AsthmaCRESTNCT03916237
Registry and Screening Tool to Identify Children With Asthma Likely to Benefit From Home Assessment and Remediation
A study testing Home assessment, Home remediation and Referral to Medical Legal Partnership in people with Asthma and Pediatric ALL, run by MetroHealth Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Asthma, Pediatric ALL, School Health Services
- What is being tested?
- Home assessment, Home remediation and Referral to Medical Legal Partnership
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2019to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Does not meet inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Asthma, Pediatric ALL, School Health Services, Registries, Medical Informatics, Home Visits
- Being tested
- Home assessment, Home remediation, Referral to Medical Legal Partnership, Regular School Based Health Asthma Care
- Keywords
- medical legal partnership, urban health services, urban health
- Medical subject headings
- Asthma, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home assessmentOther
Home assessment for environmental hazards according to protocol established by Environmental Health Watch (Healthy Home Audit https://www.ehw.org/healthy-home-audit/)
Home remediationOther
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)
Referral to Medical Legal PartnershipOther
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)
Regular School Based Health Asthma CareOther
Regular care in the School Health Program
| Study group | Role | What they receive |
|---|---|---|
| CONTROL | No intervention | Control group |
| GROUP A no referral | Experimental | Screener does not document need for home visit or medical legal partnership referral. Receives: 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. Receives: 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. Receives: Other: Home assessment; Other: 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. Receives: Other: Home assessment; Other: 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. Receives: Other: Home assessment; Other: Home remediation; Other: 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. Receives: Other: Referral to Medical Legal Partnership |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 3 and 6 months after intervention
Secondary outcomes (4)
Change in number of Asthma Related Emergency Department Visits
Self reported number of asthma related emergency department visits in past 4 months
Measured: baseline and 3 and 6 months after intervention
Change in number of Asthma Related Hospitalizations
Self reported number of asthma related hospitalizations in past 4 months
Measured: baseline and 3 and 6 months after intervention
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
Measured: baseline and 3 and 6 months after intervention
Educational Outcome: attendance
number of absences
Measured: in past 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start1 Dec 2019
- Primary completion1 Jan 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cleveland Metropolitan School District, Environmental Health Watch, Legal Aid Society of Cleveland
- Responsible party
- Principal investigator, Vanessa Maier, MD, MetroHealth Medical Center
- Investigators
- Vanessa Maier, MD, MPH, Principal investigator, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916237
- Sponsor's protocol ID
- IRB18-00771
- Acronym
- CREST
- Status last verified
- Oct 2023
- First submitted
- 11 Apr 2019
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing a Clinical Registry and Environmental Screening Tool to Identify Children With Asthma Most Likely to Benefit From Home Assessment and Remediation
- ClinicalTrials.gov ID
- NCT03916237
- Acronym / sponsor ID
- CREST / IRB18-00771
- Conditions
- Asthma, Pediatric ALL, School Health Services, Registries, Medical Informatics, Home Visits
- Keywords
- medical legal partnership, urban health services, urban health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Collaborators
- Cleveland Metropolitan School District, Environmental Health Watch, Legal Aid Society of Cleveland
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
- 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.
| Arm | Type | Receives |
|---|---|---|
| CONTROL | No intervention | –Control group |
| GROUP A no referral | Experimental | Other: Regular School Based Health Asthma CareScreener does not document need for home visit or medical legal partnership referral. |
| GROUP B1 home assessment only | Experimental | Other: Home assessmentScreener documents need for home assessment. Home assessment does not document need for home remediation. Screener does not document need for medical legal partnership. |
| GROUP B2 home assessment only | Experimental | Other: Home assessment, Other: Referral to Medical Legal PartnershipScreener documents need for home assessment. Home assessment does not document need for home remediation. Screener documents need for medical legal partnership. |
| GROUP C1 home assessment and remediation | Experimental | Other: Home assessment, Other: Home remediationScreener documents need for home assessment. Home assessment documents need for home remediation. Screener does not document need for medical legal partnership. |
| GROUP C2 home assessment and remediation | Experimental | Other: Home assessment, Other: Home remediation, Other: Referral to Medical Legal PartnershipScreener documents need for home assessment. Home assessment documents need for home remediation. Screener documents need for medical legal partnership. |
| D medical legal partnership only | Experimental | Other: Referral to Medical Legal PartnershipScreener does not document need for home assessment. Screener does not document need for medical legal partnership. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Does not meet inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home assessmentHome assessment for environmental hazards according to protocol established by Environmental Health Watch (Healthy Home Audit https://www.ehw.org/healthy-home-audit/) | Other | GROUP B1 home assessment only, GROUP B2 home assessment only, GROUP C1 home assessment and remediation, GROUP C2 home assessment and remediation |
| Home remediationLow 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) | Other | GROUP C1 home assessment and remediation, GROUP C2 home assessment and remediation |
| Referral to Medical Legal PartnershipMedical 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 | D medical legal partnership only, GROUP B2 home assessment only, GROUP C2 home assessment and remediation |
| Regular School Based Health Asthma CareRegular care in the School Health Program | Other | GROUP A no referral |
Primary outcome
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.
4 secondary outcomes
Change in number of Asthma Related Emergency Department Visits
Time frame: 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
Change in number of Asthma related Express Care or Urgent Care visits
Time frame: baseline and 3 and 6 months after intervention
Educational Outcome: attendance
Time frame: in past 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanessa Maier, MD, MPH principal investigator
MetroHealth Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home assessment, Home remediation and Referral to Medical Legal Partnership in people with Asthma and Pediatric ALL, run by MetroHealth Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Asthma Control Test Score (time frame: baseline and 3 and 6 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.