The VIP3 (Very Old Intensive Care Patients) Study: Family Involvement in Treatment Decisions for Old ICU Patients

Not yet recruiting

• Conditions: Family Members; Critical Illness; Frailty; Communication; Patient Preference

• Registration Number: NCT07035951
• Lead Sponsor: St George's, University of London

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.

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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-13
• Study Start: 2025-06-16
• Study First Submitted QC: 2025-06-16
• Last Update Submitted: 2025-06-16
• Study First Posted: 2025-06-25
• Last Update Posted: 2025-06-25
• Primary Completion: 2026-06
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Patients admitted to the Intensive Care Unit (ICU) of participating centres
• Age 75 years and above
• Expected Length of stay (LOS) > 3 days

Exclusion Criteria

• Refusal to participate
• Limitation of treatment upon ICU arrival (other than Cardiopulmonary Resuscitation-CPR)
• Planned admission

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with a structured/planned family meeting	Until Intensive care unit (ICU) discharge	The number of patients that have a family meeting during the intensive care stay

Secondary Outcome Measures

Name	Time	Method
Median day since Intensive care unit (ICU) admission when the family meeting took place	Until ICU discharge	Day number on ICU when family meeting took place
Number of people present in the Family Meeting	Until ICU discharge	The total number of participants in the family meeting
Categorical description of people present in the Family Meeting	Until ICU discharge	What were the roles of the participants in the family meeting (patient relatives, doctors, nurses, other health professionals.)
The treatment level after the family meeting	Until ICU discharge	Treatment level category decided upon at the end of the family meeting which will be either: continuation of care, therapy reduced due to improvement, therapy withheld (WH), therapy withdrawn (WD).
Change in SOFA (Sequential Organ Failure Assessment) score between ICU admission and day of Family Meeting (FM)	Until ICU discharge	Change in SOFA score from admission to the day of the family meeting. The SOFA score is a tool used to assess the severity of organ dysfunction in a critically ill patient. The total score ranges from 0-24, a higher SOFA score indicates a sicker patient and therefore a worse outcome
Survival until intensive care unit discharge	ICU discharge	The number of patients that survive to Intensive care unit discharge
Intensive care unit (ICU) length of stay	ICU discharge	The length of time the participant stays on intensive care (hours)
Hospital survival	From randomisation to hospital discharge, assessed up to 3 months	The number of participants alive at hospital discharge
Hospital length of stay	From randomisation to hospital discharge, assessed up to 3 months	The length of time the participant spends in hospital
Discharge location	From randomisation to hospital discharge, assessed up to 3 months	Where patient is discharged to after discharge from hospital. Is it home, residential home, nursing home or other
Decision to limit life sustaining treatment	Until ICU discharge	If there is a decision made to withdraw or with hold life sustaining treatment while the patient is on the intensive care unit. This is a yes / no answer
Time between limiting life sustaining treatment and death or ICU discharge	From ICU admission until the first documented progression or date of death from any cause, whichever came first, assessed up to 30 days