QI Study of a Practice Facilitator's Impact in Working With Clinics on Improving Dental, Lead & Obesity Measures for Children
NCT ID: NCT01739166
Last Updated: 2014-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
30 participants
INTERVENTIONAL
2010-10-31
2012-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Practice-tailored intervention - Early/Phase 1
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.
Practice-tailored intervention to increase rates of targeted services
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 - Late/Phase 2
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.
Practice-tailored intervention to increase rates of targeted services
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Practice-tailored intervention to increase rates of targeted services
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Practice is located in Northeast Ohio
Exclusion Criteria
* Practice is out of the targeted area
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ohio Department of Job and Family Services
UNKNOWN
University Hospitals Cleveland Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sharon Meropol, MD, PhD
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Leona Cuttler, M.D.
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital Case Medical Center
Cleveland, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
10-10-07
Identifier Type: -
Identifier Source: org_study_id