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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Preventive Health Services (PREV HEALTH SERV)

Treatments: Other: Active Comparator: Control; Behavioral: Experimental: PIVOT with MI

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03885232

17-1274

1R01HD093628-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17,446 patients

Sex: All

Ages: 1 day to 18 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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17,446 participants in 2 patient groups

PIVOT with MI

Experimental group

Description:

Clinics in which the Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing (PIVOT-MI) communication strategy has been implemented.

Treatment:

Behavioral: Experimental: PIVOT with MI

Control

Active Comparator group

Description:

Clinics delivered standard care.

Treatment:

Other: Active Comparator: Control