injury ] [ Designated as safety issue: No ]
    Assessed using Work, Disability and Legal (NSCOT) and Sheehan Disability Scale (SDS)


Estimated Enrollment: 60
Study Start Date: May 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: CBT
Behavioral: Motivational Interviewing
Motivational interviewing is designed to address alcohol and drug use.
Other Name: 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 Name: BA

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347541

Locations
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Douglas Zatzick, MD University of Washington
  More Information

Publications:
Responsible Party: Douglas Zatzick, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01347541     History of Changes
Other Study ID Numbers: 40069-C
Study First Received: April 29, 2011
Last Updated: June 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
PTSD

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 28, 2014