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

NCT ID: NCT03066596

Last Updated: 2025-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 530 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-07
• Study Completion Date: 2024-08-24

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.

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.

Conditions

Asthma Childhood

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Enhanced Multifaceted Prompting Intervention (eMPI)

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.

Group Type: EXPERIMENTAL

eMPI

Intervention Type: 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 Usual Care (eUC) Practices

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

eMPI

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

Intervention Type: BEHAVIORAL

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

• 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

• 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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marina Reznik, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

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

The Bronx, New York, United States

Countries

United States

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.nhlbi.nih.gov/guidelines/asthma/

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.

http://www.ncqa.org/Programs/Recognition/Practices/PatientCenteredMedicalHomePCMH.aspx

Patient-Centered Medical Home Recognition.

Other Identifiers

1R01HL133789

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2016-6258

Identifier Type: -

Identifier Source: org_study_id