ImmunizationCIzQIDSNCT02432430
Comparison of Immunization Quality Improvement Dissemination Study
A study testing QI support to improve DTP/Hep B/MMR/Var/PCV/Hib/IPV coverage and Incentives to improve DTP/HepB/MMR/Var/PCV/Hib/IPV coverage in people with Immunization and DTaP Vaccine, run by Children's National Research Institute.
Trial summary
Dissemination research examines the processes and factors that lead to widespread use of evidence-based interventions. There are several theories on how to best minimize the perceived and actual burdens on practitioners associated with implementing evidence-based medicine. Read more about this study
- Who is it for?
- Ages 3 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Immunization, DTaP Vaccine, Hepatitis B Vaccine
- What is being tested?
- QI support to improve DTP/Hep B/MMR/Var/PCV/Hib/IPV coverage and Incentives to improve DTP/HepB/MMR/Var/PCV/Hib/IPV coverage
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,186 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Jun 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 3 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- regular patient of a participating practice
Who cannot join
- fewer than 2 encounters at a participating practice
- moved or gone elsewhere prior to assessment date
- medical contraindication to vaccination
About this study
Dissemination research examines the processes and factors that lead to widespread use of evidence-based interventions. There are several theories on how to best minimize the perceived and actual burdens on practitioners associated with implementing evidence-based medicine. For instance, the pay for performance model attempts to improve physician compliance with quality guidelines by providing financial incentives. Recent studies suggest pay for performance is effective in improving practitioner performance, but it is unclear whether the gains are sustainable once incentives are stopped.
Another approach to promoting best practices is the Model for Improvement whose main method is to employ Plan-Do-Study-Act (PDSA) cycles of small changes Although this approach has been successful within individual institutions, there is minimal evidence of its effect when employed simultaneously in multiple autonomous institutions. There is also little evidence of the sustainability of outcomes after intervention activities end.
Read more
The specific aims of the proposed study are to examine the effect of quality improvement dissemination models on the immunization coverage of children ages 3 to 18 months old. The investigators propose to:
- Determine the effect on immunization compliance of two different models of dissemination which will provide physicians 12 months of quality improvement (QI) activity support for implementing CDC immunization best practices.
Hypothesis 1a: Study participants receiving the QI technical support intervention (QITS) will have more improvement in immunization rates from baseline to immediately after support ends than participants receiving the pay for performance intervention (P4P).
Hypothesis 1b: Study participants receiving QITS will increase immunization coverage for their practices over baseline.
Hypothesis 1c: Study participants receiving P4P will increase immunization coverage for their practices over baseline.
- Conditions
- Immunization, DTaP Vaccine, Hepatitis B Vaccine, MMR Vaccine, HIB-vaccine, Poliovirus Vaccine, Inactivated
- Being tested
- QI support to improve DTP/Hep B/MMR/Var/PCV/Hib/IPV coverage, Incentives to improve DTP/HepB/MMR/Var/PCV/Hib/IPV coverage
- Keywords
- N05.300.150.410, practice guideline, D20.215.894.899.290.130, Health Knowledge, Attitudes, Practice
- Medical subject headings
- Hepatitis B, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QI support to improve DTP/Hep B/MMR/Var/PCV/Hib/IPV coverageBehavioural
Quality improvement technical support to help providers' ability to institute best practices to improve delivery of the following vaccines: DTP, HepB, MMR, Var, PCV, Hib, IPV
Incentives to improve DTP/HepB/MMR/Var/PCV/Hib/IPV coverageBehavioural
Financial incentives to support to help providers' ability to institute best practices to improve delivery of the following vaccines: DTP, HepB, MMR, Var, PCV, Hib, IPV
| Study group | Role | What they receive |
|---|---|---|
| quality improvement technical support | Experimental | QI support to improve DTP/Hep B/MMR/Var/PCV/Hib/IPV coverage. Participants receive a Vaccinator Toolkit and attend 6 virtual QI Learning Sessions and 12 monthly conference calls with a coach and other participant teams. On a monthly basis for 11 months, participants collect, submit and review immunization data of 10-20 of their patients ages 3 months to 18 months. After 12 months, participants attend a virtual QI Debriefing Session. Receives: Behavioral: QI support to improve DTP/Hep B/MMR/Var/PCV/Hib/IPV coverage |
| pay for performance | Active comparator | Incentives to improve DTP/HepB/MMR/Var/PCV/Hib/IPV coverage. Participants receive a Vaccinator Toolkit and are informed of a tiered incentives structure. Practices receive bonuses for both improvement in individual practice coverage as well as improvement in coverage for all practices allocated to this study arm. Receives: Behavioral: Incentives to improve DTP/HepB/MMR/Var/PCV/Hib/IPV coverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
relative risk of child being up to date with all age-appropriate vaccines as assessed by random selection of 50 patients per practice for compliance with HepB, DTaP, Hib, PCV, IPV, MMR, Var
receipt of all age-appropriate immunization
Measured: 12 months
Secondary outcomes (1)
percent of all age-appropriate, indicated vaccines received (HepB, DTaP, Hib, PCV, IPV, MMR, Var)
percent of all needed vaccines received
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startJun 2013
- Primary completionJun 2014
- Study completionJun 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 ImmunizationStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Linda Fu, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432430
- Sponsor's protocol ID
- ChildrensRI
- Acronym
- CIzQIDS
- Status last verified
- Apr 2015
- First submitted
- 22 Apr 2015
- Last updated
- 4 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Fu LY, Zook K, Gingold JA, Gillespie CW, Briccetti C, Cora-Bramble D, Joseph JG, Haimowitz R, Moon RY. Strategies for Improving Vaccine Delivery: A Cluster-Randomized Trial. Pediatrics. 2016 Jun;137(6):e20154603. doi: 10.1542/peds.2015-4603. Epub 2016 May 10.
PubMed 27244859
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Immunization Quality Improvement Dissemination Study
- ClinicalTrials.gov ID
- NCT02432430
- Acronym / sponsor ID
- CIzQIDS / ChildrensRI
- Conditions
- Immunization, DTaP Vaccine, Hepatitis B Vaccine, MMR Vaccine, HIB-vaccine, Poliovirus Vaccine, Inactivated
- Keywords
- N05.300.150.410, practice guideline, D20.215.894.899.290.130, Health Knowledge, Attitudes, Practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,186 participants (actual)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jun 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 4 May 2015 (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.
Dissemination research examines the processes and factors that lead to widespread use of evidence-based interventions. There are several theories on how to best minimize the perceived and actual burdens on practitioners associated with implementing evidence-based medicine. For instance, the pay for performance model attempts to improve physician compliance with quality guidelines by providing financial incentives. Recent studies suggest pay for performance is effective in improving practitioner performance, but it is unclear whether the gains are sustainable once incentives are stopped.
Another approach to promoting best practices is the Model for Improvement whose main method is to employ Plan-Do-Study-Act (PDSA) cycles of small changes Although this approach has been successful within individual institutions, there is minimal evidence of its effect when employed simultaneously in multiple autonomous institutions. There is also little evidence of the sustainability of outcomes after intervention activities end.
The specific aims of the proposed study are to examine the effect of quality improvement dissemination models on the immunization coverage of children ages 3 to 18 months old. The investigators propose to:
- Determine the effect on immunization compliance of two different models of dissemination which will provide physicians 12 months of quality improvement (QI) activity support for implementing CDC immunization best practices.
Hypothesis 1a: Study participants receiving the QI technical support intervention (QITS) will have more improvement in immunization rates from baseline to immediately after support ends than participants receiving the pay for performance intervention (P4P).
Hypothesis 1b: Study participants receiving QITS will increase immunization coverage for their practices over baseline.
Hypothesis 1c: Study participants receiving P4P will increase immunization coverage for their practices over baseline.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| quality improvement technical support | Experimental | Behavioral: QI support to improve DTP/Hep B/MMR/Var/PCV/Hib/IPV coverageQI support to improve DTP/Hep B/MMR/Var/PCV/Hib/IPV coverage. Participants receive a Vaccinator Toolkit and attend 6 virtual QI Learning Sessions and 12 monthly conference calls with a coach and other participant teams. On a monthly basis for 11 months, participants collect, submit and review immunization data of 10-20 of their patients ages 3 months to 18 months. After 12 months, participants attend a virtual QI Debriefing Session. |
| pay for performance | Active comparator | Behavioral: Incentives to improve DTP/HepB/MMR/Var/PCV/Hib/IPV coverageIncentives to improve DTP/HepB/MMR/Var/PCV/Hib/IPV coverage. Participants receive a Vaccinator Toolkit and are informed of a tiered incentives structure. Practices receive bonuses for both improvement in individual practice coverage as well as improvement in coverage for all practices allocated to this study arm. |
Who may qualify
- Ages
- 3 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- regular patient of a participating practice
Key exclusion criteria (3 listed)
- fewer than 2 encounters at a participating practice
- moved or gone elsewhere prior to assessment date
- medical contraindication to vaccination
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 |
|---|---|---|
| QI support to improve DTP/Hep B/MMR/Var/PCV/Hib/IPV coverageQuality improvement technical support to help providers' ability to institute best practices to improve delivery of the following vaccines: DTP, HepB, MMR, Var, PCV, Hib, IPV | Behavioural | quality improvement technical support |
| Incentives to improve DTP/HepB/MMR/Var/PCV/Hib/IPV coverageFinancial incentives to support to help providers' ability to institute best practices to improve delivery of the following vaccines: DTP, HepB, MMR, Var, PCV, Hib, IPV | Behavioural | pay for performance |
Primary outcome
relative risk of child being up to date with all age-appropriate vaccines as assessed by random selection of 50 patients per practice for compliance with HepB, DTaP, Hib, PCV, IPV, MMR, Var
Time frame: 12 months
receipt of all age-appropriate immunization
1 secondary outcome
percent of all age-appropriate, indicated vaccines received (HepB, DTaP, Hib, PCV, IPV, MMR, Var)
Time frame: 12 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 4 May 2015.
- Derived from this study: PubMed 27244859Fu LY, Zook K, Gingold JA, Gillespie CW, Briccetti C, Cora-Bramble D, Joseph JG, Haimowitz R, Moon RY. Strategies for Improving Vaccine Delivery: A Cluster-Randomized Trial. Pediatrics. 2016 Jun;137(6):e20154603. doi: 10.1542/peds.2015-4603. Epub 2016 May 10.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing QI support to improve DTP/Hep B/MMR/Var/PCV/Hib/IPV coverage and Incentives to improve DTP/HepB/MMR/Var/PCV/Hib/IPV coverage in people with Immunization and DTaP Vaccine, run by Children's National Research Institute.
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 1 inclusion and 3 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 4 May 2015. 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. 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?
relative risk of child being up to date with all age-appropriate vaccines as assessed by random selection of 50 patients per practice for compliance with HepB, DTaP, Hib, PCV, IPV, MMR, Var (time frame: 12 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 NCT02432430, 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 4 May 2015.