Trial Outcomes & Findings for Virtual Immersive Communication Training on Recommending Immunizations (NCT NCT04368455)
NCT ID: NCT04368455
Last Updated: 2023-04-12
Results Overview
The primary outcome was the percent change from pre versus post VICTORI in rates of HPV vaccine initiation among eligible patients presenting to clinic.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
161 participants
Primary outcome timeframe
6 months
Results posted on
2023-04-12
Participant Flow
Participant milestones
| Measure |
Primary Care Clinic- Physicians
Physician participants will receive the self-directed app based curriculum. The physician participants will engage in the VR simulations independently.
Virtual Immersive Communication Training on Recommending Immunizations (VICTORI): An intervention that includes a self-directed app based curriculum and virtual reality simulations, designed to increase the strength and consistency of HPV vaccine recommendations among clinicians.
|
Primary Care Clinic- Staff
We will implement VICTORI with staff including nurses and medical assistants in groups of up to 15-20 participants (phase II; secondary outcome). Staff will watch a 5-minute video on evidence-based practices in recommending the HPV vaccine and observe a facilitator and clinician participating in the VICTORI VR simulations, and then engage in a 5-minute debriefing.
Virtual Immersive Communication Training on Recommending Immunizations (VICTORI): An intervention that includes a self-directed app based curriculum and virtual reality simulations, designed to increase the strength and consistency of HPV vaccine recommendations among clinicians.
|
Control Primary Care Clinic
Physician participants will receive the self-directed app based curriculum component of VICTORI though will not undergo the VR simulations.
HPV Same Way Same Day App: An intervention that includes a self-directed app based curriculum
|
|---|---|---|---|
|
Overall Study
STARTED
|
97
|
27
|
37
|
|
Overall Study
COMPLETED
|
93
|
27
|
32
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Missing responses for age
Baseline characteristics by cohort
| Measure |
Primary Care Clinic- Physicians
n=88 Participants
Physician participants will receive the self-directed app based curriculum. The physician participants will engage in the Virtual Reality (VR) simulations independently.
Virtual Immersive Communication Training on Recommending Immunizations (VICTORI): An intervention that includes a self-directed app based curriculum and virtual reality simulations, designed to increase the strength and consistency of human papillomavirus (HPV) vaccine recommendations among clinicians.
|
Primary Care Clinic- Staff
n=27 Participants
We will implement VICTORI with staff including nurses and medical assistants in groups of up to 15-20 participants (phase II; secondary outcome). Staff will watch a 5-minute video on evidence-based practices in recommending the HPV vaccine and observe a facilitator and clinician participating in the VICTORI VR simulations, and then engage in a 5-minute debriefing.
Virtual Immersive Communication Training on Recommending Immunizations (VICTORI): An intervention that includes a self-directed app based curriculum and virtual reality simulations, designed to increase the strength and consistency of HPV vaccine recommendations among clinicians.
|
Control Primary Care Clinic
n=29 Participants
Physician participants will receive the self-directed app based curriculum component of VICTORI though will not undergo the VR simulations.
HPV Same Way Same Day App: An intervention that includes a self-directed app based curriculum
|
Total
n=144 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
30.1 years
STANDARD_DEVIATION 6.0 • n=88 Participants • Missing responses for age
|
38.4 years
STANDARD_DEVIATION 10.8 • n=22 Participants • Missing responses for age
|
32.3 years
STANDARD_DEVIATION 9.4 • n=29 Participants • Missing responses for age
|
32.6 years
STANDARD_DEVIATION 8.7 • n=139 Participants • Missing responses for age
|
|
Sex: Female, Male
Female
|
59 Participants
n=88 Participants
|
27 Participants
n=27 Participants
|
17 Participants
n=29 Participants
|
103 Participants
n=144 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=88 Participants
|
0 Participants
n=27 Participants
|
12 Participants
n=29 Participants
|
41 Participants
n=144 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=88 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=29 Participants
|
2 Participants
n=144 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
87 Participants
n=88 Participants
|
26 Participants
n=27 Participants
|
29 Participants
n=29 Participants
|
142 Participants
n=144 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=88 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=144 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=88 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=29 Participants
|
2 Participants
n=144 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=88 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=29 Participants
|
11 Participants
n=144 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=88 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=144 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=88 Participants
|
7 Participants
n=27 Participants
|
3 Participants
n=29 Participants
|
15 Participants
n=144 Participants
|
|
Race (NIH/OMB)
White
|
66 Participants
n=88 Participants
|
16 Participants
n=27 Participants
|
20 Participants
n=29 Participants
|
102 Participants
n=144 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=88 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=29 Participants
|
5 Participants
n=144 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=88 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=29 Participants
|
9 Participants
n=144 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The electronic health record was used to identify patients' HPV vaccine initiation rates for participating physicians at the intervention and control sites. The pre-intervention period was 6 months before VICTORI and app-based training implementation (February 1, 2020-July 31, 2020), and the post-intervention period was 6 months following implementation (October 1, 2020-March 31, 2021). The primary outcome was the change in rates of HPV vaccine initiation pre vs post the VICTORI intervention.
The primary outcome was the percent change from pre versus post VICTORI in rates of HPV vaccine initiation among eligible patients presenting to clinic.
Outcome measures
| Measure |
Primary Care Clinic
n=88 Participants
Physician participants will receive the self-directed app based curriculum. The physician participants will engage in the VR simulations independently entitled
Virtual Immersive Communication Training on Recommending Immunizations (VICTORI): An intervention that includes a self-directed app based curriculum and virtual reality simulations, designed to increase the strength and consistency of HPV vaccine recommendations among clinicians.
|
Control Primary Care Clinic
n=29 Participants
Physician participants will receive the self-directed app based curriculum component of VICTORI though will not undergo the VR simulations.
HPV Same Way Same Day App: An intervention that includes a self-directed app based curriculum
|
|---|---|---|
|
Percent Change From Baseline in the Percentage of Participants With HPV Vaccine Initiation
|
18.1 Percent Change from Baseline
Interval 11.0 to 25.8
|
3.9 Percent Change from Baseline
Interval -11.0 to 19.0
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Secondary outcomes analyzed related to impact of curriculum over time rather than analyses compared to control participants.
Physicians level barriers for recommendation of the HPV Vaccine following participation in VICTORI. Sum of 4 survey items using a 4 point scale (minimum score =4, maximum=16). A higher score indicates more barriers.
Outcome measures
| Measure |
Primary Care Clinic
n=75 Participants
Physician participants will receive the self-directed app based curriculum. The physician participants will engage in the VR simulations independently entitled
Virtual Immersive Communication Training on Recommending Immunizations (VICTORI): An intervention that includes a self-directed app based curriculum and virtual reality simulations, designed to increase the strength and consistency of HPV vaccine recommendations among clinicians.
|
Control Primary Care Clinic
Physician participants will receive the self-directed app based curriculum component of VICTORI though will not undergo the VR simulations.
HPV Same Way Same Day App: An intervention that includes a self-directed app based curriculum
|
|---|---|---|
|
Physicians Perceived Barriers
Pre-VICTORI
|
7.39 score on a scale
Standard Deviation 1.67
|
—
|
|
Physicians Perceived Barriers
Post-VICTORI
|
6.87 score on a scale
Standard Deviation 1.66
|
—
|
|
Physicians Perceived Barriers
3-Month Post- VICTORI
|
6.75 score on a scale
Standard Deviation 1.59
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Secondary outcomes analyzed related to impact of curriculum over time rather than analyses compared to control participants.
Physicians risk of HPV for their patients following participation in VICTORI. Sum of 5 survey items using a 3 point scale (minimum score =5, maximum=15). A higher score indicates higher perceived risk for patients.
Outcome measures
| Measure |
Primary Care Clinic
n=75 Participants
Physician participants will receive the self-directed app based curriculum. The physician participants will engage in the VR simulations independently entitled
Virtual Immersive Communication Training on Recommending Immunizations (VICTORI): An intervention that includes a self-directed app based curriculum and virtual reality simulations, designed to increase the strength and consistency of HPV vaccine recommendations among clinicians.
|
Control Primary Care Clinic
Physician participants will receive the self-directed app based curriculum component of VICTORI though will not undergo the VR simulations.
HPV Same Way Same Day App: An intervention that includes a self-directed app based curriculum
|
|---|---|---|
|
Physicians Perceived Risk
Pre-VICTORI
|
10.53 score on a scale
Standard Deviation 2.43
|
—
|
|
Physicians Perceived Risk
Post-VICTORI
|
12.07 score on a scale
Standard Deviation 2.26
|
—
|
|
Physicians Perceived Risk
3 Month Post-VICTORI
|
11.36 score on a scale
Standard Deviation 2.36
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Secondary outcomes analyzed related to impact of curriculum over time rather than analyses compared to control participants.
Physicians attitudes toward the HPV vaccine following participation in VICTORI. Sum of 12 survey items using a 5 point scale (minimum score =12, maximum=60). A higher score indicates physician perception of increased importance towards the HPV vaccine.
Outcome measures
| Measure |
Primary Care Clinic
n=75 Participants
Physician participants will receive the self-directed app based curriculum. The physician participants will engage in the VR simulations independently entitled
Virtual Immersive Communication Training on Recommending Immunizations (VICTORI): An intervention that includes a self-directed app based curriculum and virtual reality simulations, designed to increase the strength and consistency of HPV vaccine recommendations among clinicians.
|
Control Primary Care Clinic
Physician participants will receive the self-directed app based curriculum component of VICTORI though will not undergo the VR simulations.
HPV Same Way Same Day App: An intervention that includes a self-directed app based curriculum
|
|---|---|---|
|
Physicians Attitudes Toward the HPV Vaccine
Pre-VICTORI
|
49.68 score on a scale
Standard Deviation 8.73
|
—
|
|
Physicians Attitudes Toward the HPV Vaccine
Post-VICTORI
|
54.24 score on a scale
Standard Deviation 6.28
|
—
|
|
Physicians Attitudes Toward the HPV Vaccine
3-Month Post-VICTORI
|
53.15 score on a scale
Standard Deviation 7.19
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Secondary outcomes analyzed related to impact of curriculum over time rather than analyses compared to control participants.
Physicians strength of recommendation of the HPV vaccine following participation in VICTORI. Sum of 8 survey items using a 4 point scale (minimum score =8, maximum=32). A higher score indicates stronger recommendation of HPV vaccine.
Outcome measures
| Measure |
Primary Care Clinic
n=75 Participants
Physician participants will receive the self-directed app based curriculum. The physician participants will engage in the VR simulations independently entitled
Virtual Immersive Communication Training on Recommending Immunizations (VICTORI): An intervention that includes a self-directed app based curriculum and virtual reality simulations, designed to increase the strength and consistency of HPV vaccine recommendations among clinicians.
|
Control Primary Care Clinic
Physician participants will receive the self-directed app based curriculum component of VICTORI though will not undergo the VR simulations.
HPV Same Way Same Day App: An intervention that includes a self-directed app based curriculum
|
|---|---|---|
|
Physicians Strength of Recommendation of the HPV Vaccine
Pre-VICTORI
|
28.49 score on a scale
Standard Deviation 3.37
|
—
|
|
Physicians Strength of Recommendation of the HPV Vaccine
Post-VICTORI
|
28.76 score on a scale
Standard Deviation 2.53
|
—
|
|
Physicians Strength of Recommendation of the HPV Vaccine
3-Month Post-VICTORI
|
29.17 score on a scale
Standard Deviation 2.35
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Secondary outcomes analyzed related to impact of curriculum over time rather than analyses compared to control participants.
Physicians self-efficacy for recommendation of the HPV Vaccine following participation in VICTORI. Sum of 5 survey items using a 5 point scale (minimum score =2, maximum=10). A higher score indicates higher self-efficacy.
Outcome measures
| Measure |
Primary Care Clinic
n=75 Participants
Physician participants will receive the self-directed app based curriculum. The physician participants will engage in the VR simulations independently entitled
Virtual Immersive Communication Training on Recommending Immunizations (VICTORI): An intervention that includes a self-directed app based curriculum and virtual reality simulations, designed to increase the strength and consistency of HPV vaccine recommendations among clinicians.
|
Control Primary Care Clinic
Physician participants will receive the self-directed app based curriculum component of VICTORI though will not undergo the VR simulations.
HPV Same Way Same Day App: An intervention that includes a self-directed app based curriculum
|
|---|---|---|
|
Physicians Self-efficacy
Post- VICTORI
|
9.55 score on a scale
Standard Deviation 0.76
|
—
|
|
Physicians Self-efficacy
Pre-VICTORI
|
7.44 score on a scale
Standard Deviation 1.27
|
—
|
|
Physicians Self-efficacy
3-Month Post-VICTORI
|
9.27 score on a scale
Standard Deviation 0.88
|
—
|
Adverse Events
Primary Care Clinic- Physicians
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Primary Care Clinic- Staff
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Primary Care Clinic
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
Dr. Francis Real
Cincinnati Children's Hospital Medical Center
Phone: 5136364200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place