Trial Outcomes & Findings for Developing and Testing a COVID-19 Vaccination Acceptance Intervention (NCT NCT05027464)
NCT ID: NCT05027464
Last Updated: 2024-11-08
Results Overview
A greater proportion of Veterans in the intervention group will receive any dose of COVID-19 vaccination compared to usual care.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
338718 participants
Primary outcome timeframe
1 year
Results posted on
2024-11-08
Participant Flow
Unit of analysis: VAHCS
Participant milestones
| Measure |
Intervention Arm
The VAHCS Internal Facilitator will partner with the trial External Facilitators (research team and designated External Facilitators in VISNS 16 and 21) to adapt and implement the study intervention to best meet the needs and preferences of their VAHCS site. In addition, each CBOC and clinic affiliated with a VAHCS in the Intervention arm will need to identify a Site Champion to provide clinic-specific information to facilitate implementation of the Vaccine Acceptance Intervention at their clinic or CBOC. In addition, for clinics and CBOCs assigned to the Vaccine Acceptance Intervention, VAHCS, clinic and CBOC leadership will need to agree to release PACT staff for an initial two-hour Motivational Interviewing (MI) training, and at least one 60-minute post-training consultation session over the one-year trial period. There will be additional consultation sessions offered to intervention clinics and CBOC staff, but these will be optional.
Moving to COVID-19 Vaccine Acceptance Intervention: The intervention utilizes a multi-pronged approach to increase Veteran vaccine acceptance. First, the research team will train Health Behavior Coordinators (HBCs) at VAI sites. HBCs will then train PACT teams at their site and Whole Health Coaches, Peer Specialists and other VA Staff in VAI strategies to use with unvaccinated Veterans. Whole Health Coaches, Peer Specialists and other VA Staff will conduct outreach calls, using strategies, with unvaccinated Veterans.
|
Usual Care Arm
A VAHCS assigned to Usual Care will have no specific trial intervention requirements beyond their usual level of participation in national and local initiatives to improve COVID-19 vaccine acceptance. At both Intervention and Usual Care sites, the study team will perform quarterly "environmental scans". The environmental scan survey will include questions about site specific barriers to COVID-19 vaccination (first dose and second dose if needed), current programs/initiatives in the clinic or local community that are improving or have had no impact on vaccination rates, and the perceived importance that the VAMC/CBOC clinic staff is placing on vaccination (Environmental Scan Survey, in preparation). At Usual Care sites, a point of contact will be chosen from each clinic and CBOC to complete the environmental scan, and at Intervention sites, the Site Champion (see below) will perform the quarterly scan.
|
|---|---|---|
|
Overall Study
STARTED
|
148291 5
|
190427 5
|
|
Overall Study
COMPLETED
|
148291 5
|
190427 5
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The number of units for this baseline measure are the number of randomization units assigned to each arm (i.e., 5 and 5). This measure is percentage of participants in each randomization unit who completed primary series at the time of randomization
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=5 VAHCS
The VAHCS Internal Facilitator will partner with the trial External Facilitators (research team and designated External Facilitators in VISNS 16 and 21) to adapt and implement the study intervention to best meet the needs and preferences of their VAHCS site. In addition, each CBOC and clinic affiliated with a VAHCS in the Intervention arm will need to identify a Site Champion to provide clinic-specific information to facilitate implementation of the Vaccine Acceptance Intervention at their clinic or CBOC. In addition, for clinics and CBOCs assigned to the Vaccine Acceptance Intervention, VAHCS, clinic and CBOC leadership will need to agree to release PACT staff for an initial two-hour Motivational Interviewing (MI) training, and at least one 60-minute post-training consultation session over the one-year trial period. There will be additional consultation sessions offered to intervention clinics and CBOC staff, but these will be optional.
Moving to COVID-19 Vaccine Acceptance Intervention: The intervention utilizes a multi-pronged approach to increase Veteran vaccine acceptance. First, the research team will train Health Behavior Coordinators (HBCs) at VAI sites. HBCs will then train PACT teams at their site and Whole Health Coaches, Peer Specialists and other VA Staff in VAI strategies to use with unvaccinated Veterans. Whole Health Coaches, Peer Specialists and other VA Staff will conduct outreach calls, using strategies, with unvaccinated Veterans.
|
Usual Care Arm
n=5 VAHCS
A VAHCS assigned to Usual Care will have no specific trial intervention requirements beyond their usual level of participation in national and local initiatives to improve COVID-19 vaccine acceptance. At both Intervention and Usual Care sites, the study team will perform quarterly "environmental scans". The environmental scan survey will include questions about site specific barriers to COVID-19 vaccination (first dose and second dose if needed), current programs/initiatives in the clinic or local community that are improving or have had no impact on vaccination rates, and the perceived importance that the VAMC/CBOC clinic staff is placing on vaccination (Environmental Scan Survey, in preparation). At Usual Care sites, a point of contact will be chosen from each clinic and CBOC to complete the environmental scan, and at Intervention sites, the Site Champion (see below) will perform the quarterly scan.
|
Total
n=10 VAHCS
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.3 Years
STANDARD_DEVIATION 15.1 • n=5 Participants
|
62.9 Years
STANDARD_DEVIATION 16.0 • n=7 Participants
|
63.1 Years
STANDARD_DEVIATION 15.6 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
14406 Participants
n=5 Participants
|
18094 Participants
n=7 Participants
|
32500 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
131215 Participants
n=5 Participants
|
168777 Participants
n=7 Participants
|
299992 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Unknown
|
2670 Participants
n=5 Participants
|
3556 Participants
n=7 Participants
|
6226 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
84404 Participants
n=5 Participants
|
130970 Participants
n=7 Participants
|
215374 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
32918 Participants
n=5 Participants
|
32313 Participants
n=7 Participants
|
65231 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
8451 Participants
n=5 Participants
|
3918 Participants
n=7 Participants
|
12369 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
6192 Participants
n=5 Participants
|
2050 Participants
n=7 Participants
|
8242 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
1081 Participants
n=5 Participants
|
1810 Participants
n=7 Participants
|
2891 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
15245 Participants
n=5 Participants
|
19366 Participants
n=7 Participants
|
34611 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
129305 Participants
n=5 Participants
|
161567 Participants
n=7 Participants
|
290872 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
9005 Participants
n=5 Participants
|
17336 Participants
n=7 Participants
|
26341 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Declined to Answer
|
1717 Participants
n=5 Participants
|
2655 Participants
n=7 Participants
|
4372 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Unknown
|
8264 Participants
n=5 Participants
|
8869 Participants
n=7 Participants
|
17133 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
148291 participants
n=5 Participants
|
190427 participants
n=7 Participants
|
338718 participants
n=5 Participants
|
|
Baseline Primary Series Rate (Randomization Unit Level)
|
61.8 Percent of Participants
STANDARD_DEVIATION 6.30 • n=5 VAHCS • The number of units for this baseline measure are the number of randomization units assigned to each arm (i.e., 5 and 5). This measure is percentage of participants in each randomization unit who completed primary series at the time of randomization
|
64.2 Percent of Participants
STANDARD_DEVIATION 6.60 • n=5 VAHCS • The number of units for this baseline measure are the number of randomization units assigned to each arm (i.e., 5 and 5). This measure is percentage of participants in each randomization unit who completed primary series at the time of randomization
|
63.0 Percent of Participants
STANDARD_DEVIATION 5.89 • n=10 VAHCS • The number of units for this baseline measure are the number of randomization units assigned to each arm (i.e., 5 and 5). This measure is percentage of participants in each randomization unit who completed primary series at the time of randomization
|
|
Marriage Status
Divorced/Separated
|
38165 Participants
n=5 Participants
|
49476 Participants
n=7 Participants
|
87641 Participants
n=5 Participants
|
|
Marriage Status
Married/Common Law
|
80240 Participants
n=5 Participants
|
105951 Participants
n=7 Participants
|
186191 Participants
n=5 Participants
|
|
Marriage Status
Single/Never Married
|
22233 Participants
n=5 Participants
|
25002 Participants
n=7 Participants
|
47235 Participants
n=5 Participants
|
|
Marriage Status
Unknown
|
2786 Participants
n=5 Participants
|
2514 Participants
n=7 Participants
|
5300 Participants
n=5 Participants
|
|
Marriage Status
Widow/Widower
|
4867 Participants
n=5 Participants
|
7484 Participants
n=7 Participants
|
12351 Participants
n=5 Participants
|
|
Rurality
Highly Rural
|
1399 Participants
n=5 Participants
|
1514 Participants
n=7 Participants
|
2913 Participants
n=5 Participants
|
|
Rurality
Rural
|
40958 Participants
n=5 Participants
|
59849 Participants
n=7 Participants
|
100807 Participants
n=5 Participants
|
|
Rurality
Unknown
|
2709 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
2737 Participants
n=5 Participants
|
|
Rurality
Urban
|
103225 Participants
n=5 Participants
|
129036 Participants
n=7 Participants
|
232261 Participants
n=5 Participants
|
|
Care Assessment Needs (CAN) Score 1 Year Event Probability
|
0.181 Probability
STANDARD_DEVIATION 0.175 • n=5 Participants
|
0.179 Probability
STANDARD_DEVIATION 0.174 • n=7 Participants
|
0.180 Probability
STANDARD_DEVIATION 0.174 • n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Veterans with at least one primary care visit during the study period.
A greater proportion of Veterans in the intervention group will receive any dose of COVID-19 vaccination compared to usual care.
Outcome measures
| Measure |
Intervention Arm
n=148291 Participants
The VAHCS Internal Facilitator will partner with the trial External Facilitators (research team and designated External Facilitators in VISNS 16 and 21) to adapt and implement the study intervention to best meet the needs and preferences of their VAHCS site. In addition, each CBOC and clinic affiliated with a VAHCS in the Intervention arm will need to identify a Site Champion to provide clinic-specific information to facilitate implementation of the Vaccine Acceptance Intervention at their clinic or CBOC. In addition, for clinics and CBOCs assigned to the Vaccine Acceptance Intervention, VAHCS, clinic and CBOC leadership will need to agree to release PACT staff for an initial two-hour Motivational Interviewing (MI) training, and at least one 60-minute post-training consultation session over the one-year trial period. There will be additional consultation sessions offered to intervention clinics and CBOC staff, but these will be optional.
Moving to COVID-19 Vaccine Acceptance Intervention: The intervention utilizes a multi-pronged approach to increase Veteran vaccine acceptance. First, the research team will train Health Behavior Coordinators (HBCs) at VAI sites. HBCs will then train PACT teams at their site and Whole Health Coaches, Peer Specialists and other VA Staff in VAI strategies to use with unvaccinated Veterans. Whole Health Coaches, Peer Specialists and other VA Staff will conduct outreach calls, using strategies, with unvaccinated Veterans.
|
Usual Care Arm
n=190427 Participants
A VAHCS assigned to Usual Care will have no specific trial intervention requirements beyond their usual level of participation in national and local initiatives to improve COVID-19 vaccine acceptance. At both Intervention and Usual Care sites, the study team will perform quarterly "environmental scans". The environmental scan survey will include questions about site specific barriers to COVID-19 vaccination (first dose and second dose if needed), current programs/initiatives in the clinic or local community that are improving or have had no impact on vaccination rates, and the perceived importance that the VAMC/CBOC clinic staff is placing on vaccination (Environmental Scan Survey, in preparation). At Usual Care sites, a point of contact will be chosen from each clinic and CBOC to complete the environmental scan, and at Intervention sites, the Site Champion (see below) will perform the quarterly scan.
|
|---|---|---|
|
Receipt of Any Dose COVID-19 Vaccination
|
57621 Participants
|
65407 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Veterans without any COVID-19 vaccination prior to study start who also had at least one primary care visit during the study.
A greater proportion of previously unvaccinated Veterans in the intervention arm will complete the primary series for COVID-19 vaccination compared to usual care
Outcome measures
| Measure |
Intervention Arm
n=29904 Participants
The VAHCS Internal Facilitator will partner with the trial External Facilitators (research team and designated External Facilitators in VISNS 16 and 21) to adapt and implement the study intervention to best meet the needs and preferences of their VAHCS site. In addition, each CBOC and clinic affiliated with a VAHCS in the Intervention arm will need to identify a Site Champion to provide clinic-specific information to facilitate implementation of the Vaccine Acceptance Intervention at their clinic or CBOC. In addition, for clinics and CBOCs assigned to the Vaccine Acceptance Intervention, VAHCS, clinic and CBOC leadership will need to agree to release PACT staff for an initial two-hour Motivational Interviewing (MI) training, and at least one 60-minute post-training consultation session over the one-year trial period. There will be additional consultation sessions offered to intervention clinics and CBOC staff, but these will be optional.
Moving to COVID-19 Vaccine Acceptance Intervention: The intervention utilizes a multi-pronged approach to increase Veteran vaccine acceptance. First, the research team will train Health Behavior Coordinators (HBCs) at VAI sites. HBCs will then train PACT teams at their site and Whole Health Coaches, Peer Specialists and other VA Staff in VAI strategies to use with unvaccinated Veterans. Whole Health Coaches, Peer Specialists and other VA Staff will conduct outreach calls, using strategies, with unvaccinated Veterans.
|
Usual Care Arm
n=43939 Participants
A VAHCS assigned to Usual Care will have no specific trial intervention requirements beyond their usual level of participation in national and local initiatives to improve COVID-19 vaccine acceptance. At both Intervention and Usual Care sites, the study team will perform quarterly "environmental scans". The environmental scan survey will include questions about site specific barriers to COVID-19 vaccination (first dose and second dose if needed), current programs/initiatives in the clinic or local community that are improving or have had no impact on vaccination rates, and the perceived importance that the VAMC/CBOC clinic staff is placing on vaccination (Environmental Scan Survey, in preparation). At Usual Care sites, a point of contact will be chosen from each clinic and CBOC to complete the environmental scan, and at Intervention sites, the Site Champion (see below) will perform the quarterly scan.
|
|---|---|---|
|
Primary Series Completion of COVID-19 Vaccination
|
378 Participants
|
533 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 YearPopulation: Veterans with at least one primary care visit and have completed the primary series either before or with enough time in the study period.
Receipt of booster requires the Veteran needs to have completed the primary series of the COVID-19 vaccination.
Outcome measures
| Measure |
Intervention Arm
n=116319 Participants
The VAHCS Internal Facilitator will partner with the trial External Facilitators (research team and designated External Facilitators in VISNS 16 and 21) to adapt and implement the study intervention to best meet the needs and preferences of their VAHCS site. In addition, each CBOC and clinic affiliated with a VAHCS in the Intervention arm will need to identify a Site Champion to provide clinic-specific information to facilitate implementation of the Vaccine Acceptance Intervention at their clinic or CBOC. In addition, for clinics and CBOCs assigned to the Vaccine Acceptance Intervention, VAHCS, clinic and CBOC leadership will need to agree to release PACT staff for an initial two-hour Motivational Interviewing (MI) training, and at least one 60-minute post-training consultation session over the one-year trial period. There will be additional consultation sessions offered to intervention clinics and CBOC staff, but these will be optional.
Moving to COVID-19 Vaccine Acceptance Intervention: The intervention utilizes a multi-pronged approach to increase Veteran vaccine acceptance. First, the research team will train Health Behavior Coordinators (HBCs) at VAI sites. HBCs will then train PACT teams at their site and Whole Health Coaches, Peer Specialists and other VA Staff in VAI strategies to use with unvaccinated Veterans. Whole Health Coaches, Peer Specialists and other VA Staff will conduct outreach calls, using strategies, with unvaccinated Veterans.
|
Usual Care Arm
n=143669 Participants
A VAHCS assigned to Usual Care will have no specific trial intervention requirements beyond their usual level of participation in national and local initiatives to improve COVID-19 vaccine acceptance. At both Intervention and Usual Care sites, the study team will perform quarterly "environmental scans". The environmental scan survey will include questions about site specific barriers to COVID-19 vaccination (first dose and second dose if needed), current programs/initiatives in the clinic or local community that are improving or have had no impact on vaccination rates, and the perceived importance that the VAMC/CBOC clinic staff is placing on vaccination (Environmental Scan Survey, in preparation). At Usual Care sites, a point of contact will be chosen from each clinic and CBOC to complete the environmental scan, and at Intervention sites, the Site Champion (see below) will perform the quarterly scan.
|
|---|---|---|
|
COVID-19 Booster Vaccination
|
56408 Participants
|
63909 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 YearPopulation: Veteran had to have at least one primary care visit during the study for primary analysis of this outcome.
Receipt of Flu Vaccine during study period.
Outcome measures
| Measure |
Intervention Arm
n=148291 Participants
The VAHCS Internal Facilitator will partner with the trial External Facilitators (research team and designated External Facilitators in VISNS 16 and 21) to adapt and implement the study intervention to best meet the needs and preferences of their VAHCS site. In addition, each CBOC and clinic affiliated with a VAHCS in the Intervention arm will need to identify a Site Champion to provide clinic-specific information to facilitate implementation of the Vaccine Acceptance Intervention at their clinic or CBOC. In addition, for clinics and CBOCs assigned to the Vaccine Acceptance Intervention, VAHCS, clinic and CBOC leadership will need to agree to release PACT staff for an initial two-hour Motivational Interviewing (MI) training, and at least one 60-minute post-training consultation session over the one-year trial period. There will be additional consultation sessions offered to intervention clinics and CBOC staff, but these will be optional.
Moving to COVID-19 Vaccine Acceptance Intervention: The intervention utilizes a multi-pronged approach to increase Veteran vaccine acceptance. First, the research team will train Health Behavior Coordinators (HBCs) at VAI sites. HBCs will then train PACT teams at their site and Whole Health Coaches, Peer Specialists and other VA Staff in VAI strategies to use with unvaccinated Veterans. Whole Health Coaches, Peer Specialists and other VA Staff will conduct outreach calls, using strategies, with unvaccinated Veterans.
|
Usual Care Arm
n=190427 Participants
A VAHCS assigned to Usual Care will have no specific trial intervention requirements beyond their usual level of participation in national and local initiatives to improve COVID-19 vaccine acceptance. At both Intervention and Usual Care sites, the study team will perform quarterly "environmental scans". The environmental scan survey will include questions about site specific barriers to COVID-19 vaccination (first dose and second dose if needed), current programs/initiatives in the clinic or local community that are improving or have had no impact on vaccination rates, and the perceived importance that the VAMC/CBOC clinic staff is placing on vaccination (Environmental Scan Survey, in preparation). At Usual Care sites, a point of contact will be chosen from each clinic and CBOC to complete the environmental scan, and at Intervention sites, the Site Champion (see below) will perform the quarterly scan.
|
|---|---|---|
|
Receipt of Flu Vaccine
|
76295 Participants
|
96561 Participants
|
Adverse Events
Intervention Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place