Clinical trial NCT05379439: Family Connections
Official title: Family Connections: Structured Family Deliberation for Decisions About Home Ventilation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Respiratory Failure
Keywords: Tracheostomy
Home mechanical ventilation
Children with medical complexity
Medical ethics
Qualitative research
Lead sponsor: Johns Hopkins All Children's Hospital
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Feasibility as assessed by proportion of families enrolled
timeFrame: Duration of study period (12 months)
measure: Feasibility as assessed by time spent engaging with the website by parents
timeFrame: Assessed at 30 day follow-up interview
measure: Feasibility as assessed by proportion of successfully completed interventions
timeFrame: Duration of study period (12 months)
Secondary outcomes:
measure: Usefulness of the Structured Family Deliberation Process will be assessed by participant responses to qualitative interview questions
timeFrame: Assessed at 30 day follow-up interview
measure: Preparedness in decision making as assessed by Preparation for Decision-Making Scale
timeFrame: Assessed at 30 day follow-up interview
measure: Factors in decision making as assessed by participants responses to qualitative interview questions
timeFrame: Assessed at 30 day follow-up interview
measure: Parental stress and coping as assessed by participants responses to qualitative interview
timeFrame: Assessed at 30 day follow-up interview
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
facility: Johns Hopkins All Children's Hospital
state: Florida
Study officials:
affiliation: Johns Hopkins All Children's Hospital
name: Nicholas A Jabre, MD
role: PRINCIPAL_INVESTIGATOR
References: