NCT02708745

Brief Summary

The overall goal of this project is to determine whether integrating a novel parent-report measure of vaccine hesitancy into pediatric primary care is effective in improving acceptance of childhood vaccines among vaccine-hesitant parents.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
562

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

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

Study Start

First participant enrolled

March 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 15, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2018

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 1, 2019

Completed
Last Updated

October 1, 2019

Status Verified

September 1, 2019

Enrollment Period

2.3 years

First QC Date

March 9, 2016

Results QC Date

June 10, 2019

Last Update Submit

September 10, 2019

Conditions

Preventive Health Services

Keywords

communicationimmunization

Outcome Measures

Primary Outcomes (1)

  • Child's Mean Percent Days Under-immunized

    Mean percent days under-immunized among children of parents who received (vs. did not receive) the intervention

    Child's immunization status at 8 months of age

Secondary Outcomes (2)

  • Number of Parents With a Highly Rated Visit Experience

    24-48 hours after the 6 month health supervision visit

  • Provider Perceptions of Barriers to the Vaccine Discussion

    Change post-intervention from pre-intervention

Study Arms (2)

Placebo Arm

PLACEBO COMPARATOR

Parent participants will receive a placebo survey about their attitudes toward common child health topics before their child's health supervision visit.

Behavioral: Placebo Survey

Intervention Arm

EXPERIMENTAL

Parent participants will also receive the intervention survey about their attitudes toward childhood vaccines before their child's health supervision visit.

Behavioral: Intervention Survey

Interventions

Intervention SurveyBEHAVIORAL
Intervention Arm
Placebo SurveyBEHAVIORAL
Placebo Arm

Eligibility Criteria

Age1 Day+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Parents: Parents must be English speaking, ≥18 years old, have a newborn singleton infant ≤2 months, born at ≥35 weeks gestation who is receiving pediatric care at an enrolled Kaiser Permanente or Allegro Pediatrics clinic, and be vaccine hesitant (defined as positive screening score on eligibility survey).
  • Newborns: Newborns 0 - 2 months old whose parents enroll in the study will be invited to participate.
  • Providers: All pediatric and family practice providers at Kaiser Permanente and Allegro Pediatrics primary clinics within a 5 county region in western Washington (Snohomish, King, Pierce, Thurston, and Kitsap Counties) will be eligible to participate.

You may not qualify if:

  • Parents/Children: Parents who are not 18 years or older, require language interpretation for medical care, have an infant born \<35 weeks gestation, are not vaccine hesitant or will not be taking their child to a participating clinic for health supervision visits will be excluded.
  • Providers: Clinics and providers outside the 5 county region in western Washington (Snohomish, King, Pierce, Thurston, and Kitsap) will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Hammer LD, Curry ES, Harlor AD, Laughlin JJ, Leeds AJ, Lessin HR, Rodgers CT, Granado-Villar DC, Brown JM, Cotton WH, Gaines BM, Gambon TB, Gitterman BA, Gorski PA, Kraft CA, Marino RV, Paz-Soldan GJ, Zind B; Committee on Practice and Ambulatory Medicine; Council on Community Pediatrics. Increasing immunization coverage. Pediatrics. 2010 Jun;125(6):1295-304. doi: 10.1542/peds.2010-0743. Epub 2010 May 31.

    PMID: 20513736BACKGROUND

  • Opel DJ, Heritage J, Taylor JA, Mangione-Smith R, Salas HS, Devere V, Zhou C, Robinson JD. The architecture of provider-parent vaccine discussions at health supervision visits. Pediatrics. 2013 Dec;132(6):1037-46. doi: 10.1542/peds.2013-2037. Epub 2013 Nov 4.

    PMID: 24190677BACKGROUND

  • Healy CM, Montesinos DP, Middleman AB. Parent and provider perspectives on immunization: are providers overestimating parental concerns? Vaccine. 2014 Jan 23;32(5):579-84. doi: 10.1016/j.vaccine.2013.11.076. Epub 2013 Dec 4.

    PMID: 24315883BACKGROUND

  • McCauley MM, Kennedy A, Basket M, Sheedy K. Exploring the choice to refuse or delay vaccines: a national survey of parents of 6- through 23-month-olds. Acad Pediatr. 2012 Sep-Oct;12(5):375-83. doi: 10.1016/j.acap.2012.06.007. Epub 2012 Aug 22.

    PMID: 22921495BACKGROUND

  • Opel DJ, Mangione-Smith R, Taylor JA, Korfiatis C, Wiese C, Catz S, Martin DP. Development of a survey to identify vaccine-hesitant parents: the parent attitudes about childhood vaccines survey. Hum Vaccin. 2011 Apr;7(4):419-25. doi: 10.4161/hv.7.4.14120. Epub 2011 Apr 1.

    PMID: 21389777BACKGROUND

  • Opel DJ, Taylor JA, Mangione-Smith R, Solomon C, Zhao C, Catz S, Martin D. Validity and reliability of a survey to identify vaccine-hesitant parents. Vaccine. 2011 Sep 2;29(38):6598-605. doi: 10.1016/j.vaccine.2011.06.115. Epub 2011 Jul 16.

    PMID: 21763384BACKGROUND

  • Opel DJ, Taylor JA, Zhou C, Catz S, Myaing M, Mangione-Smith R. The relationship between parent attitudes about childhood vaccines survey scores and future child immunization status: a validation study. JAMA Pediatr. 2013 Nov;167(11):1065-71. doi: 10.1001/jamapediatrics.2013.2483.

    PMID: 24061681BACKGROUND

  • Opel DJ, Henrikson N, Lepere K, Hawkes R, Zhou C, Dunn J, Taylor JA. Previsit Screening for Parental Vaccine Hesitancy: A Cluster Randomized Trial. Pediatrics. 2019 Nov;144(5):e20190802. doi: 10.1542/peds.2019-0802. Epub 2019 Oct 9.

    PMID: 31597690DERIVED

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Dr. Doug Opel
Organization
Seattle Children's Hospital
douglas.opel@seattlechildrens.org
206-987-2000

Study Officials

  • Douglas J Opel, MD, MPH

    Seattle Children's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 9, 2016

First Posted

March 15, 2016

Study Start

March 1, 2016

Primary Completion

June 11, 2018

Study Completion

June 11, 2018

Last Updated

October 1, 2019

Results First Posted

October 1, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share