Family Connections

Study Overview
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Brief Summary
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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
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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.

Official Title
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Family Connections: Structured Family Deliberation for Decisions About Home Ventilation

Conditions
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Chronic Respiratory Failure

Intervention / Treatment
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* Other: Structured Family Deliberation


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Intervention families will participate in the Structured Family Deliberation that includes a clinician-led review of a web-based decisional aid. | Other: Structured Family Deliberation<br>* 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.<br>|
| No Intervention: Control<br>Control families will undergo the standard decisional process for home ventilation and will also review the web-based decisional aid independently. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility as assessed by proportion of families enrolled | Feasibility will be measured by the proportion of families approached that are successfully enrolled. | Duration of study period (12 months) | 
| Feasibility as assessed by time spent engaging with the website by parents | Feasibility will be measured by time parents spend engaging with the website. | Assessed at 30 day follow-up interview | 
| Feasibility as assessed by proportion of successfully completed interventions | Feasibility will be measured by success completing the intervention by the study team | Duration of study period (12 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usefulness of the Structured Family Deliberation Process will be assessed by participant responses to qualitative interview questions | Qualitative interviews will be used to determine whether participants perceived either process as useful. | Assessed at 30 day follow-up interview | 
| Preparedness in decision making as assessed by Preparation for Decision-Making Scale | 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. | Assessed at 30 day follow-up interview | 
| Factors in decision making as assessed by participants responses to qualitative interview questions | Preparation for decision-making will be assessed by a qualitative interview with each family. | Assessed at 30 day follow-up interview | 
| Parental stress and coping as assessed by participants responses to qualitative interview | Parental stress and coping will be assessed assessed by a qualitative interview with each family. | Assessed at 30 day follow-up interview | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tracheostomy, Home mechanical ventilation, Children with medical complexity, Medical ethics, Qualitative research