ISRCTN ISRCTN14658054
DOI https://doi.org/10.1186/ISRCTN14658054
Secondary identifying numbers PID12321
Submission date
20/06/2017
Registration date
22/06/2017
Last edited
04/07/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Most patients discharged from an intensive care unit (ICU) are expected to go home. However, about 1 in 12 die unexpectedly on general wards before leaving hospital. The high death rate occurs despite hospitals using ‘early warning’ scoring systems and visits from ICU teams. A plan which reduces this death rate is urgently needed. This study uses several approaches to get a clear picture of how to improve care.

Who can participate?
Patients, relatives and staff aged 18 or over with experience of ward care after ICU

What does the study involve?
The researchers talk to patients, relatives and staff with experience of ward care after ICU,look at the notes of patients cared for in wards after discharge from ICU, and look at published research to find ways of improving care in this patient group. Patient representatives help the researchers to use this information to design a plan to deliver better care to patients who have been in ICU, whilst they remain in hospital. Information is combined from several sources with experts skilled at making plans work in order to make the best possible plan. After this study, the plan is tested to see whether it could be put in place in local hospitals and tested in a large study.

What are the possible benefits and risks of participating?
There would be no benefits to participants from taking part in this study. Sharing their experiences may help to raise awareness of common issues. It is hoped in the longer term that this study will contribute to improved standards of care in the future, and better working practices, based on the information collected. Over 2300 lives would be saved in the UK each year if this plan worked and stopped only a quarter of the unexpected deaths in patients discharged from ICU. There are no known risks to this study. However, discussing such a sensitive topic may be distressing to participants. The ICU follow-up team are available initially to answer any questions or concerns and signpost participants to other support if required. All information gathered within the interviews is anonymised at the point of collection, so no individuals are identifiable.

Where is the study run from?
Oxford University Hospitals NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
September 2015 to January 2019 (as of 22/10/2018)

Who is funding the study?
National Institute for Health Research - Research for Patient Benefit (UK)

Who is the main contact?
Mrs Sarah Vollam
sarah.vollam@ndcn.ox.ac.uk

Study website

Contact information

Mrs Sarah Vollam
Public

Kadoorie Centre
Level 3
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom

ORCiD logoORCID ID 0000-0003-2835-6271
Phone +44 (0)1865 231 440
Email sarah.vollam@ndcn.ox.ac.uk

Study information

Study designMultisite multiphase convergent parallel mixed methods study
Primary study designObservational
Secondary study designMixed methods study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet ISRCTN14658054_sub-studyC_PIS_May2017.pptx
Scientific titleDesigning an intervention to improve in-hospital outcome for patients who have been discharged from intensive care
Study acronymREFLECT
Study objectivesTo develop a multifaceted human factors-based intervention to reduce in-hospital mortality rates in patients who have been discharged from intensive care.
Ethics approval(s)Wales REC 4, 03/05/2017, ref: 17/WA/0139
Health condition(s) or problem(s) studiedPost-intensive care unit in-hospital ward stay
InterventionMixed methods exploratory study comprising four sub-studies:
A. Retrospective Case Record Review (deceased patients)
Human factors-focused review of medical notes of patients who were discharged from intensive care and did not survive to hospital discharge.
B. Patient and relative interviews
Interviews with patients and relatives of deceased patients about the delivery of care following intensive care discharge.
C. Staff focus groups/interviews
Interviews with staff involved in the delivery of ward care to patients following intensive care discharge.
D. Retrospective Case Record Review (survivors)
Human factors-focused review of medical notes of patients who were discharged from intensive care and survived to hospital discharge.
Intervention typeOther
Primary outcome measureAs 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.
Secondary outcome measuresA. Retrospective case record review (RCRR) (deceased patients): identify examples of high quality care and areas for improvement from medical records of deceased patients
Outcome measure: Aspects of care identified and the human factors-based factors which contributed
B. Interview study (patients and relatives): identify examples of high quality care and areas for improvement from patients’ and relatives’ perspective
Outcome measure: Aspects of care identified
C. Interview/focus groups study (staff): identify examples of high quality care and areas for improvement from staff perspective
Outcome measure: Aspects of care identified and potential approaches identified by patients
D. Retrospective case record review (survivors): identify examples of high quality care and areas for improvement from medical records of survivors
Outcome measure: Aspects of care identified and the human factors-based factors which contributed

All secondary outcome measures will be assessed at the end of primary data collection period, prior to intervention design (12 months into the study).
Overall study start date23/09/2015
Completion date31/01/2019

Eligibility

Participant type(s)Mixed
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants380
Total final enrolment355
Key inclusion criteriaParticipant 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
Key exclusion criteriaThe 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
Date of first enrolment01/07/2017
Date of final enrolment31/12/2018

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Oxford University Hospitals NHS Foundation Trust
John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom

Sponsor information

University of Oxford
University/education

Research Services
Clinical Trials and Research Governance
Joint Research Office
Block 60
Churchill Hospital
Headington
Oxford
OX3 7LE
England
United Kingdom

ROR logo "ROR" https://ror.org/052gg0110

Funders

Funder type

Government

National Institute for Health Research - Research for Patient Benefit
Government organisation / National government
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location
United Kingdom

Results and Publications

Intention to publish date01/07/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in high-impact peer reviewed journals.
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Mrs Sarah Vollam (sarah.vollam@ndcn.ox.ac.uk).

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet 22/06/2017 No Yes
Participant information sheet 22/06/2017 No Yes
Participant information sheet 22/06/2017 No Yes
Protocol article protocol 25/01/2019 Yes No
Interim results article case record review 06/01/2021 12/01/2021 Yes No
Interim results article Human factors analysis 24/03/2021 28/09/2021 Yes No
Interim results article Patient Harm and Institutional Avoidability of Out-of-Hours Discharge From Intensive Care: An Analysis Using Mixed Methods 01/07/2022 25/10/2022 Yes No
HRA research summary 28/06/2023 No No
Abstract results 26/07/2019 04/07/2024 No No

Additional files

ISRCTN14658054_sub-studyC_PIS_May2017.pptx
Uploaded 22/06/2017
ISRCTN14658054_sub-studyB_PIS_May2017.pptx
Uploaded 22/06/2017
ISRCTN14658054_Sub-studyD_PIS_April2017.pptx
Uploaded 22/06/2017

Editorial Notes

04/07/2024: Abstract added.
25/10/2022: Publication reference added.
14/02/2022: Total final enrolment added.
28/09/2021: Publication reference added.
12/01/2021: Publication reference added.
24/02/2020: Publication reference added.
22/10/2018: The following changes have been made to the trial record:
1. The overall trial end date has been changed from 31/07/2018 to 31/01/2019
2. The recruitment end date has been changed from 31/07/2018 to 31/12/2018
3. The plain English summary has been updated to reflect the new trial end date