Trial Outcomes & Findings for Evaluation of Vaccination Reminder/Recall Systems for Adolescent Patients (NCT NCT01057888)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10599 participants

Primary outcome timeframe

12 months

Results posted on

2016-01-20

Participant Flow

From the managed care plan's dataset of practices, we selected all primary care practices that served \>30 adolescents covered by the managed care plan in December 2009. The target population was all adolescents ages 10.5 through 17 years enrolled in Monroe Plan on December 31st 2009 with a primary care provider in a participating practice.

One individual was assessed for randomization, was found to have a previous case of anaphylaxis and was not randomized.

Participant milestones

Participant milestones
Measure	Autodialer Autodialer reminder/recall Autodialer : Autodialer telephone calls	Controls Controls Received standard of care provided by practice	Letters Mailed reminder letters Letters : Mailed reminder letters
Overall Study STARTED	2504	2406	2494
Overall Study COMPLETED	2504	2406	2494
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Vaccination Reminder/Recall Systems for Adolescent Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Autodialer n=1423 Participants Autodialer reminder/recall Autodialer : Autodialer telephone calls	Controls n=1296 Participants Controls Received standard of care provided by practice	Letters n=1396 Participants Mailed reminder letters Letters : Mailed reminder letters	Total n=4115 Participants Total of all reporting groups
Age, Categorical <=18 years	1,423 participants n=5 Participants	1,296 participants n=7 Participants	1,396 participants n=5 Participants	4115 participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants
Age, Categorical >=65 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants
Age, Continuous	14.4 years STANDARD_DEVIATION 2.0 • n=5 Participants	14.5 years STANDARD_DEVIATION 2.0 • n=7 Participants	14.4 years STANDARD_DEVIATION 2.0 • n=5 Participants	14.4 years STANDARD_DEVIATION 2.0 • n=4 Participants
Sex: Female, Male Female	699 Participants n=5 Participants	656 Participants n=7 Participants	682 Participants n=5 Participants	2037 Participants n=4 Participants
Sex: Female, Male Male	724 Participants n=5 Participants	640 Participants n=7 Participants	714 Participants n=5 Participants	2078 Participants n=4 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Individuals were randomized to one of 3 groups (letter reminders, telephone reminders or control). Individuals with a wrong/missing telephone number or a wrong address were excluded from the analyses. This left 1,396 in the letter reminder group, 1,423 in the telephone reminder group and 1,296 in the control group.

Outcome measures

Outcome measures
Measure	Letter Reminder n=1396 Participants Received mailed reminders from the managed-care organization for recommended vaccinations	Telephone Reminder n=1423 Participants Received telephone reminders (through an autodialer)from the managed-care organization for recommended vaccinations	Control n=1296 Participants Received no reminders from the managed care organization.
Fully Vaccinated (Tdap, Menactra and 3 Doses of HPV (if Female))	143 participants	160 participants	100 participants

PRIMARY outcome

Timeframe: 12 months

Received recommended well child care visit

Outcome measures

Outcome measures
Measure	Letter Reminder n=1396 Participants Received mailed reminders from the managed-care organization for recommended vaccinations	Telephone Reminder n=1423 Participants Received telephone reminders (through an autodialer)from the managed-care organization for recommended vaccinations	Control n=1296 Participants Received no reminders from the managed care organization.
Well Child Care Status	908 participants	892 participants	768 participants

Adverse Events

Mailed Reminders and Letter Reminders

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. Peter Szilagyi

University of Rochester, Deparentment of Pediatrics

Phone: 585 275-5798

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place