Asthma Clinics Helping Expand Cost Conversations | NCT04669080

Studies
Asthma Clinics Helping Expand Cost Conversations

NCT04669080

Sponsor

University of North Carolina, Chapel Hill

Status

Completed

Last Update Posted

Sep 29, 2021Actual

Enrollment

65Actual

Phase

Not Applicable

Conditions

Asthma in Children

Interventions

Health care provider cost navigation training

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 4, 2021Actual

Primary Completion Date

Jun 21, 2021Actual

Completion Date

Jul 20, 2021Actual

First Submitted Date

Dec 7, 2020

First Submission Date that Met QC Criteria

Dec 14, 2020

First Posted Date

Dec 16, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 27, 2021

Last Update Posted Date

Sep 29, 2021Actual

Name	Class
Robert Wood Johnson Foundation	OTHER
Harvard Pilgrim Health Care	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

65Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cost navigation training intervention	Other		Behavioral: Health care provider cost navigation training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Health care provider cost navigation training	Behavioral	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Melissa B Gilkey, PhD	University of North Carolina, Chapel Hill	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
North Carolina Children's Allergy and Asthma Center		Raleigh	North Carolina	27607	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

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.

Types

Not provided

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.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086522	Financial Stress

Ancestor Terms

ID	Term
D013315	Stress, Psychological
D001526	Behavioral Symptoms
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided