Trial Outcomes & Findings for Evaluation of Stepped Care for Chronic Pain in Iraq/Afghanistan Veterans (ESCAPE) (NCT NCT00386243)
NCT ID: NCT00386243
Last Updated: 2019-07-05
Results Overview
This is a 24-item pain specific disability questionnaire consisting of 24 questions which are related specifically to physical functions that are likely to be affected by back pain. The questionnaire is scored by adding up the number of items checked by the subject (0-24 range). Greater levels of disability are reflected by higher numbers.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
242 participants
Primary outcome timeframe
at baseline and 9 months
Results posted on
2019-07-05
Participant Flow
Enrollment began December 2007 and concluded June 2011. The final assessment was completed by May 2012. All subjects were recruited from the Roudebush VA Medical Center.
Participant milestones
| Measure |
Usual Care
Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
|
Stepped Care
Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.
Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.
Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.
Co-Analgesic Therapy
|
|---|---|---|
|
Overall Study
STARTED
|
121
|
121
|
|
Overall Study
COMPLETED
|
114
|
108
|
|
Overall Study
NOT COMPLETED
|
7
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Stepped Care for Chronic Pain in Iraq/Afghanistan Veterans (ESCAPE)
Baseline characteristics by cohort
| Measure |
Usual Care
n=121 Participants
Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
|
Stepped Care
n=121 Participants
Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.
Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.
Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.
Co-Analgesic Therapy
|
Total
n=242 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
121 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
241 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
38.2 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
36.4 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
36.7 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
105 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
121 participants
n=5 Participants
|
121 participants
n=7 Participants
|
242 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at baseline and 9 monthsPopulation: We had baseline data available for 241 participants; 120 in the usual care arm and 121 in the stepped care arm. At 9 months, 7 participants withdrew from the study leaving 114 usual care participants available for analysis. In the stepped care arm, 13 participants withdrew leaving 108 available for analysis
This is a 24-item pain specific disability questionnaire consisting of 24 questions which are related specifically to physical functions that are likely to be affected by back pain. The questionnaire is scored by adding up the number of items checked by the subject (0-24 range). Greater levels of disability are reflected by higher numbers.
Outcome measures
| Measure |
Usual Care
n=120 Participants
Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
|
Stepped Care
n=121 Participants
Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.
Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.
Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.
Co-Analgesic Therapy
|
|---|---|---|
|
Roland-Morris Disability Questionnaire
baseline
|
13.7 scores on a scale
Standard Deviation 4.7
|
14.0 scores on a scale
Standard Deviation 4.3
|
|
Roland-Morris Disability Questionnaire
9 months
|
12.1 scores on a scale
Standard Deviation 6.4
|
10.6 scores on a scale
Standard Deviation 6.3
|
PRIMARY outcome
Timeframe: Baseline and 9 monthsPopulation: We had baseline data available for 241 participants; 120 in the usual care arm and 121 in the stepped care arm. At 9 months, 7 participants withdrew from the study leaving 114 usual care participants available for analysis. In the stepped care arm, 13 participants withdrew leaving 108 available for analysis
This is an 7-item measure that provides scores for pain-related functional impairment. The seven (7) pain interference items are rated on a simple numeric rating scale from 0-10. On the scale 0 represents "no interference" and 10 is "completely interferes". The pain interference score is achieved by taking the total of all seven (7) scores and dividing it by the number of items (7).
Outcome measures
| Measure |
Usual Care
n=120 Participants
Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
|
Stepped Care
n=121 Participants
Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.
Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.
Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.
Co-Analgesic Therapy
|
|---|---|---|
|
Brief Pain Inventory (Interference)
At Baseline
|
5.4 units on a scale
Standard Deviation 2.4
|
5.3 units on a scale
Standard Deviation 2.1
|
|
Brief Pain Inventory (Interference)
At 9 months
|
4.5 units on a scale
Standard Deviation 2.7
|
3.8 units on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Baseline and 9 monthsPopulation: We had baseline data available for 241 participants; 120 in the usual care arm and 121 in the stepped care arm. At 9 months, 7 participants withdrew from the study leaving 114 usual care participants available for analysis. In the stepped care arm, 13 participants withdrew leaving 108 available for analysis
This scale provides a measure of mental health quality of life. It is measure on a 0 to 100 scale with higher scores representing better mental health
Outcome measures
| Measure |
Usual Care
n=120 Participants
Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
|
Stepped Care
n=121 Participants
Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.
Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.
Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.
Co-Analgesic Therapy
|
|---|---|---|
|
SF-Mental Component Summary (MCS)
Baseline
|
41.4 units on a scale
Standard Deviation 13.2
|
41.9 units on a scale
Standard Deviation 12.1
|
|
SF-Mental Component Summary (MCS)
9 months
|
42.4 units on a scale
Standard Deviation 12.5
|
42.2 units on a scale
Standard Deviation 13.1
|
SECONDARY outcome
Timeframe: Baseline and 9 monthsPopulation: We had baseline data available for 241 participants; 120 in the usual care arm and 121 in the stepped care arm. At 9 months, 7 participants withdrew from the study leaving 114 usual care participants available for analysis. In the stepped care arm, 13 participants withdrew leaving 108 available for analysis
This measure assesses depression symptoms on a 0 to 27 scale with higher scores representing more severe depression
Outcome measures
| Measure |
Usual Care
n=120 Participants
Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
|
Stepped Care
n=121 Participants
Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.
Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.
Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.
Co-Analgesic Therapy
|
|---|---|---|
|
PHQ-9 Depression
Baseline
|
11.3 scores on a scale
Standard Deviation 5.64
|
11.05 scores on a scale
Standard Deviation 6.18
|
|
PHQ-9 Depression
9 months
|
10.0 scores on a scale
Standard Deviation 6.34
|
9.45 scores on a scale
Standard Deviation 6.84
|
SECONDARY outcome
Timeframe: Baseline and 9 monthsPopulation: We had baseline data available for 241 participants; 120 in the usual care arm and 121 in the stepped care arm. At 9 months, 7 participants withdrew from the study leaving 114 usual care participants available for analysis. In the stepped care arm, 13 participants withdrew leaving 108 available for analysis
The PCL-17 is a standardized self-report rating scale for PTSD comprising 17 items that correspond to the key symptoms of PTSD. Two versions of the PCL exist: PCL-Military and PCL-Civilian.We used the PCL-Civilian version because it addresses the broadest range of possible events as the traumatic stressor. The PCL-C has demonstrated strong reliability and validity in multiple samples. A total symptom severity score (range = 17-85) can be obtained by summing the scores from each of the 17 items that have response options ranging from 1 "Not at all" to 5 "Extremely". Higher scores represent more severe PTSD symptoms.
Outcome measures
| Measure |
Usual Care
n=120 Participants
Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
|
Stepped Care
n=121 Participants
Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.
Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.
Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.
Co-Analgesic Therapy
|
|---|---|---|
|
PTSD Checklist-17 Civilian Version (PCL-C)
Baseline
|
25.15 score on a scale
Standard Deviation 19.74
|
27.62 score on a scale
Standard Deviation 19.24
|
|
PTSD Checklist-17 Civilian Version (PCL-C)
9 months
|
22.71 score on a scale
Standard Deviation 19.15
|
24.28 score on a scale
Standard Deviation 19.07
|
SECONDARY outcome
Timeframe: Baseline and 9 monthsPopulation: We had baseline data available for 241 participants; 120 in the usual care arm and 121 in the stepped care arm. At 9 months, 7 participants withdrew from the study leaving 114 usual care participants available for analysis. In the stepped care arm, 13 participants withdrew leaving 108 available for analysis
This 7-item scale assesses anxiety symptoms on a 0 to 21 scale with higher scores representing more severe anxiety symptoms
Outcome measures
| Measure |
Usual Care
n=120 Participants
Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
|
Stepped Care
n=121 Participants
Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.
Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.
Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.
Co-Analgesic Therapy
|
|---|---|---|
|
GAD-7 Anxiety Score
Baseline
|
8.66 units on a scale
Standard Deviation 5.22
|
8.95 units on a scale
Standard Deviation 5.30
|
|
GAD-7 Anxiety Score
9 months
|
7.85 units on a scale
Standard Deviation 5.5
|
7.89 units on a scale
Standard Deviation 5.55
|
SECONDARY outcome
Timeframe: Baseline and 9 monthsPopulation: We had baseline data available for 241 participants; 120 in the usual care arm and 121 in the stepped care arm. At 9 months, 7 participants withdrew from the study leaving 114 usual care participants available for analysis. In the stepped care arm, 13 participants withdrew leaving 108 available for analysis
The PCS total score is computed by summing responses to all 13 items. PCS total scores range from 0-52 with higher scores representing more pain catastrophizing.
Outcome measures
| Measure |
Usual Care
n=120 Participants
Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
|
Stepped Care
n=121 Participants
Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.
Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.
Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.
Co-Analgesic Therapy
|
|---|---|---|
|
Pain Catastrophizing Scale (PCS)
Baseline
|
21.81 units on a scale
Standard Deviation 12.38
|
21.44 units on a scale
Standard Deviation 12.26
|
|
Pain Catastrophizing Scale (PCS)
9 months
|
18.40 units on a scale
Standard Deviation 13.46
|
16.63 units on a scale
Standard Deviation 12.29
|
Adverse Events
Usual Care
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Stepped Care
Serious events: 6 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Usual Care
n=121 participants at risk
Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
|
Stepped Care
n=121 participants at risk
Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.
Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.
Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.
Co-Analgesic Therapy
|
|---|---|---|
|
Psychiatric disorders
hospital stay longer than 24 hours
|
0.83%
1/121 • Number of events 1 • The time frame in which adverse event data were collected was from the baseline evaluation to the 9-month assessment. Therefore, the assessment period was for 9 months which was through study completion.
There were 7 Serious Adverse Events reported to the IRB according to the VA definition of a serious adverse event. VA requires reporting of any hospital stay longer than 24 hours by any subject enrolled. There were 7. The IRB did not find these to be Serious Adverse Events resulting from the study and these are called "VA Events" officially.
|
2.5%
3/121 • Number of events 3 • The time frame in which adverse event data were collected was from the baseline evaluation to the 9-month assessment. Therefore, the assessment period was for 9 months which was through study completion.
There were 7 Serious Adverse Events reported to the IRB according to the VA definition of a serious adverse event. VA requires reporting of any hospital stay longer than 24 hours by any subject enrolled. There were 7. The IRB did not find these to be Serious Adverse Events resulting from the study and these are called "VA Events" officially.
|
|
Nervous system disorders
hospitalization for longer than 24 hours
|
0.00%
0/121 • The time frame in which adverse event data were collected was from the baseline evaluation to the 9-month assessment. Therefore, the assessment period was for 9 months which was through study completion.
There were 7 Serious Adverse Events reported to the IRB according to the VA definition of a serious adverse event. VA requires reporting of any hospital stay longer than 24 hours by any subject enrolled. There were 7. The IRB did not find these to be Serious Adverse Events resulting from the study and these are called "VA Events" officially.
|
1.7%
2/121 • Number of events 2 • The time frame in which adverse event data were collected was from the baseline evaluation to the 9-month assessment. Therefore, the assessment period was for 9 months which was through study completion.
There were 7 Serious Adverse Events reported to the IRB according to the VA definition of a serious adverse event. VA requires reporting of any hospital stay longer than 24 hours by any subject enrolled. There were 7. The IRB did not find these to be Serious Adverse Events resulting from the study and these are called "VA Events" officially.
|
|
Respiratory, thoracic and mediastinal disorders
hospitalization for longer than 24 hours
|
0.00%
0/121 • The time frame in which adverse event data were collected was from the baseline evaluation to the 9-month assessment. Therefore, the assessment period was for 9 months which was through study completion.
There were 7 Serious Adverse Events reported to the IRB according to the VA definition of a serious adverse event. VA requires reporting of any hospital stay longer than 24 hours by any subject enrolled. There were 7. The IRB did not find these to be Serious Adverse Events resulting from the study and these are called "VA Events" officially.
|
0.83%
1/121 • Number of events 1 • The time frame in which adverse event data were collected was from the baseline evaluation to the 9-month assessment. Therefore, the assessment period was for 9 months which was through study completion.
There were 7 Serious Adverse Events reported to the IRB according to the VA definition of a serious adverse event. VA requires reporting of any hospital stay longer than 24 hours by any subject enrolled. There were 7. The IRB did not find these to be Serious Adverse Events resulting from the study and these are called "VA Events" officially.
|
Other adverse events
| Measure |
Usual Care
n=121 participants at risk
Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
|
Stepped Care
n=121 participants at risk
Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.
Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.
Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.
Co-Analgesic Therapy
|
|---|---|---|
|
Nervous system disorders
Medication side effects
|
0.00%
0/121 • The time frame in which adverse event data were collected was from the baseline evaluation to the 9-month assessment. Therefore, the assessment period was for 9 months which was through study completion.
There were 7 Serious Adverse Events reported to the IRB according to the VA definition of a serious adverse event. VA requires reporting of any hospital stay longer than 24 hours by any subject enrolled. There were 7. The IRB did not find these to be Serious Adverse Events resulting from the study and these are called "VA Events" officially.
|
1.7%
2/121 • Number of events 2 • The time frame in which adverse event data were collected was from the baseline evaluation to the 9-month assessment. Therefore, the assessment period was for 9 months which was through study completion.
There were 7 Serious Adverse Events reported to the IRB according to the VA definition of a serious adverse event. VA requires reporting of any hospital stay longer than 24 hours by any subject enrolled. There were 7. The IRB did not find these to be Serious Adverse Events resulting from the study and these are called "VA Events" officially.
|
|
Gastrointestinal disorders
Medication side effects
|
0.00%
0/121 • The time frame in which adverse event data were collected was from the baseline evaluation to the 9-month assessment. Therefore, the assessment period was for 9 months which was through study completion.
There were 7 Serious Adverse Events reported to the IRB according to the VA definition of a serious adverse event. VA requires reporting of any hospital stay longer than 24 hours by any subject enrolled. There were 7. The IRB did not find these to be Serious Adverse Events resulting from the study and these are called "VA Events" officially.
|
1.7%
2/121 • Number of events 2 • The time frame in which adverse event data were collected was from the baseline evaluation to the 9-month assessment. Therefore, the assessment period was for 9 months which was through study completion.
There were 7 Serious Adverse Events reported to the IRB according to the VA definition of a serious adverse event. VA requires reporting of any hospital stay longer than 24 hours by any subject enrolled. There were 7. The IRB did not find these to be Serious Adverse Events resulting from the study and these are called "VA Events" officially.
|
Additional Information
Matthew J. Bair, MD MS
Center on Implementing Evidence Based Practice
Phone: 317-988-2058
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place