Presumptively Initiating Vaccines and Optimizing Talk With Motivational Interviewing (PIVOT With MI)
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| ClinicalTrials.gov Identifier: NCT03885232 |
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Recruitment Status :
Enrolling by invitation
First Posted : March 21, 2019
Last Update Posted : November 6, 2020
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| 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 |
| 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 |
|---|---|
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Experimental: PIVOT with MI
Clinics with providers trained in the Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing intervention (PIVOT with MI)
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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. |
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Active Comparator: Control
Control-Care as usual
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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- 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.
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| Ages Eligible for Study: | up to 2 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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 |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Communication Immunization |