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Reducing Delay of Vaccination in Children Study (REDIVAC)

Primary Purpose

Communicable Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tailored
Untailored
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Communicable Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Kaiser Permanente Colorado

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Tailored

Untailored

Usual Care

Arm Description

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

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.

Participants will complete surveys at each intervention time point. They will receive vaccine information sheets that are provided in the well child visits at enrollment in the study.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Maternal Vaccine values
Health values related to vaccines are measured from survey items and include conformity, security, power, self-direction, and universalism

Full Information

First Posted
January 4, 2016
Last Updated
June 11, 2019
Sponsor
Kaiser Permanente
Collaborators
University of Colorado, Denver, University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT02665013
Brief Title
Reducing Delay of Vaccination in Children Study
Acronym
REDIVAC
Official Title
Reducing Delay of Vaccination in Children Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
May 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
University of Colorado, Denver, University of Michigan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Communicable Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
824 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tailored
Arm Type
Experimental
Arm Description
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
Arm Title
Untailored
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants will complete surveys at each intervention time point. They will receive vaccine information sheets that are provided in the well child visits at enrollment in the study.
Intervention Type
Behavioral
Intervention Name(s)
Tailored
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Untailored
Intervention Description
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.
Primary Outcome Measure Information:
Title
The child's vaccination status
Description
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.
Time Frame
200 days
Secondary Outcome Measure Information:
Title
Maternal Vaccine attitudes
Description
Maternal vaccine attitudes are collected from survey items and include attitudes and beliefs about vaccines as well as level of vaccine hesitancy
Time Frame
12 months
Title
Maternal Vaccine values
Description
Health values related to vaccines are measured from survey items and include conformity, security, power, self-direction, and universalism
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Kaiser Permanente Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80231
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33046584
Citation
Glanz JM, Wagner NM, Narwaney KJ, Pyrzanowski J, Kwan BM, Sevick C, Resnicow K, Dempsey AF. Web-Based Tailored Messaging to Increase Vaccination: A Randomized Clinical Trial. Pediatrics. 2020 Nov;146(5):e20200669. doi: 10.1542/peds.2020-0669. Epub 2020 Oct 12.
Results Reference
derived
PubMed Identifier
31122997
Citation
Dempsey AF, Wagner N, Narwaney K, Pyrzanowski J, Kwan BM, Kraus C, Gleason K, Resnicow K, Sevick C, Cataldi J, Brewer SE, Glanz JM. 'Reducing Delays In Vaccination' (REDIVAC) trial: a protocol for a randomised controlled trial of a web-based, individually tailored, educational intervention to improve timeliness of infant vaccination. BMJ Open. 2019 May 22;9(5):e027968. doi: 10.1136/bmjopen-2018-027968.
Results Reference
derived

Learn more about this trial

Reducing Delay of Vaccination in Children Study

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