Asthma Link: A Real World Application of School Supervised Asthma Therapy

University of Massachusetts, Worcester66 enrolled

Overview

The goal of this study is to assess the feasibility of a clinical trial to evaluate the impact and process of deploying school-supervised asthma therapy in a real-world setting for children with poorly controlled asthma (aged 6-17 years).

The proposed 4-site pilot cluster randomized controlled trial will assess the feasibility of conducting a clinical trial of Asthma Link, a real-world school-supervised asthma therapy program. We will compare the impact of Asthma Link deployed in 2 pediatric practice sites versus Enhanced usual care deployed in 2 comparator sites, with 18 parent-child dyads enrolled per site (N=72 dyads). Primary trial outcomes will be participant recruitment, retention, and intervention fidelity. Secondary trial outcomes will be differences in the frequency of asthma symptoms, emergency department visits, hospital admissions, courses of oral corticosteroids, spirometry values, medication adherence and school absences between intervention and enhanced usual care sites at 3, 6 and 12 month follow up. Additionally we will assess process outcomes (acceptability, adoption, costs, sustainability).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Childhood Asthma

Interventions

Asthma LinkOTHER

Providers enroll patients in school nurse supervised daily controller asthma medication delivery

Enhanced Usual CareOTHER

Providers counsel patients on behavioral strategies to improve medication adherence. Patients also receive an asthma workbook outlining behavioral strategies for asthma medication adherence.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

STUDY INCLUSION/EXCLUSION CRITERIA: Child Inclusion Criteria: * Meet the eligibility criteria for Asthma Link (as described below) * Enrolled in Asthma Link (if randomized to the Asthma Link Condition) * Able and willing to provide informed assent Child Exclusion Criteria: * Unable or unwilling to provide informed assent * Diagnosis of a serious co-morbid illness during the past 5 years * Developmental delay that would prevent study participation. * Planning on moving from primary residence or moving outside of the school district in the next 1 year * A sibling to a child participating in this study Parent Inclusion Criteria: * Parent/guardian to patient * 18 years or older * Able to understand and communicate in English or Spanish * Able and willing to provide informed consent. Parent Exclusion Criteria: * Adults lacking capacity * Prisoners Medical Provider, School Nurse, Asthma Champion Inclusion Criteria: • Able and willing to provide informed consent Medical Provider, School Nurse, Asthma Champion Exclusion Criteria: • Unable or unwilling to provide informed consent Child eligibility for children enrolled in Asthma Link: * children aged 6-17 years (enrolled in grade 1-12) * prescribed daily inhaled corticosteroid (ICS) for asthma * 1 or more courses of oral steroids in the past 2 years OR 1 or more hospitalizations or ED visits for asthma in the past 2 years OR 1 or more sick visits for asthma in the past year OR Asthma Control Test (ACT) score \<19 * parent/child report of poor ICS adherence on adherence checklist- i.e. child or parent says "Yes" when provider asks if they have difficulty remembering to take their medication or if they regularly take medication holidays or breaks * able and willing to assent * parental permission * English or Spanish speaking

Locations (1)

University of Massachusetts

Worcester, Massachusetts, United States

Outcomes

Primary Outcomes

Recruitment Procedures Assessed by Number of Patients Screened

Research staff will track number of patients screened during enrollment process.

Time frame: Baseline

Recruitment Procedures Assessed by Number of Eligible Participants

Research staff will track number of eligible participants who meeting study criteria during the enrollment process.

Time frame: Baseline

Recruitment Procedures Assessed by Number of Patients Recruited Into the Study

Research staff will track number of patients recruited into the study after they are assessed for eligibility.

Time frame: Baseline

Recruitment Procedures Assessed by Number of Eligible Patients That Were Not Enrolled or Refused to Participate.

Research staff will track the number of patients that were not enrolled or refused to participate in the study along with the reasons for non-enrollment.

Time frame: Baseline

Retention of Study Participants (Drop Out)

Research staff to track number of participants who drop out of the study and note reasons for not completing study.

Time frame: Up to end of study, approximately 12 months

Retention of Study Participants (Lost to Follow-up)

Research staff to track number of participants lost to follow-up, who did not complete the 12 month study assessment.

Time frame: Up to end of study, approximately 12 months

Intervention Fidelity - Pediatric Practice

Research staff to assess for intervention fidelity within the pediatric practice through a checklist for pediatric staff to assess percentage of eligible children enrolled.

Data from ClinicalTrials.gov

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Secondary Outcomes

Acceptability - Participants

Research staff will assess acceptability of the study among stakeholders (parent-child dyads, medical providers, school nurses) via a survey in which we will ask stakeholders to rate each component of the Asthma Link intervention using a study specific Acceptability scale ranging from 1 (strongly disagree) to 5 (strongly agree). Qualitative interviews will be performed with stakeholders at 12 months

Time frame: 3 months, 6 months, 12 months

Adoption of Asthma Link Intervention - Medical Provider

Research staff will assess adoption of the intervention via Pediatric practice log to track number of providers offering Asthma Link.

Time frame: Baseline, 3 months, 6 months, 12 months

Adoption of Asthma Link Intervention - Participant

Research staff will assess adoption of the intervention via survey to family at each survey timepoint of study to assess ability to obtain 2 inhalers (one for home and one for school) and deliver medicine to school.

Time frame: 3 months, 6 months, 12 months

Adoption of Asthma Link Intervention - School Nurse

Research staff will assess adoption of the intervention via school nurse log to track family bringing in medicine to school and frequency of child coming to nurses office to receive the medication.

Time frame: Baseline, 3 months, 6 months, 12 months

Cost Effectiveness of Intervention

Research staff will use survey questions to assess time and costs for school nurses to review the toolkit and administer the intervention, pediatric providers to implement the program, and parents to participate in the intervention

Time frame: School nurses and pediatric practices 6 and 12 months/Parents 3, 6 and 12 months

Sustainability of Intervention

Research staff will use a survey questions to parents, pediatric practice staff and school staff

Time frame: 3 months, 6 months, 12 months

Asthma Symptoms - Spirometry

Research staff will assess asthma symptoms utilizing spirometry to measure Forced Expiratory Volume.

Time frame: Baseline, 3 months, 6 months, 12 months

Asthma Symptoms - Asthma Control Test

Research staff will assess asthma symptoms utilizing the validated measure: Asthma Control Test (ACT) which consists of parent's assessment of level of control over child's asthma symptoms in the previous 4 weeks.

Time frame: Baseline, 3 months, 6 months, 12 months

Asthma Symptoms - Maximum Symptoms Days

Research staff will assess asthma symptoms utilizing the validated measure: Maximum Symptom Days (the largest value of the number of days in the previous 2 weeks that a parent reports that their child experienced a) cough, wheezing, or shortness of breath, b) slowed activities due to symptoms, or 3)nocturnal awakening due to these symptoms.

Time frame: Baseline, 3 months, 6 months, 12 months

Frequency of Healthcare Utilization Over Time

Research staff will assess the frequency of healthcare utilization (# of emergency room visits, # of hospital admissions, # of oral steroid courses, and # of urgent care visits) due to asthma through parent report on surveys and medical record review.

Time frame: Baseline, 3 months, 6 months, 12 months

Medication Adherence

Research staff will assess medication adherence via a survey questions administered to parents and through pharmacy refill data.

Time frame: Baseline, 3 months, 6 months, 12 months

School Absences

Research staff will assess school absences via parent report and school nurse report

Time frame: Baseline, 3 months, 6 months, 12 months