NCT Number: NCT02708745
Screening for Hesitancy to Optimize Talk
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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
1 day and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Placebo Survey
BehavioralPrimary outcomes
-
Child's Mean Percent Days Under-immunized
Time frame: Child's immunization status at 8 months of age
Mean percent days under-immunized among children of parents who received (vs. did not receive) the intervention
Secondary outcomes
-
Number of Parents With a Highly Rated Visit Experience
Time frame: 24-48 hours after the 6 month health supervision visit
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)
-
Provider Perceptions of Barriers to the Vaccine Discussion
Time frame: Change post-intervention from pre-intervention
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
Sponsors and collaborators
Lead sponsor
Seattle Children's Hospital
Other
Collaborators
- Kaiser Permanente
- University of Washington
Registry information
Official study title
Use of a Novel Parent-Report Measure to Improve Childhood Vaccine Uptake: The Screening for Hesitancy to Optimize Talk (SHOT) Study
Acronym: SHOT
Important dates
- Study start
- 2016
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Mar 15, 2016
- Registry last updated
- Oct 1, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Effect of Health Belief Model-Based Education on Cervical Cancer Knowledge and HPV Vaccine Attitudes in Women
NCT07521163
Adherence Interventions, Behavior
Van, Turkey (Türkiye)
View Trial DetailsKettlebell-classroom Training
NCT06910085
Child Development, Feasibility Studies
Basel, Basellandschaft, Switzerland
View Trial DetailsWell-Child Care Clinical Practice Redesign: A Parent Coach-Led Model of Care
NCT03797898
Health Promotion, Preventive Health Services
Los Angeles, California, United States
View Trial DetailsPatients Engaged in Prevention: Enhancing Outreach to Increase Patient Engagement in Diabetes Prevention
NCT03550066
Diabetes Mellitus, Diabetes, Gestational
Oakland, California, United States
View Trial Details