Children's Hospital at Montefiore, Albert Einstein College of Medicine
The Bronx, New York, 10467, United States
NCT Number: NCT03066596
The overall goal of this research study is to test the effectiveness of a multifaceted and multi-level prompting intervention in a real world urban primary care office setting on improving provider-delivered guideline-based asthma care and reducing asthma morbidity among urban children with persistent or uncontrolled asthma.
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Notify Me2 year–12 year
All sexes
Interventional
Not applicable
The Bronx, New York, 10467, United States
Investigators will conduct a cluster randomized trial comparing the intervention to enhanced usual care (eUC) in 20 Bronx practices serving over 5,000 children ages 2-12 years with persistent or uncontrolled asthma. Eleven eUC practices will receive guideline information and assess children's asthma severity and control, but active intervention components will not be provided. Practices will join the study in 4 waves over 4 years (4-6 practices per year). Provider adoption of guidelines and utilization of care in all patients (~5,000) ages 2-12 years with persistent or uncontrolled asthma from intervention and eUC practices will be evaluated using Electronic Health Records (EHR) data and practice-based screening for asthma severity and control. Investigators will also enroll a random subset of 512 caregivers of children with persistent/uncontrolled asthma from both study arms to systematically evaluate caregiver-reported child morbidity outcomes and obtain measures not available in EHR.
Intervention consists of academic detailing in the EHR that follow national asthma guidelines and outreach worker care coordination for patients with persistent or uncontrolled asthma.
Comment: While caregivers reported on child outcomes, caregivers were not subjects of the study. See "Pre-Assignment Details" section within the Participant Flow module for more details.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
The criteria listed below will apply to ~5,000 children from eMPI and eUC practices:
Additional inclusion criteria will apply to a subset of 512 of children whose caregivers will be interviewed to obtain caregiver-reported morbidity outcomes:
Exclusion criteria
Additional exclusion criteria will apply to a subset of 512 children/caregivers as described above:
The core elements of the multilevel strategy for implementation include:
Direct Support for Providers' Delivery of Guideline-Based Care in Practice; Enhancements to Increase the Feasibility and Sustainability of eMPI; Involving Clinic Staff in Promoting and Supporting Use of Guidelines; Building Accountability and Commitment to Guideline-Based Care; Promoting Providers' Understanding, Acceptance, and Use of Guidelines
Time frame: Immediately post-intervention, up to 1 year
The percentage of participants with 1 or more guideline-based corrective actions taken (i.e., controller medication prescription or adjustment, trigger evaluation), as recorded in the electronic health record (EHR) is reported. Results are summarized in number/percentage of participants with 1 or more guideline-based corrective actions taken by study arm.
Time frame: Baseline, and 3 month, 6 month, 9 month, and 12 month follow-up evaluations
The number of days without symptoms during the past 14 days is summarized by study arm at baseline and every 3 months up through the 12 month follow up evaluation.
Time frame: every 3 months up to 12 months
caregiver asthma related quality of life
Time frame: every 3 months up to 12 months
number of ED visits for asthma
Time frame: every 3 months up to 12 months
number hospitalizations for asthma
Montefiore Medical Center
Other
Acronym: PRAGMATIC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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