NCT03516682

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 4, 2018

Completed
28 days until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2018

Enrollment Period

10 months

First QC Date

March 26, 2018

Last Update Submit

August 5, 2019

Conditions

Communicable Disease

Keywords

Logistic Barriers to Vaccination

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Vaccine dose (Electronic Health Record)

    up to a year of follow up

Study Arms (2)

Usual Care

NO INTERVENTION

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.

Reminders

EXPERIMENTAL

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

Interventions

RemindersBEHAVIORAL

Automated reminders for the 6 month and 12 month vaccine visits for parents experiencing logistic barriers to vaccination.

Also known as: REDIVAC-Logistic Barriers
Reminders

Eligibility Criteria

Age1 Month - 11 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Colorado Institute for Health Research

Denver, Colorado, 80231, United States

Location

Related Publications (1)

  • 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.

    PMID: 32813276DERIVED

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jason Glanz, PhD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The Investigator and Analyst will stay blinded to the randomization arm throughout the trial.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2018

First Posted

May 4, 2018

Study Start

June 1, 2018

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

August 7, 2019

Record last verified: 2018-08

Locations

US(1)