NCT04669080

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

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

December 7, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 16, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

January 4, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2021

Completed
Last Updated

September 29, 2021

Status Verified

June 1, 2021

Enrollment Period

6 months

First QC Date

December 7, 2020

Last Update Submit

September 27, 2021

Conditions

Keywords

cost of carepatient provider communicationfinancial burden

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Cost navigation training intervention

OTHER
Behavioral: Health care provider cost navigation training

Interventions

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.

Cost navigation training intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Carolina Children's Allergy and Asthma Center

Raleigh, North Carolina, 27607, United States

Location

MeSH Terms

Conditions

Financial Stress

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Melissa B Gilkey, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: non-randomized pre-post test
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2020

First Posted

December 16, 2020

Study Start

January 4, 2021

Primary Completion

June 21, 2021

Study Completion

July 20, 2021

Last Updated

September 29, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will share

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.

Time Frame
9 to 36 months following publication
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.

Locations