Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-25 @ 7:34 PM
Study NCT ID:
NCT03885232
Status:
COMPLETED
Last Update Posted:
2025-04-30
First Post:
2019-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Presumptively Initiating Vaccines and Optimizing Talk With Motivational Interviewing (PIVOT With MI)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003142', 'term': 'Communication'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sean.oleary@cuanschutz.edu', 'phone': '(303)724-1582', 'title': "Sean O'Leary, MD, MPH - Principal Investigator", 'organization': 'University of Colorado at Anschutz Medical Campus'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'up to 2 years', 'description': 'No adverse events collected', 'eventGroups': [{'id': 'EG000', 'title': 'PIVOT With MI', 'description': 'Clinics in which the Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing (PIVOT-MI) communication strategy was implemented.', 'otherNumAtRisk': 5016, 'deathsNumAtRisk': 5016, 'otherNumAffected': 0, 'seriousNumAtRisk': 5016, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Clinics delivered care as usual.', 'otherNumAtRisk': 3813, 'deathsNumAtRisk': 3813, 'otherNumAffected': 0, 'seriousNumAtRisk': 3813, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Child Immunization Status at 19 Months, 0 Days of Age Characterized as Percent Days Under-immunized (DUI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '586', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PIVOT With MI: Parent/Caregiver and Infant Dyad', 'description': 'Parent/Caregiver and Infant dyads at participating clinics trained to use the Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing (PIVOT-MI) communication strategy.'}, {'id': 'OG001', 'title': 'Control: Parent/Caregiver and Infant Dyad', 'description': 'Parent/Caregiver and Infant dyads at participating clinics in the control arm who received care as usual.'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'spread': '38', 'groupId': 'OG000'}, {'value': '24', 'spread': '32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence Rate Ratio (IRR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.68', 'ciUpperLimit': '1.60', 'statisticalMethod': 'Generalized linear mixed effects regress', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear mixed effects regression models', 'nonInferiorityComment': 'We applied a mixed zero-inflated beta regression model that included a fixed binary factor for treatment arm, a random effect for clinic to account for correlation within clinics, and unbalanced parent demographics across study arms.'}], 'paramType': 'MEAN', 'timeFrame': "Child's immunization status at 19 months of age", 'description': "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.", 'unitOfMeasure': 'percentage of days under-immunized', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Infants of parents/caregivers who had negative vaccine attitudes (Parental Attitudes about Childhood Vaccines short form (PACV-SF) score of 2 or higher)'}, {'type': 'SECONDARY', 'title': 'Post-Visit Parental Satisfaction Survey Scored on a 7-point Likert Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PIVOT With MI: Parent/Caregiver and Infant Dyad', 'description': 'Parent/Caregiver and Infant dyads at participating clinics trained to use the Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing (PIVOT-MI) communication strategy.'}, {'id': 'OG001', 'title': 'Control: Parent/Caregiver and Infant Dyad', 'description': 'Parent/Caregiver and Infant dyads at participating clinics in the control arm who received care as usual.'}], 'classes': [{'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Other', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.0', 'groupDescription': 'Calculated individual survey means for vaccine hesitant parents who participated in the survey. Survey consisted of 15 questions with a 7-point Likert scale. We then created a dichotomous variable where 1 = mean \\> or equal to 6; 0 = mean \\< 6.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'approximately 6 months post birth', 'description': '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.', 'unitOfMeasure': '% of participants scoring 4 or higher', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Change in Clinician Self-Efficacy With Parent/Infant Dyads With Negative Vaccine Attitudes - Pre-vs Post-Surveys', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PIVOT With MI: Clinicians', 'description': 'Clinicians at participating clinics randomized to the intervention arm and trained in the Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing (PIVOT-MI) communication strategy.'}, {'id': 'OG001', 'title': 'Control: Clinicians', 'description': 'Clinicians at participating control clinics who delivered care as usual.'}], 'classes': [{'title': 'Baseline Survey Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Post-Study Survey Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.92', 'ciLowerLimit': '0.66', 'ciUpperLimit': '5.64', 'groupDescription': '1. Ho: No difference in the proportion of clinicians using presumptive and Motivational Interviewing techniques between intervention and control.\n2. Ho: No difference in the proportion of clinicians time spent talking to vaccine hesitant parents between intervention and control.', 'statisticalMethod': 'Generalized linear mixed effects regress', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for: study arm, study period (pre vs. post), years in practice, provider type, interaction between study arm and study period'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Baseline and Post-Intervention (up to 2 years after baseline)', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Clinicians enrolled across n=24 clinics (n=12 intervention clinics; n=12 control clinics)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PIVOT With MI', 'description': 'Clinics in which the Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing (PIVOT-MI) communication strategy was implemented.'}, {'id': 'FG001', 'title': 'Control', 'description': 'Clinics delivered standard care.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '12', 'numSubjects': '9905'}, {'groupId': 'FG001', 'numUnits': '12', 'numSubjects': '7541'}]}, {'type': 'Participants Are Clinicians', 'achievements': [{'groupId': 'FG000', 'numUnits': '12', 'numSubjects': '127'}, {'groupId': 'FG001', 'numUnits': '12', 'numSubjects': '85'}]}, {'type': 'Participants Are Parents Within the Parent/Infant Dyads', 'achievements': [{'groupId': 'FG000', 'numUnits': '12', 'numSubjects': '4889'}, {'groupId': 'FG001', 'numUnits': '12', 'numSubjects': '3728'}]}, {'type': 'Participants Are Infants Within the Parent/Infant Dyads', 'achievements': [{'groupId': 'FG000', 'numUnits': '12', 'numSubjects': '4889'}, {'groupId': 'FG001', 'numUnits': '12', 'numSubjects': '3728'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '12', 'numSubjects': '9799'}, {'groupId': 'FG001', 'numUnits': '12', 'numSubjects': '7486'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '106'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '55'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'Staff turnover at enrolled clinics', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '23'}]}]}], 'typeUnitsAnalyzed': 'clinics'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9905', 'groupId': 'BG000'}, {'value': '7541', 'groupId': 'BG001'}, {'value': '17446', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PIVOT With MI', 'description': 'Clinics in which the Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing (PIVOT-MI) communication strategy has been implemented.'}, {'id': 'BG001', 'title': 'Control', 'description': 'Care delivered as usual.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'title': 'Parent/Infant Dyads', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4889', 'groupId': 'BG000'}, {'value': '3728', 'groupId': 'BG001'}, {'value': '8617', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4889', 'groupId': 'BG000'}, {'value': '3728', 'groupId': 'BG001'}, {'value': '8617', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '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.'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Parent/Infant Dyads', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4889', 'groupId': 'BG000'}, {'value': '3728', 'groupId': 'BG001'}, {'value': '8617', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4138', 'groupId': 'BG000'}, {'value': '3200', 'groupId': 'BG001'}, {'value': '7338', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '567', 'groupId': 'BG000'}, {'value': '425', 'groupId': 'BG001'}, {'value': '992', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '184', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}]}, {'title': 'Clinicians', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Data was collected for parent/infant dyads, where all baseline characteristics refers to parents. Characteristics were not collected for infants.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Participants are split into two groups: parent/infant dyads and clinicians. Demographics for each group were collected separately, as their data is analyzed separately.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'Parent/Infant Dyads', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4889', 'groupId': 'BG000'}, {'value': '3728', 'groupId': 'BG001'}, {'value': '8617', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '551', 'groupId': 'BG000'}, {'value': '460', 'groupId': 'BG001'}, {'value': '1011', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4,162', 'groupId': 'BG000'}, {'value': '3158', 'groupId': 'BG001'}, {'value': '7320', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '176', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '286', 'groupId': 'BG002'}]}]}, {'title': 'Clinicians', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Data was collected for parent/infant dyads, where all baseline characteristics refers to parents. Characteristics were not collected for infants.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Participants are split into two groups: parent/infant dyads and clinicians. Demographics for each group were collected separately, as their data is analyzed separately.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'Parent/Infant Dyads', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4889', 'groupId': 'BG000'}, {'value': '3728', 'groupId': 'BG001'}, {'value': '8617', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '228', 'groupId': 'BG000'}, {'value': '358', 'groupId': 'BG001'}, {'value': '586', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '3997', 'groupId': 'BG000'}, {'value': '2931', 'groupId': 'BG001'}, {'value': '6928', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '188', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '315', 'groupId': 'BG000'}, {'value': '187', 'groupId': 'BG001'}, {'value': '502', 'groupId': 'BG002'}]}]}, {'title': 'Clinicians', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Data was collected for parent/infant dyads, where all baseline characteristics refers to parents. Characteristics were not collected for infants.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Participants are split into two groups: parent/infant dyads and clinicians. Demographics for each group were collected separately, as their data is analyzed separately.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9905', 'groupId': 'BG000'}, {'value': '7541', 'groupId': 'BG001'}, {'value': '17446', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9905', 'groupId': 'BG000'}, {'value': '7541', 'groupId': 'BG001'}, {'value': '17446', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Participant totals include both parents, infants, and clinicians.', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-06', 'size': 515092, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-05T14:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Data Analysis study team members and parent participants will be masked to study assignment.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17446}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2019-02-07', 'resultsFirstSubmitDate': '2024-12-06', 'studyFirstSubmitQcDate': '2019-03-19', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-28', 'studyFirstPostDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Child Immunization Status at 19 Months, 0 Days of Age Characterized as Percent Days Under-immunized (DUI)', 'timeFrame': "Child's immunization status at 19 months of age", 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Post-Visit Parental Satisfaction Survey Scored on a 7-point Likert Scale', 'timeFrame': 'approximately 6 months post birth', 'description': '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.'}, {'measure': 'Change in Clinician Self-Efficacy With Parent/Infant Dyads With Negative Vaccine Attitudes - Pre-vs Post-Surveys', 'timeFrame': 'At Baseline and Post-Intervention (up to 2 years after baseline)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Communication', 'Immunization'], 'conditions': ['Preventive Health Services (PREV HEALTH SERV)']}, 'referencesModule': {'references': [{'pmid': '40305020', 'type': 'DERIVED', 'citation': "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."}, {'pmid': '32784263', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nSpecific 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '18 Months', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parents: must be English or Spanish speaking, ≥18 years old, have an infant ≤18 months old, have legal guardianship of the infant, and is receiving pediatric care at an enrolled clinic\n* Providers: All providers at participating study practices will be eligible to participate.\n\nExclusion Criteria:\n\n* Parents: not English or Spanish speaking, under 18 years old, have an infant older than 18 months, not the legal guardian of the infant, and/or having a child who is not receiving pediatric care at an enrolled clinic.\n* Providers: Providers who are not at participating study practices.'}, 'identificationModule': {'nctId': 'NCT03885232', 'briefTitle': 'Presumptively Initiating Vaccines and Optimizing Talk With Motivational Interviewing (PIVOT With MI)', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Presumptively Initiating Vaccines and Optimizing Talk With Motivational Interviewing (PIVOT With MI)', 'orgStudyIdInfo': {'id': '17-1274'}, 'secondaryIdInfos': [{'id': '1R01HD093628-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01HD093628-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PIVOT with MI', 'description': 'Clinics in which the Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing (PIVOT-MI) communication strategy has been implemented.', 'interventionNames': ['Behavioral: Experimental: PIVOT with MI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Clinics delivered standard care.', 'interventionNames': ['Other: Active Comparator: Control']}], 'interventions': [{'name': 'Experimental: PIVOT with MI', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['PIVOT with MI']}, {'name': 'Active Comparator: Control', 'type': 'OTHER', 'description': 'Providers at participating control clinics will deliver care as usual. Parent participants will receive standard care.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Anschutz Medical Campus', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': "Sean O'Leary, MD, MPH", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}, {'name': 'Douglas Opel, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Seattle Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Missouri, Kansas City', 'class': 'OTHER'}, {'name': 'Portland State University', 'class': 'OTHER'}, {'name': 'University of Washington', 'class': 'OTHER'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': "Seattle Children's Hospital", 'class': 'OTHER'}, {'name': "Children's Mercy Hospital Kansas City", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}