HPV VaccinesGIVENCT01159093
Giving Immunizations Through Vaccine Education
A study testing Family Decision Support, Clinician Decision Support and Family Decision Support and Clinician Decision Support in people with HPV Vaccines, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
This study will test the effectiveness of clinician-focused health IT-based decision support, family-focused health IT-based decision support, and a combination of both efforts, in increasing HPV and other adolescent vaccine rates among adolescent girls. Read more about this study
- Who is it for?
- Ages 11 to 17 years, women only
- Conditions the study is for
- HPV Vaccines
- What is being tested?
- Family Decision Support, Clinician Decision Support and Family Decision Support and Clinician Decision Support
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23,675 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to May 2011
- 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 11 to 17 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- All clinicians practicing at participating sites
- Parents with an eligible adolescent girl
- Adolescent girls
- Ages 11-17
- Has a visit at one of the primary care centers within the last 15 months.
- Has not completed the teen vaccine series
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19103
About this study
Official title: Using Health Information Technology to Improve Healthcare Quality in Primary Care Practices and in Transitions Between Care Settings
This study will test the effectiveness of clinician-focused health IT-based decision support, family-focused health IT-based decision support, and a combination of both efforts, in increasing HPV and other adolescent vaccine rates among adolescent girls. We hypothesize that a combination of clinician-focused clinical decision support and family-focused decision support will be most effective.
Read the detailed description
- Clinician-focused intervention includes an electronic health record-based decision support mechanism including reminders, education, audit and feedback on vaccination success.
- Family-focused intervention includes vaccine reminders and informational telephone calls prompted by the electronic health record.
- Conditions
- HPV Vaccines
- Being tested
- Family Decision Support, Clinician Decision Support, Family Decision Support and Clinician Decision Support, Control
- Keywords
- Clinical Decision Support Systems
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Decision SupportBehavioural
Also called Clinical Decision Support, Family Focused Intervention
Family-focused intervention includes informational vaccine reminder telephone calls prompted by an electronic health record.
Clinician Decision SupportBehavioural
Also called Clinical Decision Support, Clinician Focused Intervention
Clinician-focused intervention includes an electronic health record-based decision support mechanism including reminders, education, audit and feedback on vaccination success.
Family Decision Support and Clinician Decision SupportOther
Also called Family Decision Support, Clinician Decision Support
This will be a combination of the family-focused decision support (telephone reminder calls) and clinician-focused decision support (clinical alerts).
ControlOther
Usual care
| Study group | Role | What they receive |
|---|---|---|
| Family Decision Support | Experimental | Families will receive informational vaccine reminder telephone calls. Receives: Behavioral: Family Decision Support |
| Clinical Decision Support | Experimental | In this treatment arm, clinicians receive the decision support at the point of care within an electronic health record. Receives: Behavioral: Clinician Decision Support |
| Family DS+ Clinician DS | Experimental | Families will receive informational vaccine reminder calls and their clinicians will receive electronic health record-based decision support for immunizations. Receives: Behavioral: Family Decision Support; Behavioral: Clinician Decision Support; Other: Family Decision Support and Clinician Decision Support |
| Control | Other | This group will receive regular primary care with no decision support. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of HPV vaccination among girls actively cared for at participating sites
The outcome will be assessed monthly, until study completion (1 year).
Measured: Monthly, up to 1 year
Secondary outcomes (1)
Rates of meningococcal and tetanus, diphtheria, and pertussis vaccines among girls in the study
The outcome will be assessed monthly, until study completion (1 year).
Measured: Monthly, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2011
- Study completionMay 2011
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 HPV VaccinesStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- None (open label)
- Enrolment
- 23,675 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Alexander G Fiks, MD, MSCE, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01159093
- Sponsor's protocol ID
- 09-00-7352
- Other IDs
- AHRQ
- Acronym
- GIVE
- Status last verified
- Aug 2011
- First submitted
- 7 Jul 2010
- Last updated
- 12 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Mayne SL, duRivage NE, Feemster KA, Localio AR, Grundmeier RW, Fiks AG. Effect of decision support on missed opportunities for human papillomavirus vaccination. Am J Prev Med. 2014 Dec;47(6):734-44. doi: 10.1016/j.amepre.2014.08.010. Epub 2014 Nov 18.
PubMed 25455116
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Health Information Technology to Improve Healthcare Quality in Primary Care Practices and in Transitions Between Care Settings
- ClinicalTrials.gov ID
- NCT01159093
- Acronym / sponsor ID
- GIVE / 09-00-7352
- Conditions
- HPV Vaccines
- Keywords
- Clinical Decision Support Systems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23,675 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- May 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 9 Jul 2010 (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.
This study will test the effectiveness of clinician-focused health IT-based decision support, family-focused health IT-based decision support, and a combination of both efforts, in increasing HPV and other adolescent vaccine rates among adolescent girls. We hypothesize that a combination of clinician-focused clinical decision support and family-focused decision support will be most effective.
Detailed description
- Clinician-focused intervention includes an electronic health record-based decision support mechanism including reminders, education, audit and feedback on vaccination success.
- Family-focused intervention includes vaccine reminders and informational telephone calls prompted by the electronic health record.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Family Decision Support | Experimental | Behavioral: Family Decision SupportFamilies will receive informational vaccine reminder telephone calls. |
| Clinical Decision Support | Experimental | Behavioral: Clinician Decision SupportIn this treatment arm, clinicians receive the decision support at the point of care within an electronic health record. |
| Family DS+ Clinician DS | Experimental | Behavioral: Family Decision Support, Behavioral: Clinician Decision Support, Other: Family Decision Support and Clinician Decision SupportFamilies will receive informational vaccine reminder calls and their clinicians will receive electronic health record-based decision support for immunizations. |
| Control | Other | Other: ControlThis group will receive regular primary care with no decision support. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- All clinicians practicing at participating sites
- Parents with an eligible adolescent girl
- Adolescent girls
- Ages 11-17
- Has a visit at one of the primary care centers within the last 15 months.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Family Decision SupportAlso: Clinical Decision Support, Family Focused InterventionFamily-focused intervention includes informational vaccine reminder telephone calls prompted by an electronic health record. | Behavioural | Family DS+ Clinician DS, Family Decision Support |
| Clinician Decision SupportAlso: Clinical Decision Support, Clinician Focused InterventionClinician-focused intervention includes an electronic health record-based decision support mechanism including reminders, education, audit and feedback on vaccination success. | Behavioural | Clinical Decision Support, Family DS+ Clinician DS |
| Family Decision Support and Clinician Decision SupportAlso: Family Decision Support, Clinician Decision SupportThis will be a combination of the family-focused decision support (telephone reminder calls) and clinician-focused decision support (clinical alerts). | Other | Family DS+ Clinician DS |
| ControlUsual care | Other | Control |
Primary outcome
Rate of HPV vaccination among girls actively cared for at participating sites
Time frame: Monthly, up to 1 year
The outcome will be assessed monthly, until study completion (1 year).
1 secondary outcome
Rates of meningococcal and tetanus, diphtheria, and pertussis vaccines among girls in the study
Time frame: Monthly, up to 1 year
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 12 Mar 2015.
- Derived from this study: PubMed 25455116Mayne SL, duRivage NE, Feemster KA, Localio AR, Grundmeier RW, Fiks AG. Effect of decision support on missed opportunities for human papillomavirus vaccination. Am J Prev Med. 2014 Dec;47(6):734-44. doi: 10.1016/j.amepre.2014.08.010. Epub 2014 Nov 18.
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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.
Alexander G Fiks, MD, MSCE principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Decision Support, Clinician Decision Support and Family Decision Support and Clinician Decision Support in people with HPV Vaccines, run by Children's Hospital of Philadelphia 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 6 inclusion and 1 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 12 Mar 2015. 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?
Rate of HPV vaccination among girls actively cared for at participating sites (time frame: Monthly, up to 1 year). 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 NCT01159093, 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 12 Mar 2015.