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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 13 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MetroHealth Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cleveland Metropolitan School District
Environmental Health Watch
Legal Aid Society of Cleveland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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