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

Primary Purpose

Asthma, Pediatric ALL, School Health Services

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home assessment
Home remediation
Referral to Medical Legal Partnership
Regular School Based Health Asthma Care
Sponsored by
MetroHealth Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring medical legal partnership, urban health services, urban health

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • MetroHealth medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

CONTROL

GROUP A no referral

GROUP B1 home assessment only

GROUP B2 home assessment only

GROUP C1 home assessment and remediation

GROUP C2 home assessment and remediation

D medical legal partnership only

Arm Description

Control group

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in number of Asthma Related Emergency Department Visits
Self reported number of asthma related emergency department visits in past 4 months
Change in number of Asthma Related Hospitalizations
Self reported number of asthma related hospitalizations in past 4 months
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
Educational Outcome: attendance
number of absences

Full Information

First Posted
April 11, 2019
Last Updated
October 17, 2023
Sponsor
MetroHealth Medical Center
Collaborators
Cleveland Metropolitan School District, Environmental Health Watch, Legal Aid Society of Cleveland
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1. Study Identification

Unique Protocol Identification Number
NCT03916237
Brief Title
Registry and Screening Tool to Identify Children With Asthma Likely to Benefit From Home Assessment and Remediation
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MetroHealth Medical Center
Collaborators
Cleveland Metropolitan School District, Environmental Health Watch, Legal Aid Society of Cleveland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CONTROL
Arm Type
No Intervention
Arm Description
Control group
Arm Title
GROUP A no referral
Arm Type
Experimental
Arm Description
Screener does not document need for home visit or medical legal partnership referral.
Arm Title
GROUP B1 home assessment only
Arm Type
Experimental
Arm Description
Screener documents need for home assessment. Home assessment does not document need for home remediation. Screener does not document need for medical legal partnership.
Arm Title
GROUP B2 home assessment only
Arm Type
Experimental
Arm Description
Screener documents need for home assessment. Home assessment does not document need for home remediation. Screener documents need for medical legal partnership.
Arm Title
GROUP C1 home assessment and remediation
Arm Type
Experimental
Arm Description
Screener documents need for home assessment. Home assessment documents need for home remediation. Screener does not document need for medical legal partnership.
Arm Title
GROUP C2 home assessment and remediation
Arm Type
Experimental
Arm Description
Screener documents need for home assessment. Home assessment documents need for home remediation. Screener documents need for medical legal partnership.
Arm Title
D medical legal partnership only
Arm Type
Experimental
Arm Description
Screener does not document need for home assessment. Screener does not document need for medical legal partnership.
Intervention Type
Other
Intervention Name(s)
Home assessment
Intervention Description
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
Intervention Name(s)
Home remediation
Intervention Description
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
Intervention Name(s)
Referral to Medical Legal Partnership
Intervention Description
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
Intervention Name(s)
Regular School Based Health Asthma Care
Intervention Description
Regular care in the School Health Program
Primary Outcome Measure Information:
Title
Change in Asthma Control Test Score
Description
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.
Time Frame
baseline and 3 and 6 months after intervention
Secondary Outcome Measure Information:
Title
Change in number of Asthma Related Emergency Department Visits
Description
Self reported number of asthma related emergency department visits in past 4 months
Time Frame
baseline and 3 and 6 months after intervention
Title
Change in number of Asthma Related Hospitalizations
Description
Self reported number of asthma related hospitalizations in past 4 months
Time Frame
baseline and 3 and 6 months after intervention
Title
Change in number of Asthma related Express Care or Urgent Care visits
Description
Self reported number of asthma related Express Care or Urgent Care visits in past 4 months
Time Frame
baseline and 3 and 6 months after intervention
Title
Educational Outcome: attendance
Description
number of absences
Time Frame
in past 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanessa Maier, MD, MPH
Organizational Affiliation
MetroHealth Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MetroHealth medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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