Trial Outcomes & Findings for The STOP-HPV Trial 1: Communication Intervention (NCT NCT03599557)
NCT ID: NCT03599557
Last Updated: 2024-07-12
Results Overview
The difference in the missed opportunity rate for HPV vaccination between the baseline period (12 months long) and the feedback period (6 months long) among all the clinicians in the participating practices, regardless of whether they received the training intervention. A missed opportunity is a visit-based measure, with the denominator representing all the visits where an HPV vaccine is due at the time of the visit and the numerator representing the number of visits where an HPV vaccine was not given.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
Assessment of rates from 2 time periods- baseline period (assessed outcomes retrospectively from minus 12 months to Time 0), followed by 6 month intervention period (excluding a 4 week ramp-up period).
Results posted on
2024-07-12
Participant Flow
Practices were recruited through the American Academy of Pediatrics' PROS (Pediatric Research in Office Settings) Network. Practices were the unit of randomization (48 practices total- 24 randomized into each arm).
The unit of randomization in this cluster randomized design is the practice. Eligible patients of the practices had at least one visit in the baseline and/or communication period in this cluster-randomized design (overlap between periods is possible).
Unit of analysis: Practices
Participant milestones
| Measure |
Intervention
Arm 1 will receive the STOP-HPV communication intervention
STOP-HPV communication intervention: This intervention will be communication skills training.
|
Control
Arm 2 will receive standard of care
|
|---|---|---|
|
Baseline Period (12 Months)
STARTED
|
50569 24
|
53869 24
|
|
Baseline Period (12 Months)
COMPLETED
|
50569 24
|
53869 24
|
|
Baseline Period (12 Months)
NOT COMPLETED
|
0 0
|
0 0
|
|
Communication Intervention (6 Months)
STARTED
|
29206 24
|
33914 24
|
|
Communication Intervention (6 Months)
COMPLETED
|
29206 24
|
33914 24
|
|
Communication Intervention (6 Months)
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
Baseline characteristics by cohort
| Measure |
Intervention
n=79775 Participants
Arm 1 will receive the STOP-HPV communication intervention
STOP-HPV communication intervention: This intervention will be communication skills training.
|
Control
n=87783 Participants
Arm 2 will receive standard of care
|
Total
n=167558 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race/Ethnicity, Customized
Communication Intervention · African American
|
2705 Participants
n=29206 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
3042 Participants
n=33914 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
5747 Participants
n=63120 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
|
Age, Customized
Adolescents ages 11-17 years · Baseline Period
|
50569 Participants
n=79775 Participants
|
53869 Participants
n=87783 Participants
|
104438 Participants
n=167558 Participants
|
|
Age, Customized
Adolescents ages 11-17 years · Communication Intervention
|
29206 Participants
n=79775 Participants
|
33914 Participants
n=87783 Participants
|
63120 Participants
n=167558 Participants
|
|
Sex/Gender, Customized
Baseline Period · Male
|
25472 Participants
n=50569 Participants • Participants in the baseline analysis population included the number of adolescents of the randomized practices who were aged 11-17 years with an eligible visit (HPV vaccine due), but from 2 separate time periods- the Baseline Period (12 mo) and Communication Intervention Period (6 mo). In this cluster-randomized design, participants could have had a visit in either or both periods. The sum of the two periods will equal the Overall Number of Baseline Participants provided above.
|
27106 Participants
n=53869 Participants • Participants in the baseline analysis population included the number of adolescents of the randomized practices who were aged 11-17 years with an eligible visit (HPV vaccine due), but from 2 separate time periods- the Baseline Period (12 mo) and Communication Intervention Period (6 mo). In this cluster-randomized design, participants could have had a visit in either or both periods. The sum of the two periods will equal the Overall Number of Baseline Participants provided above.
|
52578 Participants
n=104438 Participants • Participants in the baseline analysis population included the number of adolescents of the randomized practices who were aged 11-17 years with an eligible visit (HPV vaccine due), but from 2 separate time periods- the Baseline Period (12 mo) and Communication Intervention Period (6 mo). In this cluster-randomized design, participants could have had a visit in either or both periods. The sum of the two periods will equal the Overall Number of Baseline Participants provided above.
|
|
Sex/Gender, Customized
Baseline Period · Female
|
25093 Participants
n=50569 Participants • Participants in the baseline analysis population included the number of adolescents of the randomized practices who were aged 11-17 years with an eligible visit (HPV vaccine due), but from 2 separate time periods- the Baseline Period (12 mo) and Communication Intervention Period (6 mo). In this cluster-randomized design, participants could have had a visit in either or both periods. The sum of the two periods will equal the Overall Number of Baseline Participants provided above.
|
26762 Participants
n=53869 Participants • Participants in the baseline analysis population included the number of adolescents of the randomized practices who were aged 11-17 years with an eligible visit (HPV vaccine due), but from 2 separate time periods- the Baseline Period (12 mo) and Communication Intervention Period (6 mo). In this cluster-randomized design, participants could have had a visit in either or both periods. The sum of the two periods will equal the Overall Number of Baseline Participants provided above.
|
51855 Participants
n=104438 Participants • Participants in the baseline analysis population included the number of adolescents of the randomized practices who were aged 11-17 years with an eligible visit (HPV vaccine due), but from 2 separate time periods- the Baseline Period (12 mo) and Communication Intervention Period (6 mo). In this cluster-randomized design, participants could have had a visit in either or both periods. The sum of the two periods will equal the Overall Number of Baseline Participants provided above.
|
|
Sex/Gender, Customized
Baseline Period · Missing
|
4 Participants
n=50569 Participants • Participants in the baseline analysis population included the number of adolescents of the randomized practices who were aged 11-17 years with an eligible visit (HPV vaccine due), but from 2 separate time periods- the Baseline Period (12 mo) and Communication Intervention Period (6 mo). In this cluster-randomized design, participants could have had a visit in either or both periods. The sum of the two periods will equal the Overall Number of Baseline Participants provided above.
|
1 Participants
n=53869 Participants • Participants in the baseline analysis population included the number of adolescents of the randomized practices who were aged 11-17 years with an eligible visit (HPV vaccine due), but from 2 separate time periods- the Baseline Period (12 mo) and Communication Intervention Period (6 mo). In this cluster-randomized design, participants could have had a visit in either or both periods. The sum of the two periods will equal the Overall Number of Baseline Participants provided above.
|
5 Participants
n=104438 Participants • Participants in the baseline analysis population included the number of adolescents of the randomized practices who were aged 11-17 years with an eligible visit (HPV vaccine due), but from 2 separate time periods- the Baseline Period (12 mo) and Communication Intervention Period (6 mo). In this cluster-randomized design, participants could have had a visit in either or both periods. The sum of the two periods will equal the Overall Number of Baseline Participants provided above.
|
|
Sex/Gender, Customized
Communication Intervention · Male
|
14542 Participants
n=29206 Participants • Participants in the baseline analysis population included the number of adolescents of the randomized practices who were aged 11-17 years with an eligible visit (HPV vaccine due), but from 2 separate time periods- the Baseline Period (12 mo) and Communication Intervention Period (6 mo). In this cluster-randomized design, participants could have had a visit in either or both periods. The sum of the two periods will equal the Overall Number of Baseline Participants provided above.
|
16845 Participants
n=33914 Participants • Participants in the baseline analysis population included the number of adolescents of the randomized practices who were aged 11-17 years with an eligible visit (HPV vaccine due), but from 2 separate time periods- the Baseline Period (12 mo) and Communication Intervention Period (6 mo). In this cluster-randomized design, participants could have had a visit in either or both periods. The sum of the two periods will equal the Overall Number of Baseline Participants provided above.
|
31387 Participants
n=63120 Participants • Participants in the baseline analysis population included the number of adolescents of the randomized practices who were aged 11-17 years with an eligible visit (HPV vaccine due), but from 2 separate time periods- the Baseline Period (12 mo) and Communication Intervention Period (6 mo). In this cluster-randomized design, participants could have had a visit in either or both periods. The sum of the two periods will equal the Overall Number of Baseline Participants provided above.
|
|
Sex/Gender, Customized
Communication Intervention · Female
|
14664 Participants
n=29206 Participants • Participants in the baseline analysis population included the number of adolescents of the randomized practices who were aged 11-17 years with an eligible visit (HPV vaccine due), but from 2 separate time periods- the Baseline Period (12 mo) and Communication Intervention Period (6 mo). In this cluster-randomized design, participants could have had a visit in either or both periods. The sum of the two periods will equal the Overall Number of Baseline Participants provided above.
|
17068 Participants
n=33914 Participants • Participants in the baseline analysis population included the number of adolescents of the randomized practices who were aged 11-17 years with an eligible visit (HPV vaccine due), but from 2 separate time periods- the Baseline Period (12 mo) and Communication Intervention Period (6 mo). In this cluster-randomized design, participants could have had a visit in either or both periods. The sum of the two periods will equal the Overall Number of Baseline Participants provided above.
|
31732 Participants
n=63120 Participants • Participants in the baseline analysis population included the number of adolescents of the randomized practices who were aged 11-17 years with an eligible visit (HPV vaccine due), but from 2 separate time periods- the Baseline Period (12 mo) and Communication Intervention Period (6 mo). In this cluster-randomized design, participants could have had a visit in either or both periods. The sum of the two periods will equal the Overall Number of Baseline Participants provided above.
|
|
Sex/Gender, Customized
Communication Intervention · Missing
|
0 Participants
n=29206 Participants • Participants in the baseline analysis population included the number of adolescents of the randomized practices who were aged 11-17 years with an eligible visit (HPV vaccine due), but from 2 separate time periods- the Baseline Period (12 mo) and Communication Intervention Period (6 mo). In this cluster-randomized design, participants could have had a visit in either or both periods. The sum of the two periods will equal the Overall Number of Baseline Participants provided above.
|
1 Participants
n=33914 Participants • Participants in the baseline analysis population included the number of adolescents of the randomized practices who were aged 11-17 years with an eligible visit (HPV vaccine due), but from 2 separate time periods- the Baseline Period (12 mo) and Communication Intervention Period (6 mo). In this cluster-randomized design, participants could have had a visit in either or both periods. The sum of the two periods will equal the Overall Number of Baseline Participants provided above.
|
1 Participants
n=63120 Participants • Participants in the baseline analysis population included the number of adolescents of the randomized practices who were aged 11-17 years with an eligible visit (HPV vaccine due), but from 2 separate time periods- the Baseline Period (12 mo) and Communication Intervention Period (6 mo). In this cluster-randomized design, participants could have had a visit in either or both periods. The sum of the two periods will equal the Overall Number of Baseline Participants provided above.
|
|
Race/Ethnicity, Customized
Baseline Period · White
|
36054 Participants
n=50569 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
31058 Participants
n=53869 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
67112 Participants
n=104438 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
|
Race/Ethnicity, Customized
Baseline Period · African American
|
4962 Participants
n=50569 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
5080 Participants
n=53869 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
10042 Participants
n=104438 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
|
Race/Ethnicity, Customized
Baseline Period · Asian or Pacific Islander
|
2734 Participants
n=50569 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
1901 Participants
n=53869 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
4635 Participants
n=104438 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
|
Race/Ethnicity, Customized
Baseline Period · American Indiana/Alaskan Native
|
229 Participants
n=50569 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
448 Participants
n=53869 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
677 Participants
n=104438 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
|
Race/Ethnicity, Customized
Baseline Period · Multiracial group
|
348 Participants
n=50569 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
352 Participants
n=53869 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
700 Participants
n=104438 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
|
Race/Ethnicity, Customized
Baseline Period · Other
|
178 Participants
n=50569 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
223 Participants
n=53869 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
401 Participants
n=104438 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
|
Race/Ethnicity, Customized
Baseline Period · Missing data
|
6064 Participants
n=50569 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
14807 Participants
n=53869 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
20871 Participants
n=104438 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
|
Race/Ethnicity, Customized
Communication Intervention · White
|
20824 Participants
n=29206 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
19480 Participants
n=33914 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
40304 Participants
n=63120 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
|
Race/Ethnicity, Customized
Communication Intervention · Asian or Pacific Islander
|
1583 Participants
n=29206 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
1148 Participants
n=33914 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
2731 Participants
n=63120 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
|
Race/Ethnicity, Customized
Communication Intervention · American Indiana/Alaskan Native
|
138 Participants
n=29206 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
281 Participants
n=33914 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
419 Participants
n=63120 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
|
Race/Ethnicity, Customized
Communication Intervention · Multiracial group
|
215 Participants
n=29206 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
223 Participants
n=33914 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
438 Participants
n=63120 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
|
Race/Ethnicity, Customized
Communication Intervention · Other
|
101 Participants
n=29206 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
128 Participants
n=33914 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
229 Participants
n=63120 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
|
Race/Ethnicity, Customized
Communication Intervention · Missing data
|
3640 Participants
n=29206 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
9612 Participants
n=33914 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
13252 Participants
n=63120 Participants • The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
|
PRIMARY outcome
Timeframe: Assessment of rates from 2 time periods- baseline period (assessed outcomes retrospectively from minus 12 months to Time 0), followed by 6 month intervention period (excluding a 4 week ramp-up period).Population: The Overall Number Participants analyzed is the number of unique patients with one or more visits to their practice (regardless of whether HPV vaccine was due) a study period - the Baseline Period (12 months) and the Communication Intervention Period (6 months). The number of units analyzed, serving as the denominator, is the number of eligible visits (visits where a child is due for HPV vaccine). The number of these visits where the vaccine was not given at the eligible visit is the numerator.
The difference in the missed opportunity rate for HPV vaccination between the baseline period (12 months long) and the feedback period (6 months long) among all the clinicians in the participating practices, regardless of whether they received the training intervention. A missed opportunity is a visit-based measure, with the denominator representing all the visits where an HPV vaccine is due at the time of the visit and the numerator representing the number of visits where an HPV vaccine was not given.
Outcome measures
| Measure |
Intervention
n=72372 Eligible visits (due for vaccine)
Arm 1 will receive the STOP-HPV communication intervention
STOP-HPV communication intervention: This intervention will be communication skills training.
|
Control
n=80331 Eligible visits (due for vaccine)
Arm 2 will receive standard of care
|
|---|---|---|
|
Change in the Rate of Missed Vaccination Opportunities Among All Clinicians
Baseline Period Missed Opportunity Rate
|
37063 Eligible visits (due for vaccine)
|
40764 Eligible visits (due for vaccine)
|
|
Change in the Rate of Missed Vaccination Opportunities Among All Clinicians
Communication Intervention Missed Opportunity Rate
|
14932 Eligible visits (due for vaccine)
|
18343 Eligible visits (due for vaccine)
|
PRIMARY outcome
Timeframe: Assessment of rates from 2 time periods- baseline period (assessed outcomes retrospectively from minus 12 months to Time 0), followed by 6 month intervention period (excluding a 4 week ramp-up period).Population: The unique children who made a visit (not just an HPV eligible visit) in either the baseline period (12 month) and/or the communication intervention period (6 month) to a clinician who consented to receive online training. Because the missed opportunity rate is a visit-based outcome, the overall number of units analyzed is the number of HPV eligible visits made in the two time periods and the count of units below is the number of visits where an HPV vaccination was not given in each period
The difference in the missed opportunity rate for HPV vaccination between the baseline period (12 months long) and the feedback period (6 months long) among all the clinicians in the participating practices who received the training intervention. A missed opportunity is a visit-based measure, with the denominator representing all the visits where an HPV vaccine is due at the time of the visit and the numerator representing the number of visits where an HPV vaccine was not given.
Outcome measures
| Measure |
Intervention
n=50936 Eligible visits (HPV due)
Arm 1 will receive the STOP-HPV communication intervention
STOP-HPV communication intervention: This intervention will be communication skills training.
|
Control
n=56598 Eligible visits (HPV due)
Arm 2 will receive standard of care
|
|---|---|---|
|
Change in the Rate of Missed Vaccination Opportunities Among Consenting Clinicians
Baseline Period
|
25117 Eligible visits (HPV due)
|
27817 Eligible visits (HPV due)
|
|
Change in the Rate of Missed Vaccination Opportunities Among Consenting Clinicians
Communication Intervention Period
|
11152 Eligible visits (HPV due)
|
13193 Eligible visits (HPV due)
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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
Principal Investigator
University of California, Los Angeles
Phone: (310) 206-6328
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place