Chronic Respiratory FailureNCT05379439
Family Connections
A study testing Structured Family Deliberation in people with Chronic Respiratory Failure, run by Johns Hopkins All Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Respiratory Failure
- What is being tested?
- Structured Family Deliberation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 5 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
About this study
Official title: Family Connections: Structured Family Deliberation for Decisions About Home Ventilation
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.
Read the 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.
- Conditions
- Chronic Respiratory Failure
- Being tested
- Structured Family Deliberation
- Keywords
- Tracheostomy, Home mechanical ventilation, Children with medical complexity, Medical ethics, Qualitative research
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention families will participate in the Structured Family Deliberation that includes a clinician-led review of a web-based decisional aid. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as assessed by proportion of families enrolled
Feasibility will be measured by the proportion of families approached that are successfully enrolled.
Measured: 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.
Measured: 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
Measured: 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
Qualitative interviews will be used to determine whether participants perceived either process as useful.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed at 30 day follow-up interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start1 Jul 2022
- Primary completion5 Oct 2022
- Study completion5 Oct 2022
Why it stopped: IRB protocol was terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins All Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas A Jabre, MD, Principal investigator, Johns Hopkins All Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379439
- Sponsor's protocol ID
- IRB00323418
- Status last verified
- Jun 2023
- First submitted
- 13 May 2022
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Connections: Structured Family Deliberation for Decisions About Home Ventilation
- ClinicalTrials.gov ID
- NCT05379439
- Acronym / sponsor ID
- IRB00323418
- Conditions
- Chronic Respiratory Failure
- Keywords
- Tracheostomy, Home mechanical ventilation, Children with medical complexity, Medical ethics, Qualitative research
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IRB protocol was terminated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins All Children's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 5 Oct 2022 (actual)
- Study completion
- 5 Oct 2022 (actual)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Structured Family DeliberationIntervention families will participate in the Structured Family Deliberation that includes a clinician-led review of a web-based decisional aid. |
| Control | No intervention | –Control families will undergo the standard decisional process for home ventilation and will also review the web-based decisional aid independently. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Family DeliberationIntervention 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. | Other | Intervention |
Primary outcome
Feasibility as assessed by proportion of families enrolled
Time frame: 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
Time frame: 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
Time frame: Duration of study period (12 months)
Feasibility will be measured by success completing the intervention by the study team
4 secondary outcomes
Usefulness of the Structured Family Deliberation Process will be assessed by participant responses to qualitative interview questions
Time frame: Assessed at 30 day follow-up interview
Preparedness in decision making as assessed by Preparation for Decision-Making Scale
Time frame: Assessed at 30 day follow-up interview
Factors in decision making as assessed by participants responses to qualitative interview questions
Time frame: Assessed at 30 day follow-up interview
Parental stress and coping as assessed by participants responses to qualitative interview
Time frame: Assessed at 30 day follow-up interview
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas A Jabre, MD principal investigator
Johns Hopkins All Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Family Deliberation in people with Chronic Respiratory Failure, run by Johns Hopkins All Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as assessed by proportion of families enrolled (time frame: Duration of study period (12 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2023.