Preventive Health Services (PREV HEALTH SERV)NCT03885232
Presumptively Initiating Vaccines and Optimizing Talk With Motivational Interviewing (PIVOT With MI)
A study testing Experimental: PIVOT with MI in people with Preventive Health Services (PREV HEALTH SERV), run by University of Colorado, Denver at 2 sites in United States.
Trial summary
The overall goal of this project is to determine whether a novel and innovative provider communication strategy is effective in improving vaccine acceptance among vaccine-hesitant parents (VHPs) and visit experience among VHPs and their health care providers. Read more about this study
- Who is it for?
- Ages 1 day to 18 months
- Conditions the study is for
- Preventive Health Services (PREV HEALTH SERV)
- What is being tested?
- Experimental: PIVOT with MI
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17,446 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2019to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 day to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parents: must be English or Spanish speaking, ≥18 years old, have an infant ≤18 months old, have legal guardianship of the infant, and is receiving pediatric care at an enrolled clinic
- Providers: All providers at participating study practices will be eligible to participate.
Who cannot join
- Parents: not English or Spanish speaking, under 18 years old, have an infant older than 18 months, not the legal guardian of the infant, and/or having a child who is not receiving pediatric care at an enrolled clinic.
- Providers: Providers who are not at participating study practices.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
The overall goal of this project is to determine whether a novel and innovative provider communication strategy is effective in improving vaccine acceptance among vaccine-hesitant parents (VHPs) and visit experience among VHPs and their health care providers.
Read the detailed description
The primary goal of this covariate constrained, cluster randomized controlled trial is to evaluate the effectiveness of an innovative provider communication strategy (PIVOT-MI) intervention in improving provider-parent vaccine discussions and increasing vaccine acceptance. Providers at intervention clinics will be trained to use the PIVOT-MI strategy in which a presumptive format is used to initiate the childhood vaccine recommendation with all parents, followed by use of motivational interviewing (MI) with parents who voice resistance to that recommendation. Providers at control clinics will deliver care as usual.
Specific aims are to evaluate the impact of PIVOT-MI, relative to control, on (1) child's immunization status; (2) parent-rated visit experience with their child's provider; and (3) change in provider experience of the vaccine discussion with vaccine-hesitant parents.
- Being tested
- Experimental: PIVOT with MI, Active Comparator: Control
- Keywords
- 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.
Experimental: PIVOT with MIBehavioural
Providers in participating intervention clinics will be trained in the PIVOT-MI strategy in which a presumptive format is used to initiate the childhood vaccine recommendation with all parents followed by use of motivational interviewing (MI) with parents who voice resistance to that recommendation. Parent participants will receive PIVOT-MI.
Active Comparator: ControlOther
Providers at participating control clinics will deliver care as usual. Parent participants will receive standard care.
| Study group | Role | What they receive |
|---|---|---|
| PIVOT with MI | Experimental | Clinics in which the Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing (PIVOT-MI) communication strategy has been implemented. Receives: Behavioral: Experimental: PIVOT with MI |
| Control | Active comparator | Clinics delivered standard care. Receives: Other: Active Comparator: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Immunization Status at 19 Months, 0 Days of Age Characterized as Percent Days Under-immunized (DUI)
Immunization status was obtained from WA or CO state immunization registry or directly from participating practices. At enrollment, parent/infant dyads completed the Parental Attitudes about Childhood Vaccines short version (PACV-SF), a validated survey scored from 0 to 4. A score of 2 or more represented parent/infant dyad with negative vaccine attitudes. Among parent/infant dyads with negative vaccine attitudes, the child's immunization status at 19 months was calculated based on recommended ages and intervals between doses provided by ACIP for summing late days for each dose of the 8 routine vaccines recommended by 19 months (HepB, rotavirus, DTaP, Hib, pneumococcal conjugate, inactivated polio virus, MMR, and varicella). There was a max of 23 recommended doses for the 8 vaccines - doses varied depending on brand. Total max DUI was a sum of total possible days late for each dose through 19mo(2830 days).Percent DUI was calculated by dividing child's DUI by the total maximum DUI.
Measured: Child's immunization status at 19 months of age
Secondary outcomes (2)
Post-Visit Parental Satisfaction Survey Scored on a 7-point Likert Scale
To assess parental satisfaction with their clinician during a health supervision visit, we asked all vaccine hesitant parents (identified by a Parental Attitudes about Childhood Vaccines-Short Form (PAC-V SF) score of 2 or more) in both both intervention and control arms if they would complete an additional 15-question survey over the phone within 24-48 hours after the completion of a health supervision visit for their child around 6 months of age. Due to COVID-19 restrictions, we had to extend the time frame to within 1 week after a health supervision visit at 2, 4, or 6 months of age. Ratings were on a 7-point Likert scale - Very Poor (1), Poor (2), Fair (3), Good (4), Very Good (5), Excellent (6), Outstanding (7). Overall experience with a rating of "Good (4)" or higher was considered to be a satisfactory visit.
Measured: approximately 6 months post birth
Change in Clinician Self-Efficacy With Parent/Infant Dyads With Negative Vaccine Attitudes - Pre-vs Post-Surveys
To assess changes in clinicians' perceived self-efficacy when discussing vaccines with parents/infant dyads with negative vaccine attitudes, a survey was administered to all participating clinicians at baseline and at study completion asking about vaccine recommendation behaviors and how they perceived their impact on parental decision making regarding vaccines. Self-efficacy was assessed with a 3-part question scored on a Likert Scale - Strongly Disagree, Somewhat Disagree, Somewhat Agree, Strongly Agree. Changes in perceived self-efficacy over time was assessed by comparing the number of clinicians who answered "Strongly Agree" or "Somewhat Agree" to the statement "When parents wish to delay or refuse childhood vaccines for their child, there is not much I can say to change their minds" at baseline and at post-study. Note that fewer clinicians completed the post-study survey due to such factors as retirement and staff turnover.
Measured: At Baseline and Post-Intervention (up to 2 years after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start1 Sep 2019
- Primary completion17 May 2023
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 University of Colorado, DenverThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 17,446 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- University of Missouri, Kansas City, Portland State University, University of Washington, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Seattle Children's Hospital, Children's Mercy Hospital Kansas City
- Responsible party
- Sponsor
- Investigators
- Sean O'Leary, MD, MPH, Principal investigator, University of Colorado, DenverDouglas Opel, MD, MPH, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885232
- Sponsor's protocol ID
- 17-1274
- Other IDs
- 1R01HD093628-01A1
- Status last verified
- Apr 2025
- First submitted
- 7 Feb 2019
- Last updated
- 30 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 40305020Opel DJ, Robinson JD, Spielvogle H, Spina C, Garrett K, Dempsey AF, Perreira C, Dickinson M, Zhou C, Pahud B, Taylor JA, O'Leary ST. 'Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing' (PIVOT with MI) trial: a protocol for a cluster randomised controlled trial of a clinician vaccine communication intervention. BMJ Open. 2020 Aug 11;10(8):e039299. doi: 10.1136/bmjopen-2020-039299.
PubMed 32784263
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presumptively Initiating Vaccines and Optimizing Talk With Motivational Interviewing (PIVOT With MI)
- ClinicalTrials.gov ID
- NCT03885232
- Acronym / sponsor ID
- 17-1274
- Keywords
- Communication, Immunization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17,446 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- University of Missouri, Kansas City, Portland State University, University of Washington, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Seattle Children's Hospital, Children's Mercy Hospital Kansas City
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 17 May 2023 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 21 Mar 2019 (actual)
- Results
- Posted 30 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this project is to determine whether a novel and innovative provider communication strategy is effective in improving vaccine acceptance among vaccine-hesitant parents (VHPs) and visit experience among VHPs and their health care providers.
Detailed description
The primary goal of this covariate constrained, cluster randomized controlled trial is to evaluate the effectiveness of an innovative provider communication strategy (PIVOT-MI) intervention in improving provider-parent vaccine discussions and increasing vaccine acceptance. Providers at intervention clinics will be trained to use the PIVOT-MI strategy in which a presumptive format is used to initiate the childhood vaccine recommendation with all parents, followed by use of motivational interviewing (MI) with parents who voice resistance to that recommendation. Providers at control clinics will deliver care as usual.
Specific aims are to evaluate the impact of PIVOT-MI, relative to control, on (1) child's immunization status; (2) parent-rated visit experience with their child's provider; and (3) change in provider experience of the vaccine discussion with vaccine-hesitant parents.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PIVOT with MI | Experimental | Behavioral: Experimental: PIVOT with MIClinics in which the Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing (PIVOT-MI) communication strategy has been implemented. |
| Control | Active comparator | Other: Active Comparator: ControlClinics delivered standard care. |
Who may qualify
- Ages
- 1 day to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Parents: must be English or Spanish speaking, ≥18 years old, have an infant ≤18 months old, have legal guardianship of the infant, and is receiving pediatric care at an enrolled clinic
- Providers: All providers at participating study practices will be eligible to participate.
Key exclusion criteria (2 listed)
- Parents: not English or Spanish speaking, under 18 years old, have an infant older than 18 months, not the legal guardian of the infant, and/or having a child who is not receiving pediatric care at an enrolled clinic.
- Providers: Providers who are not at participating study practices.
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 |
|---|---|---|
| Experimental: PIVOT with MIProviders in participating intervention clinics will be trained in the PIVOT-MI strategy in which a presumptive format is used to initiate the childhood vaccine recommendation with all parents followed by use of motivational interviewing (MI) with parents who voice resistance to that recommendation. Parent participants will receive PIVOT-MI. | Behavioural | PIVOT with MI |
| Active Comparator: ControlProviders at participating control clinics will deliver care as usual. Parent participants will receive standard care. | Other | Control |
Primary outcome
Child Immunization Status at 19 Months, 0 Days of Age Characterized as Percent Days Under-immunized (DUI)
Time frame: Child's immunization status at 19 months of age
Immunization status was obtained from WA or CO state immunization registry or directly from participating practices. At enrollment, parent/infant dyads completed the Parental Attitudes about Childhood Vaccines short version (PACV-SF), a validated survey scored from 0 to 4. A score of 2 or more represented parent/infant dyad with negative vaccine attitudes. Among parent/infant dyads with negative vaccine attitudes, the child's immunization status at 19 months was calculated based on recommended ages and intervals between doses provided by ACIP for summing late days for each dose of the 8 routine vaccines recommended by 19 months (HepB, rotavirus, DTaP, Hib, pneumococcal conjugate, inactivated polio virus, MMR, and varicella). There was a max of 23 recommended doses for the 8 vaccines - doses varied depending on brand. Total max DUI was a sum of total possible days late for each dose through 19mo(2830 days).Percent DUI was calculated by dividing child's DUI by the total maximum DUI.
2 secondary outcomes
Post-Visit Parental Satisfaction Survey Scored on a 7-point Likert Scale
Time frame: approximately 6 months post birth
Change in Clinician Self-Efficacy With Parent/Infant Dyads With Negative Vaccine Attitudes - Pre-vs Post-Surveys
Time frame: At Baseline and Post-Intervention (up to 2 years after baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: 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.
- Derived from this study: PubMed 32784263Opel DJ, Robinson JD, Spielvogle H, Spina C, Garrett K, Dempsey AF, Perreira C, Dickinson M, Zhou C, Pahud B, Taylor JA, O'Leary ST. 'Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing' (PIVOT with MI) trial: a protocol for a cluster randomised controlled trial of a clinician vaccine communication intervention. BMJ Open. 2020 Aug 11;10(8):e039299. doi: 10.1136/bmjopen-2020-039299.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sean O'Leary, MD, MPH principal investigator
University of Colorado, Denver
Douglas Opel, MD, MPH principal investigator
Seattle Children's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: PIVOT with MI in people with Preventive Health Services (PREV HEALTH SERV), run by University of Colorado, Denver at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 30 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Immunization Status at 19 Months, 0 Days of Age Characterized as Percent Days Under-immunized (DUI) (time frame: Child's immunization status at 19 months of age). 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 NCT03885232, 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 30 Apr 2025.