Lead PoisoningNCT01739166
QI Study of a Practice Facilitator's Impact in Working With Clinics on Improving Dental, Lead & Obesity Measures for Children
A study testing Practice-tailored intervention to increase rates of targeted services in people with Lead Poisoning and Obesity, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Lead Poisoning, Obesity, Dental Decay
- What is being tested?
- Practice-tailored intervention to increase rates of targeted services
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Practice site has 20% or more Medicaid patient population
- Practice is located in Northeast Ohio
Who cannot join
- Practice has less than 20% Medicaid patient population
- Practice is out of the targeted area
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospital Case Medical Center
Cleveland, Ohio, 44106
About this study
Official title: Child Healthcare Excellence Center - A University-Practice-Public Partnership (CHEC-UPPP)
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.
Read the 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.
- Conditions
- Lead Poisoning, Obesity, Dental Decay
- Being tested
- Practice-tailored intervention to increase rates of targeted services
- Keywords
- Health Services Research, Quality Assurance
- Medical subject headings
- Lead Poisoning, Obesity, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Practice-tailored intervention to increase rates of targeted servicesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Practice-tailored intervention to increase rates of targeted services |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Our secondary outcome for lead is assessing the rate of rate of elevated lead levels and appropriate follow-up for elevated lead levels per ODH Testing Requirements and Medical Mgmt Recommendations. This is assessed by chart review in the medical record for the index visit for those who had a lead screening at 12 and 24 months.
Measured: 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
Our secondary outcome for obesity is assessing the rate of appropriate counseling for nutrition and activity for those in the healthy weight, overweight or obese categories and the rate of appropriate screening for co-morbidities for those in overweight and obese categories. This is assessed by chart review in the medical record for the index visit for those 2-17 years of age.
Measured: 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
Our secondary outcome for dental decay prevention is assessing the rate of oral screening and referral to a dentist by age 12 months or for abnormal oral screenings.
Measured: At baseline, every 2 months during the 6 month Intervention Phase, and after the 2 month Follow-up Phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2012 (estimated)
- Study startOct 2010
- Primary completionNov 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lead PoisoningStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio Department of Job and Family Services
- Responsible party
- Principal investigator, Sharon Meropol, MD, PhD, University Hospitals Cleveland Medical Center
- Investigators
- Leona Cuttler, M.D., Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739166
- Sponsor's protocol ID
- 10-10-07
- Status last verified
- Dec 2014
- First submitted
- 27 Nov 2012
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24799539
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Child Healthcare Excellence Center - A University-Practice-Public Partnership (CHEC-UPPP)
- ClinicalTrials.gov ID
- NCT01739166
- Acronym / sponsor ID
- 10-10-07
- Conditions
- Lead Poisoning, Obesity, Dental Decay
- Keywords
- Health Services Research, Quality Assurance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Ohio Department of Job and Family Services
- Study start
- Oct 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 3 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Practice-tailored intervention - Early/Phase 1 | Experimental | Other: Practice-tailored intervention to increase rates of targeted servicesDuring 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 - Late/Phase 2 | Experimental | Other: Practice-tailored intervention to increase rates of targeted servicesThe Phase 2 group will start the practice-tailored intervention with the study facilitator 4 months post-randomization and continue through post-randomization month 10. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Practice site has 20% or more Medicaid patient population
- Practice is located in Northeast Ohio
Key exclusion criteria (2 listed)
- Practice has less than 20% Medicaid patient population
- Practice is out of the targeted area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Practice-tailored intervention to increase rates of targeted servicesOver 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. | Other | Practice-tailored intervention - Early/Phase 1, Practice-tailored intervention - Late/Phase 2 |
Primary outcome
Lead screening for at-risk 12 and 24 month olds
Time frame: At baseline, every 2 months during the 6 month Intervention Phase, and after the 2 month Follow-up Phase
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.
Identification of BMI percentile and weight diagnosis catergory in 2-17 year olds
Time frame: At baseline, every 2 months during the 6 month Intervention Phase, and after the 2 month Follow-up Phase
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.
Application of dental fluoride varnish for 12-36 month olds
Time frame: At baseline, every 2 months during the 6 month Intervention Phase, and after the 2 month Follow-up Phase
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.
3 secondary outcomes
Rates of elevated lead levels and appropriate follow-up for 12 and 24 months lead screenings
Time frame: 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
Time frame: 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
Time frame: At baseline, every 2 months during the 6 month Intervention Phase, and after the 2 month Follow-up Phase
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
- Derived from this study: PubMed 24799539Meropol 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.
Related trials for Lead Poisoning
Not yet recruiting
A Study to Assess the Efficacy of Public Health Campaigns in Reducing Lead Exposure
Lead Poisoning, Environmental Exposure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leona Cuttler, M.D. principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Practice-tailored intervention to increase rates of targeted services in people with Lead Poisoning and Obesity, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lead screening for at-risk 12 and 24 month olds (time frame: At baseline, every 2 months during the 6 month Intervention Phase, and after the 2 month Follow-up Phase). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01739166, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014.