Screening for Hesitancy to Optimize Talk

Preventive Health Services Clinical Trial

— SHOT  

Official title:

Use of a Novel Parent-Report Measure to Improve Childhood Vaccine Uptake: The Screening for Hesitancy to Optimize Talk (SHOT) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02708745
• Other study ID #: 1R21HD083770-01A1
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: June 11, 2018

Study information

• Verified date: September 2019
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 562
• Est. completion date: June 11, 2018
• Est. primary completion date: June 11, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Preventive Health Services

Intervention

Behavioral:
• Intervention Survey

• Placebo Survey

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Seattle Children's Hospital	Kaiser Permanente, University of Washington

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2011 Apr 1. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Parents With a Highly Rated Visit Experience	Score on a 15-item parent-completed visit experience survey (minimum score 15; maximum score 105, with higher scores suggesting a higher rated visit experience)	24-48 hours after the 6 month health supervision visit
Secondary	Provider Perceptions of Barriers to the Vaccine Discussion	Provider-reported ratings of the significance of 3 barriers to the vaccine discussion: a) not having enough time to discuss parental vaccine concerns, b) not realizing until late in the visit that a parent had vaccine concerns, and c) not understanding a parent's specific vaccine concerns to be barriers pre- and post-intervention	Change post-intervention from pre-intervention