Clinical trial NCT01739166: QI Study of a Practice Facilitator's Impact in Working With Clinics on Improving Dental, Lead & Obesity Measures for Children
Official title: Child Healthcare Excellence Center - A University-Practice-Public Partnership (CHEC-UPPP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lead Poisoning
Obesity
Dental Decay
Keywords: Health Services Research
Quality Assurance
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Ohio Department of Job and Family Services
First posted: 2012-12-03
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Funded by the Ohio Department of Job and Family Services - Medicaid Technical Assistance and Policy Program (MEDTAPP), the "Child Health Excellence Center - a University-Practice-Public Partnership" (CHEC-UPPP) focuses on improving the health of Ohio's children in 3 target areas: 1) prevention of dental decay; 2) detection and management of overweight and obesity; and 3) lead screening. These topics represent critical public health issues for Ohio's children.

The study is based on strong evidence that interventions are needed to improve practice in the target areas and that achieving these goals represents fundamental improvements in child health care that would reduce morbidity and costs. The approach for the study involves a trained Practice Facilitator (PF) working with multiple pediatric and family medicine practices to create change tailored to individual practice preferences and methods of operation.

Our overall hypothesis is that a university-community consortium, utilizing evidence-based methods (involving education plus a facilitated, practice-tailored approach) will increase the rates of targeted services in primary care practices.

Detailed description: The research design involves a sample of 30 primary care practices (a combination of pediatric and family medicine) from across Northeast Ohio who have at least a 20% Medicaid patient population. We are using a cross-over study design. After the run-in period during which baseline data is collected via chart review and all practices receive basic education in the 3 focal areas of lead, dental and obesity screening, the practices will be randomly assigned to one of two groups.

The Phase 1 group will receive the practice-tailored intervention with the Practice Facilitator (PF) starting immediately after randomization and continuing for 6 months. The Phase 2 group will start their practice-tailored intervention with the PF 4 months post-randomization and continue through post-randomization month 10.

This design gives us a natural 'control' group (Phase 2 group) for the first four months post-randomization. The Phase 2 group will have had the same Run-in Phase education as the Phase 1 group, but will not be starting the practice-tailored intervention with the study facilitator for 4 months, at which time they will cross-over to their Intervention Phase.

Both Phase 1 and Phase 2 groups will have a 2 month Follow-up Phase after the completion of their 6 month Intervention Phase. During the Follow-up Phase they will strive to continue reaching the outcome measures on their own without the support of the PF. This will give us an opportunity to assess short-term sustainability of the rates of delivery of services achieved during the Intervention Phase.

Eligibility criteria: Inclusion Criteria:

* Practice site has 20% or more Medicaid patient population
* Practice is located in Northeast Ohio

Exclusion Criteria:

* Practice has less than 20% Medicaid patient population
* Practice is out of the targeted area

Primary outcomes:
measure: Lead screening for at-risk 12 and 24 month olds
timeFrame: At baseline, every 2 months during the 6 month Intervention Phase, and after the 2 month Follow-up Phase
measure: Identification of BMI percentile and weight diagnosis catergory in 2-17 year olds
timeFrame: At baseline, every 2 months during the 6 month Intervention Phase, and after the 2 month Follow-up Phase
measure: Application of dental fluoride varnish for 12-36 month olds
timeFrame: At baseline, every 2 months during the 6 month Intervention Phase, and after the 2 month Follow-up Phase
Secondary outcomes:
measure: Rates of elevated lead levels and appropriate follow-up for 12 and 24 months lead screenings
timeFrame: At baseline, every 2 months during the 6 month Intervention and after the 2 month Follow-up Phase
measure: Rates of appropriate counseling for nutrition & activity and appropriate screening for co-morbidities
timeFrame: At baseline, every 2 months during the 6 month Intervention Phase, and after the 2 month Follow-up Phase
measure: Rates of oral screening and referral to a dentist for 12-36 month olds
timeFrame: At baseline, every 2 months during the 6 month Intervention Phase, and after the 2 month Follow-up Phase
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospital Case Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Leona Cuttler, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meropol SB, Schiltz NK, Sattar A, Stange KC, Nevar AH, Davey C, Ferretti GA, Howell DE, Strosaker R, Vavrek P, Bader S, Ruhe MC, Cuttler L. Practice-tailored facilitation to improve pediatric preventive care delivery: a randomized trial. Pediatrics. 2014 Jun;133(6):e1664-75. doi: 10.1542/peds.2013-1578. Epub 2014 May 5.