Comparison of Immunization Quality Improvement Dissemination Study

NCT ID: NCT02432430

Last Updated: 2015-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-06-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

QI support to improve DTP/Hep B/MMR/Var/PCV/Hib/IPV coverage

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Incentives to improve DTP/HepB/MMR/Var/PCV/Hib/IPV coverage

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: 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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Children's National Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Linda Fu

Associate Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 27244859 (View on PubMed)

Other Identifiers

ChildrensRI

Identifier Type: -

Identifier Source: org_study_id