Comparison of Immunization Quality Improvement Dissemination Study

Immunization Clinical Trial

— CIzQIDS  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02432430
• Other study ID #: ChildrensRI
• Status: Completed
• Phase: N/A
• First received: April 22, 2015
• Last updated: May 1, 2015
• Start date: June 2013
• Est. completion date: June 2014

Study information

• Verified date: April 2015
• Source: Children's Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2186
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Months to 18 Months

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

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

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Children's Research Institute	Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	receipt of all age-appropriate immunization	12 months	No
Secondary	percent of all age-appropriate, indicated vaccines received (HepB, DTaP, Hib, PCV, IPV, MMR, Var)	percent of all needed vaccines received	12 months	No