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Presumptively Initiating Vaccines and Optimizing Talk With Motivational Interviewing (PIVOT With MI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03885232
Recruitment Status : Enrolling by invitation
First Posted : March 21, 2019
Last Update Posted : November 6, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Seattle Children's Hospital
University of Missouri, Kansas City
Children's Mercy Hospital Kansas City
Portland State University
University of Washington
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Preventive Health Services (PREV HEALTH SERV) Behavioral: Experimental: PIVOT with MI Other: Active Comparator: Control Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
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 : August 31, 2022
Estimated Study Completion Date : July 31, 2023

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. Change in Provider Perception of Vaccine Discussion - Pre- and Post-Surveys [ Time Frame: At Baseline (year 1) 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 and at study completion to establish changes in provider perception.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Parents: must be English or Spanish speaking, ≥18 years old, have an infant ≤2 months old, have legal guardianship of the infant, and is receiving pediatric care at an enrolled clinic
  • Providers: All providers at participating study practices will be eligible to participate.

Exclusion Criteria:

  • Parents: not English or Spanish speaking, under 18 years old, have an infant older than 2 months, not the legal guardian of the infant, and/or having a child who is not receiving pediatric care at an enrolled clinic.
  • Providers: Providers who are not at participating study practices.

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
University of Colorado, Denver
National Institutes of Health (NIH)
Seattle Children's Hospital
University of Missouri, Kansas City
Children's Mercy Hospital Kansas City
Portland State University
University of Washington
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Sean O'Leary, MD, MPH University of Colorado, Denver
Principal Investigator: Douglas Opel, MD, MPH Seattle Children's Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03885232    
Other Study ID Numbers: 17-1274
1R01HD093628-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: November 6, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
Communication
Immunization