Condition category
Urological and Genital Diseases
Date applied
15/05/2017
Date assigned
31/05/2017
Last edited
05/07/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims:
The kidneys are responsible for filtering out the waste products and excess water in the blood, and converting them into urine. If the kidneys stop working properly, then the body is unable to get rid of the waste products building up in the blood. Eventually, the kidneys are no longer able to support the body’s needs (kidney failure) and so a treatment to replace the work of the failed kidneys is needed. When kidney function drops to 15% of normal, patients experience tiredness, loss of appetite and sickness. At this stage, dialysis or kidney transplantation is considered. Dialysis is a treatment which involves diverting the blood into an external machine so that it can be cleaned, before being returned to the body. This treatment can take place in hospital or at home. There is evidence that some older people with many medical problems (co-morbidities) do just as well with conservative care as dialysis, but more evidence is needed to help patients and their families make the best decision. The aim of this study is to provide clear evidence to help patients and their families reach the best decision for them and influence NHS policy nationally on the best care for people living with kidney disease.

Who can participate?
People with kidney failure aged 80+ and those aged 65+ with multiple health problems.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive conservative care with additional home visits. This involves home visits with a nurse to assess the patients care needs and their priorities during responsive management. The nurse calls the patient at home regularly to monitor symptoms and check that sufficient help is available. There are regular check-ups with the nurse at home and in hospital visits. Hospital visits are less frequent than in people preparing for renal dialysis. Those in the second group come to hospital clinic visits regularly as per standard practice. Surgery to prepare for dialysis takes place. Dialysis is started when the doctor, nurse and patient agree it is needed. There are regular visits to hospital for treatment or check-ups. Participants are followed up every four months until the end of data collection or death.

What are the possible benefits and risks of participating?
There are no guaranteed benefits of taking part, however the treatment given as part of the study may lead to an improvement in symptoms and general health. There are no notable risks involved with participating.

Where is the study run from?
Southmead Hospital and five other NHS hospitals in England (UK)

When is study starting and how long is it expected to run for?
January 2017 to December 2021

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

Who is the main contact?
Dr Helen Winton
helen.winton@bristol.ac.uk

Trial website

http://bristol.ac.uk/prepare-kc-trial

Contact information

Type

Scientific

Primary contact

Dr Helen Winton

ORCID ID

Contact details

University of Bristol
School of Social and Community MedicineCanynge Hall (1.01)
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
+44 117 331 4586
helen.winton@bristol.ac.uk

Type

Scientific

Additional contact

Dr Fergus Caskey

ORCID ID

http://orcid.org/0000-0002-5199-3925

Contact details

UK Renal Registry
Learning and Research
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
+44 117 414 8150
mdfjc@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

32254

Study information

Scientific title

The prepare multi-morbid older people for end-stage kidney disease trial

Acronym

Study hypothesis

The aim of this study is to establish the effectiveness and cost-effectiveness of preparing for responsive management compared with preparing for renal dialysis in relation to quality and length of life in frail, older people with multiple health problems and advanced chronic kidney disease.

Ethics approval

South Central- Berkshire Research Ethics Committee, 05/05/2017, ref: 17/SC/0070

Study design

Randomised; Interventional; Design type: Treatment, Process of Care, Complex Intervention, Management of Care, Active Monitoring

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

Specialty: Renal disorders, Primary sub-specialty: Renal disorders; UKCRC code/ Disease: Renal and Urogenital/ Other disorders of kidney and ureter

Intervention

Participants will be randomly allocated 1:1 to the "prepare for responsive management" or "prepare for dialysis" treatment arms, stratified by site to ensure a balance in terms of local differences. Minimisation will be used to ensure balance in age (65-80 vs 80+) and rate of kidney function decline (less or equal to vs more than 5 ml/min/1.73m2 in the last 12 months). Minimisation with probability weighting of 0.8 will be used in order to reduce predictability.

Prepare for responsive management (intervention): A nurse who specialises in looking after people having responsive management (conservative care plus) will arrange a date for a first home visit. The first home visit will take place within 3 weeks of the nurse telephoning patient. Over the next 8 weeks the specialists nurse will visit the patient up to three times to assess patient needs and plan future treatment. All assessments and decisions will be agreed with the local site specialist renal team. Following this, the frequency of specialist nurse visits will depend on how often the patient and the patient’s specialist kidney team think the patient should be seen. Visits will be convenient for the patient and will alternate between hospital clinical visits and the nurse visiting the patient at home. In addition, the specialist nurse will contact the patient once a month to assess symptoms and review the treatment plan. If kidney function continues to fall and the patient develops symptoms which cannot be controlled by medication, the patient’s specialist kidney team will discuss the option of moving on to the next stage of support, which may involve other professionals, such as palliative care specialists, who can help control symptoms.

Prepare for renal dialysis (comparator): Patients will attend the next scheduled kidney clinic appointment at the hospital, and will continue to attend kidney clinic appointments as often as the patient and specialist kidney team deem necessary. The specialist kidney team will discuss dialysis treatment options that are available and decided which one is most suitable. Depending on the dialysis treatment chosen, the patient may need scans and an operation to prepare for dialysis. If kidney function continues to decline and the patient develops symptoms of kidney failure, then the specialist team will recommend starting dialysis immediately. If the patient and the specialist kidney team consider it appropriate, other professionals, such as palliative care specialists, may become involved to help control symptoms.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Mean total of quality adjusted life years (QALY) between the first patient recruited and the end of data collection is collected using the EQ-5D-5L at recruitment and every 4 months thereafter until 1 October 2021 (end of data collection).

Secondary outcome measures

Survival related outcomes will be collected by research nurses from primary and secondary care clinical notes and during 4 monthly study visits/contacts. In addition, all participants will be asked on consenting to the RCT to consent to linkage to existing healthcare databases, such as Hospital Episode Statistics, the Office for National Statistics and the UK Renal Registry. This will provide data on commencement of acute or chronic dialysis, hospital admissions for medical and surgical reasons and date and cause of death.
1. All-cause mortality
2. Cause-specific mortality
3. Place of death
4. Hospital-free days alive

Patient reported outcome related:
1. Generic quality of life is measured using the EQ-5D-5L at recruitment (baseline) and every 4 months thereafter until 1 October 2021 or until withdrawal from the study or death
2. Disease specific quality of life/symptom burden is measured using the POS-S renal at recruitment (baseline) thereafter until 1 October 2021 or until withdrawal from the study or death
3. Capability gain specific to older persons is measured using the ICECAP-O at recruitment (baseline) and every 4 months thereafter until 1 October 2021 or until withdrawal from the study or death
4. Capability during end-of-life care is measured using the ICECAP-SCM at recruitment (baseline) and every 4 months thereafter until 1 October 2021 or until withdrawal from the study or death
5. Patient treatment burden is measured using the MTBQ at recruitment (baseline) and every 4 months thereafter until 1 October 2021 or until withdrawal from the study or death

Physical functioning:
1. Is measured using the 'timed get up and go'- summary score at baseline and 12 monthly time points and assessed for changes over time. The physical assessment will be performed by the research nurse annually using standard operating procedures.
2. Grip strength is measured using a Jamar hand dynamometer at baseline and 12 monthly time points and assessed for changes over time. The physical assessment will be performed by the research nurse annually using standard operating procedures.

Relative/carer reported outcomes:
1. Impact on carers is measured using the PACKS impact on carers questionnaire (added 07/06/2017: adapted from the iMTA valuation of informal care questionnaire) at participant recruitment (baseline) and every 4 months thereafter until 1 October 2021, or until participant withdraws from the study or dies
2. Impacts on carers is assessed using the QUALYCARE post-bereavement survey obtaining retrospective information covering the 1 week preceding death if the study participant dies. QUALYCARE data will be collected at 3-6 months after participant death

Health economic:
1. Incremental cost-per QALY gained from the health perspective is assessed by QALYs generated using EQ-5D-5L at recruitment (baseline) and every 4 months thereafter until 1 October 2021
2. Cost per equivalent year of full/sufficient capability gained, from health and societal perspectives is assessed using ICECAP (ICECAP-O the ICEpop capability measure for older people and ICECAP-SCM the ICEpop capability measure for supportive care management) at recruitment (baseline) and every 4 months thereafter until 1 October 2021

Overall trial start date

01/01/2017

Overall trial end date

31/12/2021

Reason abandoned

Eligibility

Participant inclusion criteria

Patients known to renal services with new or existing stage 5 CKD (eGFR <15, with at least one result confirming this in the last 12 months) and:
1. Aged 65+ with a World Health Organisation (WHO) performance status 3+ (0 = Fully active, able to carry out all normal activity without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours; 3 = Symptomatic and in a chair or in bed for greater than 50% of the day but not bedridden; 4 = Completely disabled; cannot carry out any self-care; totally confined to bed or chair), or
2. Aged 65+ with a Davies co-morbidity score 2+ (each of the following scores one point: Malignancy, ischaemic heart disease, peripheral vascular disease (including stroke), left ventricular dysfunction, diabetes mellitus, systemic collagen vascular disease, other significant pathology (including COPD, cirrhosis, psychiatric illness, HIV), or
3. Aged 80+

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 512; UK Sample Size: 512

Participant exclusion criteria

1. Unable to consent, e.g. significant cognitive impairment or psychiatric disorder
2. Not medically fit for dialysis
3. Within 4 weeks of starting dialysis

Recruitment start date

01/07/2017

Recruitment end date

30/06/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Southmead Hospital
Southmead Road Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom

Trial participating centre

Royal Free Hospital
Renal Unit Pond Street
London
NW3 2QG
United Kingdom

Trial participating centre

Lister Hospital
Renal Unit Corerys Mill Lane
Stevenage
SG1 4AB
United Kingdom

Trial participating centre

Birmingham Heartlands Hospital
Department of Renal Medicine Bordesley Green East
Birmingham
B9 5SS
United Kingdom

Trial participating centre

Royal Stoke University Hospital
Trent Building University Hospitals of North Midlands NHS Trust Newcastle Road
Stoke-on-Trent
ST4 6QG
United Kingdom

Trial participating centre

Gloucester Royal Hospital
Great Western Road
Gloucester
GL1 3NN
United Kingdom

Sponsor information

Organisation

North Bristol NHS Trust

Sponsor details

Southmead Hospital
Southmead Road
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
+44 117 414 9330
researchsponsor@nbt.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

1. Trial protocol: To be published in “Trials”, with an intention to publish by 31/12/2017
2. Trail Statistical Analysis Plan: To be published in “Trials” by 31/12/2019
3. Final study results: planned publication in a high impact peer reviewed journal with an intention to publish by 31/12/2022

IPD Sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2022

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

05/07/2017: Trial website has been updated from http://bristol.ac.uk/prepare-me-trial to http://bristol.ac.uk/prepare-kc-trial. Secondary outcome measures have been updated.