Family Connections

Chronic Respiratory Failure Clinical Trial

Official title:

Family Connections: Structured Family Deliberation for Decisions About Home Ventilation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05379439
• Other study ID #: IRB00323418
• Status: Withdrawn
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: October 5, 2022

Study information

• Verified date: June 2023
• Source: Johns Hopkins All Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study seeks to evaluate a Structured Family Deliberation that will serve as the primary intervention in a multicenter controlled trial involving families considering tracheostomy and home ventilation for the child. In this study, the investigators will evaluate the feasibility, usefulness, face validity, and preliminary impact of this approach on preparedness for decision making among participants.

Description:

The investigators will recruit 10 intervention families and 5 control families who are currently admitted to the neonatal or pediatric intensive unit and whose physician anticipates a decision about home ventilation within the next 30 days. Intervention families will receive the Structured Family Deliberation, which includes a guided review of a web-based decisional aid. Control families will receive a link to the website for independent review. All families will be assessed at 1 month with a survey assessing preparedness for decision-making, parental stress and coping, and a qualitative interview.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 5, 2022
• Est. primary completion date: October 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Parents/legal guardians of children admitted to the neonatal or pediatric intensive care unit and whose physician anticipates a decision about home ventilation within the next month.

Exclusion Criteria:

• Parents will be excluded if:

• their child is in foster care or state guardianship

• they are unable to understand the purpose of the study

• they cannot reasonably participate in study demands

• are not fluent in English (the web-based decisional aid is not yet available in other languages).

Related Conditions & MeSH terms

• Chronic Respiratory Failure
• Respiratory Insufficiency

Intervention

Other:
• Structured Family Deliberation
Intervention families will be guided through the six modules included in the web-based decisional aid using a Structured Family Deliberation Tool. Parents will view narrated videos corresponding to each module and will be asked a series of questions related to their own lives and values. The process will continue until all modules are reviewed and all questions are completed.

Locations

Country	Name	City	State
United States	Johns Hopkins All Children's Hospital	Saint Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins All Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility as assessed by proportion of families enrolled	Feasibility will be measured by the proportion of families approached that are successfully enrolled.	Duration of study period (12 months)
Primary	Feasibility as assessed by time spent engaging with the website by parents	Feasibility will be measured by time parents spend engaging with the website.	Assessed at 30 day follow-up interview
Primary	Feasibility as assessed by proportion of successfully completed interventions	Feasibility will be measured by success completing the intervention by the study team	Duration of study period (12 months)
Secondary	Usefulness of the Structured Family Deliberation Process will be assessed by participant responses to qualitative interview questions	Qualitative interviews will be used to determine whether participants perceived either process as useful.	Assessed at 30 day follow-up interview
Secondary	Preparedness in decision making as assessed by Preparation for Decision-Making Scale	Preparation for decision-making will be assessed using a validated survey (Preparation for Decision-Making Scale). Scores range from 10-50; A higher score on the Preparation for Decision-Making scale indicates greater preparedness.	Assessed at 30 day follow-up interview
Secondary	Factors in decision making as assessed by participants responses to qualitative interview questions	Preparation for decision-making will be assessed by a qualitative interview with each family.	Assessed at 30 day follow-up interview
Secondary	Parental stress and coping as assessed by participants responses to qualitative interview	Parental stress and coping will be assessed assessed by a qualitative interview with each family.	Assessed at 30 day follow-up interview