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

NCT ID: NCT03916237

Last Updated: 2023-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2023-06-01

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CONTROL

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

GROUP A no referral

Screener does not document need for home visit or medical legal partnership referral.

Group Type EXPERIMENTAL

Regular School Based Health Asthma Care

Intervention Type OTHER

Regular care in the School Health Program

GROUP B1 home assessment only

Screener documents need for home assessment. Home assessment does not document need for home remediation. Screener does not document need for medical legal partnership.

Group Type EXPERIMENTAL

Home assessment

Intervention Type OTHER

Home assessment for environmental hazards according to protocol established by Environmental Health Watch (Healthy Home Audit https://www.ehw.org/healthy-home-audit/)

GROUP B2 home assessment only

Screener documents need for home assessment. Home assessment does not document need for home remediation. Screener documents need for medical legal partnership.

Group Type EXPERIMENTAL

Home assessment

Intervention Type OTHER

Home assessment for environmental hazards according to protocol established by Environmental Health Watch (Healthy Home Audit https://www.ehw.org/healthy-home-audit/)

Referral to Medical Legal Partnership

Intervention Type OTHER

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)

GROUP C1 home assessment and remediation

Screener documents need for home assessment. Home assessment documents need for home remediation. Screener does not document need for medical legal partnership.

Group Type EXPERIMENTAL

Home assessment

Intervention Type OTHER

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

Intervention Type OTHER

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)

GROUP C2 home assessment and remediation

Screener documents need for home assessment. Home assessment documents need for home remediation. Screener documents need for medical legal partnership.

Group Type EXPERIMENTAL

Home assessment

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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)

D medical legal partnership only

Screener does not document need for home assessment. Screener does not document need for medical legal partnership.

Group Type EXPERIMENTAL

Referral to Medical Legal Partnership

Intervention Type OTHER

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)

Interventions

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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/)

Intervention Type OTHER

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)

Intervention Type OTHER

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)

Intervention Type OTHER

Regular School Based Health Asthma Care

Regular care in the School Health Program

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cleveland Metropolitan School District

UNKNOWN

Sponsor Role collaborator

Environmental Health Watch

UNKNOWN

Sponsor Role collaborator

Legal Aid Society of Cleveland

UNKNOWN

Sponsor Role collaborator

MetroHealth Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Vanessa Maier, MD

Assistant Professor & Medical Director, School Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vanessa Maier, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

MetroHealth Medical Center

Locations

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MetroHealth medical Center

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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IRB18-00771

Identifier Type: -

Identifier Source: org_study_id

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