Plain English Summary
Background and study aims
Most people prefer to be cared for and to die in the familiar surroundings of their own home. Being able to make this choice very much depends on the efforts of family carers. While taking on a caring role is normally done willingly, it can result in considerable burden and negative effects on carers health. Therefore it is important to ensure that carers are well supported to enable them to look after patients at home while also maintaining their own health and wellbeing. So far health professionals have had no clear guidelines to help them ensure that they assess and address carer support needs regularly and in detail. So we developed a simple assessment form, the Carer Support Needs Assessment Tool (CSNAT), based on what carers told us their main support needs were in end of life home care. The procedures for CSNAT assessment, prioritisation and follow-up together form the CSNAT intervention. The aim of the study is to find out whether the using the CSNAT intervention with carers during care giving makes a difference to carer outcomes in bereavement.
Who can participate?
All adult carers of patients looked after by the hospice home care (HHC) services can take part in the study.
What does the study involve?
We will ask six HHC services to use the CSNAT intervention with carers of patients under their care. We will then compare bereavement outcomes for carers who had usual care with those who had the intervention. The HHC services will start using the CSNAT at three month intervals so we can make a comparison between services who have started the intervention with those who have not, and also make a comparison before and after the start of the intervention within each service. We will measure outcomes using a postal survey of carers 4-5 months after bereavement. To reduce any potential risks, HHC will exclude carers that are believed to suffer particularly complicated grief in bereavement, and contact details to HHC bereavement support will be provided. The study will also ask the views of the HHC nurses and some of the carers who had the intervention on what made the intervention successful or not so successful. Finally, we will look at HHC CSNAT records to see whether some factors, such as how often assessments were done, seem to make a difference.
What are the possible benefits and risks of participating?
Participants in the CSNAT intervention group may receive better support during care giving and experience better health, well being and lower levels of grief in bereavement.
Where is the study run from?
University of Manchester (UK).
When is the study starting and how long is it expected to run for?
The study started in May 2012 and will run for 2 years.
Who is funding the study?
National Institute for Health Research (NIHR) (UK).
Who is the main contact?
Gunn Grande
gunn.grande@manchester.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Gunn Grande
ORCID ID
Contact details
School of Nursing
Midwifery and Social Work
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 161 306 7695
gunn.grande@manchester.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
12422
Study information
Scientific title
A randomised trial to evaluate the impact of a Carer Support Needs Assessment Tool (CSNAT) intervention in hospice home care
Acronym
CSNAT
Study hypothesis
To test whether a formalised, comprehensive procedure for carer support needs assessment, prioritisation and follow up (CSNAT intervention) improves quality of care and carer outcomes in end of life home care, compared to usual care.
Ethics approval
NRES Committee North West - Greater Manchester East, 23/03/2012, ref: 12/NW/0206
Study design
Stepped wedge cluster randomised trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Primary Care Research Network for England, Generic Health Relevance and Cross Cutting Themes; Subtopic: Not Assigned, Generic Health Relevance (all Subtopics); Disease: All Diseases, Health Services Research
Intervention
CSNAT, Formalised, comprehensive procedure for carer support needs assessment, prioritisation and follow up using the Carer Support Needs Assessment Tool (CSNAT)
Control, informal carer assessment as usual
Follow Up Length: 5 month(s)
Intervention type
Other
Phase
Phase II/III
Drug names
Primary outcome measures
SF-12 4-5 months post bereavement
Secondary outcome measures
1. Quality of care; Timepoint(s): 4-5 months post bereavement
2. Patient's place of death; Timepoint(s): Date of death
3. Texas Revised Inventory of Grief; Timepoint(s): 4-5 months post bereavement
Overall trial start date
21/09/2012
Overall trial end date
31/12/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. The main bereaved carer of patients who have been supported by participating hospice home care services (HHCs)
2. Target Gender: Male & Female ; Lower Age Limit 18 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 1003; UK Sample Size: 1003
Participant exclusion criteria
1. Age <18 years
2. Identified by HHCs as experiencing particularly complicated grief in bereavement
Recruitment start date
21/09/2012
Recruitment end date
31/12/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Nursing, Midwifery and Social Work
Manchester
M13 9PL
United Kingdom
Sponsor information
Organisation
University of Manchester (UK)
Sponsor details
c/o Samantha Wade
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 208 843 8054
Samantha.Wade@nihr-ccf.org.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Central commissioning facility (CCF); Grant Codes: PB-PG-0610-22291
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary