FOCUS – Family Or Caregiver oUtcomeS after critical illness

The profile of Intensive Care Unit (ICU) survivorship has been brought into sharp focus due to the COVID-19 pandemic. Following critical illness, patients can experience clinically important physical, emotional and cognitive symptoms. These problems can have major implications for the patient and healthcare system.

Less focus has been placed on the outcomes experienced by family members and caregivers of ICU survivors. This vulnerable group often have a challenging trajectory across the critical illness care continuum and are known to experience emotional and social problems. While these problems are important and recommended to be included in studies, they are usually partially included or not included at all. This potentially underestimates the impact of critical illness on wider social structures.

There is an urgent need to optimise and standardise outcome measures for this important and emerging cohort, in order to improve clinical services and research. The aim of this project is to define a core outcome set (COS) for critical care studies involving family members or caregivers.

Contributors

Co- Principal Investigators:
Professor Joanne McPeake
University of Cambridge

Professor Bronwen Connolly
Wellcome-Wolfson Institute for Experimental Medicine
Queen’s University Belfast

Co-investigators:
Professor Nazir Lone
University of Edinburgh

Dr Peter Hartely
University of Cambridge

Ms Claire Brown
Cambridge University Hospitals

Further Study Information

Current Stage: Ongoing
Date: January 2022 - December 2025
Funding source(s): None


Health Area

Disease Category: Other

Disease Name: Critical illness

Target Population

Age Range: 18 - 100

Sex: Either

Nature of Intervention: Intensive care

Stakeholders Involved

- Clinical experts
- Families
- Methodologists
- Patient/ support group representatives
- Researchers
- Service providers
- Service users
- Consumers (caregivers)

Study Type

- COS for clinical trials or clinical research
- Recommendations for outcome measures (measurement/how)

Method(s)

- Consensus meeting
- Delphi process
- Systematic review

Phase 1
Am updated systematic review of outcome reporting from existing studies involving family members of critical care patients. Outcomes will be reported and synthesised including definition and detail of primary and secondary outcomes, measurement variables, analysis metrics, method of aggregation, time-point of measurement and classification of the outcome.

Phase 2
A two-stage Delphi process to firstly establish stakeholder consensus on core outcomes considered priority for future research and secondly determine outcome measurement instrument selection. The findings of the systematic review from Phase 1 will form the basis of this consensus.

Consensus meeting: if required, we will conduct consensus meetings to minimise unnecessary overlap on outcomes and/or convene expert clinical and statistical agreement on appropriate measures and metrics.