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The purpose of the study is to evaluate the effectiveness of a managed care-based HPV vaccination reminder/recall system using a randomized controlled trial (RCT) across diverse practices and patient populations. The trial will measure the effectiveness of text messaging reminder/recall on (a) improving initiation and (b) completion rate of the HPV vaccine series; (c) decreasing the time between vaccine doses; and (d) improving rates of preventive visits for adolescents
The hypotheses are that text-messaged reminders to parents of adolescents will result in improved rates of HPV vaccine series initiation, HPV vaccine series completion, will decrease the intervals between vaccine doses and will improve rates of preventive care among adolescents. Parents receiving specific text-messaged reminders about services (i.e. HPV vaccination, well child care visits) for which their adolescent is due will be compared to a control group of parents receiving general health tips through text messages.
The study setting is western New York State and the Southern Tier of New York State (15 counties total). Investigators will work with the Monroe Plan for Medical Care, an IPA-model managed care organization (MCO) that serves Medicaid managed care and SCHIP enrollees. The MCO will conduct regular reviews of insurance claims data and the New York State Immunization Information System of adolescents ages 11-<16 years. Parents (all over 18 years of age) of adolescents will receive the texted messages on their phones.
There are no enrollment restrictions based upon race or ethnic origin. The inclusion criteria are that the adolescents are a) enrolled in Medicaid or SCHIP through the Monroe Plan, b) have been enrolled greater than 6 months with the Monroe Plan (in order to have sufficient claims data to determine whether they are due for a well child care visit or recommended immunizations), c) the Monroe Plan has received their consent to send preventive care text messages, d) their child attend a primary care practice that has agreed to participate and d) they are between the ages of 11-<16 years at the start of the study.
The key independent measure is group allocation (intervention vs. control); an intention-to-treat strategy will be used to assess the effectiveness of text messaging reminders. Key outcome measures will be: 1) receipt of 0, 1, 2 or 3 doses of HPV vaccine 2) interval (in days) between doses and 3) having a preventive visit in the 6 month period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Text-based reminder for HPV vaccine/WCC | Experimental | Parents of adolescents will receive text-based reminders if their adolescent is due for HPV vaccine (dose 1, 2 or 3) or well child care visit |
|
| Control arm | Active Comparator | Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text-based reminder for recommended HPV vaccine or WCC | Other | Patients due for a well visit or HPV vaccine received a text reminder |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Receiving HPV Vaccination (Dose 1) | Participants who received HPV vaccine dose 1 Kaplan-Meier failure function | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Receiving HPV Vaccination (Dose 2) | Participants who received HPV vaccine dose 2 at end of study period Kaplan-Meier failure function | 9 months |
| Percentage of Participants Receiving HPV Vaccination (Dose 3) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia M Rand, MD, MPH | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
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For this study, there was a waiver of consent; 4182 subjects met eligibility but only a subset were enrolled to receive the intervention because they has functional phone numbers.
4182 subjects met eligibility but only a subset were enrolled to receive the intervention because they has functional phone numbers
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| ID | Title | Description |
|---|---|---|
| FG000 | Text-based Reminder for HPV Vaccine/WCC | Parents of adolescents will receive text-based reminders if their adolescent is due for HPV vaccine (dose 1, 2 or 3) or well child care visit Text-based reminder for recommended HPV vaccine or well care visit |
| FG001 | Control Arm | Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due) Non-specific text-based reminder (general health tip): Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Text-based Reminder for HPV Vaccine/WCC | Parents of adolescents will receive text-based reminders if their adolescent is due for HPV vaccine (dose 1, 2 or 3) or well child care visit Text-based reminder for recommended HPV vaccine or well care visit |
| BG001 | Control Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Percentage of Participants Receiving HPV Vaccination (Dose 1) | Participants who received HPV vaccine dose 1 Kaplan-Meier failure function | Only subjects with valid phone numbers at the time dose 1 was dispensed received dose 1. | Posted | Number | percentage of eligible participants | 9 months |
|
July 2013 - December 2014
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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 | Text-based Reminder for HPV Vaccine/WCC | Parents of adolescents will receive text-based reminders if their adolescent is due for HPV vaccine (dose 1, 2 or 3) or well child care visit Text-based reminder for recommended HPV vaccine or well care visit |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cynthia Rand | University of Rochester | 585 275-9316 | cynthia_rand@urmc.rochester.edu |
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| Non-specific text-based reminder (general health tip) | Other | Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due) |
|
Participants who received HPV vaccine dose 3 at end of study period Kaplan-Meier failure function
| 9 months |
Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due) Non-specific text-based reminder (general health tip): Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due) |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Secondary | Percentage of Participants Receiving HPV Vaccination (Dose 2) | Participants who received HPV vaccine dose 2 at end of study period Kaplan-Meier failure function | Only subjects with a valid phone number at the time dose 2 was dispensed received the vaccine. The number of subjects receiving dose 2 is higher than dose 1 because some phones numbers that were inactive during dose 1 were active during dose 2. | Posted | Number | percentage of eligible participants | 9 months |
|
|
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| Secondary | Percentage of Participants Receiving HPV Vaccination (Dose 3) | Participants who received HPV vaccine dose 3 at end of study period Kaplan-Meier failure function | Only subjects with valid phone numbers were included and not all recipients got the 2nd dose. Only subjects who got the 2nd dose were then given the 3rd dose and only if they had working phone numbers. | Posted | Number | percentage of eligible participants | 9 months |
|
|
|
| 0 |
| 1,893 |
| 0 |
| 1,893 |
| EG001 | Control Arm | Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due) Non-specific text-based reminder (general health tip): Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due) | 0 | 1,919 | 0 | 1,919 |
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