Asthma in ChildrenAsthma CHECCNCT04669080
Asthma Clinics Helping Expand Cost Conversations
A study testing Health care provider cost navigation training in people with Asthma in Children, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Healthcare costs are a critical barrier to U.S. families' ability to access the preventive care needed to manage their children's asthma. Asthma specialty care teams are uniquely positioned to help families navigate these cost barriers, but lack structured approaches to discussing this sensitive and complex topic. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Health care provider cost navigation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2021to 20 Jul 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eligible caregivers will:
- attend a routine asthma care appointment for a 4-17 year old child
- screen positive for possible financial burden related to the cost of asthma care
- Eligible healthcare providers will:
- be members of a pediatric asthma specialty care team
Who cannot join
- Caregivers will not be eligible if they:
- attend an appointment for conditions other than routine asthma care
- do not screen positive for possible financial burden related to the cost of asthma care
- Healthcare providers will not be eligible if they:
- are not part of the pediatric asthma specialty care team in the participating clinic
Trial locations and contacts
1 site in 1 country.
United States1 site
North Carolina Children's Allergy and Asthma Center
Raleigh, North Carolina, 27607
About this study
Official title: Developing and Evaluating an Intervention to Enhance the Work of Asthma Specialty Care Teams in Helping Families in Cost Navigation
Healthcare costs are a critical barrier to U.S. families' ability to access the preventive care needed to manage their children's asthma. Asthma specialty care teams are uniquely positioned to help families navigate these cost barriers, but lack structured approaches to discussing this sensitive and complex topic. This study will train asthma specialty care teams to identify families at risk for financial burden and engage in conversations about strategies to manage asthma care costs. The study team will evaluate the impact of a health care provider training on the frequency of cost navigation conversations. The investigators hypothesize that the health care provider training will increase the frequency of parent-reported cost conversations in the clinic.
- Conditions
- Asthma in Children
- Being tested
- Health care provider cost navigation training
- Keywords
- cost of care, patient provider communication, financial burden
- Medical subject headings
- Financial Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health care provider cost navigation trainingBehavioural
Health care providers and asthma educators in a pediatric asthma clinic will receive an online training about the importance of cost of care conversations, how to start cost of care conversations with families, how to refer families to cost navigation resources, and how to lead asthma specialty care teams in cost navigation.
| Study group | Role | What they receive |
|---|---|---|
| Cost navigation training intervention | Other | Not described Receives: Behavioral: Health care provider cost navigation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Frequency of Cost Conversations Occurring during Asthma Specialty Care Visits
Change in the frequency of caregivers reporting cost of care conversations with the asthma specialty care team during routine asthma care visits
Measured: Baseline, 6 weeks post intervention completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start4 Jan 2021
- Primary completion21 Jun 2021
- Study completion20 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- non-randomized pre-post test
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation, Harvard Pilgrim Health Care
- Responsible party
- Sponsor
- Investigators
- Melissa B Gilkey, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669080
- Sponsor's protocol ID
- 20-2616
- Acronym
- Asthma CHECC
- Status last verified
- Jun 2021
- First submitted
- 7 Dec 2020
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual quantitative data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Evaluating an Intervention to Enhance the Work of Asthma Specialty Care Teams in Helping Families in Cost Navigation
- ClinicalTrials.gov ID
- NCT04669080
- Acronym / sponsor ID
- Asthma CHECC / 20-2616
- Conditions
- Asthma in Children
- Keywords
- cost of care, patient provider communication, financial burden
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation, Harvard Pilgrim Health Care
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 21 Jun 2021 (actual)
- Study completion
- 20 Jul 2021 (actual)
- First posted
- 16 Dec 2020 (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.
Healthcare costs are a critical barrier to U.S. families' ability to access the preventive care needed to manage their children's asthma. Asthma specialty care teams are uniquely positioned to help families navigate these cost barriers, but lack structured approaches to discussing this sensitive and complex topic. This study will train asthma specialty care teams to identify families at risk for financial burden and engage in conversations about strategies to manage asthma care costs. The study team will evaluate the impact of a health care provider training on the frequency of cost navigation conversations. The investigators hypothesize that the health care provider training will increase the frequency of parent-reported cost conversations in the clinic.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- non-randomized pre-post test
| Arm | Type | Receives |
|---|---|---|
| Cost navigation training intervention | Other | Behavioral: Health care provider cost navigation training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- attend a routine asthma care appointment for a 4-17 year old child
- screen positive for possible financial burden related to the cost of asthma care
- be members of a pediatric asthma specialty care team
Key exclusion criteria (5 listed)
- attend an appointment for conditions other than routine asthma care
- do not screen positive for possible financial burden related to the cost of asthma care
- are not part of the pediatric asthma specialty care team in the participating clinic
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 |
|---|---|---|
| Health care provider cost navigation trainingHealth care providers and asthma educators in a pediatric asthma clinic will receive an online training about the importance of cost of care conversations, how to start cost of care conversations with families, how to refer families to cost navigation resources, and how to lead asthma specialty care teams in cost navigation. | Behavioural | Cost navigation training intervention |
Primary outcome
Change in Frequency of Cost Conversations Occurring during Asthma Specialty Care Visits
Time frame: Baseline, 6 weeks post intervention completion
Change in the frequency of caregivers reporting cost of care conversations with the asthma specialty care team during routine asthma care visits
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 29 Sep 2021.
- Individual participant dataSharing planned: Yes. Deidentified individual quantitative data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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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.
Melissa B Gilkey, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health care provider cost navigation training in people with Asthma in Children, run by University of North Carolina, Chapel Hill 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 5 inclusion and 5 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 29 Sep 2021. 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 Frequency of Cost Conversations Occurring during Asthma Specialty Care Visits (time frame: Baseline, 6 weeks post intervention completion). 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 29 Sep 2021; AzTrials last refreshed its copy on 26 Oct 2026.