Preventive Health Services (PREV HEALTH SERV)PIVOT-INNCT07552857
A Vaccine Communication Training Intervention for Pediatric Inpatient Clinicians
A study testing PIVOT-IN and Standardized Vaccine Eligibility Screening in people with Preventive Health Services (PREV HEALTH SERV), run by Seattle Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Preventive Health Services (PREV HEALTH SERV)
- What is being tested?
- PIVOT-IN and Standardized Vaccine Eligibility Screening
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mersine A Bryan, MD, MPH contact
United States1 site
Seattle Children's Research Institute
Seattle, Washington, 98145
About this study
Official title: 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.
Read the 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.
- Being tested
- PIVOT-IN, Standardized Vaccine Eligibility Screening
- Keywords
- Hospital, Communication, Immunization
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIVOT-INBehavioural
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.
Standardized Vaccine Eligibility ScreeningOther
An electronic health record prompt to identify patients due or overdue for vaccines was activated by the hospital in September.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Behavioral: PIVOT-IN |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 2 months after the intervention end date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Preventive Health Services (PREV HEALTH SERV)Studies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Washington, National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Annika Hofstetter, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552857
- Sponsor's protocol ID
- STUDY00005086
- Other IDs
- R21HD113971
- Acronym
- PIVOT-IN
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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.
PubMed 40305020O'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.
PubMed 36775776
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presumptively Initiating Vaccines and Optimizing Talk for Inpatients (PIVOT-IN): A Vaccine Communication Training Intervention for Pediatric Inpatient Clinicians
- ClinicalTrials.gov ID
- NCT07552857
- Acronym / sponsor ID
- PIVOT-IN / STUDY00005086
- Keywords
- Hospital, Communication, Immunization
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Washington, National Institutes of Health (NIH)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Baseline | No intervention | –Standard care was delivered to hospitalized patients. (Sept 2023-Aug 2025) |
| Standardized Vaccine Eligibility Screening | Other | Other: Standardized Vaccine Eligibility ScreeningAn electronic health record prompt to identify patients due or overdue for vaccines was activated. (Sept 2025-Mar 2026) |
| Vaccine Communication Training | Experimental | Behavioral: PIVOT-INInpatient clinicians will be trained using the 'Presumptively Initiating Vaccines and Optimizing Talk for Inpatients (PIVOT-IN)' curriculum. (Apr 2026-Dec 2026) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PIVOT-INInpatient 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. | Behavioural | Vaccine Communication Training |
| Standardized Vaccine Eligibility ScreeningAn electronic health record prompt to identify patients due or overdue for vaccines was activated by the hospital in September. | Other | Standardized Vaccine Eligibility Screening |
Primary outcome
Percentage of vaccine-eligible hospitalized patients who receive routine childhood vaccines during hospitalization
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.
7 secondary outcomes
Number of clinicians who complete the PIVOT-IN vaccine communication curriculum
Time frame: Up to 8 months after the intervention start date
Change in clinicians' perceived self-efficacy in discussing vaccines
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
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
Time frame: Up to 2 months after the intervention end date
Perceived acceptability of the PIVOT-IN vaccine communication curriculum
Time frame: Up to 2 months after the intervention start date
Perceived appropriateness of the vaccine communication curriculum
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
Time frame: Up to 2 months after the intervention end date
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Background: PubMed 40305020Opel 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.
- Background: PubMed 36775776O'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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mersine A Bryan, MD, MPH contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PIVOT-IN and Standardized Vaccine Eligibility Screening in people with Preventive Health Services (PREV HEALTH SERV), run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annika M Hofstetter, MD, PhD, MPH (206-884-1699, annika.hofstetter@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of vaccine-eligible hospitalized patients who receive routine childhood vaccines during hospitalization (time frame: Hospital admission to discharge (up to 7 months or the intervention end date, whichever comes first)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07552857, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.