Clinical trial NCT03916237: Registry and Screening Tool to Identify Children With Asthma Likely to Benefit From Home Assessment and Remediation
Official title: Utilizing a Clinical Registry and Environmental Screening Tool to Identify Children With Asthma Most Likely to Benefit From Home Assessment and Remediation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Pediatric ALL
School Health Services
Registries
Medical Informatics
Home Visits
Housing Problems
Social Determinants of Health
Healthcare Disparity
Health Status Disparity
Keywords: medical legal partnership
urban health services
urban health
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
Collaborators: name: Cleveland Metropolitan School District
name: Environmental Health Watch
name: Legal Aid Society of Cleveland
First posted: 2019-04-16
Enrollment: 21
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Students enrolled in the School Health Program with a diagnosis of asthma will be randomized into two groups. The first group will receive regular School Health asthma care. The second group will receive the Asthma Home Assessment Intervention. Based on results of the screening tool and home assessments, participants will be placed into one of four groups: GROUP A (no referral) GROUP B (home assessment only) GROUP C (home assessment and remediation) and GROUP D (medical legal partnership referral only) Home assessment and remediation follows Environmental Health Watch Healthy Homes model previously described. Medical Legal partnership referrals follow protocols consistent with medical legal partnerships previously prescribed.
Primary purpose: TREATMENT

Brief summary: Recognizing a decline in pediatric primary care visits and immunizations rates, an increase in utilization of the emergency room and stagnating academic achievement, leaders of MetroHealth Medical Center and the Cleveland Metropolitan School District understood that an innovative delivery option would be required to meet the needs of their pediatric urban population. In the fall of 2013, with support from local and regional funders, they collaborated to open the first School Based Health Center in Cleveland. During its first year, the MetroHealth School Health Program provided primary care services to children in 98 clinical care visits. Through an emphasis on population health and care coordination, the School Health Program has grew dramatically, completing over 2,400 visits in the 2017-2018 school year at clinical sites in over 13 schools. The School Health Program has been successful in developing a care management model to improve the percentage of students who complete recommended preventive services including immunization and preventive visits. The investigators intend to apply and expand upon lessons learned to develop an effective multi component asthma care management model that includes (1) registry utilization (2) evidence based clinical care protocols (3) implementation of an Environmental Screening Tool (4) effective utilization of a Medical Legal Partnership (5) effective partnership with an environmental health justice community organization, Environmental Health Watch, for home assessment and remediation (6) utilization of a unique data sharing partnership between a large health system and school district to document health and educational outcomes.

Detailed description: Students enrolled in the MetroHealth School Health Program (signed parental consent on file in electronic health record) and have a diagnosis of asthma on active problem list, or were seen in Emergency Department or Express Care in past 12 months for asthma related diagnosis, or have a rescue or controller inhaled medication on current medication list, will be considered for inclusion. Research staff will call families who meet inclusion criteria to discuss the study, determine interest in inclusion and obtain consent. Once enrolled baseline measures will be obtained, including level of asthma control and responses on the Environmental Screening Tool (EST) and the Community Advocacy Program Home Asthma Screening Tool (CAPHAST) (see CREST phone screening tool). Participants will then be randomized into two groups. The first group will receive regular care. The second group will receive the Asthma Home Assessment Intervention. Based on results of the screening tool and home assessments, participants will be placed into one of four groups (see CREST study design): GROUP A (no referral) GROUP B (home assessment only) GROUP C (home assessment and remediation) and GROUP D (medical legal partnership referral only) Participants randomized to regular care will be assessed for outcome measures at 3 and 6 months after randomization. Those randomized to the intervention arm will be assessed at 3 and 6 months after completion of intervention.

Eligibility criteria: Inclusion Criteria:

* Enrolled in the MetroHealth School Health Program (signed parental consent on file in Epic electronic health record)
* Has diagnosis of asthma on active problem list OR was seen in Emergency Department or Express Care in past 12 months for asthma related diagnosis, OR has asthma related rescue or controller inhaled medication on current medication list.

Exclusion Criteria:

• Does not meet inclusion criteria.

Primary outcomes:
measure: Change in Asthma Control Test Score
timeFrame: baseline and 3 and 6 months after intervention
Secondary outcomes:
measure: Change in number of Asthma Related Emergency Department Visits
timeFrame: baseline and 3 and 6 months after intervention
measure: Change in number of Asthma Related Hospitalizations
timeFrame: baseline and 3 and 6 months after intervention
measure: Change in number of Asthma related Express Care or Urgent Care visits
timeFrame: baseline and 3 and 6 months after intervention
measure: Educational Outcome: attendance
timeFrame: in past 3 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth medical Center
state: Ohio
Study officials:
affiliation: MetroHealth Medical Center
name: Vanessa Maier, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: