Back to resultsPromoting Asthma Guidelines and Management Through Technology-Based Intervention and Care Coordination (PRAGMATIC)
Primary Purpose
Asthma Childhood
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PRAGMATIC
Sponsored by
About this trial
This is an interventional supportive care trial for 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.
Sites / Locations
- Children's Hospital at Montefiore, Albert Einstein College of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PRAGMATIC
Arm Description
Intervention practices will receive guideline information and assess children's asthma severity and control. For children with persistent/uncontrolled asthma, academic detailing and prompt in EHR following asthma guidelines will guide asthma management; outreach worker will follow up with patients referred to the by providers to receive care coordination to assure that provider management plan is followed by patient at home.
Outcomes
Primary Outcome Measures
Proportion of visits with >1 guideline-based corrective actions
provider adoption of guidelines
Secondary Outcome Measures
Symptom free days
number of days without symptoms in the past 14 days
Full Information
NCT ID
NCT03066596
First Posted
February 16, 2017
Last Updated
September 8, 2023
Sponsor
Montefiore Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT03066596
Brief Title
Promoting Asthma Guidelines and Management Through Technology-Based Intervention and Care Coordination
Acronym
PRAGMATIC
Official Title
Promoting Asthma Guidelines and Management Through Technology-Based Intervention and Care Coordination
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 7, 2017 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma Childhood
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
enhanced Usual Care and Intervention sites
Masking
None (Open Label)
Masking Description
Follow up assessments will be collected by blinded interviewers
Allocation
N/A
Enrollment
530 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PRAGMATIC
Arm Type
Experimental
Arm Description
Intervention practices will receive guideline information and assess children's asthma severity and control. For children with persistent/uncontrolled asthma, academic detailing and prompt in EHR following asthma guidelines will guide asthma management; outreach worker will follow up with patients referred to the by providers to receive care coordination to assure that provider management plan is followed by patient at home.
Intervention Type
Behavioral
Intervention Name(s)
PRAGMATIC
Intervention Description
Provider educational seminar, EHR prompt, outreach-worker care coordination
Primary Outcome Measure Information:
Title
Proportion of visits with >1 guideline-based corrective actions
Description
provider adoption of guidelines
Time Frame
through study completion, an average of 5 years
Secondary Outcome Measure Information:
Title
Symptom free days
Description
number of days without symptoms in the past 14 days
Time Frame
14 days
Other Pre-specified Outcome Measures:
Title
Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)
Description
caregiver asthma related quality of life
Time Frame
3-12 months
Title
Health care utilization: number of ED visits for asthma
Description
number of ED visits for asthma
Time Frame
3-12 months
Title
Health care utilization: number hospitalizations for asthma
Description
number hospitalizations for asthma
Time Frame
3-12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marina Reznik, MD, MS
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital at Montefiore, Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Investigators will share de-identified data using Data Sharing Agreement process after the study is completed and main study aims manuscripts have been published.
Learn more about this trial
Promoting Asthma Guidelines and Management Through Technology-Based Intervention and Care Coordination
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