NCT05379439

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 18, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2022

Completed
Last Updated

June 23, 2023

Status Verified

June 1, 2023

Enrollment Period

3 months

First QC Date

May 13, 2022

Last Update Submit

June 21, 2023

Conditions

Chronic Respiratory Failure

Keywords

TracheostomyHome mechanical ventilationChildren with medical complexityMedical ethicsQualitative research

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Usefulness of the Structured Family Deliberation Process will be assessed by participant responses to qualitative interview questions

    Assessed at 30 day follow-up interview

  • Preparedness in decision making as assessed by Preparation for Decision-Making Scale

    Assessed at 30 day follow-up interview

  • Factors in decision making as assessed by participants responses to qualitative interview questions

    Assessed at 30 day follow-up interview

  • Parental stress and coping as assessed by participants responses to qualitative interview

    Assessed at 30 day follow-up interview

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Structured Family DeliberationOTHER

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.

Intervention

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

Study Officials

  • Nicholas A Jabre, MD

    Johns Hopkins All Children's Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2022

First Posted

May 18, 2022

Study Start

July 1, 2022

Primary Completion

October 5, 2022

Study Completion

October 5, 2022

Last Updated

June 23, 2023

Record last verified: 2023-06

Locations

US(1)