Immunization Status, Well Child Care Visit
Conditions
Keywords
Immunization status for:, Tdap, Menactra, HPV (if female), Well child care visit
Brief summary
The investigators will design and implement a randomized clinical trial to test, on a community-wide level, the effectiveness of managed care based tracking/reminder/recall on improving vaccination coverage among adolescents. The investigators propose a randomized controlled trial to evaluate the effectiveness of reminder/recall for adolescents: 10,599 adolescents within the managed care organization (MCO) will be randomized into one of three arms: 1) mailed reminders, 2) autodialer telephone messages or 3) standard of care of their practice (no messages from the intervention). Hypothesis 1: Reminder/recall will increase the receipt of immunizations and preventive services Hypothesis 2: Telephone (autodialer) reminders will be more effective than mailed reminders Hypothesis 3: The impact of reminders will be greatest for the most high-risk subgroups which have low baseline immunization rates. Hypothesis 4: Mailed reminders will be more costly (and less effective) than telephone reminders.
Interventions
OTHERAutodialer
Autodialer telephone calls
OTHERLetters
Mailed reminder letters
Sponsors
Centers for Disease Control and Prevention
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
11 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Member of the Monroe Plan for Medical Care (managed care organization) * Patient of a participating practice * Ages 10.75 to \<18 years of age
Exclusion criteria
* Member of the Monroe Plan for Medical care for less than 6 months * ICD-9 diagnosis of 999.4 for anaphylactic reaction to a vaccine or its components. * Encephalopathy within 7 days of a previous dose of a pertussis containing vaccine not attributable to another identifiable cause * Guillain-Barre- ICD-9 code is 357.0
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fully Vaccinated (Tdap, Menactra and 3 Doses of HPV (if Female)) | 12 months | — |
| Well Child Care Status | 12 months | Received recommended well child care visit |
Participant flow
Recruitment details
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.
Pre-assignment details
One individual was assessed for randomization, was found to have a previous case of anaphylaxis and was not randomized.
Participants by arm
| Arm | Count |
|---|---|
| Autodialer Autodialer reminder/recall
Autodialer : Autodialer telephone calls | 1,423 |
| Controls Controls
Received standard of care provided by practice | 1,296 |
| Letters Mailed reminder letters
Letters : Mailed reminder letters | 1,396 |
| Total | 4,115 |
Baseline characteristics
| Characteristic | Autodialer | Controls | Letters | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 1,423 participants | 1,296 participants | 1,396 participants | 4115 participants |
| Age, Categorical >=65 years | 0 participants | 0 participants | 0 participants | 0 participants |
| Age, Categorical Between 18 and 65 years | 0 participants | 0 participants | 0 participants | 0 participants |
| Age, Continuous | 14.4 years STANDARD_DEVIATION 2 | 14.5 years STANDARD_DEVIATION 2 | 14.4 years STANDARD_DEVIATION 2 | 14.4 years STANDARD_DEVIATION 2 |
| Sex: Female, Male Female | 699 Participants | 656 Participants | 682 Participants | 2037 Participants |
| Sex: Female, Male Male | 724 Participants | 640 Participants | 714 Participants | 2078 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Fully Vaccinated (Tdap, Menactra and 3 Doses of HPV (if Female))
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Letter Reminder | Fully Vaccinated (Tdap, Menactra and 3 Doses of HPV (if Female)) | 143 participants |
| Telephone Reminder | Fully Vaccinated (Tdap, Menactra and 3 Doses of HPV (if Female)) | 160 participants |
| Control | Fully Vaccinated (Tdap, Menactra and 3 Doses of HPV (if Female)) | 100 participants |
Comparison: The null hypothesis is that there is no difference in total immunization status between the control group and the group receiving telephone (autodialer) reminders. This was analyzed using a clustered, stratified Cox model.p-value: <0.0595% CI: [1, 1.7]Regression, Cox
p-value: <0.0195% CI: [1.3, 2.1]Regression, Cox
Comparison: The null hypothesis was that there is no difference in the percentage of fully vaccinated adolescents between the mailed reminder versus the telephone reminder armsp-value: 0.07595% CI: [1, 1.6]Regression, Cox
Primary
Well Child Care Status
Received recommended well child care visit
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Letter Reminder | Well Child Care Status | 908 participants |
| Telephone Reminder | Well Child Care Status | 892 participants |
| Control | Well Child Care Status | 768 participants |
Comparison: The null hypothesis was that a difference in well child care rates among adolescents whose families received a mailed reminder compared to the control groupp-value: <0.0195% CI: [1.1, 1.3]Regression, Cox
Comparison: The null hypothesis is the the well child care rates of adolescents in the telephone reminder group would not differ from those of the control groupp-value: <0.0595% CI: [1, 1.3]Regression, Cox
Comparison: The null hypothesis was that there would be no difference in the well child care rate among adolescents in the mailed reminder arm versus adolescents in the telephone reminder arm of the interventionp-value: 0.23495% CI: [1, 1.2]Regression, Cox