Preventive Health ServicesSHOTNCT02708745

Screening for Hesitancy to Optimize Talk

A study testing Intervention Survey in people with Preventive Health Services, run by Seattle Children's Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The overall goal of this project is to determine whether integrating a novel parent-report measure of vaccine hesitancy into pediatric primary care is effective in improving acceptance of childhood vaccines among vaccine-hesitant parents. Read more about this study

Who is it for?: Ages 1 day and olderHealthy volunteers can take part
Conditions the study is for: Preventive Health Services
What is being tested?: Intervention Survey
Type of treatment: Vaccines, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 562 participants
Where: No sites listed yet
Study dates: Mar 2016to 11 Jun 2018
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 and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Parents: Parents must be English speaking, ≥18 years old, have a newborn singleton infant ≤2 months, born at ≥35 weeks gestation who is receiving pediatric care at an enrolled Kaiser Permanente or Allegro Pediatrics clinic, and be vaccine hesitant (defined as positive screening score on eligibility survey).
Newborns: Newborns 0 - 2 months old whose parents enroll in the study will be invited to participate.
Providers: All pediatric and family practice providers at Kaiser Permanente and Allegro Pediatrics primary clinics within a 5 county region in western Washington (Snohomish, King, Pierce, Thurston, and Kitsap Counties) will be eligible to participate.

Who cannot join

Parents/Children: Parents who are not 18 years or older, require language interpretation for medical care, have an infant born <35 weeks gestation, are not vaccine hesitant or will not be taking their child to a participating clinic for health supervision visits will be excluded.
Providers: Clinics and providers outside the 5 county region in western Washington (Snohomish, King, Pierce, Thurston, and Kitsap) will be excluded.

About this study

Official title: Use of a Novel Parent-Report Measure to Improve Childhood Vaccine Uptake: The Screening for Hesitancy to Optimize Talk (SHOT) Study

Read the detailed description

The primary goal of this project is to evaluate the effectiveness of an innovative intervention designed to address these barriers-the Screening for Hesitancy to Optimize Talk (SHOT) intervention-in improving provider-parent vaccine discussions and increasing vaccine acceptance. The SHOT intervention involves administering a validated parent-report measure to parents and communicating their score and item-specific responses to their child's provider before their child's 2 and 6 month health supervision visits. The survey contains 15 questions regarding Health Belief Model concepts that influence parent vaccination behavior and has been shown to predict under-immunization.

Our specific aims are to (1) evaluate the impact of the SHOT intervention on a child's immunization status using a matched-pair, cluster randomized controlled trial design; (2) assess how parents' ratings of their vaccine discussions with their child's provider change as a function of the SHOT intervention; and (3) compare pre- and post-study perceptions of barriers to quality vaccine discussions with parents between providers in the SHOT and control arm.

Conditions: Preventive Health Services
Being tested: Intervention Survey, Placebo Survey
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.

Intervention SurveyBehavioural
Placebo SurveyBehavioural

Study groups in NCT02708745
Study group	Role	What they receive
Placebo Arm	Placebo comparator	Parent participants will receive a placebo survey about their attitudes toward common child health topics before their child's health supervision visit. Receives: Behavioral: Placebo Survey
Intervention Arm	Experimental	Parent participants will also receive the intervention survey about their attitudes toward childhood vaccines before their child's health supervision visit. Receives: Behavioral: Intervention Survey

What is being measured

The primary outcome is the main question the study is designed to answer.

Child's Mean Percent Days Under-immunized
Mean percent days under-immunized among children of parents who received (vs. did not receive) the intervention
Measured: Child's immunization status at 8 months of age

Secondary outcomes (2)

Number of Parents With a Highly Rated Visit Experience
Score on a 15-item parent-completed visit experience survey (minimum score 15; maximum score 105, with higher scores suggesting a higher rated visit experience)
Measured: 24-48 hours after the 6 month health supervision visit
Provider Perceptions of Barriers to the Vaccine Discussion
Provider-reported ratings of the significance of 3 barriers to the vaccine discussion: a) not having enough time to discuss parental vaccine concerns, b) not realizing until late in the visit that a parent had vaccine concerns, and c) not understanding a parent's specific vaccine concerns to be barriers pre- and post-intervention
Measured: Change post-intervention from pre-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 201611 Jun 2018

First posted15 Mar 2016 (estimated)
Study startMar 2016
Primary completion11 Jun 2018
Study completion11 Jun 2018

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 (8)Papers the sponsor has linked to this study.
Other trials for Preventive Health ServicesStudies 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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 562 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02708745
Sponsor's protocol ID: 1R21HD083770-01A1
Acronym: SHOT
Status last verified: Sep 2019
First submitted: 9 Mar 2016
Last updated: 1 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Hammer LD, Curry ES, Harlor AD, Laughlin JJ, Leeds AJ, Lessin HR, Rodgers CT, Granado-Villar DC, Brown JM, Cotton WH, Gaines BM, Gambon TB, Gitterman BA, Gorski PA, Kraft CA, Marino RV, Paz-Soldan GJ, Zind B; Committee on Practice and Ambulatory Medicine; Council on Community Pediatrics. Increasing immunization coverage. Pediatrics. 2010 Jun;125(6):1295-304. doi: 10.1542/peds.2010-0743. Epub 2010 May 31.
PubMed 20513736
Opel DJ, Heritage J, Taylor JA, Mangione-Smith R, Salas HS, Devere V, Zhou C, Robinson JD. The architecture of provider-parent vaccine discussions at health supervision visits. Pediatrics. 2013 Dec;132(6):1037-46. doi: 10.1542/peds.2013-2037. Epub 2013 Nov 4.
PubMed 24190677
Healy CM, Montesinos DP, Middleman AB. Parent and provider perspectives on immunization: are providers overestimating parental concerns? Vaccine. 2014 Jan 23;32(5):579-84. doi: 10.1016/j.vaccine.2013.11.076. Epub 2013 Dec 4.
PubMed 24315883
McCauley MM, Kennedy A, Basket M, Sheedy K. Exploring the choice to refuse or delay vaccines: a national survey of parents of 6- through 23-month-olds. Acad Pediatr. 2012 Sep-Oct;12(5):375-83. doi: 10.1016/j.acap.2012.06.007. Epub 2012 Aug 22.
PubMed 22921495
Opel DJ, Mangione-Smith R, Taylor JA, Korfiatis C, Wiese C, Catz S, Martin DP. Development of a survey to identify vaccine-hesitant parents: the parent attitudes about childhood vaccines survey. Hum Vaccin. 2011 Apr;7(4):419-25. doi: 10.4161/hv.7.4.14120. Epub 2011 Apr 1.
PubMed 21389777
Opel DJ, Taylor JA, Mangione-Smith R, Solomon C, Zhao C, Catz S, Martin D. Validity and reliability of a survey to identify vaccine-hesitant parents. Vaccine. 2011 Sep 2;29(38):6598-605. doi: 10.1016/j.vaccine.2011.06.115. Epub 2011 Jul 16.
PubMed 21763384
Opel DJ, Taylor JA, Zhou C, Catz S, Myaing M, Mangione-Smith R. The relationship between parent attitudes about childhood vaccines survey scores and future child immunization status: a validation study. JAMA Pediatr. 2013 Nov;167(11):1065-71. doi: 10.1001/jamapediatrics.2013.2483.
PubMed 24061681
Opel DJ, Henrikson N, Lepere K, Hawkes R, Zhou C, Dunn J, Taylor JA. Previsit Screening for Parental Vaccine Hesitancy: A Cluster Randomized Trial. Pediatrics. 2019 Nov;144(5):e20190802. doi: 10.1542/peds.2019-0802. Epub 2019 Oct 9.
PubMed 31597690

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Preventive Health Services trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of a Novel Parent-Report Measure to Improve Childhood Vaccine Uptake: The Screening for Hesitancy to Optimize Talk (SHOT) Study
ClinicalTrials.gov ID: NCT02708745
Acronym / sponsor ID: SHOT / 1R21HD083770-01A1
Conditions: Preventive Health Services
Keywords: communication, immunization
Study type: Interventional
Recruitment status: Completed
Enrolment: 562 participants (actual)
Lead sponsor: Seattle Children's HospitalUniversity, hospital or other
Collaborators: Kaiser Permanente, University of Washington
Study start: Mar 2016
Primary completion: 11 Jun 2018 (actual)
Study completion: 11 Jun 2018 (actual)
First posted: 15 Mar 2016 (estimated)
Results: Posted 1 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo Arm	Placebo comparator	Behavioral: Placebo SurveyParent participants will receive a placebo survey about their attitudes toward common child health topics before their child's health supervision visit.
Intervention Arm	Experimental	Behavioral: Intervention SurveyParent participants will also receive the intervention survey about their attitudes toward childhood vaccines before their child's health supervision visit.

Who may qualify

Ages: 1 day and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Parents: Parents must be English speaking, ≥18 years old, have a newborn singleton infant ≤2 months, born at ≥35 weeks gestation who is receiving pediatric care at an enrolled Kaiser Permanente or Allegro Pediatrics clinic, and be vaccine hesitant (defined as positive screening score on eligibility survey).
Newborns: Newborns 0 - 2 months old whose parents enroll in the study will be invited to participate.
Providers: All pediatric and family practice providers at Kaiser Permanente and Allegro Pediatrics primary clinics within a 5 county region in western Washington (Snohomish, King, Pierce, Thurston, and Kitsap Counties) will be eligible to participate.

Key exclusion criteria (2 listed)

Parents/Children: Parents who are not 18 years or older, require language interpretation for medical care, have an infant born <35 weeks gestation, are not vaccine hesitant or will not be taking their child to a participating clinic for health supervision visits will be excluded.
Providers: Clinics and providers outside the 5 county region in western Washington (Snohomish, King, Pierce, Thurston, and Kitsap) will be excluded.

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
Intervention Survey	Behavioural	Intervention Arm
Placebo Survey	Behavioural	Placebo Arm

Primary outcome

Child's Mean Percent Days Under-immunized
Time frame: Child's immunization status at 8 months of age
Mean percent days under-immunized among children of parents who received (vs. did not receive) the intervention

2 secondary outcomes

Number of Parents With a Highly Rated Visit Experience
Time frame: 24-48 hours after the 6 month health supervision visit
Provider Perceptions of Barriers to the Vaccine Discussion
Time frame: Change post-intervention from pre-intervention

Results and safety

Results posted to the registry on 1 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Arm	91	91
Intervention Arm	69	65
Pre-Intervention Providers	204	121
Post-Intervention Providers	198	116

Primary outcome: Child's Mean Percent Days Under-immunized

Time frame: Child's immunization status at 8 months of age. Mean (95% Confidence Interval). Unit: percentage of days under-immunized

Measure	Placebo Arm n = 91	Intervention Arm n = 65
Value	19.1 (12 to 26.3)	25.2 (16 to 34.5)

Placebo Arm vs Intervention Arm: p = .29, t-test, 2 sided

Population analysed: Mean percent days under-immunized of child participants by study arm

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 years 1 month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Arm	0 of 91 (0%)	0 of 91 (0%)	0 of 91
Intervention Arm	0 of 65 (0%)	0 of 65 (0%)	0 of 65
Pre-Intervention Providers	0 of 121 (0%)	0 of 121 (0%)	0 of 121
Post-Intervention Providers	0 of 116 (0%)	0 of 116 (0%)	0 of 116

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20513736Hammer LD, Curry ES, Harlor AD, Laughlin JJ, Leeds AJ, Lessin HR, Rodgers CT, Granado-Villar DC, Brown JM, Cotton WH, Gaines BM, Gambon TB, Gitterman BA, Gorski PA, Kraft CA, Marino RV, Paz-Soldan GJ, Zind B; Committee on Practice and Ambulatory Medicine; Council on Community Pediatrics. Increasing immunization coverage. Pediatrics. 2010 Jun;125(6):1295-304. doi: 10.1542/peds.2010-0743. Epub 2010 May 31.
Background: PubMed 24190677Opel DJ, Heritage J, Taylor JA, Mangione-Smith R, Salas HS, Devere V, Zhou C, Robinson JD. The architecture of provider-parent vaccine discussions at health supervision visits. Pediatrics. 2013 Dec;132(6):1037-46. doi: 10.1542/peds.2013-2037. Epub 2013 Nov 4.
Background: PubMed 24315883Healy CM, Montesinos DP, Middleman AB. Parent and provider perspectives on immunization: are providers overestimating parental concerns? Vaccine. 2014 Jan 23;32(5):579-84. doi: 10.1016/j.vaccine.2013.11.076. Epub 2013 Dec 4.
Background: PubMed 22921495McCauley MM, Kennedy A, Basket M, Sheedy K. Exploring the choice to refuse or delay vaccines: a national survey of parents of 6- through 23-month-olds. Acad Pediatr. 2012 Sep-Oct;12(5):375-83. doi: 10.1016/j.acap.2012.06.007. Epub 2012 Aug 22.
Background: PubMed 21389777Opel DJ, Mangione-Smith R, Taylor JA, Korfiatis C, Wiese C, Catz S, Martin DP. Development of a survey to identify vaccine-hesitant parents: the parent attitudes about childhood vaccines survey. Hum Vaccin. 2011 Apr;7(4):419-25. doi: 10.4161/hv.7.4.14120. Epub 2011 Apr 1.
Background: PubMed 21763384Opel DJ, Taylor JA, Mangione-Smith R, Solomon C, Zhao C, Catz S, Martin D. Validity and reliability of a survey to identify vaccine-hesitant parents. Vaccine. 2011 Sep 2;29(38):6598-605. doi: 10.1016/j.vaccine.2011.06.115. Epub 2011 Jul 16.
Background: PubMed 24061681Opel DJ, Taylor JA, Zhou C, Catz S, Myaing M, Mangione-Smith R. The relationship between parent attitudes about childhood vaccines survey scores and future child immunization status: a validation study. JAMA Pediatr. 2013 Nov;167(11):1065-71. doi: 10.1001/jamapediatrics.2013.2483.
Derived from this study: PubMed 31597690Opel DJ, Henrikson N, Lepere K, Hawkes R, Zhou C, Dunn J, Taylor JA. Previsit Screening for Parental Vaccine Hesitancy: A Cluster Randomized Trial. Pediatrics. 2019 Nov;144(5):e20190802. doi: 10.1542/peds.2019-0802. Epub 2019 Oct 9.
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.

Douglas J Opel, MD, MPH principal investigator

Seattle Children's Hospital

Questions about this trial

What is this clinical trial studying?

A study testing Intervention Survey in people with Preventive Health Services, run by Seattle Children's Hospital.

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 3 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 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 1 Oct 2019). 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's Mean Percent Days Under-immunized (time frame: Child's immunization status at 8 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 NCT02708745, which also lists 8 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 1 Oct 2019.