Multicenter HomeVENT: Home Values and Experiences Navigation Track : Multicenter HomeVENT: Home Values and Experiences Navigation Track
Across 4 centers, the investigators will recruit 150 English and/ or Spanish-speaking families (up to 2 parents per family) who are currently facing a decision about tracheostomy and home ventilation for the child. The investigators will also recruit up to 2 clinicians who are central to the decision for each child.The first 50% of families will be assigned to "usual care" arm and the second 50% of families will be assigned to the "intervention" arm. Intervention families will view the study website with study staff and will answer questions related to website content in an interview that could last up to 2 hours. All families will be interviewed at 1, 6 and 12 months after enrollment (each interview lasts 15-30 minutes). Each family will designate 1-2 physician involved in the decision about home ventilation; each physician will be interviewed at 1 month interviews last ~15 minutes).This is a controlled trial of a communication intervention and requires careful attention to words used. The investigators support the intention of being inclusive, and have invested considerable effort in creating a Spanish intervention and diversifying the team to include more native Spanish-speakers. However, as a communication randomized control trial (RCT), the investigators are concerned that one-off efforts to translate the website as well as using a translator, may confound the investigatos interpretation of the data. Most significantly, the investigators risk not finding differences between the two arms if the investigators include those who do not speak English or Spanish.Primary endpoints:The investigators hypothesize that, compared to families who receive usual care related to decision-making about pediatric chronic home ventilation, families who receive the HomeVENT intervention will have increased preparedness for decision-making 1 month later.The investigators hypothesize that, compared to families who receive usual care related to decision-making about pediatric chronic home ventilation, families who receive the HomeVENT intervention will perceive increased shared decision-making 1 month later.The investigators hypothesize that, compared to physicians of families who receive usual care related to decision-making about pediatric chronic home ventilation, physicians of families who receive the HomeVENT intervention will perceive increased shared decision-making 1 month later..
Medienart: |
Klinische Studie |
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Erscheinungsjahr: |
2024 |
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Erschienen: |
2024 |
Enthalten in: |
ClinicalTrials.gov - (2024) vom: 08. Feb. Zur Gesamtaufnahme - year:2024 |
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Sprache: |
Englisch |
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Links: |
Volltext [kostenfrei] |
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Themen: |
610 |
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Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: October 26, 2023, Last downloaded: ClinicalTrials.gov processed this data on February 14, 2024, Last updated: February 14, 2024 |
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Study ID: |
NCT06102330 |
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Veröffentlichungen zur Studie: |
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fisyears: |
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Förderinstitution / Projekttitel: |
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PPN (Katalog-ID): |
CTG009475540 |
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520 | |a Across 4 centers, the investigators will recruit 150 English and/ or Spanish-speaking families (up to 2 parents per family) who are currently facing a decision about tracheostomy and home ventilation for the child. The investigators will also recruit up to 2 clinicians who are central to the decision for each child.The first 50% of families will be assigned to "usual care" arm and the second 50% of families will be assigned to the "intervention" arm. Intervention families will view the study website with study staff and will answer questions related to website content in an interview that could last up to 2 hours. All families will be interviewed at 1, 6 and 12 months after enrollment (each interview lasts 15-30 minutes). Each family will designate 1-2 physician involved in the decision about home ventilation; each physician will be interviewed at 1 month interviews last ~15 minutes).This is a controlled trial of a communication intervention and requires careful attention to words used. The investigators support the intention of being inclusive, and have invested considerable effort in creating a Spanish intervention and diversifying the team to include more native Spanish-speakers. However, as a communication randomized control trial (RCT), the investigators are concerned that one-off efforts to translate the website as well as using a translator, may confound the investigatos interpretation of the data. Most significantly, the investigators risk not finding differences between the two arms if the investigators include those who do not speak English or Spanish.Primary endpoints:The investigators hypothesize that, compared to families who receive usual care related to decision-making about pediatric chronic home ventilation, families who receive the HomeVENT intervention will have increased preparedness for decision-making 1 month later.The investigators hypothesize that, compared to families who receive usual care related to decision-making about pediatric chronic home ventilation, families who receive the HomeVENT intervention will perceive increased shared decision-making 1 month later.The investigators hypothesize that, compared to physicians of families who receive usual care related to decision-making about pediatric chronic home ventilation, physicians of families who receive the HomeVENT intervention will perceive increased shared decision-making 1 month later. | ||
650 | 2 | |a Respiratory Insufficiency | |
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