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CIzQIDS: Comparison of Immunization Quality Improvement Dissemination Study

Sponsor
Children's National Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT02432430
Collaborator
Pfizer (Industry)
2,186
Enrollment
2
Arms
12
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: QI support to improve DTP/Hep B/MMR/Var/PCV/Hib/IPV coverage
  • Behavioral: Incentives to improve DTP/HepB/MMR/Var/PCV/Hib/IPV coverage
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
2186 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
Study Start Date :
Jun 1, 2013
Actual Primary Completion Date :
Jun 1, 2014
Actual Study Completion Date :
Jun 1, 2014

Arms and Interventions

Arm Intervention/Treatment
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.

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
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.

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

Outcome Measures

Primary Outcome Measures

  1. 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 [12 months]

    receipt of all age-appropriate immunization

Secondary Outcome Measures

  1. percent of all age-appropriate, indicated vaccines received (HepB, DTaP, Hib, PCV, IPV, MMR, Var) [12 months]

    percent of all needed vaccines received

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Months to 18 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Children's National Research Institute
  • Pfizer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Linda Fu, Associate Professor of Pediatrics, Children's National Research Institute
ClinicalTrials.gov Identifier:
NCT02432430
Other Study ID Numbers:
  • ChildrensRI
First Posted:
May 4, 2015
Last Update Posted:
May 4, 2015
Last Verified:
Apr 1, 2015
Keywords provided by Linda Fu, Associate Professor of Pediatrics, Children's National Research Institute
N05.300.150.410
practice guideline
D20.215.894.899.290.130
Health Knowledge, Attitudes, Practice
Additional relevant MeSH terms:
Hepatitis B
Chickenpox

Study Results

No Results Posted as of May 4, 2015