Back to resultsAsthma Clinics Helping Expand Cost Conversations (Asthma CHECC)
Primary Purpose
Asthma in Children
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health care provider cost navigation training
Sponsored by
About this trial
This is an interventional health services research trial for Asthma in Children focused on measuring cost of care, patient provider communication, financial burden
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Sites / Locations
- North Carolina Children's Allergy and Asthma Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Cost navigation training intervention
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04669080
First Posted
December 7, 2020
Last Updated
September 27, 2021
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Robert Wood Johnson Foundation, Harvard Pilgrim Health Care
1. Study Identification
Unique Protocol Identification Number
NCT04669080
Brief Title
Asthma Clinics Helping Expand Cost Conversations
Acronym
Asthma CHECC
Official Title
Developing and Evaluating an Intervention to Enhance the Work of Asthma Specialty Care Teams in Helping Families in Cost Navigation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 4, 2021 (Actual)
Primary Completion Date
June 21, 2021 (Actual)
Study Completion Date
July 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Robert Wood Johnson Foundation, Harvard Pilgrim Health Care
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Children
Keywords
cost of care, patient provider communication, financial burden
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
non-randomized pre-post test
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cost navigation training intervention
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Health care provider cost navigation training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Frequency of Cost Conversations Occurring during Asthma Specialty Care Visits
Description
Change in the frequency of caregivers reporting cost of care conversations with the asthma specialty care team during routine asthma care visits
Time Frame
Baseline, 6 weeks post intervention completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa B Gilkey, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Carolina Children's Allergy and Asthma Center
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
9 to 36 months following publication
IPD Sharing Access Criteria
Investigator who proposes to use the data has IRB, IEC, or REB approval, as applicable, and an executed data use/sharing agreement with UNC.
Learn more about this trial
Asthma Clinics Helping Expand Cost Conversations
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