Intensive Care Outcome Network Study - Phase 3

A study of the long term survival, psychological morbidity and health-related quality of life of patients discharged from Intensive Care Units in the United Kingdom

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN88066041

Enrollment

1000

Registered

2012-08-01

Start date

2012-06-01

Completion date

Unknown

Last updated

2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Former intensive care patients of participating hospitals Not Applicable

Interventions

Postal questionnaires at 3, 12 and 24 months after ICU discharge

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged at least 16 years on admission to intensive care 2. Participants must have experienced at least 24 hours of level three dependency care (ICU care) at any time during their hospital stay and survived until the time of hospital discharge

Exclusion criteria

Exclusion criteria: 1. Aged under 16 years 2. Unable to complete questionnaires and have no consultee to fill in the forms on their behalf 3. Foreign nationals 4. In residential care 5. In prison 6. Unwilling to consent 7. Life status cannot be traced (i.e. have no GP or NHS numbers)

Design outcomes

Primary

Measure	Time frame
Data from the ICON study will allow the identification of risk factors for poor long-term outcomes after patients have been treated on an intensive care unit, which will in turn inform the development of effective treatments and enable earlier recognition of factors related to poor long-term outcome in these patients. This entire process has the ultimate goal of improving the long-term quality of life of patients who have experienced treatment on an intensive care unit.	—

Measure

Time frame

Data from the ICON study will allow the identification of risk factors for poor long-term outcomes after patients have been treated on an intensive care unit, which will in turn inform the development of effective treatments and enable earlier recognition of factors related to poor long-term outcome in these patients. This entire process has the ultimate goal of improving the long-term quality of life of patients who have experienced treatment on an intensive care unit.

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Secondary

Measure	Time frame
1. Obtain a response rate of 70% or more 2. To maintain the registry and database from ICON Phases 1 and 2 3. To determine the health-related quality of life of patients at three, twelve and twenty-four months after ICU discharge using SF-36 and EQ-5D and compare this with an age-, sex- and socio-economic status-matched historical control group 4. To determine the number of patients at risk of developing Post Traumatic Stress Disorder (PTSD) at three, twelve and twenty-four months after ICU discharge using PCL-C 5. To determine the number of patients at risk of depression and anxiety disorders at three, twelve and twenty-four months after ICU discharge 6. To assign a health utility index value to each of the first two survivor-years to allow calculation of quality-adjusted life years (QALYs) for all patients and those in specific diagnostic groups 7. To determine differences in health status for broad subgroups of patients based on diagnosis, and calculated (APACHE II and/or ICNARC score) hospital mortality risk 8. To determine the survival of these patients beyond two years after hospital discharge and so determine the relative risk of death over time of all these patients compared with an age and sex matched group drawn randomly from the UK population 9. To determine the relative risk of death over time for broad subgroups based on diagnosis, calculated hospital mortality risk (APACHE II and/or ICNARC score), sex, geography and socio-economic group (from postcodes) compared with the risk for all patients 10. To determine the relative risk of death for patients with a similar diagnosis but with or without a specific syndrome characterised by physiological changes (sepsis, ARDS etc)	—

Measure

Time frame

1. Obtain a response rate of 70% or more 2. To maintain the registry and database from ICON Phases 1 and 2 3. To determine the health-related quality of life of patients at three, twelve and twenty-four months after ICU discharge using SF-36 and EQ-5D and compare this with an age-, sex- and socio-economic status-matched historical control group 4. To determine the number of patients at risk of developing Post Traumatic Stress Disorder (PTSD) at three, twelve and twenty-four months after ICU discharge using PCL-C 5. To determine the number of patients at risk of depression and anxiety disorders at three, twelve and twenty-four months after ICU discharge 6. To assign a health utility index value to each of the first two survivor-years to allow calculation of quality-adjusted life years (QALYs) for all patients and those in specific diagnostic groups 7. To determine differences in health status for broad subgroups of patients based on diagnosis, and calculated (APACHE II and/or ICNARC score) hospital mortality risk 8. To determine the survival of these patients beyond two years after hospital discharge and so determine the relative risk of death over time of all these patients compared with an age and sex matched group drawn randomly from the UK population 9. To determine the relative risk of death over time for broad subgroups based on diagnosis, calculated hospital mortality risk (APACHE II and/or ICNARC score), sex, geography and socio-economic group (from postcodes) compared with the risk for all patients 10. To determine the relative risk of death for patients with a similar diagnosis but with or without a specific syndrome characterised by physiological changes (sepsis, ARDS etc)

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026