NCT01739166

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2012

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2012

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

2.1 years

First QC Date

November 27, 2012

Last Update Submit

December 2, 2014

Conditions

Keywords

Health Services ResearchQuality Assurance

Outcome Measures

Primary Outcomes (3)

  • Lead screening for at-risk 12 and 24 month olds

    Assessing the rate of lead screening for eligible (i.e., at risk) 12 and 24 month old children is our primary outcome. This is assessed by chart review in the medical record for the index visit.

    At baseline, every 2 months during the 6 month Intervention Phase, and after the 2 month Follow-up Phase

  • Identification of BMI percentile and weight diagnosis catergory in 2-17 year olds

    Assessing the rate of recorded BMI and 2) and rate of accurate recorded weight diagnosis category (underweight \< 5th percentile; healthy weight 5th percentile -\<85th percentile; overweight 85th percentile - \<95th percentile; or obese \> 95th percentile) for children 2-17 years of age is our primary outcome. This is assessed by chart review in the medical record for the index visit.

    At baseline, every 2 months during the 6 month Intervention Phase, and after the 2 month Follow-up Phase

  • Application of dental fluoride varnish for 12-36 month olds

    Assessing the rate of dental fluoride varnish application for eligible children 12-36 months of age is our primary outcome. This is assessed by chart review in the medical record for the index visit or within the preceding 6 months.

    At baseline, every 2 months during the 6 month Intervention Phase, and after the 2 month Follow-up Phase

Secondary Outcomes (3)

  • Rates of elevated lead levels and appropriate follow-up for 12 and 24 months lead screenings

    At baseline, every 2 months during the 6 month Intervention and after the 2 month Follow-up Phase

  • Rates of appropriate counseling for nutrition & activity and appropriate screening for co-morbidities

    At baseline, every 2 months during the 6 month Intervention Phase, and after the 2 month Follow-up Phase

  • Rates of oral screening and referral to a dentist for 12-36 month olds

    At baseline, every 2 months during the 6 month Intervention Phase, and after the 2 month Follow-up Phase

Study Arms (2)

Practice-tailored intervention - Early/Phase 1

EXPERIMENTAL

During the 6 month Intervention Phase the Practice Facilitator works with each practice to create changes that are tailored to their individual preferences and methods of operation. Sites randomized to Early/Phase 1 start their 6 month intervention immediately after randomization.

Other: Practice-tailored intervention to increase rates of targeted services

Practice-tailored intervention - Late/Phase 2

EXPERIMENTAL

The Phase 2 group will start the practice-tailored intervention with the study facilitator 4 months post-randomization and continue through post-randomization month 10.

Other: Practice-tailored intervention to increase rates of targeted services

Interventions

Over a 6 month period, the Practice Facilitator (PF), offers individualized suggestions, strategies and tools for streamlining processes and incorporating new ideas into the flow of a practice's work day to increase their rates of delivery of the 3 targeted services of lead screening, obesity detection and dental decay prevention. During the intervention visits the PF reviews a small number of recent well-visit charts. This allows for rapid feedback to a practice on their progress as they work toward reaching outcome measures. It also provides 'real time' feedback regarding the degree to which suggested interventions are working, allowing the PF to change the approach as needed.

Practice-tailored intervention - Early/Phase 1Practice-tailored intervention - Late/Phase 2

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Lead PoisoningObesityDental Caries

Condition Hierarchy (Ancestors)

Heavy Metal PoisoningPoisoningChemically-Induced DisordersOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsTooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Leona Cuttler, M.D.

    University Hospitals Cleveland Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 27, 2012

First Posted

December 3, 2012

Study Start

October 1, 2010

Primary Completion

November 1, 2012

Study Completion

December 1, 2012

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations