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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autodialer | Experimental | Autodialer reminder/recall |
|
| Letters | Experimental | Mailed reminder letters |
|
| Controls | No Intervention | Controls |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autodialer | Other | Autodialer telephone calls |
| |
| Letters |
| Measure | Description | Time Frame |
|---|---|---|
| Fully Vaccinated (Tdap, Menactra and 3 Doses of HPV (if Female)) | 12 months | |
| Well Child Care Status | Received recommended well child care visit | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter G Szilagyi, MD, MPH | University of Rochester | Principal Investigator |
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One individual was assessed for randomization, was found to have a previous case of anaphylaxis and was not randomized.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Autodialer | Autodialer reminder/recall Autodialer : Autodialer telephone calls |
| FG001 | Controls | Controls Received standard of care provided by practice |
| FG002 | Letters | Mailed reminder letters Letters : Mailed reminder letters |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Autodialer | Autodialer reminder/recall Autodialer : Autodialer telephone calls |
| BG001 | Controls | Controls Received standard of care provided by practice |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fully Vaccinated (Tdap, Menactra and 3 Doses of HPV (if Female)) | 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. | Posted | Number | participants | 12 months |
|
N/A- reviewed claims data
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mailed Reminders and Letter Reminders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter Szilagyi | University of Rochester, Deparentment of Pediatrics | 585 275-5798 | peter_szilagyi@urmc.rochester.edu |
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| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Other |
Mailed reminder letters |
|
| BG002 | Letters | Mailed reminder letters Letters : Mailed reminder letters |
| BG003 | Total | Total of all reporting groups |
| participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Control | Received no reminders from the managed care organization. |
|
|
|
| Primary | Well Child Care Status | Received recommended well child care visit | Posted | Number | participants | 12 months |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
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| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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 group |
| Regression, Cox |
| <0.05 |
| Hazard Ratio (HR) |
| 1.1 |
| 2-Sided |
| 95 |
| 1.0 |
| 1.3 |
The control group represents the denominator and the telephone reminder group represents the numerator |
| No |
| Superiority or Other |
| 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 intervention | Regression, Cox | 0.234 | Hazard Ratio (HR) | 1.1 | 2-Sided | 95 | 1.0 | 1.2 | The mail reminder arm represents the numerator and the telephone reminder arm represents the denominator | No | Superiority or Other |