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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
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

Tracking Information
First Submitted Date  ICMJE February 7, 2019
First Posted Date  ICMJE March 21, 2019
Last Update Posted Date June 29, 2021
Actual Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2021)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2019)
  • Parent Visit Experience Survey [ Time Frame: Within 24-48 hours after a health supervision visit ]
    To assess parent visit experience, we will administer surveys to all parents within 24-48 hours after the completion of their health supervision visit.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Presumptively Initiating Vaccines and Optimizing Talk With Motivational Interviewing (PIVOT With MI)
Official Title  ICMJE Presumptively Initiating Vaccines and Optimizing Talk With Motivational Interviewing (PIVOT With MI)
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Preventive Health Services (PREV HEALTH SERV)
Intervention  ICMJE
  • 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.
  • Other: Active Comparator: Control
    Providers at participating control clinics will deliver care as usual. Parent participants will receive standard care.
Study Arms  ICMJE
  • Experimental: PIVOT with MI
    Clinics with providers trained in the Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing intervention (PIVOT with MI)
    Intervention: Behavioral: Experimental: PIVOT with MI
  • Active Comparator: Control
    Control-Care as usual
    Intervention: Other: Active Comparator: Control
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: November 4, 2020)
1000
Original Estimated Enrollment  ICMJE
 (submitted: March 19, 2019)
600
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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
  • 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 18 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03885232
Other Study ID Numbers  ICMJE 17-1274
1R01HD093628-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Sean O'Leary, MD, MPH University of Colorado, Denver
Principal Investigator: Douglas Opel, MD, MPH Seattle Children's Hospital
PRS Account University of Colorado, Denver
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP