Family Connections: Structured Family Deliberation for Decisions About Home Ventilation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- Feasibility as assessed by proportion of families enrolled
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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).
Arms & Interventions
Intervention
Intervention families will participate in the Structured Family Deliberation that includes a clinician-led review of a web-based decisional aid.
Intervention: Structured Family Deliberation (Other)
Control
Control families will undergo the standard decisional process for home ventilation and will also review the web-based decisional aid independently.
Outcomes
Primary Outcomes
Feasibility as assessed by proportion of families enrolled
Time Frame: Duration of study period (12 months)
Feasibility will be measured by the proportion of families approached that are successfully enrolled.
Feasibility as assessed by time spent engaging with the website by parents
Time Frame: Assessed at 30 day follow-up interview
Feasibility will be measured by time parents spend engaging with the website.
Feasibility as assessed by proportion of successfully completed interventions
Time Frame: Duration of study period (12 months)
Feasibility will be measured by success completing the intervention by the study team
Secondary Outcomes
- Factors in decision making as assessed by participants responses to qualitative interview questions(Assessed at 30 day follow-up interview)
- Usefulness of the Structured Family Deliberation Process will be assessed by participant responses to qualitative interview questions(Assessed at 30 day follow-up interview)
- Preparedness in decision making as assessed by Preparation for Decision-Making Scale(Assessed at 30 day follow-up interview)
- Parental stress and coping as assessed by participants responses to qualitative interview(Assessed at 30 day follow-up interview)