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

Tracking Information

First Received Date ^ICMJE

June 12, 2008

Last Updated Date

April 18, 2013

Start Date ^ICMJE

May 2009

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00699660 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Enhancing Equitable and Effective PTSD Disability Assessment

Brief Summary

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

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Post-Traumatic Stress Disorder

Intervention ^ICMJE

Behavioral: Clinician Assessment of PTSD Symptoms (CAPS)
CAPS/WHODAS structured clinical PTSD interview
Behavioral: Nonstructured Interview
Usual PTSD clinical PTSD interview, not CAPS or SCID

Study Arm (s)

Experimental: Arm 1
PTSD interview using CAPS and WHODAS

Intervention: Behavioral: Clinician Assessment of PTSD Symptoms (CAPS)
Active Comparator: Arm 2
Usual PTSD interview, without CAPS or WHODAS

Intervention: Behavioral: Nonstructured Interview

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

370

Completion Date

September 2011

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Veterans referred to VHA for an Initial PTSD Compensation and Pension Examination
Informed consent

Exclusion Criteria:

Mentally impaired, not able to give informed consent
English speaking

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00699660

Other Study ID Numbers ^ICMJE

SDR 06-331

Has Data Monitoring Committee

Yes

Responsible Party

Department of Veterans Affairs

Study Sponsor ^ICMJE

Department of Veterans Affairs

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Theodore Speroff, PhD

Department of Veterans Affairs

Information Provided By

Department of Veterans Affairs

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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