Clinical trial NCT03066596: Promoting Asthma Guidelines and Management Through Technology-Based Intervention and Care Coordination
Official title: Promoting Asthma Guidelines and Management Through Technology-Based Intervention and Care Coordination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma Childhood
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-02-28
Enrollment: 530
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: enhanced Usual Care and Intervention sites
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Proportion of visits with >1 guideline-based corrective actions
timeFrame: through study completion, an average of 5 years
Secondary outcomes:
measure: Symptom free days
timeFrame: every 3 months up to 12 months
Other outcomes:
measure: Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)
timeFrame: every 3 months up to 12 months
measure: Health care utilization: number of ED visits for asthma
timeFrame: every 3 months up to 12 months
measure: Health care utilization: number hospitalizations for asthma
timeFrame: every 3 months up to 12 months
Locations:
city: Bronx
country: United States
facility: Children's Hospital at Montefiore, Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Marina Reznik, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: