The VIP3 (Very Old Intensive Care Patients) Study: Family Involvement in Treatment Decisions for Old ICU Patients
NCT ID: NCT07035951
Last Updated: 2025-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
2000 participants
OBSERVATIONAL
2025-06-16
2026-12-31
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age 75 years and above
* Expected Length of stay (LOS) \> 3 days
Exclusion Criteria
* Limitation of treatment upon ICU arrival (other than Cardiopulmonary Resuscitation-CPR)
* Planned admission
75 Years
ALL
No
Sponsors
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St George's, University of London
OTHER
Responsible Party
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Principal Investigators
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Susannah Leaver, PhD FRCP FICM
Role: PRINCIPAL_INVESTIGATOR
St George's Hospital
Bertrand Guidet
Role: PRINCIPAL_INVESTIGATOR
l'Hôpital Saint Antoine, Paris
Central Contacts
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References
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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.
Vink 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.
Beil 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.
Chang 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.
Robinson 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.
Flaatten 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.
Guidet 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.
Vallet 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.
Guidet 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.
Guidet 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.
Bassford 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/
Other Identifiers
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337942
Identifier Type: -
Identifier Source: org_study_id
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