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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02432430
Other study ID # ChildrensRI
Secondary ID
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


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
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