Recovery following intensive care treatment

Not Applicable

Completed

• Conditions: Post-intensive care unit in-hospital ward stay; Not Applicable

• Registration Number: ISRCTN14658054
• Lead Sponsor: niversity of Oxford

Brief Summary

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30813113 protocol 2021 Interim results article in https://pubmed.ncbi.nlm.nih.gov/33407702/ case record review (added 12/01/2021) 2021 Interim results article in https://pubmed.ncbi.nlm.nih.gov/34571285/ Human factors analysis (added 28/09/2021) 2022 Interim results article in https://pubmed.ncbi.nlm.nih.gov/35245235/ Patient Harm and Institutional Avoidability of Out-of-Hours Discharge From Intensive Care: An Analysis Using Mixed Methods (added 25/10/2022) 2019 Abstract results in https://doi.org/10.1177/1751143719835452 (added 04/07/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-22
• Study Completion: 2019-01-31
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 355

Inclusion Criteria

Participant group by sub-study:
A. RCRR (deceased patients):
Patients discharged from ICU to wards who subsequently died before hospital discharge.

B. Patient and relative interviews and focus groups:
1. Patients discharged from ICU to a ward and subsequently discharged out of hospital
2. Relatives of patients who survived their post-ICU ward stay
3. Relatives of patients who died following ICU discharge before hospital discharge
Participants will be sought with varying experiences, to facilitate maximum variation in the sample (76)

C. Staff interviews/focus groups:
Staff involved in the care of patients discharge from intensive care to wards (including nurses, doctors, physiotherapists, dieticians and other allied health professionals). As above, purposive sampling will be utilised to ensure a diverse range of exposure, experience and background training.

D. RCRR (survivors):
Patients discharged from ICU to a ward and subsequently discharged out of hospital. Ideally including some of those interviewed as above

Inclusion criteria by sub-study:
A. RCRR (deceased):
1. Male or female, aged 18 years or over
2. Patient discharged from ICU to a ward and died prior to hospital discharge

B. Patient/relative interviews:
1. Participant is willing and able to give informed consent for participation in the study
2. Male or female, aged 18 years or over
3. Patient or relative of patient who was discharged from ICU to a ward and survived to hospital discharge, or relative of patient who was discharged from ICU and did not survive to hospital discharge

C. Staff interviews/focus groups:
1. Participant is willing and able to give informed consent for participation in the study
2. Male or female, aged 18 years or over
3. A member of NHS staff involved in the care of patients discharged from ICU to wards

D. RCRR (survivors):
1. Participant is willing and able to give informed consent for participation in the study
2. Male or female, aged 18 years or over
3. Discharged from ICU to a ward and subsequently discharged from hospital

Exclusion Criteria

The participant may not enter the study if ANY of the following apply:
A. RCRR (deceased):
1. Inaccessible medical notes (all efforts will be made to obtain access to medical notes, but these are occasionally misplaced within the hospital system, or are unavailable due to investigation of an ongoing complaint)

B. Patient/relatives interviews/focus groups:
1. Lack of capacity to consent
2. Poor spoken English (it will not be possible to conduct the interviews through an interpreter)

C. Staff focus groups:
1. Does not meet inclusion criteria

D. RCRR (survivors):
1. Does not meet inclusion criteria

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
As this is a mixed methods exploratory study, the outcomes are not as clearly defined as in an interventional study. The primary objective is to develop a multifaceted human factors based intervention to reduce in-hospital mortality rates in patients who have been discharged from intensive care. The primary outcome measure is the intervention plan which will be delivered at the end of the study.