An interventional study of PIVOT-IN and Standardized Vaccine Eligibility Screening in Preventive Health Services (PREV HEALTH SERV), sponsored by Seattle Children's Hospital. Not yet recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by Seattle Children's Hospital · Not applicable, Interventional, and Health services research
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.
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.
719 studies on the registry are indexed under Communication; 159 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 144 across 571 interventional studies indexed under Communication.
Browse Communication studies →Seattle Children's Hospital is the lead sponsor of 215 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient Inclusion Criteria:
Patient Exclusion Criteria:
Clinician Inclusion Criteria:
Clinician Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard care was delivered to hospitalized patients. (Sept 2023-Aug 2025)
An electronic health record prompt to identify patients due or overdue for vaccines was activated. (Sept 2025-Mar 2026)
Other: Standardized Vaccine Eligibility Screening
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.
An electronic health record prompt to identify patients due or overdue for vaccines was activated by the hospital in September.
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.
Time frame: Hospital admission to discharge (up to 7 months or the intervention end date, whichever comes first)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 2 months after the intervention end date
Plan to share: Yes — 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.
Data sharing details ↗ · dash.nichd.nih.gov
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