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

October 17, 2023 updated by: Vanessa Maier, MD, MetroHealth Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 15 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: CONTROL
Control group
Experimental: GROUP A no referral
Screener does not document need for home visit or medical legal partnership referral.
Other: Regular School Based Health Asthma Care
Regular care in the School Health Program
Experimental: 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.
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/)
Experimental: 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.
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/)
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)
Experimental: 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.
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/)
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)
Experimental: 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.
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/)
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)
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)
Experimental: D medical legal partnership only
Screener does not document need for home assessment. Screener does not document need for medical legal partnership.
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Asthma Control Test Score
Time Frame: baseline and 3 and 6 months after intervention
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in number of Asthma Related Emergency Department Visits
Time Frame: baseline and 3 and 6 months after intervention
Self reported number of asthma related emergency department visits in past 4 months
baseline and 3 and 6 months after intervention
Change in number of Asthma Related Hospitalizations
Time Frame: baseline and 3 and 6 months after intervention
Self reported number of asthma related hospitalizations in past 4 months
baseline and 3 and 6 months after intervention
Change in number of Asthma related Express Care or Urgent Care visits
Time Frame: baseline and 3 and 6 months after intervention
Self reported number of asthma related Express Care or Urgent Care visits in past 4 months
baseline and 3 and 6 months after intervention
Educational Outcome: attendance
Time Frame: in past 3 months
number of absences
in past 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MetroHealth Medical Center

Collaborators

Cleveland Metropolitan School District
Environmental Health Watch
Legal Aid Society of Cleveland

Investigators

  • Principal Investigator: Vanessa Maier, MD, MPH, MetroHealth Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

April 11, 2019

First Submitted That Met QC Criteria

April 12, 2019

First Posted (Actual)

April 16, 2019

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB18-00771

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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