Piloting Acute Care to Primary Care Linkage of Safety Net Patients

NCT01347541 | Terminated Phase 1 Results

• 1 other identifier: 40069
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder

Keywords

PTSD

Outcome Measures

Primary Outcomes (3)

• Change From Baseline Alcohol Use Disorders Identification at 1 Month

  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.

  Baseline, Up to 12 months after injury

• Change From Baseline PTSD Checklist Civilian (PCL-C) at 1 Month

  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.

  Baseline, Up to 12 months after injury

• Change in Functional Status at 1 Month

  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.

  Baseline, Up to 12 months after injury

Secondary Outcomes (3)

• Increased Satisfaction With Global Care

  Up to 12 months after injury

• Injury Relapse

  Up to 5 years after injury

• Work, Disability, and Legal Outcomes

  Up to 12 months after injury

Study Arms (2)

Stepped care

EXPERIMENTAL

Combination of behavioral therapy and drug therapy

Behavioral: Cognitive Behavioral Therapy; Behavioral: Motivational Interviewing; Drug: FDA-Approved Anti-Anxiety Medications

Standard care provided to injured trauma survivors

ACTIVE COMPARATOR

Behavioral: Standard Care Control

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

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.

Also known as: CBT

Stepped care

Motivational Interviewing BEHAVIORAL

Motivational interviewing is designed to address alcohol and drug use.

Also known as: MI

Stepped care

FDA-Approved Anti-Anxiety Medications DRUG

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.

Stepped care

Standard Care Control BEHAVIORAL

Standard care control includes the usual treatment for injured trauma survivors

Also known as: BA

Standard care provided to injured trauma survivors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (2)

• 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. doi: 10.1016/s0163-8343(01)00140-2.

  PMID: 11427243 BACKGROUND

• 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. doi: 10.1001/archpsyc.61.5.498.

  PMID: 15123495 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Cognitive Behavioral Therapy; Motivational Interviewing

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Directive Counseling; Counseling; Mental Health Services; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr, Douglas Zatzick
• Organization: University of Washington School of Medicine

dzatzick@uw.edu

206-744-6701

Study Officials

• Douglas Zatzick, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 29, 2011
• First Posted: May 4, 2011
• Study Start: January 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: March 10, 2021
• Results First Posted: February 11, 2021

Record last verified: 2021-02

Locations

US (1)