Post-Traumatic Stress Disorder
Conditions
Keywords
Disability Examination, Clinician Administered PTSD Scale, Quality of Care
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.
Interventions
BEHAVIORALCAPS/WHODAS
CAPS/WHODAS structured clinical PTSD interview
BEHAVIORALNonstructured Interview
Usual PTSD clinical PTSD interview, not CAPS or SCID
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Patient Satisfaction | post-exam, same day | Mean score on satisfaction survey rating scale from 1 to 5 (higher) |
| Resource Utilization | same day | time spent administering the exam |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 PTSD interview using CAPS and WHODAS
Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview | 176 |
| Arm 2 Usual PTSD interview, without CAPS or WHODAS
Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID | 208 |
| Total | 384 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 2 |
| Overall Study | missing reports and recording failures | 10 | 6 |
Baseline characteristics
| Characteristic | Arm 2 | Arm 1 | Total |
|---|---|---|---|
| Age, Continuous | 59 years | 60 years | 59 years |
| Marital Status Married | 130 participants | 108 participants | 238 participants |
| Marital Status Other/Missing | 6 participants | 8 participants | 14 participants |
| Marital Status Separated | 37 participants | 32 participants | 69 participants |
| Marital Status Single | 35 participants | 28 participants | 63 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 56 Participants | 44 Participants | 100 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 28 Participants | 29 Participants | 57 Participants |
| Race (NIH/OMB) White | 124 Participants | 103 Participants | 227 Participants |
| Sex: Female, Male Female | 13 Participants | 6 Participants | 19 Participants |
| Sex: Female, Male Male | 195 Participants | 170 Participants | 365 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 176 | 0 / 208 |
| serious Total, serious adverse events | 0 / 176 | 0 / 208 |
Outcome results
Primary
Completeness and Quality of PTSD Interview
total completeness of diagnostic assessment score, range from 0 to 100% and completeness of functional assessment
Time frame: Post-exam, same day
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | Completeness and Quality of PTSD Interview | completeness of diagnostic assessment | 84.8 percentage of criteria PTSD assessment | Standard Deviation 17.3 |
| Arm 1 | Completeness and Quality of PTSD Interview | completeness of functional assessment | 76.2 percentage of criteria PTSD assessment | Standard Deviation 24.4 |
| Arm 2 | Completeness and Quality of PTSD Interview | completeness of diagnostic assessment | 29.8 percentage of criteria PTSD assessment | Standard Deviation 24.4 |
| Arm 2 | Completeness and Quality of PTSD Interview | completeness of functional assessment | 3.1 percentage of criteria PTSD assessment | Standard Deviation 7.5 |
Comparison: 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.p-value: <0.001Regression, Linear
Secondary
Patient Satisfaction
Mean score on satisfaction survey rating scale from 1 to 5 (higher)
Time frame: post-exam, same day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | Patient Satisfaction | 4.69 units on a scale | Standard Deviation 0.44 |
| Arm 2 | Patient Satisfaction | 4.74 units on a scale | Standard Deviation 0.38 |
p-value: >0.05t-test, 2 sided
Secondary
PTSD Diagnosis
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1 | PTSD Diagnosis | Uanble to determine clinician PTSD+ diagnosis | 49 participants |
| Arm 1 | PTSD Diagnosis | Unable to determine PTSD- diagnosis | 14 participants |
| Arm 2 | PTSD Diagnosis | Uanble to determine clinician PTSD+ diagnosis | 110 participants |
| Arm 2 | PTSD Diagnosis | Unable to determine PTSD- diagnosis | 73 participants |
p-value: <0.01Regression, Logistic
Secondary
Resource Utilization
time spent administering the exam
Time frame: same day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | Resource Utilization | 216.6 minutes | Standard Deviation 88.6 |
| Arm 2 | Resource Utilization | 157.2 minutes | Standard Deviation 63.8 |
Comparison: Estimates of the influence on total time and tests of statistical significance were derived from multilevel mixed-effects linear regression (xtmixed in Stata)p-value: 0.012Regression, Linear