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Family Connections

Primary Purpose

Chronic Respiratory Failure

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Structured Family Deliberation
Sponsored by
Johns Hopkins All Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Respiratory Failure focused on measuring Tracheostomy, Home mechanical ventilation, Children with medical complexity, Medical ethics, Qualitative research

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Johns Hopkins All Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Intervention families will participate in the Structured Family Deliberation that includes a clinician-led review of a web-based decisional aid.

Control families will undergo the standard decisional process for home ventilation and will also review the web-based decisional aid independently.

Outcomes

Primary Outcome Measures

Feasibility as assessed by proportion of families enrolled
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
Feasibility will be measured by time parents spend engaging with the website.
Feasibility as assessed by proportion of successfully completed interventions
Feasibility will be measured by success completing the intervention by the study team

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
May 13, 2022
Last Updated
June 21, 2023
Sponsor
Johns Hopkins All Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05379439
Brief Title
Family Connections
Official Title
Family Connections: Structured Family Deliberation for Decisions About Home Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Withdrawn
Why Stopped
IRB protocol was terminated
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
October 5, 2022 (Actual)
Study Completion Date
October 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins All Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Respiratory Failure
Keywords
Tracheostomy, Home mechanical ventilation, Children with medical complexity, Medical ethics, Qualitative research

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intervention families will participate in the Structured Family Deliberation that includes a clinician-led review of a web-based decisional aid.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control families will undergo the standard decisional process for home ventilation and will also review the web-based decisional aid independently.
Intervention Type
Other
Intervention Name(s)
Structured Family Deliberation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility as assessed by proportion of families enrolled
Description
Feasibility will be measured by the proportion of families approached that are successfully enrolled.
Time Frame
Duration of study period (12 months)
Title
Feasibility as assessed by time spent engaging with the website by parents
Description
Feasibility will be measured by time parents spend engaging with the website.
Time Frame
Assessed at 30 day follow-up interview
Title
Feasibility as assessed by proportion of successfully completed interventions
Description
Feasibility will be measured by success completing the intervention by the study team
Time Frame
Duration of study period (12 months)
Secondary Outcome Measure Information:
Title
Usefulness of the Structured Family Deliberation Process will be assessed by participant responses to qualitative interview questions
Description
Qualitative interviews will be used to determine whether participants perceived either process as useful.
Time Frame
Assessed at 30 day follow-up interview
Title
Preparedness in decision making as assessed by Preparation for Decision-Making Scale
Description
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.
Time Frame
Assessed at 30 day follow-up interview
Title
Factors in decision making as assessed by participants responses to qualitative interview questions
Description
Preparation for decision-making will be assessed by a qualitative interview with each family.
Time Frame
Assessed at 30 day follow-up interview
Title
Parental stress and coping as assessed by participants responses to qualitative interview
Description
Parental stress and coping will be assessed assessed by a qualitative interview with each family.
Time Frame
Assessed at 30 day follow-up interview

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas A Jabre, MD
Organizational Affiliation
Johns Hopkins All Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins All Children's Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Family Connections

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