Caring for the dying at home: can lay carers safely give extra, as-needed, ... | Recruiting
Caring for the dying at home: can l... | Recruiting
Caring for the dying at home: can lay carers safely give extra, as-needed, symptom control to their loved ones using injections under the skin?
CARIAD

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Medical Conditions
  • End of life care
Primary Contact Details
Prof Clare Wilkinson
See all trial contact details
Recruitment Status
Recruiting
Trial source and source ID number
ISRCTN11211024
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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)
Research Details
  • Carer-administration of as-needed subcutaneous medication for breakthrough symptoms in home-based dying patients is feasible and acceptable in the UK.
Phase
Sorry, this information is not available
Study Design
Developmental work, including qualitative work, followed by a pragmatic, multi-centre, randomised feasibility trial
Study Type
Interventional
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
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
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Adult
Who Can Participate
Mixed
Number of Participants
Randomise 100 dyads, analyze full data for 50 dyads (25 per arm)
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 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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Bangor University
Wrexham
LL13 7YP
Cardiff
CF14 4YS
Cheltenham
GL53 OQJ
Trial Contact(s)
Primary Trial Contact
Prof Clare Wilkinson
Other Trial Contacts
Dr Marlise Poolman
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Carer administration of as-needed subcutaneous medication for breakthrough symptoms in home-based dying patients: a UK study (CARIAD)
EudraCT Number
Sorry, this information is not available
Funder(s)
  • Health Technology Assessment Programme
Other Study ID Numbers
HTA 15/10/37
Sponsor(s)
Bangor University
Key Dates

Recruitment Start Date

01 Jan 2018

Recruitment End Date

01 Jun 2019

Trial Start Date

01 Nov 2016

Trial End Date

01 May 2019

Date added to source

27 Sep 2016

Date updated in source

27 Mar 2018