NCT07552857

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
Apr 2026Feb 2027

Study Start

First participant enrolled

April 1, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2026

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 27, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

April 2, 2026

Last Update Submit

April 29, 2026

Conditions

Keywords

HospitalCommunicationImmunization

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Number of clinicians who complete the PIVOT-IN vaccine communication curriculum

    Up to 8 months after the intervention start date

  • Change in clinicians' perceived self-efficacy in discussing vaccines

    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

    At Baseline and Post-Intervention (up to 10 months after the intervention start date)

  • Perceived feasibility of the PIVOT-IN vaccine communication curriculum

    Up to 2 months after the intervention end date

  • Perceived acceptability of the PIVOT-IN vaccine communication curriculum

    Up to 2 months after the intervention start date

  • +2 more secondary outcomes

Study Arms (3)

Baseline

NO INTERVENTION

Standard care was delivered to hospitalized patients. (Sept 2023-Aug 2025)

Standardized Vaccine Eligibility Screening

OTHER

An electronic health record prompt to identify patients due or overdue for vaccines was activated. (Sept 2025-Mar 2026)

Other: Standardized Vaccine Eligibility Screening

Vaccine Communication Training

EXPERIMENTAL

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

Interventions

PIVOT-INBEHAVIORAL

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.

Vaccine Communication Training

An electronic health record prompt to identify patients due or overdue for vaccines was activated by the hospital in September.

Standardized Vaccine Eligibility Screening

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Medical contraindication to vaccination
  • Died during hospitalization
  • Discharged from intensive care unit
  • Discharged to hospice care
  • 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)
  • Works only night shifts or on short-term contract (i.e., travel nurse)
  • Will complete residency training during intervention period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle Children's Research Institute

Seattle, Washington, 98145, United States

Location

Related Publications (2)

  • 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.

    PMID: 40305020BACKGROUND
  • 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.

    PMID: 36775776BACKGROUND

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Annika M Hofstetter, MD, PhD, MPH

CONTACT

Mersine A Bryan, MD, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

April 2, 2026

First Posted

April 27, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

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.
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.
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