Family MembersVIP3NCT07035951
The VIP3 (Very Old Intensive Care Patients) Study: Family Involvement in Treatment Decisions for Old ICU Patients
An observational study of Family Members and Critical Illness, run by St George's, University of London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Family Members, Critical Illness, Frailty
- How many people
- 2,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Jun 2025to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Emergency patients admitted to the intensive care unit age 75 years and older. The investigators will ask participating ICUs to include the first consecutive 20 patients or all patients (if <20) admitted within a 6 month period.
Who may be able to join
- Patients admitted to the Intensive Care Unit (ICU) of participating centres
- Age 75 years and above
- Expected Length of stay (LOS) > 3 days
Who cannot join
- Refusal to participate
- Limitation of treatment upon ICU arrival (other than Cardiopulmonary Resuscitation-CPR)
- Planned admission
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jesper Fjølner, MD contact
United Kingdom1 site, 1 recruiting
- Recruiting
St George's University Hospitals NHS Foundation Trust
London
Nikki Yun, nikki.yun@stgeorges.nhs.uk
About this study
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?
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.
Read more
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.
Read the 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.
- 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.
- Conditions
- Family Members, Critical Illness, Frailty, Communication, Patient Preference
- Keywords
- Elderly, Critical illness, communication, frailty, family meetings, Intensive care, critical care, shared decision making, patient preference
- Medical subject headings
- Critical Illness, Frailty, Communication, Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients age 75 and above admitted as an emergency to Intensive Care | The investigators will be looking at communication whilst these patients are on the Intensive Care Unit (ICU). In particular whether a family meeting takes place (to discuss progress and patient wishes) and if so what is discussed in the meeting. In addition to the information taken during the family meeting, the investigators will be collecting the following: baseline demographics, physiological data, frailty score and baseline function, treatments received and outcome data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with a structured/planned family meeting
The number of patients that have a family meeting during the intensive care stay
Measured: Until Intensive care unit (ICU) discharge
Secondary outcomes (12)
Median day since Intensive care unit (ICU) admission when the family meeting took place
Day number on ICU when family meeting took place
Measured: Until ICU discharge
Number of people present in the Family Meeting
The total number of participants in the family meeting
Measured: Until ICU discharge
Categorical description of people present in the Family Meeting
What were the roles of the participants in the family meeting (patient relatives, doctors, nurses, other health professionals.)
Measured: Until ICU discharge
The treatment level after the family meeting
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).
Measured: Until ICU discharge
Change in SOFA (Sequential Organ Failure Assessment) score between ICU admission and day of Family Meeting (FM)
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
Measured: Until ICU discharge
Survival until intensive care unit discharge
The number of patients that survive to Intensive care unit discharge
Measured: ICU discharge
Intensive care unit (ICU) length of stay
The length of time the participant stays on intensive care (hours)
Measured: ICU discharge
Hospital survival
The number of participants alive at hospital discharge
Measured: From randomisation to hospital discharge, assessed up to 3 months
Hospital length of stay
The length of time the participant spends in hospital
Measured: From randomisation to hospital discharge, assessed up to 3 months
Discharge location
Where patient is discharged to after discharge from hospital. Is it home, residential home, nursing home or other
Measured: From randomisation to hospital discharge, assessed up to 3 months
Decision to limit life sustaining treatment
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
Measured: Until ICU discharge
Time between limiting life sustaining treatment and death or ICU discharge
Measured: From ICU admission until the first documented progression or date of death from any cause, whichever came first, assessed up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start16 Jun 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Family MembersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susannah Leaver, PhD FRCP FICM, Principal investigator, St George's HospitalBertrand Guidet, Principal investigator, l'Hôpital Saint Antoine, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035951
- Sponsor's protocol ID
- 337942
- Acronym
- VIP3
- Status last verified
- Jun 2026
- First submitted
- 13 May 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ranzani OT, Besen BAMP, Herridge MS. Focus on the frail and elderly: who should have a trial of ICU treatment? Intensive Care Med. 2020 May;46(5):1030-1032. doi: 10.1007/s00134-020-05963-1. Epub 2020 Mar 2. No abstract available.
PubMed 32123988Vink EE, Azoulay E, Caplan A, Kompanje EJO, Bakker J. Time-limited trial of intensive care treatment: an overview of current literature. Intensive Care Med. 2018 Sep;44(9):1369-1377. doi: 10.1007/s00134-018-5339-x. Epub 2018 Aug 22.
PubMed 30136140Beil M, Guidet B, Flaatten H, Jung C, Sviri S, van Heerden PV. Is It TIME for More Research on Time-Limited Trials in Critical Care? Chest. 2022 Jun;161(6):e397. doi: 10.1016/j.chest.2022.01.065. No abstract available.
PubMed 35680329Chang DW, Neville TH, Parrish J, Ewing L, Rico C, Jara L, Sim D, Tseng CH, van Zyl C, Storms AD, Kamangar N, Liebler JM, Lee MM, Yee HF Jr. Evaluation of Time-Limited Trials Among Critically Ill Patients With Advanced Medical Illnesses and Reduction of Nonbeneficial ICU Treatments. JAMA Intern Med. 2021 Jun 1;181(6):786-794. doi: 10.1001/jamainternmed.2021.1000.
PubMed 33843946Robinson JD, Jagsi R. Physician-Patient Communication-An Actionable Target for Reducing Overly Aggressive Care Near the End of Life. JAMA Oncol. 2016 Nov 1;2(11):1407-1408. doi: 10.1001/jamaoncol.2016.1948. No abstract available.
PubMed 27414802Flaatten H, De Lange DW, Morandi A, Andersen FH, Artigas A, Bertolini G, Boumendil A, Cecconi M, Christensen S, Faraldi L, Fjolner J, Jung C, Marsh B, Moreno R, Oeyen S, Ohman CA, Pinto BB, Soliman IW, Szczeklik W, Valentin A, Watson X, Zaferidis T, Guidet B; VIP1 study group. The impact of frailty on ICU and 30-day mortality and the level of care in very elderly patients (>/= 80 years). Intensive Care Med. 2017 Dec;43(12):1820-1828. doi: 10.1007/s00134-017-4940-8. Epub 2017 Sep 21.
PubMed 28936626Guidet B, de Lange DW, Boumendil A, Leaver S, Watson X, Boulanger C, Szczeklik W, Artigas A, Morandi A, Andersen F, Zafeiridis T, Jung C, Moreno R, Walther S, Oeyen S, Schefold JC, Cecconi M, Marsh B, Joannidis M, Nalapko Y, Elhadi M, Fjolner J, Flaatten H; VIP2 study group. The contribution of frailty, cognition, activity of daily life and comorbidities on outcome in acutely admitted patients over 80 years in European ICUs: the VIP2 study. Intensive Care Med. 2020 Jan;46(1):57-69. doi: 10.1007/s00134-019-05853-1. Epub 2019 Nov 29.
PubMed 31784798Vallet H, Schwarz GL, Flaatten H, de Lange DW, Guidet B, Dechartres A. Mortality of Older Patients Admitted to an ICU: A Systematic Review. Crit Care Med. 2021 Feb 1;49(2):324-334. doi: 10.1097/CCM.0000000000004772.
PubMed 33332816Guidet B, Leblanc G, Simon T, Woimant M, Quenot JP, Ganansia O, Maignan M, Yordanov Y, Delerme S, Doumenc B, Fartoukh M, Charestan P, Trognon P, Galichon B, Javaud N, Patzak A, Garrouste-Orgeas M, Thomas C, Azerad S, Pateron D, Boumendil A; ICE-CUB 2 Study Network. Effect of Systematic Intensive Care Unit Triage on Long-term Mortality Among Critically Ill Elderly Patients in France: A Randomized Clinical Trial. JAMA. 2017 Oct 17;318(15):1450-1459. doi: 10.1001/jama.2017.13889.
PubMed 28973065Guidet B, Flaatten H, Boumendil A, Morandi A, Andersen FH, Artigas A, Bertolini G, Cecconi M, Christensen S, Faraldi L, Fjolner J, Jung C, Marsh B, Moreno R, Oeyen S, Ohman CA, Pinto BB, Soliman IW, Szczeklik W, Valentin A, Watson X, Zafeiridis T, De Lange DW; VIP1 study group. Withholding or withdrawing of life-sustaining therapy in older adults (>/= 80 years) admitted to the intensive care unit. Intensive Care Med. 2018 Jul;44(7):1027-1038. doi: 10.1007/s00134-018-5196-7. Epub 2018 May 17.
PubMed 29774388Bassford C, Griffiths F, Svantesson M, Ryan M, Krucien N, Dale J, Rees S, Rees K, Ignatowicz A, Parsons H, Flowers N, Fritz Z, Perkins G, Quinton S, Symons S, White C, Huang H, Turner J, Brooke M, McCreedy A, Blake C, Slowther A. Developing an intervention around referral and admissions to intensive care: a mixed-methods study. Southampton (UK): NIHR Journals Library; 2019 Nov. Available from http://www.ncbi.nlm.nih.gov/books/NBK549962/
PubMed 31765112
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT07035951
- Acronym / sponsor ID
- VIP3 / 337942
- Conditions
- Family Members, Critical Illness, Frailty, Communication, Patient Preference
- Keywords
- Elderly, Critical illness, communication, frailty, family meetings, Intensive care, critical care, shared decision making
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 25 Jun 2025 (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.
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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients age 75 and above admitted as an emergency to Intensive Care | – | –The investigators will be looking at communication whilst these patients are on the Intensive Care Unit (ICU). In particular whether a family meeting takes place (to discuss progress and patient wishes) and if so what is discussed in the meeting. In addition to the information taken during the family meeting, the investigators will be collecting the following: baseline demographics, physiological data, frailty score and baseline function, treatments received and outcome data |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Emergency patients admitted to the intensive care unit age 75 years and older. The investigators will ask participating ICUs to include the first consecutive 20 patients or all patients (if <20) admitted within a 6 month period.
Key inclusion criteria (3 listed)
- Patients admitted to the Intensive Care Unit (ICU) of participating centres
- Age 75 years and above
- Expected Length of stay (LOS) > 3 days
Key exclusion criteria (3 listed)
- Refusal to participate
- Limitation of treatment upon ICU arrival (other than Cardiopulmonary Resuscitation-CPR)
- Planned admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
12 secondary outcomes
Median day since Intensive care unit (ICU) admission when the family meeting took place
Time frame: Until ICU discharge
Number of people present in the Family Meeting
Time frame: Until ICU discharge
Categorical description of people present in the Family Meeting
Time frame: Until ICU discharge
The treatment level after the family meeting
Time frame: Until ICU discharge
Change in SOFA (Sequential Organ Failure Assessment) score between ICU admission and day of Family Meeting (FM)
Time frame: Until ICU discharge
Survival until intensive care unit discharge
Time frame: ICU discharge
Intensive care unit (ICU) length of stay
Time frame: ICU discharge
Hospital survival
Time frame: From randomisation to hospital discharge, assessed up to 3 months
Hospital length of stay
Time frame: From randomisation to hospital discharge, assessed up to 3 months
Discharge location
Time frame: From randomisation to hospital discharge, assessed up to 3 months
Decision to limit life sustaining treatment
Time frame: Until ICU discharge
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Background: PubMed 32123988Ranzani OT, Besen BAMP, Herridge MS. Focus on the frail and elderly: who should have a trial of ICU treatment? Intensive Care Med. 2020 May;46(5):1030-1032. doi: 10.1007/s00134-020-05963-1. Epub 2020 Mar 2. No abstract available.
- Background: PubMed 30136140Vink EE, Azoulay E, Caplan A, Kompanje EJO, Bakker J. Time-limited trial of intensive care treatment: an overview of current literature. Intensive Care Med. 2018 Sep;44(9):1369-1377. doi: 10.1007/s00134-018-5339-x. Epub 2018 Aug 22.
- Background: PubMed 35680329Beil M, Guidet B, Flaatten H, Jung C, Sviri S, van Heerden PV. Is It TIME for More Research on Time-Limited Trials in Critical Care? Chest. 2022 Jun;161(6):e397. doi: 10.1016/j.chest.2022.01.065. No abstract available.
- Background: PubMed 33843946Chang DW, Neville TH, Parrish J, Ewing L, Rico C, Jara L, Sim D, Tseng CH, van Zyl C, Storms AD, Kamangar N, Liebler JM, Lee MM, Yee HF Jr. Evaluation of Time-Limited Trials Among Critically Ill Patients With Advanced Medical Illnesses and Reduction of Nonbeneficial ICU Treatments. JAMA Intern Med. 2021 Jun 1;181(6):786-794. doi: 10.1001/jamainternmed.2021.1000.
- Background: PubMed 27414802Robinson JD, Jagsi R. Physician-Patient Communication-An Actionable Target for Reducing Overly Aggressive Care Near the End of Life. JAMA Oncol. 2016 Nov 1;2(11):1407-1408. doi: 10.1001/jamaoncol.2016.1948. No abstract available.
- Background: PubMed 28936626Flaatten H, De Lange DW, Morandi A, Andersen FH, Artigas A, Bertolini G, Boumendil A, Cecconi M, Christensen S, Faraldi L, Fjolner J, Jung C, Marsh B, Moreno R, Oeyen S, Ohman CA, Pinto BB, Soliman IW, Szczeklik W, Valentin A, Watson X, Zaferidis T, Guidet B; VIP1 study group. The impact of frailty on ICU and 30-day mortality and the level of care in very elderly patients (>/= 80 years). Intensive Care Med. 2017 Dec;43(12):1820-1828. doi: 10.1007/s00134-017-4940-8. Epub 2017 Sep 21.
- Background: PubMed 31784798Guidet B, de Lange DW, Boumendil A, Leaver S, Watson X, Boulanger C, Szczeklik W, Artigas A, Morandi A, Andersen F, Zafeiridis T, Jung C, Moreno R, Walther S, Oeyen S, Schefold JC, Cecconi M, Marsh B, Joannidis M, Nalapko Y, Elhadi M, Fjolner J, Flaatten H; VIP2 study group. The contribution of frailty, cognition, activity of daily life and comorbidities on outcome in acutely admitted patients over 80 years in European ICUs: the VIP2 study. Intensive Care Med. 2020 Jan;46(1):57-69. doi: 10.1007/s00134-019-05853-1. Epub 2019 Nov 29.
- Background: PubMed 33332816Vallet H, Schwarz GL, Flaatten H, de Lange DW, Guidet B, Dechartres A. Mortality of Older Patients Admitted to an ICU: A Systematic Review. Crit Care Med. 2021 Feb 1;49(2):324-334. doi: 10.1097/CCM.0000000000004772.
- Background: PubMed 28973065Guidet B, Leblanc G, Simon T, Woimant M, Quenot JP, Ganansia O, Maignan M, Yordanov Y, Delerme S, Doumenc B, Fartoukh M, Charestan P, Trognon P, Galichon B, Javaud N, Patzak A, Garrouste-Orgeas M, Thomas C, Azerad S, Pateron D, Boumendil A; ICE-CUB 2 Study Network. Effect of Systematic Intensive Care Unit Triage on Long-term Mortality Among Critically Ill Elderly Patients in France: A Randomized Clinical Trial. JAMA. 2017 Oct 17;318(15):1450-1459. doi: 10.1001/jama.2017.13889.
- Background: PubMed 29774388Guidet B, Flaatten H, Boumendil A, Morandi A, Andersen FH, Artigas A, Bertolini G, Cecconi M, Christensen S, Faraldi L, Fjolner J, Jung C, Marsh B, Moreno R, Oeyen S, Ohman CA, Pinto BB, Soliman IW, Szczeklik W, Valentin A, Watson X, Zafeiridis T, De Lange DW; VIP1 study group. Withholding or withdrawing of life-sustaining therapy in older adults (>/= 80 years) admitted to the intensive care unit. Intensive Care Med. 2018 Jul;44(7):1027-1038. doi: 10.1007/s00134-018-5196-7. Epub 2018 May 17.
- Background: PubMed 31765112Bassford C, Griffiths F, Svantesson M, Ryan M, Krucien N, Dale J, Rees S, Rees K, Ignatowicz A, Parsons H, Flowers N, Fritz Z, Perkins G, Quinton S, Symons S, White C, Huang H, Turner J, Brooke M, McCreedy A, Blake C, Slowther A. Developing an intervention around referral and admissions to intensive care: a mixed-methods study. Southampton (UK): NIHR Journals Library; 2019 Nov. Available from http://www.ncbi.nlm.nih.gov/books/NBK549962/
- Individual participant dataSharing planned: Undecided
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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.
Jesper Fjølner, MD contact
Susannah Leaver, PhD FRCP FICM principal investigator
St George's Hospital
Bertrand Guidet principal investigator
l'Hôpital Saint Antoine, Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Family Members and Critical Illness, run by St George's, University of London at 1 site in United Kingdom.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 15 Sep 2026. 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 Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nikki Yun (+44208 725 0249, vip3.study@stgeorges.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with a structured/planned family meeting (time frame: Until Intensive care unit (ICU) discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07035951, which also lists 11 linked publications.
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 15 Sep 2026.