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

Primary Purpose

Posttraumatic Stress Disorder

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Motivational Interviewing
FDA-Approved Anti-Anxiety Medications
Standard Care Control
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring PTSD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Harborview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stepped care

Standard care provided to injured trauma survivors

Arm Description

Combination of behavioral therapy and drug therapy

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Increased Satisfaction With Global Care
Assessed using the Posttraumatic Growth Inventory (PTGI) and Satisfaction with Care (NSCOT)
Injury Relapse
Assessed using Healthcare Utilization Questions (NSCOT)
Work, Disability, and Legal Outcomes
Assessed using Work, Disability and Legal (NSCOT) and Sheehan Disability Scale (SDS)

Full Information

First Posted
April 29, 2011
Last Updated
February 18, 2021
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT01347541
Brief Title
Piloting Acute Care to Primary Care Linkage of Safety Net Patients
Acronym
TSOS III
Official Title
Piloting Acute Care to Primary Care Linkage of Safety Net Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
Inadequate recruitment
Study Start Date
January 2011 (Actual)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
PTSD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stepped care
Arm Type
Experimental
Arm Description
Combination of behavioral therapy and drug therapy
Arm Title
Standard care provided to injured trauma survivors
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Other Intervention Name(s)
CBT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Other Intervention Name(s)
MI
Intervention Description
Motivational interviewing is designed to address alcohol and drug use.
Intervention Type
Drug
Intervention Name(s)
FDA-Approved Anti-Anxiety Medications
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Care Control
Other Intervention Name(s)
BA
Intervention Description
Standard care control includes the usual treatment for injured trauma survivors
Primary Outcome Measure Information:
Title
Change From Baseline Alcohol Use Disorders Identification at 1 Month
Description
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.
Time Frame
Baseline, Up to 12 months after injury
Title
Change From Baseline PTSD Checklist Civilian (PCL-C) at 1 Month
Description
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.
Time Frame
Baseline, Up to 12 months after injury
Title
Change in Functional Status at 1 Month
Description
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.
Time Frame
Baseline, Up to 12 months after injury
Secondary Outcome Measure Information:
Title
Increased Satisfaction With Global Care
Description
Assessed using the Posttraumatic Growth Inventory (PTGI) and Satisfaction with Care (NSCOT)
Time Frame
Up to 12 months after injury
Title
Injury Relapse
Description
Assessed using Healthcare Utilization Questions (NSCOT)
Time Frame
Up to 5 years after injury
Title
Work, Disability, and Legal Outcomes
Description
Assessed using Work, Disability and Legal (NSCOT) and Sheehan Disability Scale (SDS)
Time Frame
Up to 12 months after injury

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Zatzick, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11427243
Citation
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.
Results Reference
background
PubMed Identifier
15123495
Citation
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.
Results Reference
background

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Piloting Acute Care to Primary Care Linkage of Safety Net Patients

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