Adolescent Immunizations, Preventive Care
Conditions
Brief summary
This study will examine whether the implementation of an outreach program that employs a tracking/reminder/recall/home visiting strategy will have any impact on receipt of immunizations and preventive care among urban adolescents.
Detailed description
Outreach workers will be placed at 9 primary care pediatric and family medicine practices throughout one urban area. Adolescent patients at these 9 practices will be identified and then randomized into two groups; (1) those receiving outreach intervention during Year 1 of the study and (2) those receiving outreach intervention during Year 2 of the study. Randomization will be stratified by practice site, patient age, and patient gender. After randomization, the list of Year 1 subjects will be distributed to the appropriate outreach worker. The outreach worker will track the immunization status of 11-15yo patients within their practice, identify patients who are eligible for but have not yet received immunizations recommended for their age group (MMR, Varicella, Hepatitis B, HPV, Meningococcal Conjugate, Tdap) and/or a well child visit within the past year, and then attempt to connect these patients with medical care through three levels of outreach activity. First level of outreach activity involves contacting the parent/guardian of the patient by telephone. Outreach workers will attempt to inform patient's parent/guardian of needed immunizations/preventive visit and facilitate the scheduling of a medical appointment. If unable to successfully complete the task through telephone contact, outreach workers will initiate the second level of outreach activity - contact by mail. If contact by mail is unsuccessful, the third and most intense level of outreach activity will be implemented. The outreach worker will attempt to notify the patient's parent/guardian of need for immunization/preventive appointment by visiting the patient's listed home address. During this visit, the outreach worker will attempt to inform the parent/guardian of recommended immunizations, provide information pertaining to these immunizations, facilitate appointment scheduling, and assist patient in compliance with scheduled medical appointment Interventions directed towards the subjects of the Year 1 group will cease after 15 months of outreach activity. A chart review of intervention and control groups will be conducted to determine immunization and well child visit rates within the two groups. At this time, the tracking/reminder/recall/home visiting strategy employed with the Year 1 group will be repeated for Year 2 subjects.
Interventions
OTHERoutreach services
Tracking/reminder/recall/home visit strategy.
Sponsors
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to 15 Years
Healthy volunteers
Yes
Inclusion criteria
* 11-15 years of age * receive medical care at one of the 9 pediatric or family medicine practices identified as study sites
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Receipt of Adolescent Immunization at End of Study Period (Tdap, Menactra, HPV) | 15 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Receipt of a Well Child Visit Within a 12 Month Period | 1 year | We 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3,839 |
| 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. | 3,707 |
| Total | 7,546 |
Baseline characteristics
| Characteristic | Outreach | Standard of Care | Total |
|---|---|---|---|
| Age, Customized 11 years old | 784 participants | 757 participants | 1541 participants |
| Age, Customized 12 years old | 743 participants | 701 participants | 1444 participants |
| Age, Customized 13 years old | 714 participants | 686 participants | 1400 participants |
| Age, Customized 14 years old | 781 participants | 758 participants | 1539 participants |
| Age, Customized 15 years old | 817 participants | 805 participants | 1622 participants |
| Sex: Female, Male Female | 1903 Participants | 1849 Participants | 3752 Participants |
| Sex: Female, Male Male | 1936 Participants | 1858 Participants | 3794 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 3,839 | 0 / 3,707 |
| serious Total, serious adverse events | 0 / 3,839 | 0 / 3,707 |
Outcome results
Primary
Receipt of Adolescent Immunization at End of Study Period (Tdap, Menactra, HPV)
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.
Time frame: 15 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Outreach | Receipt of Adolescent Immunization at End of Study Period (Tdap, Menactra, HPV) | Menactra | 1783 participants |
| Outreach | Receipt of Adolescent Immunization at End of Study Period (Tdap, Menactra, HPV) | HPV 2 | 827 participants |
| Outreach | Receipt of Adolescent Immunization at End of Study Period (Tdap, Menactra, HPV) | HPV 1 | 634 participants |
| Outreach | Receipt of Adolescent Immunization at End of Study Period (Tdap, Menactra, HPV) | HPV 3 | 671 participants |
| Outreach | Receipt of Adolescent Immunization at End of Study Period (Tdap, Menactra, HPV) | Tdap | 1091 participants |
| Standard of Care | Receipt of Adolescent Immunization at End of Study Period (Tdap, Menactra, HPV) | HPV 3 | 432 participants |
| Standard of Care | Receipt of Adolescent Immunization at End of Study Period (Tdap, Menactra, HPV) | Tdap | 885 participants |
| Standard of Care | Receipt of Adolescent Immunization at End of Study Period (Tdap, Menactra, HPV) | Menactra | 1367 participants |
| Standard of Care | Receipt of Adolescent Immunization at End of Study Period (Tdap, Menactra, HPV) | HPV 1 | 453 participants |
| Standard of Care | Receipt of Adolescent Immunization at End of Study Period (Tdap, Menactra, HPV) | HPV 2 | 560 participants |
Secondary
Receipt of a Well Child Visit Within a 12 Month Period
We 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.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Outreach | Receipt of a Well Child Visit Within a 12 Month Period | 2609 participants |
| Standard of Care | Receipt of a Well Child Visit Within a 12 Month Period | 2045 participants |