Reducing Delay of Vaccination in Children Study

Communicable Diseases Clinical Trial

— REDIVAC  

Official title:

Reducing Delay of Vaccination in Children Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02665013
• Other study ID #: 1R01HD079457-01
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: May 2019

Study information

• Verified date: April 2019
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial will assess the effectiveness of a tailored message intervention on decreasing infant undervaccination.

Description:

This intervention is based on the concept of "message tailoring," whereby each mother is provided with individually customized vaccine- related information that addresses their unique concerns, values, questions and logistical barriers. Message tailoring is an evidence-based health messaging strategy that has been shown to improve compliance with a wide variety of preventive health care behaviors among diverse patient populations.

In this three-armed trial the investigator will examine how providing mothers with multiple "doses" of a tailored versus untailored version of our intervention compares with "usual care" for the impact on infant under-vaccination. Secondary outcomes will include maternal vaccine-related attitudes (including level of vaccine hesitancy), alignment of maternal values with provider recommendations, and self-efficacy for overcoming logistical barriers to vaccination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 824
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Enrolled at Kaiser Permanente Colorado, Pregnant in the 3rd trimester, and plan to use Kaiser Permanente Colorado for the child's medical care received.

Exclusion Criteria:

• less then 18 years of age, non-english speaking and an inability to consent

Related Conditions & MeSH terms

• Communicable Diseases
• Infection

Intervention

Behavioral:
• Tailored
Pregnant women will be recruited to the study. The intervention will be delivered to participants prior to the child's 2 month well child visit, when the child is between 4 and 6 months of age, and when the child is 10-12 months of age. The first intervention occurs at enrollment in the study. Participants in the tailored intervention arm will receive vaccine information tailored specific to her concerns and values at each intervention point.
• Untailored
Pregnant women will be recruited to the study. The intervention will be delivered to participants prior to the child's 2 month well child visit, when the child is between 4 and 6 months of age, and when the child is 10-12 months of age. The first intervention occurs at enrollment in the study. Participants in the untailored arm will receive vaccine information at each intervention time point, but it will not be tailored to her specific concerns.

Locations

Country	Name	City	State
United States	Kaiser Permanente Colorado	Denver	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
Kaiser Permanente	University of Colorado, Denver, University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The child's vaccination status	assessed using both a continuous and dichotomous measure. Continuous: measure of average days under-vaccinated is a recently developed metric measuring the average number of days a child is unvaccinated based on the vaccines given and the date when the vaccines where given. Dichotomous: mesauring the child's days undervaccinated or whether or not the child is up-to-date with no vaccination delays.	200 days
Secondary	Maternal Vaccine attitudes	Maternal vaccine attitudes are collected from survey items and include attitudes and beliefs about vaccines as well as level of vaccine hesitancy	12 months
Secondary	Maternal Vaccine values	Health values related to vaccines are measured from survey items and include conformity, security, power, self-direction, and universalism	12 months