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Comparison of Immunization Quality Improvement Dissemination Study (CIzQIDS)

Primary Purpose

Immunization, DTaP Vaccine, Hepatitis B Vaccine

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
QI support to improve DTP/Hep B/MMR/Var/PCV/Hib/IPV coverage
Incentives to improve DTP/HepB/MMR/Var/PCV/Hib/IPV coverage
Sponsored by
Children's National Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Immunization focused on measuring N05.300.150.410, practice guideline, D20.215.894.899.290.130, Health Knowledge, Attitudes, Practice

Eligibility Criteria

3 Months - 18 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    quality improvement technical support

    pay for performance

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    percent of all age-appropriate, indicated vaccines received (HepB, DTaP, Hib, PCV, IPV, MMR, Var)
    percent of all needed vaccines received

    Full Information

    First Posted
    April 22, 2015
    Last Updated
    May 1, 2015
    Sponsor
    Children's National Research Institute
    Collaborators
    Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02432430
    Brief Title
    Comparison of Immunization Quality Improvement Dissemination Study
    Acronym
    CIzQIDS
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2013 (undefined)
    Primary Completion Date
    June 2014 (Actual)
    Study Completion Date
    June 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Children's National Research Institute
    Collaborators
    Pfizer

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Immunization, DTaP Vaccine, Hepatitis B Vaccine, MMR Vaccine, HIB-vaccine, Poliovirus Vaccine, Inactivated, Chickenpox Vaccine, Pneumococcal Polysaccharide Vaccine
    Keywords
    N05.300.150.410, practice guideline, D20.215.894.899.290.130, Health Knowledge, Attitudes, Practice

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    2186 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    quality improvement technical support
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    pay for performance
    Arm Type
    Active Comparator
    Arm Description
    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 Type
    Behavioral
    Intervention Name(s)
    QI support to improve DTP/Hep B/MMR/Var/PCV/Hib/IPV coverage
    Intervention Description
    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
    Intervention Type
    Behavioral
    Intervention Name(s)
    Incentives to improve DTP/HepB/MMR/Var/PCV/Hib/IPV coverage
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    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
    Description
    receipt of all age-appropriate immunization
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    percent of all age-appropriate, indicated vaccines received (HepB, DTaP, Hib, PCV, IPV, MMR, Var)
    Description
    percent of all needed vaccines received
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Months
    Maximum Age & Unit of Time
    18 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27244859
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    Comparison of Immunization Quality Improvement Dissemination Study

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