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

July 19, 2018 updated by: VA Office of Research and Development

Enhancing Equitable and Effective PTSD Disability Assessment

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

406

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • North Little Rock, Arkansas, United States, 72114-1706
        • Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
    • California
      • Palo Alto, California, United States, 94304-1290
        • VA Palo Alto Health Care System, Palo Alto, CA
    • Connecticut
      • West Haven, Connecticut, United States, 06516
        • VA Connecticut Healthcare System West Haven Campus, West Haven, CT
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Southeast Louisiana Veterans Health Care System, New Orleans, LA
    • Massachusetts
      • Boston, Massachusetts, United States, 02130
        • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
    • Michigan
      • Detroit, Michigan, United States, 48201
        • John D. Dingell VA Medical Center, Detroit, MI
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Minneapolis VA Health Care System, Minneapolis, MN
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108-5153
        • New Mexico VA Health Care System, Albuquerque, NM
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Memphis VA Medical Center, Memphis, TN
      • Nashville, Tennessee, United States, 37212-2637
        • Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53295-1000
        • Clement J. Zablocki VA Medical Center, Milwaukee, WI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAPS/WHODAS
PTSD assessed using Clinical Assessment of PTSD Symptoms (CAPS) and WHODAS functional impairment structured evidence-based interview
Behavioral: CAPS/WHODAS
CAPS/WHODAS structured clinical PTSD interview
Active Comparator: Nonstructured Interview
Usual clinical interview to assess PTSD, without CAPS or WHODAS
Behavioral: Nonstructured Interview
Usual PTSD clinical PTSD interview, not CAPS or SCID
Other Names:
  • Usual Clinical Interview

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completeness and Quality of PTSD Interview
Time Frame: Post-exam, same day
total completeness of diagnostic assessment score, range from 0 to 100% and completeness of functional assessment
Post-exam, same day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTSD Diagnosis
Time Frame: Post-exam, same day
Number of participants who were unable to receive a conclusive clinician PTSD diagnosis for positive or negative PTSD symptoms (unable to determine clinician diagnosis).
Post-exam, same day
Patient Satisfaction
Time Frame: post-exam, same day
Mean score on satisfaction survey rating scale from 1 to 5 (higher)
post-exam, same day
Resource Utilization
Time Frame: same day
time spent administering the exam
same day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Theodore Speroff, PhD, Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

June 12, 2008

First Submitted That Met QC Criteria

June 17, 2008

First Posted (Estimate)

June 18, 2008

Study Record Updates

Last Update Posted (Actual)

August 16, 2018

Last Update Submitted That Met QC Criteria

July 19, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDR 06-331

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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