Piloting Acute Care to Primary Care Linkage of Safety Net Patients
Information source: University of Washington
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Posttraumatic Stress Disorder
Intervention: Cognitive Behavioral Therapy (Behavioral); Motivational Interviewing (Behavioral); FDA-Approved Anti-Anxiety Medications (Drug); Standard Care Control (Behavioral)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: University of Washington Official(s) and/or principal investigator(s): Douglas Zatzick, MD, Principal Investigator, Affiliation: University of Washington
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.
Clinical Details
Official title: Piloting Acute Care to Primary Care Linkage of Safety Net Patients
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Substance usePTSD ratings General functioning reports
Secondary outcome: Increased satisfaction with global careInjury relapse Work, disability, and legal outcomes
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Harborview Medical Center, Seattle, Washington 98104, United States
Additional Information
Related 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.
Starting date: May 2011
Last updated: June 19, 2012
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