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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD093628-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Missouri, Kansas City | OTHER |
| Portland State University | OTHER |
| University of Washington | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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The overall goal of this project is to determine whether a novel and innovative provider communication strategy is effective in improving vaccine acceptance among vaccine-hesitant parents (VHPs) and visit experience among VHPs and their health care providers.
The primary goal of this covariate constrained, cluster randomized controlled trial is to evaluate the effectiveness of an innovative provider communication strategy (PIVOT-MI) intervention in improving provider-parent vaccine discussions and increasing vaccine acceptance. Providers at intervention clinics will be trained to use the PIVOT-MI strategy in which a presumptive format is used to initiate the childhood vaccine recommendation with all parents, followed by use of motivational interviewing (MI) with parents who voice resistance to that recommendation. Providers at control clinics will deliver care as usual.
Specific aims are to evaluate the impact of PIVOT-MI, relative to control, on (1) child's immunization status; (2) parent-rated visit experience with their child's provider; and (3) change in provider experience of the vaccine discussion with vaccine-hesitant parents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PIVOT with MI | Experimental | Clinics in which the Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing (PIVOT-MI) communication strategy has been implemented. |
|
| Control | Active Comparator | Clinics delivered standard care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: PIVOT with MI | Behavioral | Providers in participating intervention clinics will be trained in the PIVOT-MI strategy in which a presumptive format is used to initiate the childhood vaccine recommendation with all parents followed by use of motivational interviewing (MI) with parents who voice resistance to that recommendation. Parent participants will receive PIVOT-MI. |
| Measure | Description | Time Frame |
|---|---|---|
| Child Immunization Status at 19 Months, 0 Days of Age Characterized as Percent Days Under-immunized (DUI) | Immunization status was obtained from WA or CO state immunization registry or directly from participating practices. At enrollment, parent/infant dyads completed the Parental Attitudes about Childhood Vaccines short version (PACV-SF), a validated survey scored from 0 to 4. A score of 2 or more represented parent/infant dyad with negative vaccine attitudes. Among parent/infant dyads with negative vaccine attitudes, the child's immunization status at 19 months was calculated based on recommended ages and intervals between doses provided by ACIP for summing late days for each dose of the 8 routine vaccines recommended by 19 months (HepB, rotavirus, DTaP, Hib, pneumococcal conjugate, inactivated polio virus, MMR, and varicella). There was a max of 23 recommended doses for the 8 vaccines - doses varied depending on brand. Total max DUI was a sum of total possible days late for each dose through 19mo(2830 days).Percent DUI was calculated by dividing child's DUI by the total maximum DUI. | Child's immunization status at 19 months of age |
| Measure | Description | Time Frame |
|---|---|---|
| Post-Visit Parental Satisfaction Survey Scored on a 7-point Likert Scale | To assess parental satisfaction with their clinician during a health supervision visit, we asked all vaccine hesitant parents (identified by a Parental Attitudes about Childhood Vaccines-Short Form (PAC-V SF) score of 2 or more) in both both intervention and control arms if they would complete an additional 15-question survey over the phone within 24-48 hours after the completion of a health supervision visit for their child around 6 months of age. Due to COVID-19 restrictions, we had to extend the time frame to within 1 week after a health supervision visit at 2, 4, or 6 months of age. Ratings were on a 7-point Likert scale - Very Poor (1), Poor (2), Fair (3), Good (4), Very Good (5), Excellent (6), Outstanding (7). Overall experience with a rating of "Good (4)" or higher was considered to be a satisfactory visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sean O'Leary, MD, MPH | University of Colorado, Denver | Principal Investigator |
| Douglas Opel, MD, MPH | Seattle Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States | ||
| Seattle Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40305020 | Derived | Opel DJ, Robinson JD, Zhou C, Colborn K, Spielvogle H, Furniss A, Spina C, Perreira C, O'Leary ST. Tiered Clinician Vaccine Communication Strategy to Improve Childhood Vaccine Uptake: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2025 Apr 1;8(4):e257814. doi: 10.1001/jamanetworkopen.2025.7814. | |
| 32784263 | Derived | Opel DJ, Robinson JD, Spielvogle H, Spina C, Garrett K, Dempsey AF, Perreira C, Dickinson M, Zhou C, Pahud B, Taylor JA, O'Leary ST. 'Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing' (PIVOT with MI) trial: a protocol for a cluster randomised controlled trial of a clinician vaccine communication intervention. BMJ Open. 2020 Aug 11;10(8):e039299. doi: 10.1136/bmjopen-2020-039299. |
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| ID | Title | Description |
|---|---|---|
| FG000 | PIVOT With MI | Clinics in which the Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing (PIVOT-MI) communication strategy was implemented. |
| FG001 | Control | Clinics delivered standard care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | PIVOT With MI | Clinics in which the Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing (PIVOT-MI) communication strategy has been implemented. |
| BG001 | Control |
| 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 collected for parent/infant dyads, where all baseline characteristics refers to parents. Characteristics were not collected for infants. Age was not a measure collected for clinicians. |
| 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 Immunization Status at 19 Months, 0 Days of Age Characterized as Percent Days Under-immunized (DUI) | Immunization status was obtained from WA or CO state immunization registry or directly from participating practices. At enrollment, parent/infant dyads completed the Parental Attitudes about Childhood Vaccines short version (PACV-SF), a validated survey scored from 0 to 4. A score of 2 or more represented parent/infant dyad with negative vaccine attitudes. Among parent/infant dyads with negative vaccine attitudes, the child's immunization status at 19 months was calculated based on recommended ages and intervals between doses provided by ACIP for summing late days for each dose of the 8 routine vaccines recommended by 19 months (HepB, rotavirus, DTaP, Hib, pneumococcal conjugate, inactivated polio virus, MMR, and varicella). There was a max of 23 recommended doses for the 8 vaccines - doses varied depending on brand. Total max DUI was a sum of total possible days late for each dose through 19mo(2830 days).Percent DUI was calculated by dividing child's DUI by the total maximum DUI. | Infants of parents/caregivers who had negative vaccine attitudes (Parental Attitudes about Childhood Vaccines short form (PACV-SF) score of 2 or higher) | Posted | Mean | Standard Deviation | percentage of days under-immunized | Child's immunization status at 19 months of age |
up to 2 years
No adverse events collected
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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 | PIVOT With MI | Clinics in which the Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing (PIVOT-MI) communication strategy was implemented. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sean O'Leary, MD, MPH - Principal Investigator | University of Colorado at Anschutz Medical Campus | (303)724-1582 | sean.oleary@cuanschutz.edu |
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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 6, 2021 | Dec 5, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003142 | Communication |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| NIH |
| National Institutes of Health (NIH) | NIH |
| Seattle Children's Hospital | OTHER |
| Children's Mercy Hospital Kansas City | OTHER |
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Data Analysis study team members and parent participants will be masked to study assignment.
|
| Active Comparator: Control | Other | Providers at participating control clinics will deliver care as usual. Parent participants will receive standard care. |
|
| approximately 6 months post birth |
| Change in Clinician Self-Efficacy With Parent/Infant Dyads With Negative Vaccine Attitudes - Pre-vs Post-Surveys | To assess changes in clinicians' perceived self-efficacy when discussing vaccines with parents/infant dyads with negative vaccine attitudes, a survey was administered to all participating clinicians at baseline and at study completion asking about vaccine recommendation behaviors and how they perceived their impact on parental decision making regarding vaccines. Self-efficacy was assessed with a 3-part question scored on a Likert Scale - Strongly Disagree, Somewhat Disagree, Somewhat Agree, Strongly Agree. Changes in perceived self-efficacy over time was assessed by comparing the number of clinicians who answered "Strongly Agree" or "Somewhat Agree" to the statement "When parents wish to delay or refuse childhood vaccines for their child, there is not much I can say to change their minds" at baseline and at post-study. Note that fewer clinicians completed the post-study survey due to such factors as retirement and staff turnover. | At Baseline and Post-Intervention (up to 2 years after baseline) |
| Seattle |
| Washington |
| 98105 |
| United States |
Care delivered as usual.
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex/Gender, Customized | Data was collected for parent/infant dyads, where all baseline characteristics refers to parents. Characteristics were not collected for infants. | Participants are split into two groups: parent/infant dyads and clinicians. Demographics for each group were collected separately, as their data is analyzed separately. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Data was collected for parent/infant dyads, where all baseline characteristics refers to parents. Characteristics were not collected for infants. | Participants are split into two groups: parent/infant dyads and clinicians. Demographics for each group were collected separately, as their data is analyzed separately. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Data was collected for parent/infant dyads, where all baseline characteristics refers to parents. Characteristics were not collected for infants. | Participants are split into two groups: parent/infant dyads and clinicians. Demographics for each group were collected separately, as their data is analyzed separately. | Count of Participants | Participants |
|
| Region of Enrollment | Participant totals include both parents, infants, and clinicians. | Number | participants |
|
|
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|
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| Secondary | Post-Visit Parental Satisfaction Survey Scored on a 7-point Likert Scale | To assess parental satisfaction with their clinician during a health supervision visit, we asked all vaccine hesitant parents (identified by a Parental Attitudes about Childhood Vaccines-Short Form (PAC-V SF) score of 2 or more) in both both intervention and control arms if they would complete an additional 15-question survey over the phone within 24-48 hours after the completion of a health supervision visit for their child around 6 months of age. Due to COVID-19 restrictions, we had to extend the time frame to within 1 week after a health supervision visit at 2, 4, or 6 months of age. Ratings were on a 7-point Likert scale - Very Poor (1), Poor (2), Fair (3), Good (4), Very Good (5), Excellent (6), Outstanding (7). Overall experience with a rating of "Good (4)" or higher was considered to be a satisfactory visit. | A subset of parent/infant dyads in both intervention and control clinics who were identified as vaccine hesitant (score of 2 or more on the Parental Attitudes about Childhood Vaccines short form (PACV-SF)) and who completed the post-healthcare visit satisfaction survey. | Posted | Number | % of participants scoring 4 or higher | approximately 6 months post birth |
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| Secondary | Change in Clinician Self-Efficacy With Parent/Infant Dyads With Negative Vaccine Attitudes - Pre-vs Post-Surveys | To assess changes in clinicians' perceived self-efficacy when discussing vaccines with parents/infant dyads with negative vaccine attitudes, a survey was administered to all participating clinicians at baseline and at study completion asking about vaccine recommendation behaviors and how they perceived their impact on parental decision making regarding vaccines. Self-efficacy was assessed with a 3-part question scored on a Likert Scale - Strongly Disagree, Somewhat Disagree, Somewhat Agree, Strongly Agree. Changes in perceived self-efficacy over time was assessed by comparing the number of clinicians who answered "Strongly Agree" or "Somewhat Agree" to the statement "When parents wish to delay or refuse childhood vaccines for their child, there is not much I can say to change their minds" at baseline and at post-study. Note that fewer clinicians completed the post-study survey due to such factors as retirement and staff turnover. | Clinicians enrolled across n=24 clinics (n=12 intervention clinics; n=12 control clinics) | Posted | Count of Participants | Participants | At Baseline and Post-Intervention (up to 2 years after baseline) |
|
|
|
|
| 0 |
| 5,016 |
| 0 |
| 5,016 |
| 0 |
| 5,016 |
| EG001 | Control | Clinics delivered care as usual. | 0 | 3,813 | 0 | 3,813 | 0 | 3,813 |
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| Unknown |
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| Male |
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| Unknown |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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| Post-Study Survey Results |
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|