Brief Summary
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.
Brief Title
Promoting Asthma Guidelines and Management Through Technology-Based Intervention and Care Coordination
Detailed Description
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.
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.
Completion Date
Completion Date Type
Actual
Conditions
Asthma Childhood
Eligibility Criteria
Inclusion Criteria:
The criteria listed below will apply to \~5,000 children from eMPI and eUC practices:
* Physician-diagnosed asthma (based on EHR)
* Persistent or uncontrolled asthma as per clinic assessment. Based on NHLBI guidelines, any one of the following: in past month, \> 2 days/week with asthma symptoms, \>2 days/week with rescue medication use, \>2 days/month with nighttime symptoms, or \> 2 episodes in the past year that required systemic corticosteroids
* Age 2 and 12 years, inclusive
Additional inclusion criteria will apply to a subset of 512 of children whose caregivers will be interviewed to obtain caregiver-reported morbidity outcomes:
* Caregiver is able to speak and understand either English or Spanish. Participants unable to read will be eligible as all surveys will be administered verbally by research personnel
* Consent from the primary caregiver, caregiver permission for the child to participate as well as assent from the child (\>7 years). If there are eligible siblings, only one child will be randomly selected
Exclusion Criteria:
* The child has other significant medical conditions, such as congenital heart disease, cystic fibrosis, or other chronic lung disease, that could interfere with the assessment of asthma-related measures
Additional exclusion criteria will apply to a subset of 512 children/caregivers as described above:
* No access to a telephone to conduct follow-up surveys
* Children in foster care or other situations in which consent cannot be obtained from a guardian
The criteria listed below will apply to \~5,000 children from eMPI and eUC practices:
* Physician-diagnosed asthma (based on EHR)
* Persistent or uncontrolled asthma as per clinic assessment. Based on NHLBI guidelines, any one of the following: in past month, \> 2 days/week with asthma symptoms, \>2 days/week with rescue medication use, \>2 days/month with nighttime symptoms, or \> 2 episodes in the past year that required systemic corticosteroids
* Age 2 and 12 years, inclusive
Additional inclusion criteria will apply to a subset of 512 of children whose caregivers will be interviewed to obtain caregiver-reported morbidity outcomes:
* Caregiver is able to speak and understand either English or Spanish. Participants unable to read will be eligible as all surveys will be administered verbally by research personnel
* Consent from the primary caregiver, caregiver permission for the child to participate as well as assent from the child (\>7 years). If there are eligible siblings, only one child will be randomly selected
Exclusion Criteria:
* The child has other significant medical conditions, such as congenital heart disease, cystic fibrosis, or other chronic lung disease, that could interfere with the assessment of asthma-related measures
Additional exclusion criteria will apply to a subset of 512 children/caregivers as described above:
* No access to a telephone to conduct follow-up surveys
* Children in foster care or other situations in which consent cannot be obtained from a guardian
Inclusion Criteria
Inclusion Criteria:
The criteria listed below will apply to \~5,000 children from eMPI and eUC practices:
* Physician-diagnosed asthma (based on EHR)
* Persistent or uncontrolled asthma as per clinic assessment. Based on NHLBI guidelines, any one of the following: in past month, \> 2 days/week with asthma symptoms, \>2 days/week with rescue medication use, \>2 days/month with nighttime symptoms, or \> 2 episodes in the past year that required systemic corticosteroids
* Age 2 and 12 years, inclusive
Additional inclusion criteria will apply to a subset of 512 of children whose caregivers will be interviewed to obtain caregiver-reported morbidity outcomes:
* Caregiver is able to speak and understand either English or Spanish. Participants unable to read will be eligible as all surveys will be administered verbally by research personnel
* Consent from the primary caregiver, caregiver permission for the child to participate as well as assent from the child (\>7 years). If there are eligible siblings, only one child will be randomly selected
The criteria listed below will apply to \~5,000 children from eMPI and eUC practices:
* Physician-diagnosed asthma (based on EHR)
* Persistent or uncontrolled asthma as per clinic assessment. Based on NHLBI guidelines, any one of the following: in past month, \> 2 days/week with asthma symptoms, \>2 days/week with rescue medication use, \>2 days/month with nighttime symptoms, or \> 2 episodes in the past year that required systemic corticosteroids
* Age 2 and 12 years, inclusive
Additional inclusion criteria will apply to a subset of 512 of children whose caregivers will be interviewed to obtain caregiver-reported morbidity outcomes:
* Caregiver is able to speak and understand either English or Spanish. Participants unable to read will be eligible as all surveys will be administered verbally by research personnel
* Consent from the primary caregiver, caregiver permission for the child to participate as well as assent from the child (\>7 years). If there are eligible siblings, only one child will be randomly selected
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Maximum Age
12 Years
Minimum Age
2 Years
NCT Id
NCT03066596
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2016-6258
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Promoting Asthma Guidelines and Management Through Technology-Based Intervention and Care Coordination
Primary Outcomes
Outcome Description
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.
Outcome Measure
Percentage of Participants With 1 or More Guideline-based Corrective Actions Taken
Outcome Time Frame
Immediately post-intervention, up to 1 year
Secondary Ids
Secondary Id
1R01HL133789
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
Baseline, and 3 month, 6 month, 9 month, and 12 month follow-up evaluations
Outcome Measure
Symptom Free Days (SFDs)
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
12
Minimum Age Number (converted to Years and rounded down)
2
Investigators
Investigator Type
Principal Investigator
Investigator Name
Marina Reznik
Investigator Email
MREZNIK@montefiore.org
Investigator Phone
718-405-5260