Trial Outcomes & Findings for Self-Management to Prevent Ulcers in Veterans With SCI (Spinal Cord Injury) (NCT NCT00763282)
NCT ID: NCT00763282
Last Updated: 2015-04-27
Results Overview
Skin Behavior Change was calculated as the percentage of Self-Reported Behavior at 3 and 6 months (minus the percentage at baseline). The study reported the number of guideline-recommended skin care behaviors, assessed by the Skin Care Behavior Checklist, a self-reported measure of adherence to 8 guideline recommended skin care behaviors. The average percentage of the 8 behaviors adhered to for each participant was measured by intervention arms at admission (baseline), 3 and 6 months post-discharge.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
144 participants
Primary outcome timeframe
Admission (Baseline), 3 months, 6 months
Results posted on
2015-04-27
Participant Flow
Participant milestones
| Measure |
Self Management (SM) + Motivational Interviewing (MI)
Self Management (SM) + Motivational Interviewing (MI)
Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology.
|
Education (ED)
Education (ED)
Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care.
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
72
|
|
Overall Study
COMPLETED
|
40
|
38
|
|
Overall Study
NOT COMPLETED
|
32
|
34
|
Reasons for withdrawal
| Measure |
Self Management (SM) + Motivational Interviewing (MI)
Self Management (SM) + Motivational Interviewing (MI)
Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology.
|
Education (ED)
Education (ED)
Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
5
|
|
Overall Study
Death
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
22
|
26
|
Baseline Characteristics
Self-Management to Prevent Ulcers in Veterans With SCI (Spinal Cord Injury)
Baseline characteristics by cohort
| Measure |
Self Management (SM) + Motivational Interviewing (MI)
n=71 Participants
Self Management (SM) + Motivational Interviewing (MI)
Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology.
|
Education (ED)
n=72 Participants
Education (ED)
Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care.
|
Total
n=143 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Locations of Current Pressure Ulcers
Trochanter
|
11 Pressure Ulcers
n=99 Participants
|
9 Pressure Ulcers
n=107 Participants
|
20 Pressure Ulcers
n=206 Participants
|
|
Locations of Current Pressure Ulcers
Sacrum
|
15 Pressure Ulcers
n=99 Participants
|
13 Pressure Ulcers
n=107 Participants
|
28 Pressure Ulcers
n=206 Participants
|
|
Locations of Current Pressure Ulcers
Coccyx
|
9 Pressure Ulcers
n=99 Participants
|
6 Pressure Ulcers
n=107 Participants
|
15 Pressure Ulcers
n=206 Participants
|
|
Locations of Current Pressure Ulcers
Other locations (e.g., feet)
|
16 Pressure Ulcers
n=99 Participants
|
16 Pressure Ulcers
n=107 Participants
|
32 Pressure Ulcers
n=206 Participants
|
|
Age, Continuous
|
59.4 years
n=99 Participants
|
59.0 years
n=107 Participants
|
59.3 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
139 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
46 participants
n=99 Participants
|
52 participants
n=107 Participants
|
98 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
20 participants
n=99 Participants
|
18 participants
n=107 Participants
|
38 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 participants
n=99 Participants
|
2 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Residence Type
House
|
50 participants
n=99 Participants
|
56 participants
n=107 Participants
|
106 participants
n=206 Participants
|
|
Residence Type
Apartment
|
15 participants
n=99 Participants
|
12 participants
n=107 Participants
|
27 participants
n=206 Participants
|
|
Residence Type
Nursing Home
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Residence Type
Other
|
5 participants
n=99 Participants
|
4 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Marital Status
Married
|
29 participants
n=99 Participants
|
28 participants
n=107 Participants
|
57 participants
n=206 Participants
|
|
Marital Status
Never Married
|
11 participants
n=99 Participants
|
10 participants
n=107 Participants
|
21 participants
n=206 Participants
|
|
Marital Status
Widowed
|
5 participants
n=99 Participants
|
6 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Marital Status
Divorced
|
25 participants
n=99 Participants
|
27 participants
n=107 Participants
|
52 participants
n=206 Participants
|
|
Marital Status
Live with Partner
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Marital Status
Missing
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Educational Level
High School Graduate or Lower
|
23 participants
n=99 Participants
|
22 participants
n=107 Participants
|
45 participants
n=206 Participants
|
|
Educational Level
Some College
|
35 participants
n=99 Participants
|
38 participants
n=107 Participants
|
73 participants
n=206 Participants
|
|
Educational Level
College Graduate
|
10 participants
n=99 Participants
|
9 participants
n=107 Participants
|
19 participants
n=206 Participants
|
|
Educational Level
Graduate School
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Duration of Spinal Cord Injury
|
23.8 years
n=99 Participants
|
24.0 years
n=107 Participants
|
24.0 years
n=206 Participants
|
|
Etiology
Driving
|
35 participants
n=99 Participants
|
35 participants
n=107 Participants
|
70 participants
n=206 Participants
|
|
Etiology
Diving
|
5 participants
n=99 Participants
|
4 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Etiology
Fall
|
5 participants
n=99 Participants
|
6 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Etiology
Gunshot Wound
|
6 participants
n=99 Participants
|
11 participants
n=107 Participants
|
17 participants
n=206 Participants
|
|
Etiology
Other
|
20 participants
n=99 Participants
|
16 participants
n=107 Participants
|
36 participants
n=206 Participants
|
|
Level of Injury
Cervical
|
30 participants
n=99 Participants
|
30 participants
n=107 Participants
|
60 participants
n=206 Participants
|
|
Level of Injury
Thoracic
|
40 participants
n=99 Participants
|
36 participants
n=107 Participants
|
76 participants
n=206 Participants
|
|
Level of Injury
Lumbar
|
1 participants
n=99 Participants
|
6 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
American Spinal Injury Association (ASIA) Score
A = Complete
|
53 participants
n=99 Participants
|
48 participants
n=107 Participants
|
101 participants
n=206 Participants
|
|
American Spinal Injury Association (ASIA) Score
B = Sensory Incomplete
|
7 participants
n=99 Participants
|
8 participants
n=107 Participants
|
15 participants
n=206 Participants
|
|
Stage of PrUs at randomization
Stage III = Full thickness
|
22 Pressure Ulcers
n=99 Participants
|
31 Pressure Ulcers
n=107 Participants
|
53 Pressure Ulcers
n=206 Participants
|
|
American Spinal Injury Association (ASIA) Score
C = Motor Incomplete
|
7 participants
n=99 Participants
|
10 participants
n=107 Participants
|
17 participants
n=206 Participants
|
|
American Spinal Injury Association (ASIA) Score
D = Motor Incomplete
|
4 participants
n=99 Participants
|
6 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Source of Assistance
Spouse; partner/significant other; Relative
|
50 participants
n=99 Participants
|
45 participants
n=107 Participants
|
95 participants
n=206 Participants
|
|
Source of Assistance
Paid Attendant
|
30 participants
n=99 Participants
|
18 participants
n=107 Participants
|
48 participants
n=206 Participants
|
|
Source of Assistance
Other Regular Assistance
|
5 participants
n=99 Participants
|
8 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Source of Assistance
No Regular Assistance
|
12 participants
n=99 Participants
|
11 participants
n=107 Participants
|
23 participants
n=206 Participants
|
|
Comorbid Conditions (baseline)
Diabetes
|
34 participants
n=99 Participants
|
22 participants
n=107 Participants
|
56 participants
n=206 Participants
|
|
Comorbid Conditions (baseline)
Depression
|
29 participants
n=99 Participants
|
29 participants
n=107 Participants
|
58 participants
n=206 Participants
|
|
Comorbid Conditions (baseline)
Osteomyelitis
|
18 participants
n=99 Participants
|
10 participants
n=107 Participants
|
28 participants
n=206 Participants
|
|
Salzburg PrU Risk Score
|
9.8 Scores on a scale
n=99 Participants
|
9.3 Scores on a scale
n=107 Participants
|
9.5 Scores on a scale
n=206 Participants
|
|
Pressure Ulcer (PrU) Characteristics
Number of prior PrUs
|
2.89 Pressure Ulcers
n=99 Participants
|
1.93 Pressure Ulcers
n=107 Participants
|
2.41 Pressure Ulcers
n=206 Participants
|
|
Pressure Ulcer (PrU) Characteristics
Number of current PrUs
|
1.6 Pressure Ulcers
n=99 Participants
|
1.3 Pressure Ulcers
n=107 Participants
|
1.4 Pressure Ulcers
n=206 Participants
|
|
PrU Size of Largest Ulcer
|
8.2 cm^2
n=99 Participants
|
4.5 cm^2
n=107 Participants
|
6.3 cm^2
n=206 Participants
|
|
PrU Duration for Largest PrU
|
213 days
STANDARD_DEVIATION 244 • n=99 Participants
|
407 days
STANDARD_DEVIATION 631 • n=107 Participants
|
307 days
STANDARD_DEVIATION 482 • n=206 Participants
|
|
Prior PrU Surgery
Yes
|
51 participants
n=99 Participants
|
46 participants
n=107 Participants
|
97 participants
n=206 Participants
|
|
Prior PrU Surgery
No
|
20 participants
n=99 Participants
|
26 participants
n=107 Participants
|
46 participants
n=206 Participants
|
|
History of PrUs
|
56 participants
n=99 Participants
|
56 participants
n=107 Participants
|
112 participants
n=206 Participants
|
|
Locations of Current Pressure Ulcers
Ischium
|
40 Pressure Ulcers
n=99 Participants
|
38 Pressure Ulcers
n=107 Participants
|
78 Pressure Ulcers
n=206 Participants
|
|
Stage of PrUs at randomization
Stage IV = Full thickness
|
54 Pressure Ulcers
n=99 Participants
|
43 Pressure Ulcers
n=107 Participants
|
97 Pressure Ulcers
n=206 Participants
|
|
Hospital-acquired PrU
|
12 Pressure Ulcers
n=99 Participants
|
9 Pressure Ulcers
n=107 Participants
|
21 Pressure Ulcers
n=206 Participants
|
|
Current Employment
Unemployed
|
60 participants
n=99 Participants
|
61 participants
n=107 Participants
|
121 participants
n=206 Participants
|
|
Current Employment
Employed
|
11 participants
n=99 Participants
|
11 participants
n=107 Participants
|
22 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Admission (Baseline), 3 months, 6 monthsSkin Behavior Change was calculated as the percentage of Self-Reported Behavior at 3 and 6 months (minus the percentage at baseline). The study reported the number of guideline-recommended skin care behaviors, assessed by the Skin Care Behavior Checklist, a self-reported measure of adherence to 8 guideline recommended skin care behaviors. The average percentage of the 8 behaviors adhered to for each participant was measured by intervention arms at admission (baseline), 3 and 6 months post-discharge.
Outcome measures
| Measure |
Self Management (SM) + Motivational Interviewing (MI)
n=71 Participants
Self Management (SM) + Motivational Interviewing (MI)
Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology.
|
Education (ED)
n=72 Participants
Education (ED)
Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care.
|
|---|---|---|
|
Percent of Possible Self-Reported Skin Care Behaviors
Admission
|
73.8 % of Possible Self-Reported Behaviors
Standard Deviation 23.3
|
74.1 % of Possible Self-Reported Behaviors
Standard Deviation 18.6
|
|
Percent of Possible Self-Reported Skin Care Behaviors
3 Months
|
83.5 % of Possible Self-Reported Behaviors
Standard Deviation 17.5
|
79.5 % of Possible Self-Reported Behaviors
Standard Deviation 19.6
|
|
Percent of Possible Self-Reported Skin Care Behaviors
6 Months
|
85.0 % of Possible Self-Reported Behaviors
Standard Deviation 15.2
|
83.0 % of Possible Self-Reported Behaviors
Standard Deviation 14.6
|
PRIMARY outcome
Timeframe: Admission (Baseline), 3 months, 6 monthsSelf-reported improvement in skin care behaviors in the SM+MI versus ED control intervention arms. The study reported the number of guideline-recommended skin care behaviors, assessed by the Skin Care Behavior Checklist, a self-report measure of adherence to 8 skin care behaviors for each participant.The difference in the average percentage of the 8 behaviors adhered to by each participant was measured for the different intervention arms from admission (baseline) to 3 and 6 months post-discharge.
Outcome measures
| Measure |
Self Management (SM) + Motivational Interviewing (MI)
n=71 Participants
Self Management (SM) + Motivational Interviewing (MI)
Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology.
|
Education (ED)
n=72 Participants
Education (ED)
Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care.
|
|---|---|---|
|
Skin Behavior Change
Baseline to 3 months
|
9.7 % Change
Standard Deviation 19.3
|
5.4 % Change
Standard Deviation 22.9
|
|
Skin Behavior Change
Baseline to 6 months
|
11.3 % Change
Standard Deviation 20.0
|
8.9 % Change
Standard Deviation 18.1
|
PRIMARY outcome
Timeframe: 6 monthsSkin worsening was defined as when a participant with an open wound at the time of discharge is found to have \>20% wound area at 3 or 6 months post-discharge (including new wounds and reopened wounds). Worsening was also defined as a when a participant with a closed wound at discharge is found to have a new or reopened wound at 3 or 6 months post-discharge.
Outcome measures
| Measure |
Self Management (SM) + Motivational Interviewing (MI)
n=71 Participants
Self Management (SM) + Motivational Interviewing (MI)
Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology.
|
Education (ED)
n=72 Participants
Education (ED)
Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care.
|
|---|---|---|
|
Any Skin Worsening
No
|
36 participants
|
33 participants
|
|
Any Skin Worsening
Yes
|
35 participants
|
39 participants
|
PRIMARY outcome
Timeframe: Admission (Baseline), 3 months, 6 monthsSkin worsening was defined as when a participant with an open wound at the time of discharge is found to have \>20% wound area at 3 or 6 months post-discharge (including new wounds and reopened wounds). Worsening was also defined as a when a participant with a closed wound at discharge is found to have a new or reopened wound at 3 or 6 months post-discharge.
Outcome measures
| Measure |
Self Management (SM) + Motivational Interviewing (MI)
n=71 Participants
Self Management (SM) + Motivational Interviewing (MI)
Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology.
|
Education (ED)
n=72 Participants
Education (ED)
Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care.
|
|---|---|---|
|
Skin Status
No Skin Worsening
|
36 participants
|
33 participants
|
|
Skin Status
Worse 0-3 Months
|
26 participants
|
28 participants
|
|
Skin Status
Worse 4-6 Months
|
9 participants
|
11 participants
|
SECONDARY outcome
Timeframe: Discharge to end of study (6 months)Population: Mean number of skin-related post-discharge admissions (ICD9 code =707.xx)
Post-discharge skin-related hospitalizations were for both groups (SM+MI vs. ED) but not as study-related or as an adverse event. This study examined an outpatient intervention during which rehospitalization could be triggered by the participants' early reporting of skin breakdown.
Outcome measures
| Measure |
Self Management (SM) + Motivational Interviewing (MI)
n=72 Participants
Self Management (SM) + Motivational Interviewing (MI)
Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology.
|
Education (ED)
n=72 Participants
Education (ED)
Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care.
|
|---|---|---|
|
Mean Number of Skin-related Admissions
|
1.5 admissions/participant
Standard Deviation 0.8
|
1.6 admissions/participant
Standard Deviation 0.7
|
Adverse Events
Self Management (SM) + Motivational Interviewing (MI)
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Education (ED)
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Self Management (SM) + Motivational Interviewing (MI)
n=72 participants at risk
Self Management (SM) + Motivational Interviewing (MI)
Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology.
|
Education (ED)
n=72 participants at risk
Education (ED)
Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care.
|
|---|---|---|
|
Investigations
Death
|
5.6%
4/72 • Number of events 4 • 6 Months
|
4.2%
3/72 • Number of events 3 • 6 Months
|
Other adverse events
Adverse event data not reported
Additional Information
Marylou Guihan, PhD
Center of Innovation for Complex Chronic Health Care
Phone: 708-202-2414
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place