Presumptively Initiating Vaccines and Optimizing Talk With Motivational Interviewing (PIVOT With MI)
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|ClinicalTrials.gov Identifier: NCT03885232|
Recruitment Status : Enrolling by invitation
First Posted : March 21, 2019
Last Update Posted : June 29, 2021
|Condition or disease||Intervention/treatment||Phase|
|Preventive Health Services (PREV HEALTH SERV)||Behavioral: Experimental: PIVOT with MI Other: Active Comparator: Control||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||Data Analysis study team members and parent participants will be masked to study assignment.|
|Primary Purpose:||Health Services Research|
|Official Title:||Presumptively Initiating Vaccines and Optimizing Talk With Motivational Interviewing (PIVOT With MI)|
|Actual Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
Experimental: PIVOT with MI
Clinics with providers trained in the Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing intervention (PIVOT with MI)
Behavioral: Experimental: PIVOT with MI
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.
Active Comparator: Control
Control-Care as usual
Other: Active Comparator: Control
Providers at participating control clinics will deliver care as usual. Parent participants will receive standard care.
- Child's Immunization Status [ Time Frame: Child's immunization status at 19 months of age ]Immunization status will be obtained from either state's immunization registry or directly from the participating practices.
- Parent Visit Experience Survey [ Time Frame: Within 1 week after a health supervision visit ]To assess parent visit experience, we will administer surveys to all vaccine hesitant parents within 24-48 hours after the completion of their health supervision visit. (Update: Due to COVID-19 restrictions, we have extended the time frame to within 1 week after their health supervision visit)
- Change in Provider Perception of Vaccine Discussion - Pre- Interim- and Post-Surveys [ Time Frame: At Baseline (year 1), Interim (year 3) and Post-Intervention (years 4 and 5) ]To assess provider perception of the vaccine discussion with parents, we will administer surveys to all study providers at baseline, interim and at study completion to establish changes in provider perception.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885232
|United States, Colorado|
|University of Colorado Anschutz Medical Campus|
|Aurora, Colorado, United States, 80045|
|United States, Washington|
|Seattle Children's Hospital|
|Seattle, Washington, United States, 98105|
|Principal Investigator:||Sean O'Leary, MD, MPH||University of Colorado, Denver|
|Principal Investigator:||Douglas Opel, MD, MPH||Seattle Children's Hospital|