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Enhancing Equitable and Effective (E-3) Post Traumatic Stress Disorder (PTSD) Disability Assessment (E-3 PTSD)
This study is not yet open for participant recruitment.
Verified by Department of Veterans Affairs, November 2008
First Received: June 12, 2008   Last Updated: November 24, 2008   History of Changes
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00699660
  Purpose

This project will evaluate variations of the inital PTSD C&P interview on the examination process..


Condition Intervention
Post-Traumatic Stress Disorder
Behavioral: Clinician Assessment of PTSD Symptoms (CAPS)
Behavioral: Nonstructured Interview

MedlinePlus related topics: Post-Traumatic Stress Disorder
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Enhancing Equitable and Effective PTSD Disability Assessment

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • completeness and quality of PTSD interview [ Time Frame: Post-exam, same day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PTSD diagnosis [ Time Frame: post-exam, same day ] [ Designated as safety issue: No ]
  • PTSD diagnosis [ Time Frame: Post-exam, same day ] [ Designated as safety issue: No ]
  • Patient Satisfaction [ Time Frame: post-exam, same day ] [ Designated as safety issue: No ]
  • resource utilization [ Time Frame: same day ] [ Designated as safety issue: No ]

Estimated Enrollment: 688
Study Start Date: February 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
PTSD interview using CAPS and WHODAS
Behavioral: Clinician Assessment of PTSD Symptoms (CAPS)
CAPS/WHODAS structured clinical PTSD interview
2: Active Comparator
Usual PTSD interview, without CAPS or WHODAS
Behavioral: Nonstructured Interview
Usual PTSD clinical PTSD interview, not CAPS or SCID

Detailed Description:

Our objective is to compare the process and outcomes of C&P exams for PTSD conducted with CAPS and WHODAS-II interviews versus the PTSD exams conducted without the CAPS and WHODAS-II interviews. This project will conduct a randomized controlled trial on 688 veterans to evaluate the effects of the CAPS/WHODAS instruments on the initial PTSD C&P examination process. Study outcomes include variation in assessing the DSM-IV components of PTSD, diagnostic accuracy, veteran perception of the exam process, VBA rater utility and resource utilization. This project will 1) demonstrate the feasibility of conducting program evaluation and intervention studies on the PTSD C&P examination process, 2) develop research tools, instruments and methods for C&P evaluation, 3) provide data on the value-added contribution of CAPS and WHODAS-II to the PTSD assessment process and examination report, and 4) inform the business case of utilizing the CAPS and WHODAS-II in the PTSD C&P process. The ultimate aim is to improve the reproducibility, consistency and validity of the PTSD examination process while maintaining a level of efficiency and cost restraint that provides veterans with an exam process that is fair, accurate and equitable across VHA.

  Eligibility

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

Inclusion Criteria:

  1. Veterans refered to VHA for an Initial PTSD Compensation and Pension Examination
  2. Informed consent

Exclusion Criteria:

  1. Mentally impaired, not able to give informed consent
  2. English speaking
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00699660

Contacts
Contact: Theodore Speroff, PhD MS PhD (615) 340-2357 ted.speroff@va.gov
Contact: Heather J Davis-Underwood, MPH MBA BA (615) 340-2354 heather.davis-underwood@va.gov

Locations
United States, Arkansas
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
No. Little Rock, Arkansas, United States, 72114-1706
United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304-1290
United States, Connecticut
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, United States, 06516
United States, Louisiana
Southeast Veterans Healthcare System, New Orleans
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
VA Medical Center
Boston, Massachusetts, United States, 02130
United States, Michigan
John D. Dingell VA Medical Center, Detroit
Detroit, Michigan, United States, 48201
United States, Minnesota
VA Medical Center
Minneapolis, Minnesota, United States, 55417
United States, New Mexico
New Mexico VA Health Care System, Albuquerque
Albuquerque, New Mexico, United States, 87108-5153
United States, Tennessee
VA Medical Center
Nashville, Tennessee, United States, 37212-2637
VA Medical Center, Memphis
Memphis, Tennessee, United States, 38104
United States, Texas
VA South Texas Health Care System, San Antonio
San Antonio, Texas, United States, 78229
United States, Wisconsin
Zablocki VA Medical Center, Milwaukee
Milwaukee, Wisconsin, United States, 53295-1000
Sponsors and Collaborators
Investigators
Principal Investigator: Theodore Speroff, PhD MS PhD Department of Veterans Affairs
  More Information

Publications:
Responsible Party: Department of Veterans Affairs ( Speroff, Theodore - Principal Investigator )
Study ID Numbers: SDR 06-331
Study First Received: June 12, 2008
Last Updated: November 24, 2008
ClinicalTrials.gov Identifier: NCT00699660     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Disability Examination
Clinician Administered PTSD Scale
Quality of Care

Study placed in the following topic categories:
Anxiety Disorders
Mental Disorders
Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

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

ClinicalTrials.gov processed this record on May 07, 2009