CClinicalTrials.gg
CompletedNCT03916237CRESTUpdated Oct 19, 2023

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

An interventional study of Home assessment and Home remediation in Asthma, Pediatric ALL and School Health Services, sponsored by MetroHealth Medical Center. Completed at 1 site in United States. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-10-19.

Sponsored by MetroHealth Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
5 Years to 17 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Browse trials for

Keywords

  • medical legal partnership
  • urban health services
  • urban health
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 21 is below the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

MetroHealth Medical Center is the lead sponsor of 101 studies on the registry; 19 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Does not meet inclusion criteria.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • 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

  • 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

  • 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 · Other: Referral to Medical Legal Partnership

  • 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 · Other: Home remediation

  • 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 · Other: Home remediation · Other: Referral to Medical Legal Partnership

  • 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

Interventions

  • OtherHome assessment

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

  • OtherHome 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)

  • OtherReferral 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)

  • OtherRegular School Based Health Asthma Care

    Regular care in the School Health Program

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline and 3 and 6 months after intervention

Secondary outcomes

  1. Change in number of Asthma Related Emergency Department Visits

    Self reported number of asthma related emergency department visits in past 4 months

    Time frame: baseline and 3 and 6 months after intervention

  2. Change in number of Asthma Related Hospitalizations

    Self reported number of asthma related hospitalizations in past 4 months

    Time frame: baseline and 3 and 6 months after intervention

  3. 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

    Time frame: baseline and 3 and 6 months after intervention

  4. Educational Outcome: attendance

    number of absences

    Time frame: in past 3 months

07

Study locations

1 site
  • MetroHealth medical Center
    Cleveland, Ohio 44109, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03916237
Lead sponsor
MetroHealth Medical Center
Collaborators
Cleveland Metropolitan School District, Environmental Health Watch, Legal Aid Society of Cleveland
Responsible party
Vanessa Maier, MD (Assistant Professor & Medical Director, School Health, MetroHealth Medical Center) — Principal investigator
First posted
Apr 16, 2019
Start date
Dec 1, 2019
Primary completion
Jan 1, 2023
Completion
Jun 1, 2023
Last update
Oct 19, 2023

Study contacts

Vanessa Maier, MD, MPH
principal investigator · MetroHealth Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion