Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:46 PM
Study NCT ID:
NCT07035951
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-25
First Post:
2025-05-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The VIP3 (Very Old Intensive Care Patients) Study: Family Involvement in Treatment Decisions for Old ICU Patients
Sponsor:
St George's, University of London
Organization:
Study Overview
Official Title:
The VIP-3 (Very Old Intensive Care Patients) Study: Decision-making in the Older Intensive Care Unit (ICU) Patient: How Are Family Meetings Implemented Across Diverse Cultures in Europe?
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIP3
Brief Summary:
The demographics of the global population is changing with increasing numbers of elderly and co-morbid patients. As a result, more elderly patients will be admitted to the Intensive Care Unit (ICU), which will bring several ethical challenges. It is for this reason the investigators have chosen to focus on this historically neglected and important patient population.
Little is known about how family meetings are implemented in ICUs in Europe and other parts of the world. However, these meetings contribute to building trust between the family and the ICU team. They are a crucial component for planning and conducting a time limited trials as they provide the opportunity for shared-decision making with the ICU team and with other stakeholders.
The investigators plan to determine the current practice of communication between ICU staff and patients and their relatives. The investigators expect to find a substantial variation in approaches to family meetings. This information may then help design and further investigate targeted interventions enabling shared decision-making focused on family and patient values.
The investigators research aim is to to investigate whether Family meetings are used in ICUs across Europe and other regions and, if so, how they are conducted and the influence on patient-centred outcome measures.
Little is known about how family meetings are implemented in ICUs in Europe and other parts of the world. However, these meetings contribute to building trust between the family and the ICU team. They are a crucial component for planning and conducting a time limited trials as they provide the opportunity for shared-decision making with the ICU team and with other stakeholders.
The investigators plan to determine the current practice of communication between ICU staff and patients and their relatives. The investigators expect to find a substantial variation in approaches to family meetings. This information may then help design and further investigate targeted interventions enabling shared decision-making focused on family and patient values.
The investigators research aim is to to investigate whether Family meetings are used in ICUs across Europe and other regions and, if so, how they are conducted and the influence on patient-centred outcome measures.
Detailed Description:
This is a prospective observational cohort study in patients aged 75 years old and above admitted as an emergency to the ICU and expected to have a length of stay of 3 days or more.
Consent varies between European countries. In some countries it will be taken on admission, in some (UK) it will be taken after the family meeting or on discharge from ICU and in others it has been waived.
1. information about the study will be given to the patient/consultee and around 24 hours will be allowed for them to have a think about participating or ask the research team any questions
2. If consent has been gained, the research team will record basic demographics of the patient and specific physiological data from the day of admission to the ICU.
3. The research nurse will have a conversation with the patient or next of kin regarding how the patient was prior to admission. If there are no next of kin information will be taken from the notes. From this information, the investigator can determine the clinical frailty scale which will be determined by looking at a proforma and determining which category of frailty the patient best fits. Other baseline information taken will be activities of daily living and co-morbidities.
4. The research nurse will document whether a Family Meeting (FM) takes place, if it does, they will document information about the FM in the electronic CRF. The information will be sought from the patient notes and the doctor or nurse who was in the meeting. If a FM does not take place this will be recorded. In the UK only ,a separate questionnaire about communication on ICU will be given to family members to complete.
5. The outcome of the FM and the patient will be documented
6. survival at 30 days, discharge information and location will be recorded by looking at the hospital records.
Consent varies between European countries. In some countries it will be taken on admission, in some (UK) it will be taken after the family meeting or on discharge from ICU and in others it has been waived.
1. information about the study will be given to the patient/consultee and around 24 hours will be allowed for them to have a think about participating or ask the research team any questions
2. If consent has been gained, the research team will record basic demographics of the patient and specific physiological data from the day of admission to the ICU.
3. The research nurse will have a conversation with the patient or next of kin regarding how the patient was prior to admission. If there are no next of kin information will be taken from the notes. From this information, the investigator can determine the clinical frailty scale which will be determined by looking at a proforma and determining which category of frailty the patient best fits. Other baseline information taken will be activities of daily living and co-morbidities.
4. The research nurse will document whether a Family Meeting (FM) takes place, if it does, they will document information about the FM in the electronic CRF. The information will be sought from the patient notes and the doctor or nurse who was in the meeting. If a FM does not take place this will be recorded. In the UK only ,a separate questionnaire about communication on ICU will be given to family members to complete.
5. The outcome of the FM and the patient will be documented
6. survival at 30 days, discharge information and location will be recorded by looking at the hospital records.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: