Trial Outcomes & Findings for Primary Care and Adolescent Immunization for Rochester (NCT NCT00581347)
NCT ID: NCT00581347
Last Updated: 2016-09-23
Results Overview
We compared the number of participants in the intervention group who received vaccinations for Tdap, Menactra, and (for girls only) HPV at the end of the study period versus those in the control group.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
7546 participants
Primary outcome timeframe
15 months
Results posted on
2016-09-23
Participant Flow
The target population was teens with birthdates between 7/1/92 \& 6/30/97 at 8 practices in Rochester, NY. 2 methods were used to identify eligible adolescents;(1)2 insurance plans in the region provided a list of all their pts at these practices. (2)2 practices added to the list all teens who made a visit within 2 years of the study start date.
We preformed a stratified random sample, allocating all adolescents to either an intervention or standard of care group (using SAS 9.1). We stratified by practice, age and gender. For families with 2 or more eligible siblings, we assigned all siblings to the same group. Healthcare providers were unaware of group assignment.
Participant milestones
| Measure |
Outreach
The intervention consisted of a tiered protocol, with each step being more intensive and targeting a progressively smaller proportion of adolescents who remained behind in immunizations. The intervention was delivered by trained patient immunization navigators.
Step 1- Patient tracking: We used a web-based database to track the adolescents in the intervention group, record immunizations and preventive visits, and document tasks they performed.
Step 2: Reminders and recall: The navigators performed reminder/recall for adolescents who were eligible for either a vaccination or a preventive care visit. They attempted to contact families by telephone and mail.
Step 3: Home visits: If adolescents remained unvaccinated despite the above steps, the navigators performed a home visit to further assess barriers, promote the importance of preventive care, and encourage families to make appointments.
|
Standard of Care
Control subjects received standard of care. All practices routinely sent letter or telephone reminders to families who had upcoming scheduled visits, but none used active reminder/recall based on vaccinations.
|
|---|---|---|
|
Overall Study
STARTED
|
3839
|
3707
|
|
Overall Study
COMPLETED
|
3839
|
3707
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Primary Care and Adolescent Immunization for Rochester
Baseline characteristics by cohort
| Measure |
Outreach
n=3839 Participants
The intervention consisted of a tiered protocol, with each step being more intensive and targeting a progressively smaller proportion of adolescents who remained behind in immunizations. The intervention was delivered by trained patient immunization navigators.
Step 1- Patient tracking: We used a web-based database to track the adolescents in the intervention group, record immunizations and preventive visits, and document tasks they performed.
Step 2: Reminders and recall: The navigators performed reminder/recall for adolescents who were eligible for either a vaccination or a preventive care visit. They attempted to contact families by telephone and mail.
Step 3: Home visits: If adolescents remained unvaccinated despite the above steps, the navigators performed a home visit to further assess barriers, promote the importance of preventive care, and encourage families to make appointments.
|
Standard of Care
n=3707 Participants
Control subjects received standard of care. All practices routinely sent letter or telephone reminders to families who had upcoming scheduled visits, but none used active reminder/recall based on vaccinations.
|
Total
n=7546 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
11 years old
|
784 participants
n=99 Participants
|
757 participants
n=107 Participants
|
1541 participants
n=206 Participants
|
|
Age, Customized
12 years old
|
743 participants
n=99 Participants
|
701 participants
n=107 Participants
|
1444 participants
n=206 Participants
|
|
Age, Customized
13 years old
|
714 participants
n=99 Participants
|
686 participants
n=107 Participants
|
1400 participants
n=206 Participants
|
|
Age, Customized
14 years old
|
781 participants
n=99 Participants
|
758 participants
n=107 Participants
|
1539 participants
n=206 Participants
|
|
Age, Customized
15 years old
|
817 participants
n=99 Participants
|
805 participants
n=107 Participants
|
1622 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
1903 Participants
n=99 Participants
|
1849 Participants
n=107 Participants
|
3752 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1936 Participants
n=99 Participants
|
1858 Participants
n=107 Participants
|
3794 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 15 monthsWe compared the number of participants in the intervention group who received vaccinations for Tdap, Menactra, and (for girls only) HPV at the end of the study period versus those in the control group.
Outcome measures
| Measure |
Outreach
n=3839 Participants
The intervention consisted of a tiered protocol, with each step being more intensive and targeting a progressively smaller proportion of adolescents who remained behind in immunizations. The intervention was delivered by trained patient immunization navigators.
Step 1- Patient tracking: We used a web-based database to track the adolescents in the intervention group, record immunizations and preventive visits, and document tasks they performed.
Step 2: Reminders and recall: The navigators performed reminder/recall for adolescents who were eligible for either a vaccination or a preventive care visit. They attempted to contact families by telephone and mail.
Step 3: Home visits: If adolescents remained unvaccinated despite the above steps, the navigators performed a home visit to further assess barriers, promote the importance of preventive care, and encourage families to make appointments.
|
Standard of Care
n=3707 Participants
Control subjects received standard of care. All practices routinely sent letter or telephone reminders to families who had upcoming scheduled visits, but none used active reminder/recall based on vaccinations.
|
|---|---|---|
|
Receipt of Adolescent Immunization at End of Study Period (Tdap, Menactra, HPV)
Tdap
|
1091 participants
|
885 participants
|
|
Receipt of Adolescent Immunization at End of Study Period (Tdap, Menactra, HPV)
Menactra
|
1783 participants
|
1367 participants
|
|
Receipt of Adolescent Immunization at End of Study Period (Tdap, Menactra, HPV)
HPV 1
|
634 participants
|
453 participants
|
|
Receipt of Adolescent Immunization at End of Study Period (Tdap, Menactra, HPV)
HPV 2
|
827 participants
|
560 participants
|
|
Receipt of Adolescent Immunization at End of Study Period (Tdap, Menactra, HPV)
HPV 3
|
671 participants
|
432 participants
|
SECONDARY outcome
Timeframe: 1 yearWe compared the number of participants in the intervention group who received a well child visit within a 12 month period versus those in the control group.
Outcome measures
| Measure |
Outreach
n=3839 Participants
The intervention consisted of a tiered protocol, with each step being more intensive and targeting a progressively smaller proportion of adolescents who remained behind in immunizations. The intervention was delivered by trained patient immunization navigators.
Step 1- Patient tracking: We used a web-based database to track the adolescents in the intervention group, record immunizations and preventive visits, and document tasks they performed.
Step 2: Reminders and recall: The navigators performed reminder/recall for adolescents who were eligible for either a vaccination or a preventive care visit. They attempted to contact families by telephone and mail.
Step 3: Home visits: If adolescents remained unvaccinated despite the above steps, the navigators performed a home visit to further assess barriers, promote the importance of preventive care, and encourage families to make appointments.
|
Standard of Care
n=3707 Participants
Control subjects received standard of care. All practices routinely sent letter or telephone reminders to families who had upcoming scheduled visits, but none used active reminder/recall based on vaccinations.
|
|---|---|---|
|
Receipt of a Well Child Visit Within a 12 Month Period
|
2609 participants
|
2045 participants
|
Adverse Events
Outreach
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Outreach
n=3839 participants at risk
The intervention consisted of a tiered protocol, with each step being more intensive and targeting a progressively smaller proportion of adolescents who remained behind in immunizations. The intervention was delivered by trained patient immunization navigators.
Step 1- Patient tracking: We used a web-based database to track the adolescents in the intervention group, record immunizations and preventive visits, and document tasks they performed.
Step 2: Reminders and recall: The navigators performed reminder/recall for adolescents who were eligible for either a vaccination or a preventive care visit. They attempted to contact families by telephone and mail.
Step 3: Home visits: If adolescents remained unvaccinated despite the above steps, the navigators performed a home visit to further assess barriers, promote the importance of preventive care, and encourage families to make appointments.
|
Standard of Care
n=3707 participants at risk
Control subjects received standard of care. All practices routinely sent letter or telephone reminders to families who had upcoming scheduled visits, but none used active reminder/recall based on vaccinations.
|
|---|---|---|
|
Social circumstances
HIPAA violation
|
0.00%
0/3839 • 15 months
|
—
0/0 • 15 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place