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

Primary Purpose

Communicable Disease

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

About this trial

This is an interventional prevention trial for Communicable Disease focused on measuring Logistic Barriers to Vaccination

Eligibility Criteria

1 Month - 11 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaiser Permanente Colorado Institute for Health Research

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

Reminders

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 26, 2018
Last Updated
August 5, 2019
Sponsor
Kaiser Permanente
Collaborators
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT03516682
Brief Title
Reducing Delay in Vaccination of Children: Logistic Barriers
Acronym
REDIVAC-LB
Official Title
The REDIVAC Study-Reducing Delay in Vaccination of Children Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
March 31, 2019 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Communicable Disease
Keywords
Logistic Barriers to Vaccination

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
The Investigator and Analyst will stay blinded to the randomization arm throughout the trial.
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
Reminders
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Reminders
Other Intervention Name(s)
REDIVAC-Logistic Barriers
Intervention Description
Automated reminders for the 6 month and 12 month vaccine visits for parents experiencing logistic barriers to vaccination.
Primary Outcome Measure Information:
Title
Vaccines received (Electronic Health Record)
Description
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
Time Frame
up to a year of follow up
Secondary Outcome Measure Information:
Title
Vaccine dose (Electronic Health Record)
Description
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
Time Frame
up to a year of follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
11 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Glanz, PhD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Colorado Institute for Health Research
City
Denver
State/Province
Colorado
ZIP/Postal Code
80231
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32813276
Citation
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.
Results Reference
derived

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Reducing Delay in Vaccination of Children: Logistic Barriers

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