Comparison of Immunization Quality Improvement Dissemination Study

Not Applicable

Completed

• Conditions: HIB-vaccine; DTaP Vaccine; Immunization; Hepatitis B Vaccine; MMR Vaccine; Chickenpox Vaccine; Pneumococcal Polysaccharide Vaccine; Poliovirus Vaccine, Inactivated
• Interventions: 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

• Registration Number: NCT02432430
• Lead Sponsor: Children's National Research Institute

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 available

Study Timeline

• Study Start: 2013-06
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-04
• Study First Submitted: 2015-04-22
• Study First Submitted QC: 2015-05-01
• Last Update Submitted: 2015-05-01
• Study First Posted: 2015-05-04
• Last Update Posted: 2015-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2186

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
quality improvement technical support	QI support to improve DTP/Hep B/MMR/Var/PCV/Hib/IPV coverage	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.
pay for performance	Incentives to improve DTP/HepB/MMR/Var/PCV/Hib/IPV coverage	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
percent of all age-appropriate, indicated vaccines received (HepB, DTaP, Hib, PCV, IPV, MMR, Var)	12 months	percent of all needed vaccines received