Promoting Asthma Guidelines and Management Through Technology-Based Intervention and Care Coordination

Asthma Childhood Clinical Trial

— PRAGMATIC  

Official title:

Promoting Asthma Guidelines and Management Through Technology-Based Intervention and Care Coordination

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03066596
• Other study ID #: 2016-6258
• Secondary ID: 1R01HL133789-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 7, 2017
• Est. completion date: August 31, 2024

Study information

• Verified date: September 2023
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 530
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Asthma Childhood

Intervention

Behavioral:
• PRAGMATIC
Provider educational seminar, EHR prompt, outreach-worker care coordination

Locations

Country	Name	City	State
United States	Children's Hospital at Montefiore, Albert Einstein College of Medicine	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Montefiore Medical Center	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)	caregiver asthma related quality of life	3-12 months
Other	Health care utilization: number of ED visits for asthma	number of ED visits for asthma	3-12 months
Other	Health care utilization: number hospitalizations for asthma	number hospitalizations for asthma	3-12 months
Primary	Proportion of visits with >1 guideline-based corrective actions	provider adoption of guidelines	through study completion, an average of 5 years
Secondary	Symptom free days	number of days without symptoms in the past 14 days	14 days