Reducing Delay in Vaccination of Children: Logistic Barriers (REDIVAC-LB)

The REDIVAC Study-Reducing Delay in Vaccination of Children Study

This study will assess the impact of automated reminders for the 6 month and 12 month vaccine visits to increase vaccination in parents experiencing logistic barriers to vaccination.

Study Overview

• Status: Completed
• Conditions: Communicable Disease
• Intervention / Treatment: Behavioral: Reminders

Detailed Description

Parents of children less than 11 months of age will be identified as delayed or missing vaccinations due to logistic barriers in the Kaiser Permanente Colorado population. Parents identified will be randomized to the intervention arm or the usual care arm. Those in the intervention arm will receive automated reminders for the 6 month and 12 month vaccine visits. Reminders will include scheduling information as well as access to a website with vaccine and scheduling information. They will also have an opportunity to provide preferences in how they receive the automated reminders (text, phone or email). There will be 2 reminders before the 6 and 12 month visits and 2 after the 6 and 12 month visits. Parents will be excluded from receiving reminders if they have received vaccines within the time frame when they are eligible to receive another vaccine or have a well child visit scheduled.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80231
      • Kaiser Permanente Colorado Institute for Health Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 11 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Parents of children less than 11 months of age
• Currently enrolled at Kaiser Permanente Colorado at the time of identification
• The child is missing recommended vaccinations

Exclusion Criteria:

• Non-english speaking
• diagnosis code indicating parent vaccine refusal

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Parents will receive usual care for their child at Kaiser Permanente Colorado. This includes recommendations for well child visits at 2, 4, 6 and 12 months of age as well as automated reminders for age eligible children to receive the flu shot during flu season.
Experimental: Reminders; Parents randomized to the reminder arm will receive automated reminders to complete a 6 month and 12 month vaccine visit for their child. They will receive 2 reminders before the child is 6 and 12 months of age and 2 reminders after their child is 6 and 12 months of age. Reminders will not occur if they have received vaccines within the eligible time frame to receive a vaccine or have a visit scheduled. After randomization, participants in the intervention arm will have an opportunity to provide their preference on how they receive reminders (text, phone and/or email). Participants not providing a preference will receive text reminders. If a child is randomized into the study after the child is 7 months of age, the parent will only be eligible for reminders for the 12 month vaccine visit.	Behavioral: Reminders; Automated reminders for the 6 month and 12 month vaccine visits for parents experiencing logistic barriers to vaccination.; Other Names: REDIVAC-Logistic Barriers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaccines received (Electronic Health Record)	Vaccination records from the participants electronic health record will be used to measure vaccines received. Vaccines received is a dichotomous variable indicating if any vaccines were received while enrolled in the study	up to a year of follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaccine dose (Electronic Health Record)	Vaccination records from the participants electronic health record will be used to measure vaccine dose. Vaccine dose is a measure of the vaccine doses that the child could have received while enrolled in the study, the number of vaccine doses received	up to a year of follow up

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: University of Colorado, Denver
• Investigators: Principal Investigator: Jason Glanz, PhD, Kaiser Permanente

Publications and helpful links

General Publications

• Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): March 31, 2019
• Study Completion (Actual): March 31, 2019

Study Registration Dates

• First Submitted: March 26, 2018
• First Submitted That Met QC Criteria: May 3, 2018
• First Posted (Actual): May 4, 2018

Study Record Updates

• Last Update Posted (Actual): August 7, 2019
• Last Update Submitted That Met QC Criteria: August 5, 2019
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Logistic Barriers to Vaccination
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: 1R01HD079457 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No