Piloting Acute Care to Primary Care Linkage of Safety Net Patients - Full Text View

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:

MedlinePlus related topics: Anxiety Injuries Post-Traumatic Stress Disorder Wounds

U.S. FDA Resources

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

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

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:

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.

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.

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 May 23, 2013

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