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NCT Number: NCT07035951

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

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.

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Key information

Conditions

Family Members Behavior Communication Critical Illness Disease Attributes Frailty Health Behavior Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Preference Patient Satisfaction Treatment Adherence and Compliance

Age range

75 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

  • 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
  • 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.
  • 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.
  • 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.
  • The outcome of the FM and the patient will be documented
  • survival at 30 days, discharge information and location will be recorded by looking at the hospital records.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of patients with a structured/planned family meeting

    Time frame: Until Intensive care unit (ICU) discharge

    The number of patients that have a family meeting during the intensive care stay

Secondary outcomes

  1. Median day since Intensive care unit (ICU) admission when the family meeting took place

    Time frame: Until ICU discharge

    Day number on ICU when family meeting took place

  2. Number of people present in the Family Meeting

    Time frame: Until ICU discharge

    The total number of participants in the family meeting

  3. Categorical description of people present in the Family Meeting

    Time frame: Until ICU discharge

    What were the roles of the participants in the family meeting (patient relatives, doctors, nurses, other health professionals.)

  4. The treatment level after the family meeting

    Time frame: 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).

  5. Change in SOFA (Sequential Organ Failure Assessment) score between ICU admission and day of Family Meeting (FM)

    Time frame: 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

  6. Survival until intensive care unit discharge

    Time frame: ICU discharge

    The number of patients that survive to Intensive care unit discharge

  7. Intensive care unit (ICU) length of stay

    Time frame: ICU discharge

    The length of time the participant stays on intensive care (hours)

  8. Hospital survival

    Time frame: From randomisation to hospital discharge, assessed up to 3 months

    The number of participants alive at hospital discharge

  9. Hospital length of stay

    Time frame: From randomisation to hospital discharge, assessed up to 3 months

    The length of time the participant spends in hospital

  10. Discharge location

    Time frame: 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

  11. Decision to limit life sustaining treatment

    Time frame: 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

  12. Time between limiting life sustaining treatment and death or ICU discharge

    Time frame: From ICU admission until the first documented progression or date of death from any cause, whichever came first, assessed up to 30 days

Study contacts

Contact information is provided by the study sponsor or research team.

Jesper Fjølner, MD

CONTACT

[email protected]

Nikki Yun

CONTACT

[email protected]

+44208 725 0249

Sponsors and collaborators

Lead sponsor

St George's, University of London

Other

Registry information

Official study 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?

Acronym: VIP3

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 25, 2025
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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