A Vaccine Communication Training Intervention for Pediatric Inpatient Clinicians (PIVOT-IN)

Presumptively Initiating Vaccines and Optimizing Talk for Inpatients (PIVOT-IN): A Vaccine Communication Training Intervention for Pediatric Inpatient Clinicians

This study will examine a novel stakeholder-informed intervention to identify vaccine-eligible children and promote evidence-based clinician vaccine communication with families with the goal of increasing vaccine uptake during hospitalization.

Study Overview

• Status: Not yet recruiting
• Conditions: Preventive Health Services (PREV HEALTH SERV)
• Intervention / Treatment: Other: Standardized Vaccine Eligibility Screening; Behavioral: PIVOT-IN

Detailed Description

This study aims to examine a novel stakeholder-informed intervention to improve routine vaccination of hospitalized children. Inpatient clinicians at Seattle Children's Hospital, including nurses, advanced practice providers, and physicians, will be trained using the 'Presumptively Initiating Vaccines and Optimizing Talk for Inpatients (PIVOT-IN)' curriculum. During this training, inpatient clinicians will learn, practice, and use a presumptive format to initiate their vaccine recommendations and motivational interviewing techniques in their vaccine conversations with hospitalized patients and families.

Specific aims are to (1) evaluate the impact of the intervention relative to baseline on routine vaccine administration to vaccine-eligible hospitalized children, and (2) to examine the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) of the intervention using mixed methods.

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Annika M Hofstetter, MD, PhD, MPH; Phone Number: 206-884-1699; Email: annika.hofstetter@seattlechildrens.org
• Study Contact Backup: Name: Mersine A Bryan, MD, MPH; Email: mersine.bryan@seattlechildrens.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98145
      • Seattle Children's Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Patient Inclusion Criteria:

• Hospitalized on medical or surgical unit (non-critical care) at Seattle Children's
• Age 0-17 years during hospitalization
• Eligible for vaccination during hospitalization

Patient Exclusion Criteria:

• Medical contraindication to vaccination
• Died during hospitalization
• Discharged from intensive care unit
• Discharged to hospice care

Clinician Inclusion Criteria:

• Nurse, physician, or advanced practice provider (APP)
• Cares for patients hospitalized on medical or surgical unit (non-critical care) at Seattle Children's
• Practices on general medicine, general surgery, pulmonology, or ENT service (physician, APP)

Clinician Exclusion Criteria:

• Works only night shifts or on short-term contract (i.e., travel nurse)
• Will complete residency training during intervention period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Baseline; Standard care was delivered to hospitalized patients. (Sept 2023-Aug 2025)
Other: Standardized Vaccine Eligibility Screening; An electronic health record prompt to identify patients due or overdue for vaccines was activated. (Sept 2025-Mar 2026)	Other: Standardized Vaccine Eligibility Screening; An electronic health record prompt to identify patients due or overdue for vaccines was activated by the hospital in September.
Experimental: Vaccine Communication Training; Inpatient clinicians will be trained using the 'Presumptively Initiating Vaccines and Optimizing Talk for Inpatients (PIVOT-IN)' curriculum. (Apr 2026-Dec 2026)	Behavioral: PIVOT-IN; Inpatient clinicians at Seattle Children's Hospital, including nurses, advanced practice providers, and physicians, will be trained using the 'Presumptively Initiating Vaccines and Optimizing Talk for Inpatients (PIVOT-IN)' curriculum. During this training, inpatient clinicians will learn, practice, and use a presumptive format to initiate their vaccine recommendations and motivational interviewing techniques in their vaccine conversations with hospitalized patients and families.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of vaccine-eligible hospitalized patients who receive routine childhood vaccines during hospitalization	The percentage of vaccine-eligible hospitalized patients who receive one or more needed routine childhood vaccines (non-influenza, non-COVID-19) during hospitalization will be calculated using patient electronic health record data. Vaccine eligibility at hospital admission will be determined based upon the patient's age and, if applicable, underlying medical conditions or treatment regimens, per American Academy of Pediatrics recommendations for routine childhood vaccination.	Hospital admission to discharge (up to 7 months or the intervention end date, whichever comes first)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of clinicians who complete the PIVOT-IN vaccine communication curriculum	The number of clinicians who complete the 3 main activities in the PIVOT vaccine communication curriculum will be calculated: (a) view the introductory video; (b) participate in the initial training session; and (c) participate in the refresher training session based upon the study's curriculum activity tracking log.	Up to 8 months after the intervention start date
Change in clinicians' perceived self-efficacy in discussing vaccines	To assess the change in clinicians' perceived self-efficacy in discussing vaccines with hospitalized patients and families, a survey of all participating clinicians will be administered at baseline and at study completion. The survey will ask about the clinician's perceived impact on parental decision-making about vaccine administration during hospitalization. Self-efficacy will be assessed with a 2-part question scored on a 4-point Likert Scale (Strongly Disagree, Somewhat Disagree, Somewhat Agree, Strongly Agree). Changes in perceived self-efficacy over time will be assessed by comparing the percentage of clinicians who answered "Strongly Agree" or "Somewhat Agree" to the statement "I am influential in caregivers' decisions about whether or not to get vaccines for their hospitalized child" at baseline and post-intervention.	At Baseline and Post-Intervention (up to 10 months after the intervention start date)
Change in clinicians' reported use of a presumptive approach to initiate their vaccine recommendation	To assess the change in clinicians' reported use of a presumptive approach to initiate their vaccine recommendation with hospitalized patients and families, a survey of all participating clinicians will be administered at baseline and at study completion. The survey will ask about the clinician's approach to initiating their vaccine recommendation with hospitalized patients and families. A presumptive approach will be defined as a response of "telling the caregivers which shots their child would be getting without asking their opinion" or "telling the caregivers which shots their child would be getting and then asking their opinion about that shot plan." Changes over time will be assessed by comparing the percentage of clinicians who reported use of a presumptive approach to initiate their vaccine conversation at baseline and post-intervention.	At Baseline and Post-Intervention (up to 10 months after the intervention start date)
Perceived feasibility of the PIVOT-IN vaccine communication curriculum	To assess the perceived feasibility of the PIVOT-IN vaccine communication curriculum, a survey of all participating clinicians will be administered at study completion. The validated Feasibility of Intervention Measure (FIM), which includes 4 items to evaluate feasibility on a 5-point Likert scale, will be used. The score mean and standard deviation will be calculated. A higher score indicates greater perceived feasibility.	Up to 2 months after the intervention end date
Perceived acceptability of the PIVOT-IN vaccine communication curriculum	To assess the perceived acceptability of the PIVOT-IN vaccine communication curriculum, a survey of all participating clinicians will be administered at study completion. The validated Acceptability of Intervention Measure (AIM), which includes 4 items to evaluate acceptability on a 5-point Likert scale, will be used. The score mean and standard deviation will be calculated. A higher score indicates greater perceived acceptability.	Up to 2 months after the intervention start date
Perceived appropriateness of the vaccine communication curriculum	To assess the perceived appropriateness of the PIVOT-IN vaccine communication curriculum, a survey of all participating clinicians will be administered at study completion. The validated Intervention Appropriateness Measure (IAM), which includes 4 items to evaluate appropriateness on a 5-point Likert scale, will be used. The mean score and standard deviation will be calculated. A higher score indicates greater perceived appropriateness.	Up to 2 months after intervention end date
Percentage of clinicians who intend to use the vaccine communication strategies presented in the PIVOT-IN curriculum	To assess the clinicians' intentions to use the PIVOT-IN vaccine communication strategies post-intervention, a survey of all participating clinicians will be administered at study completion. The percentage of participating clinicians who report that they "plan to use the vaccine communication strategies presented in the PIVOT-IN curriculum with [their] patients" to a "great extent" or "very great extent" will be calculated.	Up to 2 months after the intervention end date

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH); University of Washington

Publications and helpful links

General Publications

• Opel DJ, Robinson JD, Zhou C, Colborn K, Spielvogle H, Furniss A, Spina C, Perreira C, O'Leary ST. Tiered Clinician Vaccine Communication Strategy to Improve Childhood Vaccine Uptake: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2025 Apr 1;8(4):e257814. doi: 10.1001/jamanetworkopen.2025.7814.
• O'Leary ST, Spina CI, Spielvogle H, Robinson JD, Garrett K, Perreira C, Pahud B, Dempsey AF, Opel DJ. Development of PIVOT with MI: A motivational Interviewing-Based vaccine communication training for pediatric clinicians. Vaccine. 2023 Mar 3;41(10):1760-1767. doi: 10.1016/j.vaccine.2023.02.010. Epub 2023 Feb 10.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: April 2, 2026
• First Submitted That Met QC Criteria: April 22, 2026
• First Posted (Actual): April 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Hospital; Communication; Immunization
• Additional Relevant MeSH Terms: Behavior; Communication
• Other Study ID Numbers: STUDY00005086; R21HD113971 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual-level clinician survey responses and interview data will be shared. The investigators do not plan to share patient health record data publicly.
• IPD Sharing Time Frame: Shared data generated from this project will be made available at the time of publication. The duration of sharing of the data will be a minimum of 3 years after the end of the funding period.
• IPD Sharing Access Criteria: The final de-identified individual-level clinician survey and interview data will be deposited in the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH). DASH data are findable through the DASH faceted search interface, and DASH data are indexed for public search. The NICHD DASH Data or Biospecimen Access Committee reviews all requests to determine that a requester's proposed use of the data and/or biospecimens is scientifically and ethically appropriate and does not conflict with constraints or informed consent limitations identified by the institution(s) that submitted the data or biospecimens. More information is available on the NICHD DASH website.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No