Trial Outcomes & Findings for Re-Engineering Systems for the Primary Care Treatment for PTSD (NCT NCT00373698)
NCT ID: NCT00373698
Last Updated: 2015-04-24
Results Overview
PTSD Symptom Severity was measured using the Postraumatic Diagnostic Scale (PDS)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
195 participants
Primary outcome timeframe
3 and 6 months after initial assessment
Results posted on
2015-04-24
Participant Flow
Participant milestones
| Measure |
Three Component Model of Collaborative Care and Usual Care
Participants randomized to this arm received the Three Component Model of Collaborative Care (3CM) as well as usual care. 3CM model consists of 1) education and tools for primary care clinicians and staff including content regarding PTSD; 2) telephone care management by a centrally located care manager (the purpose of the calls was to identify barriers to adherance with the primary care provider's plan, aid participant to overcome them, and measure treatment response. Calls occurred 1, 4, and 8 weeks after the initial visit and then every 4 weeks for 6 months or until a participant acheived 30% reduction in PTSD symptoms as measure by the PCL); 3) support from a psychiatrist who supervises care managers by telephone, provides consultation to primary care clinicians, and facilitates mental health referral. Participant's "Usual Care" is at the VA provider's discretion and could include referral to mental health specialty care.specialty care.
|
Usual Care
Participants randomized to "Usual Care" received care at the VA provider's discretion and could include referral to mental health specialty care.
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|---|---|---|
|
Overall Study
STARTED
|
96
|
99
|
|
Overall Study
COMPLETED
|
85
|
99
|
|
Overall Study
NOT COMPLETED
|
11
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Re-Engineering Systems for the Primary Care Treatment for PTSD
Baseline characteristics by cohort
| Measure |
Three Component Model
n=96 Participants
Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
|
Usual Care
n=99 Participants
Patients randomized to "Usual Care" will receive care as usual by VA clinicians.
|
Total
n=195 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Customized
Age, >=18
|
46.1 years
n=99 Participants
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44.4 years
n=107 Participants
|
NA years
n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=99 Participants
|
89 Participants
n=107 Participants
|
178 Participants
n=206 Participants
|
|
Region of Enrollment
United States
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96 participants
n=99 Participants
|
99 participants
n=107 Participants
|
195 participants
n=206 Participants
|
|
PTSD symptom severity (used Posttraumatic Diagnostic Scale (PDS))
|
33.2 units on a scale
STANDARD_DEVIATION 8.3 • n=99 Participants
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34.0 units on a scale
STANDARD_DEVIATION 9.7 • n=107 Participants
|
NA units on a scale
STANDARD_DEVIATION NA • n=206 Participants
|
|
Depression (Hopkins Symptom Checklist-20)
|
1.98 units on a scale
STANDARD_DEVIATION 0.69 • n=99 Participants
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2.06 units on a scale
STANDARD_DEVIATION 0.78 • n=107 Participants
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NA units on a scale
STANDARD_DEVIATION NA • n=206 Participants
|
|
SF-36 Mental Component
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33.8 units on a scale
STANDARD_DEVIATION 8.8 • n=99 Participants
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32.7 units on a scale
STANDARD_DEVIATION 8.1 • n=107 Participants
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NA units on a scale
STANDARD_DEVIATION NA • n=206 Participants
|
|
SF-36 Physical Component
|
42.2 units on a scale
STANDARD_DEVIATION 13.0 • n=99 Participants
|
43.4 units on a scale
STANDARD_DEVIATION 12.6 • n=107 Participants
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NA units on a scale
STANDARD_DEVIATION NA • n=206 Participants
|
PRIMARY outcome
Timeframe: 3 and 6 months after initial assessmentPTSD Symptom Severity was measured using the Postraumatic Diagnostic Scale (PDS)
Outcome measures
| Measure |
Arm1/Three Component Model of Care Collaborative Care
n=96 Participants
Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
|
Arm 2/Usual Care
n=99 Participants
Patients randomized to "Usual Care" will receive care as usual by VA clinicians.
|
|---|---|---|
|
PTSD Symptom Severity
3 months after initial assessment
|
31.4 units on a scale
Standard Deviation 10.2
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31.5 units on a scale
Standard Deviation 10.3
|
|
PTSD Symptom Severity
6 months after initial assessment
|
30.2 units on a scale
Standard Deviation 10.3
|
29.9 units on a scale
Standard Deviation 10.8
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SECONDARY outcome
Timeframe: 3 and 6 months after initial assessmentMeasure using the Hopkins Symptom Checklist-20
Outcome measures
| Measure |
Arm1/Three Component Model of Care Collaborative Care
n=96 Participants
Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
|
Arm 2/Usual Care
n=99 Participants
Patients randomized to "Usual Care" will receive care as usual by VA clinicians.
|
|---|---|---|
|
Depression
3 months after initial assessment
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1.8 units on a scale
Standard Deviation 0.8
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1.84 units on a scale
Standard Deviation 0.82
|
|
Depression
6 months after initial assessment
|
1.81 units on a scale
Standard Deviation 0.84
|
1.83 units on a scale
Standard Deviation 0.90
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SECONDARY outcome
Timeframe: 3 and 6 months after initial assessmentOutcome measures
| Measure |
Arm1/Three Component Model of Care Collaborative Care
n=96 Participants
Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
|
Arm 2/Usual Care
n=99 Participants
Patients randomized to "Usual Care" will receive care as usual by VA clinicians.
|
|---|---|---|
|
SF-36 Mental Component
Mental Component-3 months after initial assessment
|
33.9 units on a scale
Standard Deviation 8.3
|
33.8 units on a scale
Standard Deviation 8.1
|
|
SF-36 Mental Component
Mental Component-6 months after initial assessment
|
33.7 units on a scale
Standard Deviation 9.4
|
33.4 units on a scale
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: 3 and 6 months after initial assessmentOutcome measures
| Measure |
Arm1/Three Component Model of Care Collaborative Care
n=96 Participants
Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
|
Arm 2/Usual Care
n=99 Participants
Patients randomized to "Usual Care" will receive care as usual by VA clinicians.
|
|---|---|---|
|
SF-36 Physical Component
Physical Component-3 months after initial assessme
|
43.8 units on a scale
Standard Deviation 13.1
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43.7 units on a scale
Standard Deviation 12.2
|
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SF-36 Physical Component
Physical Component-6 monthsafter initial assessmen
|
44.4 units on a scale
Standard Deviation 12.6
|
44.8 units on a scale
Standard Deviation 11.8
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Adverse Events
Three Component Model
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Three Component Model
n=96 participants at risk
Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
|
Usual Care
n=99 participants at risk
Patients randomized to "Usual Care" will receive care as usual by VA clinicians.
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|---|---|---|
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Surgical and medical procedures
hospitalization
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5.2%
5/96
|
4.0%
4/99
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Other adverse events
Adverse event data not reported
Additional Information
Dr. Paula Schnurr and Dr. Mathew Friedman
VA Medical Center, White River Junction, VT
Phone: 802-296-5132
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place