Family Connections
- Conditions
- Chronic Respiratory Failure
- Interventions
- Other: Structured Family Deliberation
- Registration Number
- NCT05379439
- Lead Sponsor
- Johns Hopkins All Children's Hospital
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Structured Family Deliberation Intervention families will participate in the Structured Family Deliberation that includes a clinician-led review of a web-based decisional aid.
- Primary Outcome Measures
Name Time Method Feasibility as assessed by proportion of families enrolled 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 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 Duration of study period (12 months) Feasibility will be measured by success completing the intervention by the study team
- Secondary Outcome Measures
Name Time Method Factors in decision making as assessed by participants responses to qualitative interview questions Assessed at 30 day follow-up interview Preparation for decision-making will be assessed by a qualitative interview with each family.
Usefulness of the Structured Family Deliberation Process will be assessed by participant responses to qualitative interview questions Assessed at 30 day follow-up interview Qualitative interviews will be used to determine whether participants perceived either process as useful.
Preparedness in decision making as assessed by Preparation for Decision-Making Scale Assessed at 30 day follow-up interview 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.
Parental stress and coping as assessed by participants responses to qualitative interview Assessed at 30 day follow-up interview Parental stress and coping will be assessed assessed by a qualitative interview with each family.
Trial Locations
- Locations (1)
Johns Hopkins All Children's Hospital
🇺🇸Saint Petersburg, Florida, United States