Family Connections

Johns Hopkins Medicine

Status: Withdrawn

Conditions: Chronic Respiratory Failure

Treatments: Other: Structured Family Deliberation

Study type: Interventional

Funder types: Other

Identifiers

NCT05379439

IRB00323418

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Intervention

Experimental group

Description:

Intervention families will participate in the Structured Family Deliberation that includes a clinician-led review of a web-based decisional aid.

Treatment:

Other: Structured Family Deliberation

Control

No Intervention group

Description:

Control families will undergo the standard decisional process for home ventilation and will also review the web-based decisional aid independently.