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

NCT03066596 | Completed Results

• 2 other identifiers: 2016-62581R01HL133789
• Study Type: interventional
• Target: 530
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma Childhood

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With 1 or More Guideline-based Corrective Actions Taken

  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.

  Immediately post-intervention, up to 1 year

Secondary Outcomes (1)

• Symptom Free Days (SFDs)

  Baseline, and 3 month, 6 month, 9 month, and 12 month follow-up evaluations

Other Outcomes (3)

• Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)

  every 3 months up to 12 months

• Health Care Utilization: Number of ED Visits for Asthma

  every 3 months up to 12 months

• Health Care Utilization: Number Hospitalizations for Asthma

  every 3 months up to 12 months

Study Arms (2)

Enhanced Multifaceted Prompting Intervention (eMPI)

EXPERIMENTAL

The enhanced MPI program (eMPI) consists of innovative multi-level and team-based strategies to enable providers to effectively and efficiently adopt asthma care guidelines. eMPI uses guideline-based prompts at the time of an office visit to support providers' decision-making, increasing the likelihood that they will recommend corrective actions (i.e., preventive medication prescription) to improve asthma management.

Behavioral: eMPI

Enhanced Usual Care (eUC) Practices

NO INTERVENTION

Participants will receive a review packet of the National Asthma Education and Prevention Program (NAEPP) guidelines and educational resources for families. Children will be assessed for asthma severity and level of control at each visit as part of best-practice care, but active intervention components will not be provided.

Interventions

eMPI BEHAVIORAL

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

Enhanced Multifaceted Prompting Intervention (eMPI)

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Children's Hospital at Montefiore, Albert Einstein College of Medicine

The Bronx, New York, 10467, United States

Location

Related Publications (122)

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• Telzak A, Fiori KP, Chambers EC, Haughton J, Levano S, Reznik M. Unmet Social Needs and Pediatric Asthma Severity in an Urban Primary Care Setting. Acad Pediatr. 2023 Sep-Oct;23(7):1361-1367. doi: 10.1016/j.acap.2023.02.009. Epub 2023 Feb 27.

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Related Links

• National Heart Lung and Blood Institute. National Asthma Education and Prevention Program. Expert panel report 3: guidelines for the diagnosis and management of asthma. NIH Publication Number 08 5846. Bethesda, MD: 2007.
• Patient-Centered Medical Home Recognition.

Results Point of Contact

• Title: Marina Reznik, MD, MS
• Organization: Montefiore Medical Center

mreznik@montefiore.org

718-741-2494

Study Officials

• Marina Reznik, MD, MS

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Follow up assessments will be collected by blinded interviewers
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomized design

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: February 28, 2017
• Study Start: March 7, 2017
• Primary Completion: August 24, 2024
• Study Completion: August 24, 2024
• Last Updated: October 21, 2025
• Results First Posted: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)