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

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?

Overview

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.

Primary outcome measures

• Number of patients with a structured/planned family meeting [Time frame: Until Intensive care unit (ICU) discharge]

Secondary outcome measures (12)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 32123988
• 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
• 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
• 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
• 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
• 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 PMID 28936626
• 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 ove PMID 31784798
• 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

Identifiers

NCT: NCT07035951 · 337942

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗