ImmunizationSTOP-HPVNCT03599570
The STOP-HPV Trial 2: Performance Feedback Intervention
A study testing STOP-HPV performance feedback intervention in people with Immunization and Vaccination, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Most adolescents who receive human papillomavirus (HPV) vaccine are vaccinated in pediatric practices, yet missed opportunities (MOs) for HPV vaccination occur often and lead to low HPV vaccination rates. Read more about this study
- Who is it for?
- Ages 11 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Immunization, Vaccination
- What is being tested?
- STOP-HPV performance feedback intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2018to 6 Mar 2020
- 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
- All sexes
- Healthy volunteers accepted
- Child
Practice Inclusion Criteria:
- The practice provides HPV vaccination services to adolescents.
- The practice is part of Physician's Computer Company (PCC), Office Practicum (OP) or (a) yet-to-be selected health system(s).
- The practice has had the same EHR system in place for a year or more (with special consideration on a case by case basis if they are close to but not do not reach a year).
- The practice agrees to not participate in other HPV-related QI projects or research interventions during the study period (with special consideration on a case by case basis).
Practice Exclusion Criteria:
- The practice plans to change EHR systems in the next three years.
- The practice participated in the last year, is currently engaged in, or plans to participate in an office-based HPV-related quality improvement (QI) project or research intervention during the study period (with special consideration on a case by case basis).
- Estimated 20% or more of adolescents at the practice receive HPV vaccinations at schools or health department clinics (given standard practice and published data, the investigators expect that few to no practices will need to be excluded based on this restriction).
Patient inclusion criteria:
-All patients of participating practices (intervention and comparison) aged 11-17 years who have at least 1 visit to the practice within the past two years.
Patient exclusion criteria:
-None apart from age of patients (above).
Trial locations and contacts
1 site in 1 country.
United States1 site
American Academy of Pediatrics
Itasca, Illinois, 60143
About this study
Official title: Improving HPV Vaccination Delivery in Pediatric Primary Care: The STOP-HPV Trial 2 Comparison of Performance Feedback (in the Presence of Communication Skills) and Standard of Care
Most adolescents who receive human papillomavirus (HPV) vaccine are vaccinated in pediatric practices, yet missed opportunities (MOs) for HPV vaccination occur often and lead to low HPV vaccination rates. This cluster randomized clinical trial (RCT) will test the effectiveness (and cost-effectiveness) of the addition of performance feedback (period 2) to training providers previously received on HPV vaccine communication (period 1) to reduce MOs and increase HPV vaccination rates.
Read the detailed description
HPV vaccine rates remain lower than rates for other adolescent vaccines. Missed opportunities (MOs) are healthcare visits during which a patient is eligible, but does not receive a vaccine. MOs for vaccination contribute strongly to low HPV vaccination rates. This trial focuses on period 2, the addition of performance feedback in the presence of communication skills training. Arm-1 intervention study practices add performance feedback (period 2), building upon their prior training in communication skills (period 1); Arm-2 comparison study practices continue delivering standard of care. During this period, the investigators will be measuring captured opportunities - the inverse of MOs, or visits when an eligible patient receives a vaccine. Providers rarely receive feedback to track their captured opportunities, but feedback has been shown to be an effective tool. Performance feedback reports will pull from electronic health record (EHR) data, and will compare participants performance to their own previous performance and those of others. Throughout the intervention participants will also receive weekly text message mini-lessons that will remind participants of the project.
- Conditions
- Immunization, Vaccination
- Being tested
- STOP-HPV performance feedback intervention
- Keywords
- HPV, Vaccination, Practice based intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STOP-HPV performance feedback interventionBehavioural
This intervention will be the addition of performance feedback (in the presence of communication skills).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Arm 1 will receive the STOP-HPV performance feedback intervention Receives: Behavioral: STOP-HPV performance feedback intervention |
| Control | No intervention | Arm 2 will receive standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the rate of missed vaccination opportunities among all clinicians
Change in the rate of missed vaccination opportunities from baseline (period 0) through the end of period 2 among all clinicians, with a focus on the contrast between the end of period 1 and period 2.
Measured: Monthly for Period 2 and also aggregated over the 6-month period from start date, where start date is site specific and depends on study decision on completion of training and readiness of site to proceed.
Change in the rate of missed vaccination opportunities among consenting clinicians
Change in the rate of missed vaccination opportunities from baseline (period 0) through the end of period 2 among consenting clinicians, with a focus on the contrast between periods 1 and 2.
Measured: Monthly for Period 2 and also aggregated over the 6-month period from start date, where start date is site specific and depends on study decision on completion of training and readiness of site to proceed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start7 Aug 2018
- Primary completion11 Feb 2020
- Study completion6 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunizationStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Model description
- A cluster RCT study design will test the impact of performance feedback to reduce missed opportunities (MOs) and raise HPV vaccine rates
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, American Academy of Pediatrics, University of Pennsylvania, National Institutes of Health (NIH), National Cancer Institute (NCI), University of Rochester
- Responsible party
- Principal investigator, Peter G Szilagyi, MD MPH, University of California, Los Angeles
- Investigators
- Peter Szilagyi, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599570
- Sponsor's protocol ID
- 2R01CA202261
- Other IDs
- R01CA202261
- Acronym
- STOP-HPV
- Status last verified
- Apr 2020
- First submitted
- 29 Jun 2018
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving HPV Vaccination Delivery in Pediatric Primary Care: The STOP-HPV Trial 2 Comparison of Performance Feedback (in the Presence of Communication Skills) and Standard of Care
- ClinicalTrials.gov ID
- NCT03599570
- Acronym / sponsor ID
- STOP-HPV / 2R01CA202261
- Conditions
- Immunization, Vaccination
- Keywords
- HPV, Vaccination, Practice based intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, American Academy of Pediatrics, University of Pennsylvania, National Institutes of Health (NIH), National Cancer Institute (NCI), University of Rochester
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 11 Feb 2020 (actual)
- Study completion
- 6 Mar 2020 (actual)
- First posted
- 26 Jul 2018 (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.
Most adolescents who receive human papillomavirus (HPV) vaccine are vaccinated in pediatric practices, yet missed opportunities (MOs) for HPV vaccination occur often and lead to low HPV vaccination rates. This cluster randomized clinical trial (RCT) will test the effectiveness (and cost-effectiveness) of the addition of performance feedback (period 2) to training providers previously received on HPV vaccine communication (period 1) to reduce MOs and increase HPV vaccination rates.
Detailed description
HPV vaccine rates remain lower than rates for other adolescent vaccines. Missed opportunities (MOs) are healthcare visits during which a patient is eligible, but does not receive a vaccine. MOs for vaccination contribute strongly to low HPV vaccination rates. This trial focuses on period 2, the addition of performance feedback in the presence of communication skills training. Arm-1 intervention study practices add performance feedback (period 2), building upon their prior training in communication skills (period 1); Arm-2 comparison study practices continue delivering standard of care. During this period, the investigators will be measuring captured opportunities - the inverse of MOs, or visits when an eligible patient receives a vaccine. Providers rarely receive feedback to track their captured opportunities, but feedback has been shown to be an effective tool. Performance feedback reports will pull from electronic health record (EHR) data, and will compare participants performance to their own previous performance and those of others. Throughout the intervention participants will also receive weekly text message mini-lessons that will remind participants of the project.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A cluster RCT study design will test the impact of performance feedback to reduce missed opportunities (MOs) and raise HPV vaccine rates
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: STOP-HPV performance feedback interventionArm 1 will receive the STOP-HPV performance feedback intervention |
| Control | No intervention | –Arm 2 will receive standard of care |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
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 |
|---|---|---|
| STOP-HPV performance feedback interventionThis intervention will be the addition of performance feedback (in the presence of communication skills). | Behavioural | Intervention |
Primary outcome
Change in the rate of missed vaccination opportunities among all clinicians
Time frame: Monthly for Period 2 and also aggregated over the 6-month period from start date, where start date is site specific and depends on study decision on completion of training and readiness of site to proceed.
Change in the rate of missed vaccination opportunities from baseline (period 0) through the end of period 2 among all clinicians, with a focus on the contrast between the end of period 1 and period 2.
Change in the rate of missed vaccination opportunities among consenting clinicians
Time frame: Monthly for Period 2 and also aggregated over the 6-month period from start date, where start date is site specific and depends on study decision on completion of training and readiness of site to proceed.
Change in the rate of missed vaccination opportunities from baseline (period 0) through the end of period 2 among consenting clinicians, with a focus on the contrast between periods 1 and 2.
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 30 Apr 2020.
- 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.
Peter Szilagyi, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STOP-HPV performance feedback intervention in people with Immunization and Vaccination, run by University of California, Los Angeles 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?
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 2020. 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?
Change in the rate of missed vaccination opportunities among all clinicians (time frame: Monthly for Period 2 and also aggregated over the 6-month period from start date, where start date is site specific and depends on study decision on completion of training and readiness of site to proceed.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2020.