Childhood VaccinationVHIPNCT01667354
Vaccine Hesitancy Intervention--Provider (VHIP)
A study testing Academic Detailing in people with Childhood Vaccination, run by Kaiser Permanente at 1 site in United States.
Trial summary
The primary aim of this trial is to test the effectiveness of an intervention to train primary care physicians to determine if it leads to decreased parental vaccine hesitancy. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Childhood Vaccination
- What is being tested?
- Academic Detailing
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 491 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Located in King, Snohomish, Pierce Counties, WA;
- Family practice clinics;
- Pediatric practice clinics;
- Order > 1000 doses of vaccine in 2009 from State of Washington Department of Health.
- Babies born at participating hospitals;
- Mother can be recruited before discharged post-birth;
- Mothers declare pediatric care at one of participating clinics;
- Singleton or twin pregnancies.
Who cannot join
- Babies born < 36 weeks gestational age;
- Known medical vaccine contraindications;
- Parental age < 18;
- NICU;
- Triplet or more;
- Maternal complications.
Trial locations and contacts
1 site in 1 country.
United States1 site
Group Health Research Institute
Seattle, Washington, 98101
About this study
The primary aim of this trial is to test the effectiveness of an intervention to train primary care physicians to determine if it leads to decreased parental vaccine hesitancy.
Read the detailed description
The primary aim of this trial is to test the effectiveness of an intervention to train primary care physicians to determine if it leads to decreased parental vaccine hesitancy. The investigators will train primary care teams with an initial training followed by telephone coaching and follow-up visits, and assess the outcomes of parental vaccine hesitancy (primary) and physician self-efficacy (secondary) at baseline and 6 months.
- Conditions
- Childhood Vaccination
- Being tested
- Academic Detailing
- Keywords
- Parental Childhood Vaccine Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Academic DetailingBehavioural
The intervention design is based on "academic detailing," an effective method of changing physician behavior. The aim of the training is effective communication with parents who are hesitant about childhood vaccinations.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Clinics | Experimental | Providers in intervention clinics will receive a training followed by telephone coaching and follow-up visits for six months. Receives: Behavioral: Academic Detailing |
| Control Clinics | No intervention | Control clinics will receive all intervention materials at the completion of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental Vaccine Hesitancy Measure
The investigators will contact mothers of newborns in study practices and conduct a telephone survey at two time points: baseline and 6 months. Surveys will assess parental hesitancy, parental trust in provider, and other covariates such as perceived social norms, other sources of information about vaccines, and demographic information.
Measured: Change from Baseline in Parental Hesitancy at 6 months
Secondary outcomes (1)
Physician Self Efficacy Measure
Assessed via self-administered surveys of providers in all participating clinics at baseline and 6-months. The investigators will measure physician attitudes, perceived norms, intentions to change behavior, practice characteristics, and physician demographics.
Measured: Change from Baseline in Physician Attitudes at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startFeb 2012
- Primary completionOct 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood VaccinationStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 491 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Seattle Children's Hospital, Washington State, Department of Health, WithinReach
- Responsible party
- Sponsor
- Investigators
- David Grossman, MD, MPH, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01667354
- Sponsor's protocol ID
- 250147
- Acronym
- VHIP
- Status last verified
- Oct 2017
- First submitted
- 6 Mar 2012
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Henrikson NB, Opel DJ, Grothaus L, Nelson J, Scrol A, Dunn J, Faubion T, Roberts M, Marcuse EK, Grossman DC. Physician Communication Training and Parental Vaccine Hesitancy: A Randomized Trial. Pediatrics. 2015 Jul;136(1):70-9. doi: 10.1542/peds.2014-3199. Epub 2015 Jun 1.
PubMed 26034240
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccine Hesitancy Intervention--Provider (VHIP)
- ClinicalTrials.gov ID
- NCT01667354
- Acronym / sponsor ID
- VHIP / 250147
- Conditions
- Childhood Vaccination
- Keywords
- Parental Childhood Vaccine Hesitancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 491 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Seattle Children's Hospital, Washington State, Department of Health, WithinReach
- Study start
- Feb 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 17 Aug 2012 (estimated)
- 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.
The primary aim of this trial is to test the effectiveness of an intervention to train primary care physicians to determine if it leads to decreased parental vaccine hesitancy.
Detailed description
The primary aim of this trial is to test the effectiveness of an intervention to train primary care physicians to determine if it leads to decreased parental vaccine hesitancy. The investigators will train primary care teams with an initial training followed by telephone coaching and follow-up visits, and assess the outcomes of parental vaccine hesitancy (primary) and physician self-efficacy (secondary) at baseline and 6 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Clinics | Experimental | Behavioral: Academic DetailingProviders in intervention clinics will receive a training followed by telephone coaching and follow-up visits for six months. |
| Control Clinics | No intervention | –Control clinics will receive all intervention materials at the completion of the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Located in King, Snohomish, Pierce Counties, WA;
- Family practice clinics;
- Pediatric practice clinics;
- Order > 1000 doses of vaccine in 2009 from State of Washington Department of Health.
- Babies born at participating hospitals;
Key exclusion criteria (6 listed)
- Babies born < 36 weeks gestational age;
- Known medical vaccine contraindications;
- Parental age < 18;
- NICU;
- Triplet or more;
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 |
|---|---|---|
| Academic DetailingThe intervention design is based on "academic detailing," an effective method of changing physician behavior. The aim of the training is effective communication with parents who are hesitant about childhood vaccinations. | Behavioural | Intervention Clinics |
Primary outcome
Parental Vaccine Hesitancy Measure
Time frame: Change from Baseline in Parental Hesitancy at 6 months
The investigators will contact mothers of newborns in study practices and conduct a telephone survey at two time points: baseline and 6 months. Surveys will assess parental hesitancy, parental trust in provider, and other covariates such as perceived social norms, other sources of information about vaccines, and demographic information.
1 secondary outcome
Physician Self Efficacy Measure
Time frame: Change from Baseline in Physician Attitudes at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
- Derived from this study: PubMed 26034240Henrikson NB, Opel DJ, Grothaus L, Nelson J, Scrol A, Dunn J, Faubion T, Roberts M, Marcuse EK, Grossman DC. Physician Communication Training and Parental Vaccine Hesitancy: A Randomized Trial. Pediatrics. 2015 Jul;136(1):70-9. doi: 10.1542/peds.2014-3199. Epub 2015 Jun 1.
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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.
David Grossman, MD, MPH principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Academic Detailing in people with Childhood Vaccination, run by Kaiser Permanente at 1 site 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 8 inclusion and 6 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 13 Oct 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Parental Vaccine Hesitancy Measure (time frame: Change from Baseline in Parental Hesitancy at 6 months). 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 NCT01667354, which also lists 1 linked publication.
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 13 Oct 2017.