Clinical trial NCT02432430: Comparison of Immunization Quality Improvement Dissemination Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2015-05-04
Enrollment: 2186
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: 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
timeFrame: 12 months
Secondary outcomes:
measure: percent of all age-appropriate, indicated vaccines received (HepB, DTaP, Hib, PCV, IPV, MMR, Var)
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
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.