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Enhancing Equitable and Effective (E-3) Post Traumatic Stress Disorder (PTSD) Disability Assessment (E-3 PTSD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00699660
First received: June 12, 2008
Last updated: April 18, 2013
Last verified: March 2012
History of Changes
  Purpose

This project evaluated the impact of semi-structured, standardized interviews on the initial PTSD C&P on the examination.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Enhancing Equitable and Effective PTSD Disability Assessment

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 370
Study Start Date: May 2009
Study Completion Date: September 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
PTSD interview using CAPS and WHODAS
 Behavioral: Clinician Assessment of PTSD Symptoms (CAPS)
CAPS/WHODAS structured clinical PTSD interview
Active Comparator: Arm 2
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 referred 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

Locations
United States, Arkansas
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
No. Little Rock, Arkansas, United States, 72114-1706
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, Memphis
Memphis, Tennessee, United States, 38104
VA Medical Center, Nashville
Nashville, Tennessee, United States, 37212-2637
United States, Wisconsin
Zablocki VA Medical Center, Milwaukee
Milwaukee, Wisconsin, United States, 53295-1000
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Theodore Speroff, PhD Department of Veterans Affairs
  More Information

Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00699660     History of Changes
Other Study ID Numbers: SDR 06-331
Study First Received: June 12, 2008
Last Updated: April 18, 2013
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on May 21, 2013