Comparison of Immunization Quality Improvement Dissemination Study

NCT02432430

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Immunization, DTaP Vaccine, Hepatitis B Vaccine, MMR Vaccine, HIB-vaccine, Inactivated Poliovirus Vaccine, Chickenpox Vaccine, Pneumococcal Polysaccharide Vaccine
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
3-18 months
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- regular patient of a participating practice

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- fewer than 2 encounters at a participating practice


- moved or gone elsewhere prior to assessment date


- medical contraindication to vaccination

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Immunization, DTaP Vaccine, Hepatitis B Vaccine, MMR Vaccine, HIB-vaccine, Inactivated Poliovirus Vaccine, Chickenpox Vaccine, Pneumococcal Polysaccharide VaccineComparison of Immunization Quality Improvement Dissemination Study
NCT02432430
ALL GENDERS
3 Months+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Comparison of Immunization Quality Improvement Dissemination Study
Official Title  ICMJE Not Provided
Brief 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. 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:

1. 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Immunization
  • DTaP Vaccine
  • Hepatitis B Vaccine
  • MMR Vaccine
  • HIB-vaccine
  • Poliovirus Vaccine, Inactivated
  • Chickenpox Vaccine
  • Pneumococcal Polysaccharide Vaccine
Intervention  ICMJE
  • Behavioral: QI support to improve DTP/Hep B/MMR/Var/PCV/Hib/IPV coverage
    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
  • Behavioral: Incentives to improve DTP/HepB/MMR/Var/PCV/Hib/IPV coverage
    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 Arms  ICMJE
  • Experimental: quality improvement technical support
    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.
    Intervention: Behavioral: QI support to improve DTP/Hep B/MMR/Var/PCV/Hib/IPV coverage
  • Active Comparator: pay for performance
    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.
    Intervention: Behavioral: Incentives to improve DTP/HepB/MMR/Var/PCV/Hib/IPV coverage
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). pii: e20154603. doi: 10.1542/peds.2015-4603. Epub 2016 May 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 1, 2015)
2186
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • regular patient of a participating practice

Exclusion Criteria:

  • fewer than 2 encounters at a participating practice
  • moved or gone elsewhere prior to assessment date
  • medical contraindication to vaccination
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 3 Months to 18 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02432430
Other Study ID Numbers  ICMJE ChildrensRI
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Linda Fu, Children's National Research Institute
Study Sponsor  ICMJE Children's National Research Institute
Collaborators  ICMJE Pfizer
Investigators  ICMJE Not Provided
PRS Account Children's National Research Institute
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP