NCT03916237

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

3.1 years

First QC Date

April 11, 2019

Last Update Submit

October 17, 2023

Conditions

Keywords

medical legal partnershipurban health servicesurban health

Outcome Measures

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.

    baseline and 3 and 6 months after intervention

Secondary Outcomes (4)

  • Change in number of Asthma Related Emergency Department Visits

    baseline and 3 and 6 months after intervention

  • Change in number of Asthma Related Hospitalizations

    baseline and 3 and 6 months after intervention

  • Change in number of Asthma related Express Care or Urgent Care visits

    baseline and 3 and 6 months after intervention

  • Educational Outcome: attendance

    in past 3 months

Study Arms (7)

CONTROL

NO INTERVENTION

Control group

GROUP A no referral

EXPERIMENTAL

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

Other: Regular School Based Health Asthma Care

GROUP B1 home assessment only

EXPERIMENTAL

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

GROUP B2 home assessment only

EXPERIMENTAL

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

Other: Home assessmentOther: Referral to Medical Legal Partnership

GROUP C1 home assessment and remediation

EXPERIMENTAL

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

Other: Home assessmentOther: Home remediation

GROUP C2 home assessment and remediation

EXPERIMENTAL

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

Other: Home assessmentOther: Home remediationOther: Referral to Medical Legal Partnership

D medical legal partnership only

EXPERIMENTAL

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

Other: Referral to Medical Legal Partnership

Interventions

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

GROUP B1 home assessment onlyGROUP B2 home assessment onlyGROUP C1 home assessment and remediationGROUP C2 home assessment and 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)

GROUP C1 home assessment and remediationGROUP C2 home assessment and remediation

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 onlyGROUP B2 home assessment onlyGROUP C2 home assessment and remediation

Regular care in the School Health Program

GROUP A no referral

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MetroHealth medical Center

Cleveland, Ohio, 44109, United States

Location

MeSH Terms

Conditions

AsthmaPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative Disorders

Study Officials

  • Vanessa Maier, MD, MPH

    MetroHealth Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor & Medical Director, School Health

Study Record Dates

First Submitted

April 11, 2019

First Posted

April 16, 2019

Study Start

December 1, 2019

Primary Completion

January 1, 2023

Study Completion

June 1, 2023

Last Updated

October 19, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations