Trial Outcomes & Findings for ACCESS (Access for Cancer Caregivers for Education and Support for Shared Decision Making) (NCT NCT02929108)
NCT ID: NCT02929108
Last Updated: 2023-04-20
Results Overview
A screening tool to quantify participant's anxiety. The scale ranges from 0-21. A higher score indicates a higher level of anxiety.
COMPLETED
NA
489 participants
Upon enrollment, 14 days, 28 days, 60 days and 90 days
2023-04-20
Participant Flow
This is a crossover cluster-randomized study where 7 hospice sites were assigned to an intervention sequence consisting of 2 of the 3 interventions: Facebook, Enhanced UsualCare, or ACCESS. There was at least one washout period of up to 90 days between interventions. The intervention for the hospice sites also started at different times.
Hospice patients were not enrolled to this study. Only family caregivers were enrolled to this study. Each family caregiver was only assigned to one group (intervention) and stayed in that group for the duration of their time in the study (up to 90 days). They were given surveys at 14, 28, 60, and 90 days. The number of family caregivers who received each intervention at each site is listed below.
Participant milestones
| Measure |
Site 5: Facebook First, Then Enhanced Usual Care, Then Facebook
This site was assigned to the intervention sequence: Access First, Then Enhanced Usual Care, Then Access, and started in January 2018. Each intervention was approximately 12 months in length, with up to a 3-month washout period only between the first and second intervention. Caregivers only received one intervention for up to 90 days.
|
Site 6: Enhanced Usual Care First, Then Facebook, Then Enhanced Usual Care
This site was assigned to the intervention sequence: Enhanced Usual Care First, Then Facebook, Then Enhanced Usual Care, and started in February 2018. Each intervention was approximately 12 months in length, with up to a 3-month washout period only between the second and third intervention. Caregivers only received one intervention for up to 90 days.
|
Site 7: Access First ,Then Facebook
This site was assigned to the intervention sequence: Access First, Then Facebook, and started in September 2019. Each intervention was approximately 12 months in length, with up to a 3-month washout period between both interventions. Caregivers only received one intervention for up to 90 days.
|
Site 1: Facebook First, Then Access, Then Facebook
This site was assigned to the intervention sequence: Facebook First, Then Access, Then Facebook, and started in August 2017. Each intervention was approximately 12 months in length, with up to a 3-month washout period between interventions. Caregivers only received one intervention for up to 90 days.
|
Site 2: Access First Then Enhanced Usual Care, Then Access
This site was assigned to the intervention sequence: Access First, Then Enhanced Usual Care, Then Access, and started in November 2017. Each intervention was approximately 12 months in length, with up to a 3-month washout period only between the first and second intervention. Caregivers only received one intervention for up to 90 days.
|
Site 3: Access First, Then Enhanced Usual Care, Then Access
This site was assigned to the intervention sequence: Access First, Then Enhanced Usual Care, Then Access, and started in December 2017. Each intervention was approximately 12 months in length, with up to a 3-month washout period only between the first and second intervention. Caregivers only received one intervention for up to 90 days.
|
Site 4: Enhanced Usual Care First, Then Facebook, Then Enhanced Usual Care
This site was assigned to the intervention sequence: Enhanced Usual Care First, Then Facebook, Then Enhanced Usual Care, and started in December 2017. Each intervention was approximately 12 months in length, with up to a 3-month washout period only between the second and third intervention. Caregivers only received one intervention for up to 90 days.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
73
|
32
|
88
|
122
|
75
|
39
|
60
|
|
Overall Study
Facebook
|
57
|
10
|
42
|
94
|
0
|
0
|
11
|
|
Overall Study
Access
|
5
|
0
|
46
|
28
|
47
|
23
|
0
|
|
Overall Study
Enhanced Usual Care
|
11
|
22
|
0
|
0
|
28
|
16
|
49
|
|
Overall Study
COMPLETED
|
18
|
4
|
10
|
22
|
11
|
11
|
14
|
|
Overall Study
NOT COMPLETED
|
55
|
28
|
78
|
100
|
64
|
28
|
46
|
Reasons for withdrawal
| Measure |
Site 5: Facebook First, Then Enhanced Usual Care, Then Facebook
This site was assigned to the intervention sequence: Access First, Then Enhanced Usual Care, Then Access, and started in January 2018. Each intervention was approximately 12 months in length, with up to a 3-month washout period only between the first and second intervention. Caregivers only received one intervention for up to 90 days.
|
Site 6: Enhanced Usual Care First, Then Facebook, Then Enhanced Usual Care
This site was assigned to the intervention sequence: Enhanced Usual Care First, Then Facebook, Then Enhanced Usual Care, and started in February 2018. Each intervention was approximately 12 months in length, with up to a 3-month washout period only between the second and third intervention. Caregivers only received one intervention for up to 90 days.
|
Site 7: Access First ,Then Facebook
This site was assigned to the intervention sequence: Access First, Then Facebook, and started in September 2019. Each intervention was approximately 12 months in length, with up to a 3-month washout period between both interventions. Caregivers only received one intervention for up to 90 days.
|
Site 1: Facebook First, Then Access, Then Facebook
This site was assigned to the intervention sequence: Facebook First, Then Access, Then Facebook, and started in August 2017. Each intervention was approximately 12 months in length, with up to a 3-month washout period between interventions. Caregivers only received one intervention for up to 90 days.
|
Site 2: Access First Then Enhanced Usual Care, Then Access
This site was assigned to the intervention sequence: Access First, Then Enhanced Usual Care, Then Access, and started in November 2017. Each intervention was approximately 12 months in length, with up to a 3-month washout period only between the first and second intervention. Caregivers only received one intervention for up to 90 days.
|
Site 3: Access First, Then Enhanced Usual Care, Then Access
This site was assigned to the intervention sequence: Access First, Then Enhanced Usual Care, Then Access, and started in December 2017. Each intervention was approximately 12 months in length, with up to a 3-month washout period only between the first and second intervention. Caregivers only received one intervention for up to 90 days.
|
Site 4: Enhanced Usual Care First, Then Facebook, Then Enhanced Usual Care
This site was assigned to the intervention sequence: Enhanced Usual Care First, Then Facebook, Then Enhanced Usual Care, and started in December 2017. Each intervention was approximately 12 months in length, with up to a 3-month washout period only between the second and third intervention. Caregivers only received one intervention for up to 90 days.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Hospice patient death
|
55
|
28
|
78
|
100
|
64
|
28
|
46
|
Baseline Characteristics
Age is missing for some participants.
Baseline characteristics by cohort
| Measure |
Enhanced Usual Care
n=126 Participants
The family caregivers in this group will receive usual hospice care which has been enhanced as the staff have been trained in shared decision making.
|
Facebook
n=214 Participants
The family caregivers in this group only participates in the Facebook groups, not in the shared decision making
|
ACCESS
n=149 Participants
The family caregivers in this group participates in Facebook and web conferencing for shared decision making
|
Total
n=489 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.8 years
STANDARD_DEVIATION 12.2 • n=125 Participants • Age is missing for some participants.
|
55.0 years
STANDARD_DEVIATION 12.8 • n=214 Participants • Age is missing for some participants.
|
56.5 years
STANDARD_DEVIATION 12.0 • n=143 Participants • Age is missing for some participants.
|
56.2 years
STANDARD_DEVIATION 12.4 • n=482 Participants • Age is missing for some participants.
|
|
Sex: Female, Male
Female
|
87 Participants
n=126 Participants • Sex is missing for one participant.
|
169 Participants
n=214 Participants • Sex is missing for one participant.
|
119 Participants
n=148 Participants • Sex is missing for one participant.
|
375 Participants
n=488 Participants • Sex is missing for one participant.
|
|
Sex: Female, Male
Male
|
39 Participants
n=126 Participants • Sex is missing for one participant.
|
45 Participants
n=214 Participants • Sex is missing for one participant.
|
29 Participants
n=148 Participants • Sex is missing for one participant.
|
113 Participants
n=488 Participants • Sex is missing for one participant.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=126 Participants
|
5 Participants
n=214 Participants
|
4 Participants
n=149 Participants
|
10 Participants
n=489 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
125 Participants
n=126 Participants
|
209 Participants
n=214 Participants
|
141 Participants
n=149 Participants
|
475 Participants
n=489 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=126 Participants
|
0 Participants
n=214 Participants
|
4 Participants
n=149 Participants
|
4 Participants
n=489 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=126 Participants
|
1 Participants
n=214 Participants
|
1 Participants
n=149 Participants
|
2 Participants
n=489 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=126 Participants
|
0 Participants
n=214 Participants
|
1 Participants
n=149 Participants
|
1 Participants
n=489 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=126 Participants
|
0 Participants
n=214 Participants
|
0 Participants
n=149 Participants
|
0 Participants
n=489 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=126 Participants
|
34 Participants
n=214 Participants
|
16 Participants
n=149 Participants
|
56 Participants
n=489 Participants
|
|
Race (NIH/OMB)
White
|
118 Participants
n=126 Participants
|
172 Participants
n=214 Participants
|
125 Participants
n=149 Participants
|
415 Participants
n=489 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=126 Participants
|
1 Participants
n=214 Participants
|
3 Participants
n=149 Participants
|
6 Participants
n=489 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=126 Participants
|
6 Participants
n=214 Participants
|
3 Participants
n=149 Participants
|
9 Participants
n=489 Participants
|
|
Region of Enrollment
United States
|
126 participants
n=126 Participants
|
214 participants
n=214 Participants
|
149 participants
n=149 Participants
|
489 participants
n=489 Participants
|
PRIMARY outcome
Timeframe: Upon enrollment, 14 days, 28 days, 60 days and 90 daysPopulation: Some questionnaires were not completed by the participant.
A screening tool to quantify participant's anxiety. The scale ranges from 0-21. A higher score indicates a higher level of anxiety.
Outcome measures
| Measure |
Enhanced Usual Care
n=126 Participants
The family caregivers in this group will receive usual hospice care which has been enhanced as the staff have been trained in shared decision making.
|
Facebook
n=214 Participants
The family caregivers in this group only participates in the Facebook groups, not in the shared decision making
|
ACCESS
n=149 Participants
The family caregivers in this group participates in Facebook and web conferencing for shared decision making
|
|---|---|---|---|
|
Change in Generalized Anxiety Disorder- 7
Baseline (upon enrollment)
|
7.73 score on a scale
Standard Deviation 5.84
|
8.81 score on a scale
Standard Deviation 5.98
|
8.42 score on a scale
Standard Deviation 5.73
|
|
Change in Generalized Anxiety Disorder- 7
14 days
|
7.06 score on a scale
Standard Deviation 5.97
|
6.93 score on a scale
Standard Deviation 5.28
|
7.39 score on a scale
Standard Deviation 5.03
|
|
Change in Generalized Anxiety Disorder- 7
28 days
|
6.81 score on a scale
Standard Deviation 5.74
|
6.02 score on a scale
Standard Deviation 4.50
|
7.55 score on a scale
Standard Deviation 4.98
|
|
Change in Generalized Anxiety Disorder- 7
60 days
|
5.06 score on a scale
Standard Deviation 4.82
|
6.54 score on a scale
Standard Deviation 4.20
|
8.81 score on a scale
Standard Deviation 5.69
|
|
Change in Generalized Anxiety Disorder- 7
90 days
|
6.43 score on a scale
Standard Deviation 5.52
|
6.10 score on a scale
Standard Deviation 3.91
|
7.43 score on a scale
Standard Deviation 4.52
|
SECONDARY outcome
Timeframe: Upon enrollment and 28 daysPopulation: Some questionnaires were not completed by the participant.
A scale which measures caregiver's experience dealing with patient pain. Scale ranges from 0-70. A higher score indicates higher pain experience.
Outcome measures
| Measure |
Enhanced Usual Care
n=126 Participants
The family caregivers in this group will receive usual hospice care which has been enhanced as the staff have been trained in shared decision making.
|
Facebook
n=214 Participants
The family caregivers in this group only participates in the Facebook groups, not in the shared decision making
|
ACCESS
n=149 Participants
The family caregivers in this group participates in Facebook and web conferencing for shared decision making
|
|---|---|---|---|
|
Change in Family Pain Questionnaire - Experience
Baseline (upon enrollment)
|
38.9 score on a scale
Standard Deviation 11.0
|
40.9 score on a scale
Standard Deviation 10.8
|
40.2 score on a scale
Standard Deviation 11.0
|
|
Change in Family Pain Questionnaire - Experience
28 days
|
39.3 score on a scale
Standard Deviation 10.7
|
39.0 score on a scale
Standard Deviation 9.53
|
40.8 score on a scale
Standard Deviation 9.88
|
SECONDARY outcome
Timeframe: Upon enrollment and 28 daysPopulation: Some questionnaires were not completed by the participant.
A scale which measures pain knowledge. The scale ranges from 0-90. A higher score indicates a higher knowledge of pain.
Outcome measures
| Measure |
Enhanced Usual Care
n=126 Participants
The family caregivers in this group will receive usual hospice care which has been enhanced as the staff have been trained in shared decision making.
|
Facebook
n=214 Participants
The family caregivers in this group only participates in the Facebook groups, not in the shared decision making
|
ACCESS
n=149 Participants
The family caregivers in this group participates in Facebook and web conferencing for shared decision making
|
|---|---|---|---|
|
Change in Family Pain Questionnaire - Knowledge
Baseline (upon enrollment)
|
53.2 score on a scale
Standard Deviation 12.4
|
54.6 score on a scale
Standard Deviation 11.2
|
54.3 score on a scale
Standard Deviation 11.0
|
|
Change in Family Pain Questionnaire - Knowledge
28 days
|
60.9 score on a scale
Standard Deviation 11.3
|
55.2 score on a scale
Standard Deviation 11.0
|
54.8 score on a scale
Standard Deviation 8.75
|
SECONDARY outcome
Timeframe: Upon enrollment, 14 days, 28 days, 60 days and 90 daysPopulation: Some questionnaires were not completed by the participant.
Four question scale that measures caregivers quality of life. Scale ranges from 0-40. Higher score indicates higher quality of life.
Outcome measures
| Measure |
Enhanced Usual Care
n=126 Participants
The family caregivers in this group will receive usual hospice care which has been enhanced as the staff have been trained in shared decision making.
|
Facebook
n=214 Participants
The family caregivers in this group only participates in the Facebook groups, not in the shared decision making
|
ACCESS
n=149 Participants
The family caregivers in this group participates in Facebook and web conferencing for shared decision making
|
|---|---|---|---|
|
Change in Caregiver Quality of Life
Baseline (upon enrollment)
|
26.7 score on a scale
Standard Deviation 8.76
|
24.4 score on a scale
Standard Deviation 8.26
|
24.9 score on a scale
Standard Deviation 8.19
|
|
Change in Caregiver Quality of Life
14 days
|
25.1 score on a scale
Standard Deviation 9.33
|
24.8 score on a scale
Standard Deviation 7.59
|
24.3 score on a scale
Standard Deviation 7.60
|
|
Change in Caregiver Quality of Life
28 days
|
25.3 score on a scale
Standard Deviation 9.40
|
23.6 score on a scale
Standard Deviation 7.92
|
22.6 score on a scale
Standard Deviation 7.14
|
|
Change in Caregiver Quality of Life
60 days
|
27.0 score on a scale
Standard Deviation 8.12
|
22.6 score on a scale
Standard Deviation 8.06
|
21.9 score on a scale
Standard Deviation 8.57
|
|
Change in Caregiver Quality of Life
90 days
|
26.3 score on a scale
Standard Deviation 8.03
|
22.7 score on a scale
Standard Deviation 6.91
|
23.4 score on a scale
Standard Deviation 6.73
|
SECONDARY outcome
Timeframe: Upon enrollment, 14 days, 28 days, and 90 daysPopulation: Some questionnaires were not completed by the participant.
A scale measuring perceived involvement of care. Scale ranges from 13-65. Higher score indicates higher perceived involvement in care.
Outcome measures
| Measure |
Enhanced Usual Care
n=126 Participants
The family caregivers in this group will receive usual hospice care which has been enhanced as the staff have been trained in shared decision making.
|
Facebook
n=214 Participants
The family caregivers in this group only participates in the Facebook groups, not in the shared decision making
|
ACCESS
n=149 Participants
The family caregivers in this group participates in Facebook and web conferencing for shared decision making
|
|---|---|---|---|
|
Perceived Involvement of Care Scale
Baseline (upon enrollment)
|
44.1 score on a scale
Standard Deviation 8.69
|
43.7 score on a scale
Standard Deviation 10.6
|
42.9 score on a scale
Standard Deviation 8.85
|
|
Perceived Involvement of Care Scale
14 days
|
41.0 score on a scale
Standard Deviation 8.93
|
42.5 score on a scale
Standard Deviation 9.35
|
43.9 score on a scale
Standard Deviation 9.22
|
|
Perceived Involvement of Care Scale
28 days
|
41.8 score on a scale
Standard Deviation 10.8
|
44.3 score on a scale
Standard Deviation 9.95
|
46.3 score on a scale
Standard Deviation 6.24
|
|
Perceived Involvement of Care Scale
90 days
|
45.4 score on a scale
Standard Deviation 10.8
|
45.9 score on a scale
Standard Deviation 8.58
|
49.3 score on a scale
Standard Deviation 6.88
|
SECONDARY outcome
Timeframe: Upon enrollment, 14 days, 28 days, 60 days, and 90 daysPopulation: Some questionnaires were not completed by the participant.
A measure of depression. Scale ranges from 0-27. A higher score indicates higher depression.
Outcome measures
| Measure |
Enhanced Usual Care
n=126 Participants
The family caregivers in this group will receive usual hospice care which has been enhanced as the staff have been trained in shared decision making.
|
Facebook
n=214 Participants
The family caregivers in this group only participates in the Facebook groups, not in the shared decision making
|
ACCESS
n=149 Participants
The family caregivers in this group participates in Facebook and web conferencing for shared decision making
|
|---|---|---|---|
|
Public Health Questionnaire (PHQ 9)
Baseline (upon enrollment)
|
7.05 score on a scale
Standard Deviation 6.59
|
7.88 score on a scale
Standard Deviation 6.20
|
7.87 score on a scale
Standard Deviation 6.30
|
|
Public Health Questionnaire (PHQ 9)
14 days
|
6.43 score on a scale
Standard Deviation 6.37
|
6.30 score on a scale
Standard Deviation 5.24
|
6.82 score on a scale
Standard Deviation 5.41
|
|
Public Health Questionnaire (PHQ 9)
28 days
|
6.37 score on a scale
Standard Deviation 6.47
|
6.18 score on a scale
Standard Deviation 4.86
|
6.85 score on a scale
Standard Deviation 4.64
|
|
Public Health Questionnaire (PHQ 9)
60 days
|
4.74 score on a scale
Standard Deviation 5.24
|
6.20 score on a scale
Standard Deviation 4.65
|
7.91 score on a scale
Standard Deviation 5.84
|
|
Public Health Questionnaire (PHQ 9)
90 days
|
5.50 score on a scale
Standard Deviation 4.98
|
5.59 score on a scale
Standard Deviation 4.04
|
6.43 score on a scale
Standard Deviation 4.08
|
SECONDARY outcome
Timeframe: Upon enrollment, 14 days, 28 days, 60 days, and 90 daysPopulation: Some questionnaires were not completed by the participant.
A scale that measures various patient symptoms as reported by caregiver such as pain, fatigue, depression, anxiety, appetite, and nausea. Scale ranges from 0-90. A higher score indicates higher degree of symptoms.
Outcome measures
| Measure |
Enhanced Usual Care
n=126 Participants
The family caregivers in this group will receive usual hospice care which has been enhanced as the staff have been trained in shared decision making.
|
Facebook
n=214 Participants
The family caregivers in this group only participates in the Facebook groups, not in the shared decision making
|
ACCESS
n=149 Participants
The family caregivers in this group participates in Facebook and web conferencing for shared decision making
|
|---|---|---|---|
|
Edmonton Symptom Assessment
Baseline (upon enrollment)
|
45.6 score on a scale
Standard Deviation 15.9
|
46.1 score on a scale
Standard Deviation 14.3
|
42.6 score on a scale
Standard Deviation 13.5
|
|
Edmonton Symptom Assessment
14 days
|
43.6 score on a scale
Standard Deviation 16.3
|
42.2 score on a scale
Standard Deviation 15.1
|
43.6 score on a scale
Standard Deviation 14.6
|
|
Edmonton Symptom Assessment
28 days
|
51.6 score on a scale
Standard Deviation 17.7
|
41.7 score on a scale
Standard Deviation 14.5
|
27.5 score on a scale
Standard Deviation 10.3
|
|
Edmonton Symptom Assessment
60 days
|
43.9 score on a scale
Standard Deviation 15.6
|
43.4 score on a scale
Standard Deviation 15.2
|
45.4 score on a scale
Standard Deviation 14.2
|
|
Edmonton Symptom Assessment
90 days
|
51.2 score on a scale
Standard Deviation 17.6
|
42.3 score on a scale
Standard Deviation 14.1
|
42.0 score on a scale
Standard Deviation 16.7
|
SECONDARY outcome
Timeframe: Upon enrollment and 28 daysPopulation: Some questionnaires were not completed by the participant.
A scale that measures the level of burden on caregiver. Scale ranges from 0-28. A higher score indicates greater burden.
Outcome measures
| Measure |
Enhanced Usual Care
n=126 Participants
The family caregivers in this group will receive usual hospice care which has been enhanced as the staff have been trained in shared decision making.
|
Facebook
n=214 Participants
The family caregivers in this group only participates in the Facebook groups, not in the shared decision making
|
ACCESS
n=149 Participants
The family caregivers in this group participates in Facebook and web conferencing for shared decision making
|
|---|---|---|---|
|
Zarit Burden Scale
Baseline (upon enrollment)
|
8.78 score on a scale
Standard Deviation 6.05
|
9.74 score on a scale
Standard Deviation 6.26
|
10.3 score on a scale
Standard Deviation 6.25
|
|
Zarit Burden Scale
28 days
|
9.53 score on a scale
Standard Deviation 5.58
|
9.79 score on a scale
Standard Deviation 4.82
|
10.7 score on a scale
Standard Deviation 5.15
|
SECONDARY outcome
Timeframe: 14 days, 28 days, and 60 daysPopulation: Some questionnaires were not completed by the participant.
A scale that measures the level of perception of caregiver centered communication by hospice staff. Scale ranges from 30-150. A higher score indicates greater perception of caregiver centered communication.
Outcome measures
| Measure |
Enhanced Usual Care
n=126 Participants
The family caregivers in this group will receive usual hospice care which has been enhanced as the staff have been trained in shared decision making.
|
Facebook
n=214 Participants
The family caregivers in this group only participates in the Facebook groups, not in the shared decision making
|
ACCESS
n=149 Participants
The family caregivers in this group participates in Facebook and web conferencing for shared decision making
|
|---|---|---|---|
|
Caregiver Communication Questionnaire (CCCQ)
14 days
|
117 score on a scale
Standard Deviation 19.9
|
112 score on a scale
Standard Deviation 22.5
|
117 score on a scale
Standard Deviation 20.7
|
|
Caregiver Communication Questionnaire (CCCQ)
28 days
|
120 score on a scale
Standard Deviation 26.9
|
119 score on a scale
Standard Deviation 20.9
|
114 score on a scale
Standard Deviation 24.0
|
|
Caregiver Communication Questionnaire (CCCQ)
60 days
|
116 score on a scale
Standard Deviation 22.1
|
116 score on a scale
Standard Deviation 21.0
|
121 score on a scale
Standard Deviation 20.0
|
Adverse Events
Enhanced Usual Care
ACCESS
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Debra Oliver, Ph.D.
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place