Comparison of Immunization Quality Improvement Dissemination Study (CIzQIDS)

May 1, 2015 updated by: Linda Fu, Children's National Research Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2186

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percent of all age-appropriate, indicated vaccines received (HepB, DTaP, Hib, PCV, IPV, MMR, Var)
Time Frame: 12 months
percent of all needed vaccines received
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's National Research Institute

Collaborators

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

April 22, 2015

First Submitted That Met QC Criteria

May 1, 2015

First Posted (Estimate)

May 4, 2015

Study Record Updates

Last Update Posted (Estimate)

May 4, 2015

Last Update Submitted That Met QC Criteria

May 1, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChildrensRI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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