The Intensive Care Platform Trial (INCEPT) – defining a Core Outcome Set informed by patients, families and other stakeholders

Aim: We aim to identify a core outcome set involving patients, family and other stakeholders. We also aim to describe how the identified outcomes could be defined and assessed. Further, we wish to establish a permanent panel of stakeholders which can be used in all parts of the research process, including but not limited to the INCEPT project.

Design: Qualitative individual interviews and Delphi process to ensure consensus for a core outcome set and definition of measurement.

Health condition: Critical illness (life-threatening illness requiring treatment in an Intensive Care Unit (ICU).

Population: Adults =18 years of age who have been acutely admitted to an ICU (patient) or are a relative or close caregiver to an ICU patients or ICU survivor (family) and clinical/research stakeholders who have an attentiveness and interest in improving the care and treatment in the ICU (other stakeholders).

Interviews: Approximately 20-30 interviews per group (patients/relatives/other stakeholders, 60-90 interviews in total).

Delphi process: Approximately 100 per group (patients n=100)/(relatives n=100)/(other stakeholders n=100; total n=300), but higher number is preferred if possible.

Timeframe: Recruitment for interviews will start in the spring of 2021, Delphi process will start in the fall of 2021 and continue until spring of 2022. From fall 2021 and onwards, we will define a user panel for the INCEPT project.

Contributors

Principal investigator Marie Collet.

Further Study Information

Current Stage: Ongoing
Date: May 2021 - August 2023
Funding source(s):


Health Area

Disease Category: Other

Disease Name: Critical illness

Target Population

Age Range: 18 - 110

Sex: Either

Nature of Intervention: Intensive care

Stakeholders Involved

- Consumers (caregivers)
- Consumers (patients)
- Families
- Methodologists
- Patient/ support group representatives
- Researchers
- Statisticians

Study Type

- COS for clinical trials or clinical research

Method(s)

- Delphi process
- Interview
- Literature review

Linked Studies

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