Seattle Children's Research Institute
Seattle, Washington, 98145, United States
NCT Number: NCT07552857
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.
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Interventional
Not applicable
Seattle, Washington, 98145, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Patient Inclusion Criteria:
Patient Exclusion Criteria:
Clinician Inclusion Criteria:
Clinician Exclusion Criteria:
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.
Time frame: Hospital admission to discharge (up to 7 months or the intervention end date, whichever comes first)
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: Up to 8 months after the intervention start date
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: At Baseline and Post-Intervention (up to 10 months after the intervention start date)
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)
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: Up to 2 months after the intervention end date
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 start date
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 intervention end date
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 the intervention end date
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.
Contact information is provided by the study sponsor or research team.
Annika M Hofstetter, MD, PhD, MPH
CONTACT
Mersine A Bryan, MD, MPH
CONTACT
Seattle Children's Hospital
Other
Presumptively Initiating Vaccines and Optimizing Talk for Inpatients (PIVOT-IN): A Vaccine Communication Training Intervention for Pediatric Inpatient Clinicians
Acronym: PIVOT-IN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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