Registry and Screening Tool to Identify Children With Asthma Likely to Benefit From Home Assessment and Remediation

Asthma Clinical Trial

— CREST  

Official title:

Utilizing a Clinical Registry and Environmental Screening Tool to Identify Children With Asthma Most Likely to Benefit From Home Assessment and Remediation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03916237
• Other study ID #: IRB18-00771
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: June 1, 2023

Study information

• Verified date: October 2023
• Source: MetroHealth Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Health Status Disparity
• Healthcare Disparity
• Home Visits
• Housing Problems
• Medical Informatics
• Pediatric ALL
• Registries
• School Health Services
• Social Determinants of Health

Intervention

Other:
• Home assessment
Home assessment for environmental hazards according to protocol established by Environmental Health Watch (Healthy Home Audit https://www.ehw.org/healthy-home-audit/)
• Home remediation
Low level home remediation according to previously established protocol (Kercsmar CM, Dearborn DG, Schluchter M, et al. Reduction in asthma morbidity in children as a result of home remediation aimed at moisture sources. Environ Health Perspect. 2006;114(10):1574-80)
• Referral to Medical Legal Partnership
Medical Legal Partnership referral as described by the National Center for Medical Legal partnerships and others (Beck AF, Identifying and treating a substandard housing cluster using a medical-legal partnership. Pediatrics. 2012;130(5):831-838)
• Regular School Based Health Asthma Care
Regular care in the School Health Program

Locations

Country	Name	City	State
United States	MetroHealth medical Center	Cleveland	Ohio

Sponsors (4)

Lead Sponsor	Collaborator
MetroHealth Medical Center	Cleveland Metropolitan School District, Environmental Health Watch, Legal Aid Society of Cleveland

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Asthma Control Test Score	Score on: Asthma Control Test (for children 12 and over) or Child Asthma Control Test (for children under 12) The Asthma Control Test is used to identify asthma control with scores ranging from a minimum of 5 (poor control) to a maximum of 25 (complete control) A score of over 19 indicated well controlled asthma.	baseline and 3 and 6 months after intervention
Secondary	Change in number of Asthma Related Emergency Department Visits	Self reported number of asthma related emergency department visits in past 4 months	baseline and 3 and 6 months after intervention
Secondary	Change in number of Asthma Related Hospitalizations	Self reported number of asthma related hospitalizations in past 4 months	baseline and 3 and 6 months after intervention
Secondary	Change in number of Asthma related Express Care or Urgent Care visits	Self reported number of asthma related Express Care or Urgent Care visits in past 4 months	baseline and 3 and 6 months after intervention
Secondary	Educational Outcome: attendance	number of absences	in past 3 months