Asthma Clinics Helping Expand Cost Conversations (Asthma CHECC)

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.

Study Overview

• Status: Completed
• Conditions: Asthma in Children
• Intervention / Treatment: Behavioral: Health care provider cost navigation training

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • North Carolina Children's Allergy and Asthma Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cost navigation training intervention	Behavioral: Health care provider cost navigation training; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline, 6 weeks post intervention completion

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Harvard Pilgrim Health Care; Robert Wood Johnson Foundation
• Investigators: Principal Investigator: Melissa B Gilkey, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Actual): June 21, 2021
• Study Completion (Actual): July 20, 2021

Study Registration Dates

• First Submitted: December 7, 2020
• First Submitted That Met QC Criteria: December 14, 2020
• First Posted (Actual): December 16, 2020

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: financial burden; cost of care; patient provider communication
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 20-2616

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No