Plain English Summary
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
Trial website
Contact information
Type
Public
Primary contact
Mrs Sarah Vollam
ORCID ID
http://orcid.org/0000-0003-2835-6271
Contact details
Kadoorie Centre
Level 3
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 231 440
sarah.vollam@ndcn.ox.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PID12321
Study information
Scientific title
Designing an intervention to improve in-hospital outcome for patients who have been discharged from intensive care
Acronym
REFLECT
Study hypothesis
To develop a multifaceted human factors-based intervention to reduce in-hospital mortality rates in patients who have been discharged from intensive care.
Ethics approval
Wales REC 4, 03/05/2017, ref: 17/WA/0139
Study design
Multisite multiphase convergent parallel mixed methods study
Primary study design
Observational
Secondary study design
Mixed methods study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
See additional files
Condition
Post-intensive care unit in-hospital ward stay
Intervention
Mixed 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 type
Other
Phase
Drug names
Primary outcome measure
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.
Secondary outcome measures
A. 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 trial start date
23/09/2015
Overall trial end date
31/01/2019
Reason abandoned (if study stopped)
Eligibility
Participant 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 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 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 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 or over
3. Discharged from ICU to a ward and subsequently discharged from hospital
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
380
Participant 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
Recruitment start date
01/07/2017
Recruitment end date
31/12/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Oxford University Hospitals NHS Foundation Trust
John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research - Research for Patient Benefit
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in high-impact peer reviewed journals.
IPD sharing statement
The 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).
Intention to publish date
01/07/2019
Participant level data
Available on request
Basic results (scientific)
Publication list
2019 protocol in https://www.ncbi.nlm.nih.gov/pubmed/30813113
Publication citations
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