Reducing Delay of Vaccination in Children Study

Not Applicable

Completed

• Conditions: Communicable Diseases
• Interventions: Behavioral: Tailored; Behavioral: Untailored

• Registration Number: NCT02665013
• Lead Sponsor: Kaiser Permanente

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2016-01-04
• Study First Submitted QC: 2016-01-22
• Study First Posted: 2016-01-27
• Study Start: 2016-04
• Status Verified: 2019-04
• Primary Completion: 2019-05
• Study Completion: 2019-05
• Last Update Submitted: 2019-06-11
• Last Update Posted: 2019-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 824

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tailored	Tailored	Participants will complete surveys at each intervention time point. Based on survey responses, they will receive vaccine information on the study website tailored to their vaccine concerns and values
Untailored	Untailored	Participants will complete surveys at each intervention time point and receive vaccine information on the study website. The vaccine information will NOT be tailored to their concerns and values.

Primary Outcome Measures

Name	Time	Method
The child's vaccination status	200 days	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.

Secondary Outcome Measures

Name	Time	Method
Maternal Vaccine attitudes	12 months	Maternal vaccine attitudes are collected from survey items and include attitudes and beliefs about vaccines as well as level of vaccine hesitancy
Maternal Vaccine values	12 months	Health values related to vaccines are measured from survey items and include conformity, security, power, self-direction, and universalism

Trial Locations

Locations (1)

Kaiser Permanente Colorado; 🇺🇸 Denver, Colorado, United States