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

NCT07035951 | Not Yet Recruiting

• 1 other identifier: 337942
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• Number of patients with a structured/planned family meeting

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

  Until Intensive care unit (ICU) discharge

Secondary Outcomes (12)

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

  Until ICU discharge

• Number of people present in the Family Meeting

  Until ICU discharge

• Categorical description of people present in the Family Meeting

  Until ICU discharge

• The treatment level after the family meeting

  Until ICU discharge

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

  Until ICU discharge

Study Arms (1)

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

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• St George's, University of London: lead

Related Publications (11)

• 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.

  PMID: 32123988 BACKGROUND

• 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.

  PMID: 30136140 BACKGROUND

• 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.

  PMID: 35680329 BACKGROUND

• 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.

  PMID: 33843946 BACKGROUND

• 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.

  PMID: 27414802 BACKGROUND

• 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.

  PMID: 28936626 BACKGROUND

• 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.

  PMID: 31784798 BACKGROUND

• 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.

  PMID: 33332816 BACKGROUND

• 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.

  PMID: 28973065 BACKGROUND

• 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.

  PMID: 29774388 BACKGROUND

• 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/

  PMID: 31765112 BACKGROUND

MeSH Terms

Conditions

Critical Illness; Frailty; Communication; Patient Preference

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Patient Satisfaction; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Susannah Leaver, PhD FRCP FICM

  St George's Hospital

  PRINCIPAL INVESTIGATOR

• Bertrand Guidet

  l'Hôpital Saint Antoine, Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikki Yun

CONTACT

+44208 725 0249; vip3.study@stgeorges.nhs.uk

Jesper Fjølner, MD

CONTACT

contact@vipstudy.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: June 25, 2025
• Study Start: June 16, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 25, 2025

Record last verified: 2025-05