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| Name | Class |
|---|---|
| Kaiser Permanente | OTHER |
| University of Washington | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Intervention Arm | Experimental | Parent participants will also receive the intervention survey about their attitudes toward childhood vaccines before their child's health supervision visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention Survey | Behavioral |
| ||
| Placebo Survey |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Provider Perceptions of Barriers to the Vaccine Discussion |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Douglas J Opel, MD, MPH | Seattle Children's Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20513736 | Background | 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. | |
| 24190677 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Arm | Parent participants will receive a placebo survey about their attitudes toward common child health topics before their child's health supervision visit. Placebo Survey |
| FG001 | Intervention Arm | Parent participants will also receive the intervention survey about their attitudes toward childhood vaccines before their child's health supervision visit. Intervention Survey |
| FG002 | Pre-Intervention Providers | Providers at enrolled clinics who completed a survey before the parent-level intervention period |
| FG003 | Post-Intervention Providers | Providers at enrolled clinics who completed a survey after the parent-level intervention period |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
In 'placebo arm' and 'intervention arm': parent/child dyads; In 'pre-intervention providers' group: providers at enrolled clinics who completed a survey before the parent-level intervention; In 'post-intervention providers' group: providers at enrolled clinics who completed a survey after the parent-level intervention
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Arm | Parent participants will receive a placebo survey about their attitudes toward common child health topics before their child's health supervision visit. Placebo Survey |
| BG001 | Intervention Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Data was not collected from providers for this measure |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Mean percent days under-immunized of child participants by study arm | Posted | Mean | 95% Confidence Interval | percentage of days under-immunized | Child's immunization status at 8 months of age |
|
2 years 1 month
No adverse events occurred
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Arm | Parent participants will receive a placebo survey about their attitudes toward common child health topics before their child's health supervision visit. Placebo Survey |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Doug Opel | Seattle Children's Hospital | 206-987-2000 | douglas.opel@seattlechildrens.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2018 | Jul 17, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003142 | Communication |
| ID | Term |
|---|---|
| D001519 | Behavior |
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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 |
| 24315883 | Background | 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. |
| 22921495 | Background | 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. |
| 21389777 | Background | 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. |
| 21763384 | Background | 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. |
| 24061681 | Background | 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. |
| 31597690 | Derived | 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. |
Parent participants will also receive the intervention survey about their attitudes toward childhood vaccines before their child's health supervision visit.
Intervention Survey
| BG002 | Pre-Intervention Providers | Providers at enrolled clinics who completed a survey before the parent-level intervention period |
| BG003 | Post-Intervention Providers | Providers at enrolled clinics who completed a survey after the parent-level intervention period |
| BG004 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | There was missing data from providers on this measure | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Number of parent participants married or living with a partner | Married or living with a partner | Data was not collected from providers for this measure | Count of Participants | Participants |
|
| Number of parent participants with a level of education greater than or equal to 4 years of college | greater than or equal to 4 years of college | Data was not collected from providers for this measure | Count of Participants | Participants |
|
| Number of parent participants with a household income of greater than $75,000 per year | greater than $75,000 per year | Data was not collected from providers for this measure | Count of Participants | Participants |
|
| Number of parent participants who were mothers | mother | Data was not collected from providers for this measure | Count of Participants | Participants |
|
| Number of parent participants who had 1 child in the household | 1 Child in Household | Data was not collected from providers for this measure | Count of Participants | Participants |
|
| PACV-4 Score | The PACV-4 is a 4-item survey to identify vaccine-hesitant parents. The 4 items are 1) Have you ever delayed having your child get a shot for reasons other than illness or allergy?; 2) How concerned are you that a shot might not prevent the disease?; 3) Overall, how hesitant about childhood shots would you consider yourself to be?; and 4) I trust the information I receive about shots. The PACV-4 is scored from 1-4, with the hesitant response for each item (e.g. the 'yes' response to item 1) receiving a numeric score of 1. A parent was eligible for the study if they scored 2 or higher. | Data was not collected from providers for this measure | Count of Participants | Participants |
|
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| 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) | Proportion of parents with a highly-rated visit experience by study arm, defined as those who scored 90 or higher (out of 105) on the visit experience survey | Posted | Count of Participants | Participants | 24-48 hours after the 6 month health supervision visit |
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|
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| 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 | Proportion in arm who rated barrier as significant (3-5 on a 1-5 scale, where 1=not at all significant and 5=very significant) | Posted | Count of Participants | Participants | Change post-intervention from pre-intervention |
|
|
|
|
| 0 |
| 91 |
| 0 |
| 91 |
| 0 |
| 91 |
| EG001 | Intervention Arm | Parent participants will also receive the intervention survey about their attitudes toward childhood vaccines before their child's health supervision visit. Intervention Survey | 0 | 65 | 0 | 65 | 0 | 65 |
| EG002 | Pre-Intervention Providers | Providers at enrolled clinics who completed a survey before the parent-level intervention period | 0 | 121 | 0 | 121 | 0 | 121 |
| EG003 | Post-Intervention Providers | Providers at enrolled clinics who completed a survey after the parent-level intervention period | 0 | 116 | 0 | 116 | 0 | 116 |
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| >=65 years |
|
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
|
| More than one race |
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| Unknown or Not Reported |
|
| 4 |
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| missing |
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| Intervention Arm |
|
| Barrier: Not realizing until late in the visit |
|
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| Barrier: Not understanding a parent's concerns |
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