Chronic Respiratory Failure
Conditions
Keywords
Tracheostomy, Home mechanical ventilation, Children with medical complexity, Medical ethics, Qualitative research
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.
Interventions
OTHERStructured 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.
Sponsors
Johns Hopkins All Children's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed