Preventive Health Services
Conditions
Keywords
communication, immunization
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.
Detailed 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.
Interventions
BEHAVIORALIntervention Survey
BEHAVIORALPlacebo Survey
Sponsors
Kaiser Permanente
University of Washington
Seattle Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Days to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child's Mean Percent Days Under-immunized | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Parents With a Highly Rated Visit Experience | 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 | 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 91 |
| 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 | 65 |
| Pre-Intervention Providers Providers at enrolled clinics who completed a survey before the parent-level intervention period | 121 |
| Post-Intervention Providers Providers at enrolled clinics who completed a survey after the parent-level intervention period | 116 |
| Total | 393 |
Baseline characteristics
| Characteristic | Placebo Arm | Intervention Arm | Total | Post-Intervention Providers | Pre-Intervention Providers |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | — | — |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | — | — |
| Age, Categorical Between 18 and 65 years | 91 Participants | 65 Participants | 156 Participants | — | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 5 Participants | 15 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 79 Participants | 58 Participants | 362 Participants | 108 Participants | 117 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants | 2 Participants | 16 Participants | 5 Participants | 1 Participants |
| Number of parent participants married or living with a partner | 79 Participants | 59 Participants | 138 Participants | — | — |
| Number of parent participants who had 1 child in the household | 37 Participants | 38 Participants | 75 Participants | — | — |
| Number of parent participants who were mothers | 61 Participants | 41 Participants | 102 Participants | — | — |
| Number of parent participants with a household income of greater than $75,000 per year | 53 Participants | 43 Participants | 96 Participants | — | — |
| Number of parent participants with a level of education greater than or equal to 4 years of college | 66 Participants | 45 Participants | 111 Participants | — | — |
| PACV-4 Score 2 | 45 Participants | 27 Participants | 72 Participants | — | — |
| PACV-4 Score 3 | 28 Participants | 23 Participants | 51 Participants | — | — |
| PACV-4 Score 4 | 17 Participants | 13 Participants | 30 Participants | — | — |
| PACV-4 Score missing | 1 Participants | 2 Participants | 3 Participants | — | — |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 25 Participants | 14 Participants | 88 Participants | 26 Participants | 23 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 9 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 8 Participants | 23 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 7 Participants | 7 Participants | 14 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 1 Participants | 16 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 43 Participants | 35 Participants | 243 Participants | 80 Participants | 85 Participants |
| Sex: Female, Male Female | 61 Participants | 41 Participants | 268 Participants | 82 Participants | 84 Participants |
| Sex: Female, Male Male | 30 Participants | 24 Participants | 121 Participants | 31 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 91 | 0 / 65 | 0 / 121 | 0 / 116 |
| other Total, other adverse events | 0 / 91 | 0 / 65 | 0 / 121 | 0 / 116 |
| serious Total, serious adverse events | 0 / 91 | 0 / 65 | 0 / 121 | 0 / 116 |
Outcome results
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
Time frame: Child's immunization status at 8 months of age
Population: Mean percent days under-immunized of child participants by study arm
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo Arm | Child's Mean Percent Days Under-immunized | 19.1 percentage of days under-immunized |
| Intervention Arm | Child's Mean Percent Days Under-immunized | 25.2 percentage of days under-immunized |
p-value: 0.29t-test, 2 sided
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)
Time frame: 24-48 hours after the 6 month health supervision visit
Population: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo Arm | Number of Parents With a Highly Rated Visit Experience | 44 Participants |
| Intervention Arm | Number of Parents With a Highly Rated Visit Experience | 52 Participants |
p-value: 0.18Chi-squared
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
Time frame: Change post-intervention from pre-intervention
Population: 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)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo Arm | Provider Perceptions of Barriers to the Vaccine Discussion | Barrier: Not having enough time | Placebo Arm | 31 Participants |
| Placebo Arm | Provider Perceptions of Barriers to the Vaccine Discussion | Barrier: Not having enough time | Intervention Arm | 31 Participants |
| Placebo Arm | Provider Perceptions of Barriers to the Vaccine Discussion | Barrier: Not realizing until late in the visit | Placebo Arm | 26 Participants |
| Placebo Arm | Provider Perceptions of Barriers to the Vaccine Discussion | Barrier: Not realizing until late in the visit | Intervention Arm | 27 Participants |
| Placebo Arm | Provider Perceptions of Barriers to the Vaccine Discussion | Barrier: Not understanding a parent's concerns | Placebo Arm | 25 Participants |
| Placebo Arm | Provider Perceptions of Barriers to the Vaccine Discussion | Barrier: Not understanding a parent's concerns | Intervention Arm | 28 Participants |
| Intervention Arm | Provider Perceptions of Barriers to the Vaccine Discussion | Barrier: Not understanding a parent's concerns | Placebo Arm | 6 Participants |
| Intervention Arm | Provider Perceptions of Barriers to the Vaccine Discussion | Barrier: Not having enough time | Placebo Arm | 6 Participants |
| Intervention Arm | Provider Perceptions of Barriers to the Vaccine Discussion | Barrier: Not realizing until late in the visit | Intervention Arm | 5 Participants |
| Intervention Arm | Provider Perceptions of Barriers to the Vaccine Discussion | Barrier: Not having enough time | Intervention Arm | 5 Participants |
| Intervention Arm | Provider Perceptions of Barriers to the Vaccine Discussion | Barrier: Not understanding a parent's concerns | Intervention Arm | 5 Participants |
| Intervention Arm | Provider Perceptions of Barriers to the Vaccine Discussion | Barrier: Not realizing until late in the visit | Placebo Arm | 9 Participants |
p-value: 0.78Chi-squared