Screening for Hesitancy to Optimize Talk

NCT ID: NCT02708745

Last Updated: 2019-10-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

562 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-06-11

Brief Summary

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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.

Detailed Description

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The primary goal of this project is to evaluate the effectiveness of an innovative intervention designed to address these barriers-the Screening for Hesitancy to Optimize Talk (SHOT) intervention-in improving provider-parent vaccine discussions and increasing vaccine acceptance. The SHOT intervention involves administering a validated parent-report measure to parents and communicating their score and item-specific responses to their child's provider before their child's 2 and 6 month health supervision visits. The survey contains 15 questions regarding Health Belief Model concepts that influence parent vaccination behavior and has been shown to predict under-immunization.

Our specific aims are to (1) evaluate the impact of the SHOT intervention on a child's immunization status using a matched-pair, cluster randomized controlled trial design; (2) assess how parents' ratings of their vaccine discussions with their child's provider change as a function of the SHOT intervention; and (3) compare pre- and post-study perceptions of barriers to quality vaccine discussions with parents between providers in the SHOT and control arm.

Conditions

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Preventive Health Services

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo Arm

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

Group Type PLACEBO_COMPARATOR

Placebo Survey

Intervention Type BEHAVIORAL

Intervention Arm

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

Group Type EXPERIMENTAL

Intervention Survey

Intervention Type BEHAVIORAL

Interventions

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Intervention Survey

Intervention Type BEHAVIORAL

Placebo Survey

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

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.
Minimum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kaiser Permanente

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role collaborator

Seattle Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Douglas Opel

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Douglas J Opel, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital

References

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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.

Reference Type BACKGROUND
PMID: 20513736 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24190677 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24315883 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22921495 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21389777 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21763384 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24061681 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31597690 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1R21HD083770-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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