Condition category
Not Applicable
Date applied
31/08/2016
Date assigned
27/09/2016
Last edited
27/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Most people want to be cared for and die at home. As people get weaker in the last weeks or days of life, they usually can’t swallow. In the UK, when this happens, it is standard practice for medicines to be given by a drip under the skin to relieve symptoms. Four symptoms are common in dying people: pain, agitation, nausea and noisy breathing (rattle). These are called breakthrough symptoms. These can happen even when a drip is already in place. When they do, a family member is advised to call a healthcare professional (HCP), usually a district nurse. The nurse will visit and give the patient an injection under the skin, but it can take a long time, often much more than an hour, for the nurse to arrive and give the medicine. This wait can be distressing for patient and carer and the symptom can worsen by the time the nurse arrives. Carers tell us that this makes them feel powerless to help their loved ones. In some countries, like Australia, carers are trained to give symptom-relieving medicine to their dying relatives at home. It is not known whether this approach would be welcomed in the UK, so it needs to be tested. Before doing a large study, it is good practice to first test the feasibility in a smaller group of patients. The aim of this study is to find out whether it is feasible and acceptable for carers to administer medication to dying patients for breakthrough symptoms.

Who can participate?
Dying patients in the last weeks of life and their carers, aged over 18

What does the study involve?
Participants are randomly allocated to either the ‘usual care’ or ‘new care’ group. Carers in the ‘usual care’ group are asked to call a HCP if their loved one has breakthrough symptoms. Carers in the ‘new care’ group are trained how to recognise symptoms, to give injections and then see if they work to relieve the symptom. Carers in both groups are asked to keep a diary of symptoms and treatments. They are invited to talk about how they found the study and the experience of giving injections.

What are the possible benefits and risks of participating?
Information from this study will help the researchers to understand if a large study, to give a final answer, is possible. Possible benefits of carers administering medication include more rapid symptom control for the patient, and the carer feeling more in control. The risks are increased anxiety for the carer taking on this new role, which should be lessened by the good training the study will provide.

Where is the study run from?
1. North Wales Centre for Primary Care Research (UK)
2. Marie Curie Palliative Care Research Centre (UK)
3. Sue Ryder Hospice Gloucestershire (UK)

When is the study starting and how long is it expected to run for?
November 2016 to May 2019

Who is funding the study?
Health Technology Assessment Programme (UK)

Who is the main contact?
1. Prof. Clare Wilkinson (public)
2. Dr Marlise Poolman (scientific)

Trial website

Contact information

Type

Public

Primary contact

Prof Clare Wilkinson

ORCID ID

http://orcid.org/0000-0003-0378-8078

Contact details

North Wales Centre for Primary Care Research
Bangor University
Bangor
LL13 7YP
United Kingdom

Type

Scientific

Additional contact

Dr Marlise Poolman

ORCID ID

Contact details

North Wales Centre for Primary Care Research
Bangor University
Bangor
LL13 7YP
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 15/10/37

Study information

Scientific title

Carer administration of as-needed subcutaneous medication for breakthrough symptoms in home-based dying patients: a UK study (CARIAD)

Acronym

CARIAD

Study hypothesis

Carer-administration of as-needed subcutaneous medication for breakthrough symptoms in home-based dying patients is feasible and acceptable in the UK.

Ethics approval

Not provided at time of registration

Study design

Developmental work, including qualitative work, followed by a pragmatic, multi-centre, randomised feasibility trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Quality of life

Patient information sheet

No participant information sheet available

Condition

End of life care

Intervention

Firstly, the trialists will ensure that everyone understands it is legal for carers to give symptom-relieving injections to dying patients as long as they are supported to do so. A time-tested education package made by the trialists' Australian partners will be reworked for UK patients, carers and healthcare professionals. An expert consensus group (comprising of carers and healthcare professionals) will hold workshops on to do this, and to decide how best to explain the study to carers and patients. Patients and their carers will then be randomised to either ‘usual care’ or ‘new care':
1. Carers in the ‘new care’ group will be trained how to recognise symptoms, to give injections and then to see if they work to relieve the symptom.
2. Carers in the ‘usual care’ group will be asked to call a healthcare professional if their loved one has breakthrough symptoms (pain, agitation, nausea and noisy breathing [rattle]).
Carers in both groups will be asked to keep a diary of symptoms and treatments. They will be invited to talk about how they found the study and the experience of giving injections.

Intervention type

Other

Phase

Drug names

Primary outcome measures

As this is a feasibility trial, one of the goals is to establish the best primary and secondary outcome measures. The most likely candidates for primary outcome measures for a future definitive trial are:
1. Overall symptom burden/distress in the last 7 days of life, measured using the Family MSAS-GDI
A either after the patient’s death or amended for use on a daily basis
2. Quality of life of carers, incorporating elements of control and self-efficacy, measured using QOLLTI-F by a research nurse every 48 hours

Secondary outcome measures

Time to symptom relief, calculated using data items from the Carer Diary, collected from the carer after the patient has died

Overall trial start date

01/11/2016

Overall trial end date

01/05/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Dyads of dying patients and their home-based carers
2. Adult patients in the last weeks of life
3. Who are likely to use the oral route for medication
4. Have expressed a preference to die at home
5. Have a family carer who is over 18
6. Carer is willing to have this extended role
7. Carer is willing to have subcutaneous injection training

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

Randomise 100 dyads, analyze full data for 50 dyads (25 per arm)

Participant exclusion criteria

1. Patient or carer is under 18
2. Patient or carer not willing to entertain concept of lay carer administering subcutaneous medication
3. Patient or carer has a known history of substance abuse
4. Patient has had previous known adverse reactions to substance meds
5. Clinician judges that risk assessment criteria are not met for a dyad

Recruitment start date

01/06/2018

Recruitment end date

01/06/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

North Wales Centre for Primary Care Research
Bangor University
LL13 7YP
United Kingdom

Trial participating centre

Marie Curie Palliative Care Research Centre
CF14 4YS
United Kingdom

Trial participating centre

Sue Ryder Hospice Gloucestershire
GL53 OQJ
United Kingdom

Sponsor information

Organisation

Bangor University

Sponsor details

School of Healthcare Sciences
Bangor University
Bangor
LL57 2EF
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The protocol and results from this trial will be widely disseminated. In addition to peer-reviewed publication, a wide dissemination plan will be developed across primary care networks and palliative care networks, so that teams looking after the dying in home settings can be fully informed about the results. Should the intervention prove favourable, the methods and results will be disseminated using a broad implementation plan and utilizing a creative commons license for all materials generated.

IPD sharing plan
The datasets generated and/or analysed during the current study are available from Clare Wilkinson and Marlise Poolman on reasonable request.

Intention to publish date

01/11/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes