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

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00699660
• Collaborator: (none)
• Enrollment: 406
• Locations: 11
• Arms: 2
• Duration (Months): 28
• Patients Per Site: 36.9
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Post-Traumatic Stress Disorder	Behavioral: CAPS/WHODAS; Behavioral: Nonstructured Interview	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 406 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Enhancing Equitable and Effective PTSD Disability Assessment
• Study Start Date: May 1, 2009
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Completeness and Quality of PTSD Interview [Post-exam, same day]

   total completeness of diagnostic assessment score, range from 0 to 100% and completeness of functional assessment

Secondary Outcome Measures

1. PTSD Diagnosis [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).

2. Patient Satisfaction [post-exam, same day]

   Mean score on satisfaction survey rating scale from 1 to 5 (higher)

3. Resource Utilization [same day]

   time spent administering the exam

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

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

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT00699660
• Other Study ID Numbers: SDR 06-331
• First Posted: Jun 18, 2008
• Last Update Posted: Aug 16, 2018
• Last Verified: Jul 1, 2018

• Keywords provided by VA Office of Research and Development: Disability Examination; Clinician Administered PTSD Scale; Quality of Care
• Additional relevant MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic

Study Results

Participant Flow

Arm/Group Title	Arm 1	Arm 2
Arm/Group Description	PTSD interview using CAPS and WHODAS Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview	Usual PTSD interview, without CAPS or WHODAS Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID
Period Title: Overall Study
STARTED	190	216
COMPLETED	176	208
NOT COMPLETED	14	8

Baseline Characteristics

Arm/Group Title	Arm 1	Arm 2	Total
Arm/Group Description	PTSD interview using CAPS and WHODAS Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview	Usual PTSD interview, without CAPS or WHODAS Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID	Total of all reporting groups
Overall Participants	176	208	384
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	60	59	59
Sex: Female, Male (Count of Participants)
Female	6 3.4%	13 6.3%	19 4.9%
Male	170 96.6%	195 93.8%	365 95.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	44 25%	56 26.9%	100 26%
White	103 58.5%	124 59.6%	227 59.1%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	29 16.5%	28 13.5%	57 14.8%
Marital Status (participants) [Number]
Married	108 61.4%	130 62.5%	238 62%
Single	28 15.9%	35 16.8%	63 16.4%
Separated	32 18.2%	37 17.8%	69 18%
Other/Missing	8 4.5%	6 2.9%	14 3.6%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1	Arm 2
Arm/Group Description	PTSD interview using CAPS and WHODAS Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview	Usual PTSD interview, without CAPS or WHODAS Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID
Measure Participants	176	208
completeness of diagnostic assessment	84.8 (17.3)	29.8 (24.4)
completeness of functional assessment	76.2 (24.4)	3.1 (7.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1, Arm 2
	Comments	Our sample size calculation yielded 466 for a power of 0.80 to detect a 10% absolute difference in sensitivity and adjusted for intraclass correlation. The number of covariates in regression models was limited to ensure the effective sample size remained ten times greater than the degrees of freedom in the model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments	Comparison of CAPS/WHODAS vs Nonstructured Interview study arms: linear and logistic mixed effects regression with clinical examiner stratified by study group as a random effect and study group as a fixed effect.
	Method	Regression, Linear
	Comments	Covariates included experience, use of template,tests,reviewing records,age,education, study site,reviewer, and expert reviewer by group interaction.

2. Secondary Outcome

Title	PTSD Diagnosis
Description	Number of participants who were unable to receive a conclusive clinician PTSD diagnosis for positive or negative PTSD symptoms (unable to determine clinician diagnosis).
Time Frame	Post-exam, same day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1	Arm 2
Arm/Group Description	PTSD interview using CAPS and WHODAS Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview	Usual PTSD interview, without CAPS or WHODAS Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID
Measure Participants	176	208
Uanble to determine clinician PTSD+ diagnosis	49 27.8%	110 52.9%
Unable to determine PTSD- diagnosis	14 8%	73 35.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1, Arm 2
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<.01
	Comments
	Method	Regression, Logistic
	Comments

3. Secondary Outcome

Title	Patient Satisfaction
Description	Mean score on satisfaction survey rating scale from 1 to 5 (higher)
Time Frame	post-exam, same day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1	Arm 2
Arm/Group Description	PTSD interview using CAPS and WHODAS Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview	Usual PTSD interview, without CAPS or WHODAS Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID
Measure Participants	176	208
Mean (Standard Deviation) [units on a scale]	4.69 (.44)	4.74 (.38)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1, Arm 2
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>.05
	Comments	Descriptive statistics on mean and standard deviation.
	Method	t-test, 2 sided
	Comments

4. Secondary Outcome

Title	Resource Utilization
Description	time spent administering the exam
Time Frame	same day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1	Arm 2
Arm/Group Description	PTSD interview using CAPS and WHODAS Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview	Usual PTSD interview, without CAPS or WHODAS Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID
Measure Participants	176	208
Mean (Standard Deviation) [minutes]	216.6 (88.6)	157.2 (63.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1, Arm 2
	Comments	Estimates of the influence on total time and tests of statistical significance were derived from multilevel mixed-effects linear regression (xtmixed in Stata)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.012
	Comments	0.05 level based on a two tailed test.
	Method	Regression, Linear
	Comments	Covariates included years of experience, use of template, use of tests, age, education, study site.
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	47.3
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 18.86
	Estimation Comments

Adverse Events

Time Frame	Day of disability examination
Arm/Group Title	Arm 1		Arm 2
Arm/Group Description	PTSD interview using CAPS and WHODAS Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview		Usual PTSD interview, without CAPS or WHODAS Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID
All Cause Mortality
	Arm 1		Arm 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm 1		Arm 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/176 (0%)		0/208 (0%)
Other (Not Including Serious) Adverse Events
	Arm 1		Arm 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/176 (0%)		0/208 (0%)

Limitations/Caveats

Information external to interview such as psychological testing or charts were not available to the expert reviewers. Another limitation is that Veterans in our study did not undergo a concurrent, independent evaluation for assessment of PTSD.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.