ImproveCare - The management of clinical uncertainty in hospital settings

ISRCTN	ISRCTN36040085
DOI	https://doi.org/10.1186/ISRCTN36040085
Protocol serial number	v2.0 07.12.16
Sponsor	King’s College London and King’s College Hospital NHS Foundation Trust
Funder	Health Technology Assessment Programme

Submission date: 16/01/2017
Registration date: 18/01/2017
Last edited: 24/02/2023

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
Around 500,000 people die every year in the UK and around half of all these deaths occur in hospital. Most people prefer to die at home but this doesn’t always happen because there is little discussion about what they want. It is made worse when it’s difficult for health care professionals (HCP) to identify patients, whose situation is clinically uncertain, a care area many professionals do not have enough knowledge/skills in. Reports have highlighted what can go wrong when there is clinical uncertainty, and at the end of life it can be devastating for patients and families. The AMBER care bundle has been developed to care better for hospital patients whose situations are clinically uncertain and are at risk of dying during their hospital stay despite treatment. For these patients, staff develop a plan with patients and their family that documents what is important to them. The patient’s health status and their wishes are revisited daily. A small study explored the AMBER care bundle, highlighting some benefits and concerns with the program. Before more hospitals use the AMBER care bundle, it’s important to find out whether the it actually improves care, or not. The aim of this study is to find out if a study comparing the AMBER care bundle and usual care is feasible. In addition, open interviews with patients, caregivers and staff will help improve understanding about what they value about the AMBER care bundle and how it works.

Who can participate?
Patients in hospital whose situation is clinically uncertain and are at risk of dying during their hospital stay and their relatives and friends; healthcare professionals working on the study wards; and bereaved relatives/friends of who died at wards supported patients with the AMBER care bundle or up to 100 days post-discharge.

What does the study involve?
Patients who agree to take part are interviewed by a research nurse at the start of the study and then 3-5 and 10-15 days later about how they are feeling physically and emotionally and if they feel that they are receiving enough care and support while they are on the hospital ward. Willing relatives/friends of the patients are also interviewed by a researcher about their experiences of the quality of care the patient has received, their understanding of the patient’s illness and of the treatment and care being given, and their views on being involved in important decisions about the patient’s care with an interview. If the teams on the ward agree, a researcher also observes multidisciplinary team meetings (where different professionals involved in patient’s care discuss cases) on the ward to collect information on the structure of the meeting, processes, details of patients with clinically uncertain situations, where their condition is irreversible, and where there is a risk they will die during their stay despite treatment, and how decisions are made regarding their care, particularly at the end of life. Healthcare professionals are invited to take part in in a ward-based focus group to explore their views about caring for patients whose situations are clinically uncertain, views about whether a large scale trial would be possible.

What are the possible benefits and risks of participating?
People find it helpful to talk in confidence about what is happening to them or their relative. Many patients and relatives benefit from the knowledge that what they share during interviews contributes to improving care in hospitals and other settings. These interviews, will take some of their time. The interview can be a relief or a challenge. There is a small risk that the nature of the questionnaires might be distressing for some people. If the participant feels distressed, the highly trained researcher will be present to talk to the participant. If required, the participant will be referred to a colleague who can help more. For HCPs, taking part in the focus groups, could contribute to our findings and recommendations for the improvement of the care and support of patients whose situations are clinically uncertain, where their condition is irreversible, and where there is a risk they will die during their current episode of care despite receiving treatment. Partaking in the focus groups should not have any disadvantages, but the interview will take between 30-60 minutes. For relatives/friends engaging in follow-back surveys can evoke some distress. Many participants, nevertheless, report it to be a positive experience. Relatives will get a chance to express their views about the quality of care received by the patients and could potentially lead to improvements in care.

Where is the study run from?
1. Chesterfield Royal Hospital (UK)
2. East Surrey Hospital (UK)
3. Northwick Park Hospital (UK)
4. Tunbridge Wells Hospital (UK)

When is the study starting and how long is it expected to run for?
February 2015 to April 2018

Who is funding the study?
National Institute for Health Research (NIHR) Heath Technology Assessment (HTA) Programme (UK)

Who is the main contact?
Dr Jonathan Koffman
Jonathan.koffman@kcl.ac.uk

Contact information

Dr Jonathan Koffman
Scientific

King's College London
Cicely Saunders Institute
Department of Palliative Care, Policy and Rehabilitation
Bessemer Road
London
SE5 9PJ
United Kingdom

ORCID ID	0000-0001-8513-5681
Phone	+44 20 7848 5590
Email	jonathan.koffman@kcl.ac.uk

Miss Emel Yorganci
Scientific

King's College London
Cicely Saunders Institute, Department of Palliative Care, Policy and Rehabilitation
Bessemer Road, London, SE5 9PJ, UK
London
SE5 9PJ
United Kingdom

Phone	(+44) 02078485418
Email	emel.yorganci@kcl.ac.uk

Study information

Primary study design	Interventional
Study design	Multi-centre feasibility cluster randomised controlled trial with embedded qualitative evaluation
Secondary study design	Cluster randomised trial
Participant information sheet	ISRCTN36040085_PIS_06Jan17_Intervention_Relative_V2.docx
Scientific title	ImproveCare – The management of clinical uncertainty in end of life care – a feasibility cluster randomised controlled trial
Study acronym	ImproveCare
Study objectives	The aim of this study is to determine the feasibility of a pragmatic, multi-centre, cluster randomised control trial to optimise the design, and to define the outcomes, for a fully powered definitive trial of the AMBER care bundle versus standard care.
Ethics approval(s)	London Camden & King's Cross Research Ethics Committee, 20/12/2016, ref: 16/LO/2010
Health condition(s) or problem(s) studied	End of life care
Intervention	Randomisation was at the level of the cluster (NHS Trusts) which was performed by King's College Clinical Trials Unit. The four clusters were randomised prior to collection of data at sites, but after all sites had agreed to participate. The four clusters were randomised at once by randomly sequencing the order of randomisation and then randomising the sites in this order into fixed blocks of two, to active or control arms. As a result of computerised randomisation, in the first wave of the study, East Surrey Hospital will be the active arm and Chesterfield Royal Hospital will be the control arm. In the second wave of the study, Maidstone and Tunbridge Wells NHS Trust will be the active arm and Northwick Park Hospital will be the control arm. Active arm: The AMBER care bundle will be implemented on a selected general medical ward. The AMBER care bundle is an approach used in hospitals when clinicians are uncertain whether a patient may recover and are concerned that they may only have a few months left to live. The AMBER care bundle is intended to encourage staff to identify patients who fulfilled these criteria, for the clinical team responsible for those patients to then to develop and document, within a reasonable period of time, a clear medical plan in conjunction with the patient and their family, to consider anticipated outcomes, and resuscitation and escalation status. This involves communicating openly with the patient and their family about their wishes and preferences should the worst happen. The person’s condition is then monitored closely on daily basis to record any changes, and address any concerns that they or their family may have. Staff working on the ward where the AMBER care bundle is being implemented (the intervention board) will be introduced to, and will be trained in the use of the AMBER care bundle, in March 2017. The intervention will continue until the end of data collection (Beginning of October 2017). The intervention ward staff in the second wave of the study will be introduced to and trained in the use of the AMBER care bundle in April 2017, and the AMBER care bundle will be used until the end of data collection (Beginning of October 2017). Patients who fulfil the criteria to be supported by the AMBER care (i. Patients who are deteriorating; ii. Patients whose situations are clinically uncertain, with limited reversibility; iii. Patients at risk of dying during their current episode of care, despite treatment), and who have provided their written informed consent for data to be shared with the research team, will complete a questionnaire at up to three time points. Relatives of patients who participated, and who died on the ward or 100 days after discharge, will be contacted for a follow-up post-bereavement survey, after waiting at least 3 months to pass after the death of the patient. Control arm: Participants continue to receive usual care. Patients will be recruited for data collection and the questionnaires will be completed at the same three time points. Relatives of patients who participated, who died on the ward or 100 days after discharge will be contacted for a follow-up post-bereavement survey, after waiting at least 3 months to pass after the death of the patient. Qualitative component of the study: For the qualitative component of the study, interviews will be conducted with a purposefully selected sample of patients and relatives across both the intervention and which will include questions related to their illness, information and communication issues, their involvement in decision making, and their confidence in care provided. Focus groups with healthcare professionals on the intervention wards will explore their views on the AMBER care bundle and the study. Focus groups with healthcare professionals on the control wards will explore their views on caring for patients with advanced illness who are deteriorating, clinically unstable and likely to die during their episode of care, despite receiving treatment. Finally, a researcher will observe and take notes of consenting healthcare professionals in the multi-disciplinary meetings taking place on the wards.
Intervention type	Other
Primary outcome measure(s)	1. The effect of the AMBER care bundle is measured using the Patient/family anxiety and communication subscale of the Integrated Palliative care Outcome Scale (I-POS) at baseline, 3-5 days, 10-15 days 2. Patients reported experiences of health care are measured using the howRwe questionnaire at baseline, 3-5 days, 10-15 days
Key secondary outcome measure(s)	1. Cost of care is measured with the EQ-5D at baseline, 3-5 days, 10-15 days 2. Other subscales of the Integrated Palliative Care Outcome Scale (I-POS) questionnaire at baseline, 3-5 days, 10-15 days 3. What patients and carers value most about AMBER care bundle and how it may be working is assessed through qualitative interviews, focus groups and non-participatory observation of multidisciplinary team meetings 4. Patients views on how they feel about taking part in this study are collected at 3-5 days and 10-15 days Embedded qualitative study: Preferred place of death and whether this is realized, along with satisfaction which will be collected from the relatives of patients who have lost their lives is measured using the QUALYCARE postal survey.
Completion date	31/10/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	280
Total final enrolment	65
Key inclusion criteria	Patient inclusion criteria: 1. Participants must be 18 or over 2. Participants can be female or male 3. Patients who are deteriorating 4. Patients whose situations are clinically uncertain, with limited reversibility 5. Patients at risk of dying during their current episode of care, despite treatment Relative inclusion criteria: Relative or close friends of the patients who fulfil the criteria above. Healthcare professional inclusion criteria: Working on the study wards.
Key exclusion criteria	Patient exclusion criteria: 1. Participants under 18 years old 2. Patients whose situations are clinically certain Relative exclusion criteria: Relatives or close friends of the patients who do not meet the inclusion criteria Healthcare professional exclusion criteria: Not working on the study wards
Date of first enrolment	01/05/2017
Date of final enrolment	01/10/2017

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

East Surrey Hospital

Canada Avenue
Redhill
RH1 5RH
United Kingdom

Northwich Park Hospital

Watford Road
Harrow
HA1 3UJ
United Kingdom

Tunbridge Wells Hospital

Tonbridge Road
Tunbridge Wells
TN2 4QJ
United Kingdom

Chesterfield Royal Hospital

Calow Top Road
Chesterfield
S44 5BL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The current data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	16/08/2019	21/08/2019	Yes	No
Results article	results	01/10/2019	10/10/2019	Yes	No
HRA research summary			28/06/2023	No	No
Other publications		21/02/2020	24/02/2023	Yes	No
Other publications	Multi-method process evaluation	16/09/2020	24/02/2023	Yes	No
Participant information sheet	version V2	06/01/2017	18/01/2017	No	Yes
Participant information sheet	version V1	19/12/2016	18/01/2017	No	Yes
Participant information sheet	version V2	06/12/2016	18/01/2017	No	Yes
Participant information sheet	version V3	03/01/2017	18/01/2017	No	Yes
Participant information sheet	version V2	12/12/2016	18/01/2017	No	Yes
Participant information sheet	version V1	19/12/2016	18/01/2017	No	Yes
Participant information sheet	version V2	06/12/2016	18/01/2017	No	Yes
Participant information sheet	version V2	06/12/2016	18/01/2017	No	Yes
Participant information sheet	version V2	06/01/2017	18/01/2017	No	Yes
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	version v6.0	02/02/2018	17/10/2018	No	No

Additional files

ISRCTN36040085_PIS_03Jan17_HCP_V3.docx: Uploaded 18/01/2017
ISRCTN36040085_PIS_06Dec16_Control_Relative_V2.docx: Uploaded 18/01/2017
ISRCTN36040085_PIS_06Dec16_ControlWard_Relative_V2.docx: Uploaded 18/01/2017
ISRCTN36040085_PIS_06Dec16_Patient_V2.docx: Uploaded 18/01/2017
ISRCTN36040085_PIS_06Jan17_Intervention_Relative_V2.docx: Uploaded 18/01/2017
ISRCTN36040085_PIS_06Jan17_Patient_Intervention_V2.docx: Uploaded 18/01/2017
ISRCTN36040085_PIS_12Dec16_InterventionWard_Relative_V2.docx: Uploaded 18/01/2017
ISRCTN36040085_PIS_19Dec16_ControlWard_Patient_V1.docx: Uploaded 18/01/2017
ISRCTN36040085_PIS_19Dec16_InterventionWard_Patient_V1.docx: Uploaded 18/01/2017
ISRCTN36040085_Protocol_v6.0_02Feb2018.pdf: Uploaded 17/10/2018

Editorial Notes

24/02/2023: Publication references added.
10/10/2019: Publication reference added.
21/08/2019: Publication reference added.
10/04/2019: The following changes have been made:
1. The overall trial end date has been changed from 30/04/2018 to 31/10/2018.
2. The intention to publish date has been changed from 30/04/2019 to 30/09/2019.
3. The total final enrolment number has been added.
17/10/2018: Uploaded protocol Version 6.0 02 February 2017 (not peer reviewed).