Ignite Creation Date:
2024-05-06 @ 6:42 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05753072
Status:
COMPLETED
Last Update Posted:
2024-01-23
First Post:
2023-02-08
Brief Title:
Value and Impact of a Carer Support Nurse
Sponsor:
University of East Anglia
Organization:
University of East Anglia
Study Overview
Official Title:
Value and Impact of a Stakeholder-operationalised Carer Support Nurse Role and Feasibility of a Future Wider Implementation Study
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Families and friends play a crucial role supporting people they care for as their unpaid carers However they are not always well prepared for this and it can damage their own health and wellbeing This can impact their ability to keep caring Carers often lack time to look after themselves putting their own needs last These needs tend to be hidden until crises Carers need support to 1 look after their own health and wellbeing and 2 boost their skills and confidence to care Healthcare policy says this should happen but healthcare professionals can find this difficult alongside supporting the patient
To address this we have worked with carers health and social care professionals voluntary organisations and national leaders in carer support to develop a new Carer Support Nurse role This role is designed to help carers who have their own needs or who need extra support for their caring role that cannot be met by their usual healthcare team The nurse will also work with other healthcare providers to raise their awareness of carer needs and how to support them
The Carer Support Nurse is now in post This study explores the roles value and impact by analysing data on 1 what the nurse does and 2 the views of carers patients health and social care professionals voluntary organisations and the nurse themself This will involve collecting data from 1 the nurse through a weekly diary and monthly interviews 2 carers who have had contact with the nurse through a survey and interviews 3 patients these carers support through interviews and 4 health and social care professionals and voluntary organisations through interviews and focus groups It will also develop recommendations for whether and how the role could be introduced more widely and the design of a future multi-site study
To address this we have worked with carers health and social care professionals voluntary organisations and national leaders in carer support to develop a new Carer Support Nurse role This role is designed to help carers who have their own needs or who need extra support for their caring role that cannot be met by their usual healthcare team The nurse will also work with other healthcare providers to raise their awareness of carer needs and how to support them
The Carer Support Nurse is now in post This study explores the roles value and impact by analysing data on 1 what the nurse does and 2 the views of carers patients health and social care professionals voluntary organisations and the nurse themself This will involve collecting data from 1 the nurse through a weekly diary and monthly interviews 2 carers who have had contact with the nurse through a survey and interviews 3 patients these carers support through interviews and 4 health and social care professionals and voluntary organisations through interviews and focus groups It will also develop recommendations for whether and how the role could be introduced more widely and the design of a future multi-site study
Detailed Description:
Five-task study using qualitative and quantitative data to answer its research questions Sample sizes are indicators rather than target sample sizes
TASK 1 Carer Support Nurse role data capture
The Carer Support Nurse CSN will receive a recruitment pack comprising an invitation letter participant information sheet and with reply by email The CSN job description informed applicants of the research being conducted alongside the role and it was discussed at interview The CSN will therefore expect to receive the recruitment pack and will have an opportunity to ask further questions before informed consent is taken
Once consented the CSN will complete a very brief templated Weekly Reflective Diary Gabbay 2003 what was done what worked what didnt and CSNAT-I Activity Template anonymised group-level data on carer needs identified and types of actions taken no namesidentifiers included Monthly data-generating meetings informed by the data collected weekly will monitor how the role is working and identifyaddress any emerging barriers to the role Additionally an adapted version of a tool designed to capture the activities the nurse is carrying out within the role will be used the Cassandra tool httpswwwapollonursingresourcecomshowing-how-i-spend-my-timecassandra-app and costs Data collected through these monthly meetings will include
referral sources including repeat referrals
CSNs use of time eg working hours activities with carers activities not directly with carers
delivery of five Evidence-based Design Principles for the role or whether these had to be modified
types of actions taken in response to carers needs
potential impacts costsbenefits on the CSN carers patients or other services
This will provide evidence on the value and cost of the role and help commissioners understand what activities are undertaken to achieve the roles outcomes and how complex the CSNs work is The monthly meetings will not be audio-recorded but notes will be taken onto a template method used successfully previously The activities the nurse carries out within the role eg types of interventions for whom where will be compared with an established dataset of activities usually carried out by other specialist nursing roles Punshon et al 2019 to inform how the role is working
Each month anonymised group-level data will be provided by the site aggregated data at a group or system level rather than for individual carers eg number of carers seen by the CSN number of repeat contacts This will inform the design of a future multi-site study eg population description carer needs identified actions taken to meet needs costs capacity cost-per-carer
Task 1 will run in parallel with Task 2 below
TASK 2 Carer outcomes and experiences of carers and patients
Once the CSN is established in the post with a working caseload estimated three months into post carers who have had contact with the nurse will be invited to participate in the study It is estimated that the nurse will see about 120 carers during the planned 6-month data collection period for this task Carer baseline and outcome data will be collected from adult carers who have contact with the nurse through a baseline and follow up postal survey and interviews with a sub-sample of carers Patients will also be invited to be interviewed
The CSN will provide carers who fit the study inclusionexclusion criteria with a recruitment pack for the study It will include an invitation letter participant information sheet consent form and baseline Carer Postal Survey Booklet The participant information sheet will include contact details for the research team should the carer have any questions The invitation letter and participant information sheet will invite carers to complete the baseline survey a follow up survey and potentially be contacted for interview Those carers willing to receive a follow-up survey andor potentially be contacted for interview will provide their contact details on a reply form Carers may opt not to complete the follow-up survey but still to take part in the interview The recruitment pack was developed with our Carer PPI group
The Baseline Carer Postal Survey Booklet reviewed by our Carer PPI group includes six items
Item 1 Preparedness for Caregiving Scale 8 items Archbold et al 1990
Item 2 Warwick-Edinburgh Mental Wellbeing Scale 7 items Stewart-Brown 2009 httpswarwickacukfacscimedresearchplatformwemwbsabout
Item 3 EQ-5D-5L 6 item health status questionnaire Feng et al 2021 httpseuroqolorgeq-5d-instrumentseq-5d-5l-about
Item 4 resource use questions in last 6 weeks eg primary care secondary care social care respite care
Item 5 contact with the CSN as could occur and planned appointments
Item 6 background questions age sex ethnic group number of people carer is supporting living situation ie with patientsdistance from patients relationship to patients patientss primary diagnosis caregiving hours employment status funding status receipt of funded care The Follow-up Carer Postal Survey Booklet will be sent to consenters approximately six weeks from the carers first contact with the CSN It will include items 1-5 only not 6
Interviews with a sub-sample of carers and the patients they support who have received the CSN intervention will explore their experiences of the CSN ideally within two weeks of their main CSN contact about 12 carers will be sought in order to provide enough data - known as information power Malterud et al 2016 Purposive sampling will seek as much variation in this sub-sample as possible in relation to carer sex age and ethnic group Data on the timing of interviews in relation to the carers contacts with the nurse will be collected to inform the design of a future multi-site study Carers who earlier agreed to be contacted for interview and who meet the purposive sampling criteria will be contacted by letter email or phone depending on their indicated preference to invite them to be interviewed
These carers will also be asked if the research team can send them an additional recruitment pack for the patient they support inviting the patient to also be interviewed separately If the contact with the carer about the interview is by letter then the patient recruitment pack will be included with it to optionally share with the patient if the contact with the carer is by email or phone the patient recruitment pack will be sent to the carer to share with the patient if the carer agrees The patient recruitment pack will include an invitation letter participant information sheet with reply-options by email post or at the end or the start of the carer interview if they live in the same household
Carers and patients will be able to ask any questions before informed consent is taken online by email or by post The topic-guided interviews will be conducted online or by phone They will be audio-recorded with permission then transcribed by a professional transcription company The research team will then anonymise them and analyse the anonymised transcripts using a method called framework analysis Ritchie et al 2003 The carer interview topic guide will cover their caring role support they may have had before contact with the CSN their contact with the CSN and what was helpful or unhelpful about it The patient interview topic guide will explore whether patients felt the CSN was helpful or if anything was unhelpful and any impact it has had on them as the patient The interviews will also help inform the design of a future multi-site study
TASK 3 Experiences and impacts from the viewpoint of the CSN and colleagues from different sectors
End of study interviews with the CSN and their line manager interviewed separately and focus groups with key colleagues from different sectors health social care and the voluntary sector will explore
the role experiences of delivering it or working alongside it
role activity eg activities with carers activities not directly with carers activities with colleagues
whether the CSN delivered the five Evidence-based Design Principles or whether they were modified and how and the impact of this
perceived impacts positivenegative
mechanisms of action how the role worked
barriers enablers and strategies influencing implementation of the role
learnings for the design of a future multi-site study
The line manager interview and cross-sector colleague focus groups will additionally explore
impacts on own or team members awareness of attitudes to and engagement with carers subsequent to the CSN starting in post
For Task 3 the CSN will already have been recruited at Task 1 The CSNs line manager will be invited to take part in Task 3 via an emailed recruitment pack from the study team The line manager is already in contact with the research team The recruitment pack will include an invitation letter and participant information sheet with reply by email directly back to the study team They will have an opportunity to ask any questions before informed consent is taken in person or online depending on interview mode The interviews will be topic guided and audio-recorded with permission and will either be conducted in person online or by phone
The focus groups two in total to enable people to take part but they will only attend one of them will involve health social and voluntary sector working partners up to nine participants in total across the two groups These key cross-sector colleagues will be identified first from the CSNs role activity in the preceding months and secondly through other stakeholders consulted during study work-up from across health settings social care voluntary sector and HealthWatch if needed to ensure representation of each sector These cross-sector colleagues will be invited to participate via an emailed recruitment pack an invitation letter participant information sheet with reply by email They will have an opportunity to ask any questions before informed consent is taken online or by email The focus groups will be topic guided and audio-recorded with permission and conducted online
The interview and focus group audio-recordings will be transcribed anonymised then analysed using framework analysis Ritchie et al 2003
TASK 4 Establishing mechanisms of action and effect and recommendations
The core team our Carer PPI group and Project Advisory Group will bring together the findings of Task 1-3 to explore whether and how the role worked The findings will also inform any suggestions for improving the CSN role going forward We will then work together to develop recommendations on whether and how to keep the role going and introduce it elsewhere This will also inform the design of a future multi-site study
FUTURE WORK
If the CSN role shows promise funding will be sought to further develop and evaluate the role in a future multi-site study informed by the feasibility data gathered
TASK 1 Carer Support Nurse role data capture
The Carer Support Nurse CSN will receive a recruitment pack comprising an invitation letter participant information sheet and with reply by email The CSN job description informed applicants of the research being conducted alongside the role and it was discussed at interview The CSN will therefore expect to receive the recruitment pack and will have an opportunity to ask further questions before informed consent is taken
Once consented the CSN will complete a very brief templated Weekly Reflective Diary Gabbay 2003 what was done what worked what didnt and CSNAT-I Activity Template anonymised group-level data on carer needs identified and types of actions taken no namesidentifiers included Monthly data-generating meetings informed by the data collected weekly will monitor how the role is working and identifyaddress any emerging barriers to the role Additionally an adapted version of a tool designed to capture the activities the nurse is carrying out within the role will be used the Cassandra tool httpswwwapollonursingresourcecomshowing-how-i-spend-my-timecassandra-app and costs Data collected through these monthly meetings will include
referral sources including repeat referrals
CSNs use of time eg working hours activities with carers activities not directly with carers
delivery of five Evidence-based Design Principles for the role or whether these had to be modified
types of actions taken in response to carers needs
potential impacts costsbenefits on the CSN carers patients or other services
This will provide evidence on the value and cost of the role and help commissioners understand what activities are undertaken to achieve the roles outcomes and how complex the CSNs work is The monthly meetings will not be audio-recorded but notes will be taken onto a template method used successfully previously The activities the nurse carries out within the role eg types of interventions for whom where will be compared with an established dataset of activities usually carried out by other specialist nursing roles Punshon et al 2019 to inform how the role is working
Each month anonymised group-level data will be provided by the site aggregated data at a group or system level rather than for individual carers eg number of carers seen by the CSN number of repeat contacts This will inform the design of a future multi-site study eg population description carer needs identified actions taken to meet needs costs capacity cost-per-carer
Task 1 will run in parallel with Task 2 below
TASK 2 Carer outcomes and experiences of carers and patients
Once the CSN is established in the post with a working caseload estimated three months into post carers who have had contact with the nurse will be invited to participate in the study It is estimated that the nurse will see about 120 carers during the planned 6-month data collection period for this task Carer baseline and outcome data will be collected from adult carers who have contact with the nurse through a baseline and follow up postal survey and interviews with a sub-sample of carers Patients will also be invited to be interviewed
The CSN will provide carers who fit the study inclusionexclusion criteria with a recruitment pack for the study It will include an invitation letter participant information sheet consent form and baseline Carer Postal Survey Booklet The participant information sheet will include contact details for the research team should the carer have any questions The invitation letter and participant information sheet will invite carers to complete the baseline survey a follow up survey and potentially be contacted for interview Those carers willing to receive a follow-up survey andor potentially be contacted for interview will provide their contact details on a reply form Carers may opt not to complete the follow-up survey but still to take part in the interview The recruitment pack was developed with our Carer PPI group
The Baseline Carer Postal Survey Booklet reviewed by our Carer PPI group includes six items
Item 1 Preparedness for Caregiving Scale 8 items Archbold et al 1990
Item 2 Warwick-Edinburgh Mental Wellbeing Scale 7 items Stewart-Brown 2009 httpswarwickacukfacscimedresearchplatformwemwbsabout
Item 3 EQ-5D-5L 6 item health status questionnaire Feng et al 2021 httpseuroqolorgeq-5d-instrumentseq-5d-5l-about
Item 4 resource use questions in last 6 weeks eg primary care secondary care social care respite care
Item 5 contact with the CSN as could occur and planned appointments
Item 6 background questions age sex ethnic group number of people carer is supporting living situation ie with patientsdistance from patients relationship to patients patientss primary diagnosis caregiving hours employment status funding status receipt of funded care The Follow-up Carer Postal Survey Booklet will be sent to consenters approximately six weeks from the carers first contact with the CSN It will include items 1-5 only not 6
Interviews with a sub-sample of carers and the patients they support who have received the CSN intervention will explore their experiences of the CSN ideally within two weeks of their main CSN contact about 12 carers will be sought in order to provide enough data - known as information power Malterud et al 2016 Purposive sampling will seek as much variation in this sub-sample as possible in relation to carer sex age and ethnic group Data on the timing of interviews in relation to the carers contacts with the nurse will be collected to inform the design of a future multi-site study Carers who earlier agreed to be contacted for interview and who meet the purposive sampling criteria will be contacted by letter email or phone depending on their indicated preference to invite them to be interviewed
These carers will also be asked if the research team can send them an additional recruitment pack for the patient they support inviting the patient to also be interviewed separately If the contact with the carer about the interview is by letter then the patient recruitment pack will be included with it to optionally share with the patient if the contact with the carer is by email or phone the patient recruitment pack will be sent to the carer to share with the patient if the carer agrees The patient recruitment pack will include an invitation letter participant information sheet with reply-options by email post or at the end or the start of the carer interview if they live in the same household
Carers and patients will be able to ask any questions before informed consent is taken online by email or by post The topic-guided interviews will be conducted online or by phone They will be audio-recorded with permission then transcribed by a professional transcription company The research team will then anonymise them and analyse the anonymised transcripts using a method called framework analysis Ritchie et al 2003 The carer interview topic guide will cover their caring role support they may have had before contact with the CSN their contact with the CSN and what was helpful or unhelpful about it The patient interview topic guide will explore whether patients felt the CSN was helpful or if anything was unhelpful and any impact it has had on them as the patient The interviews will also help inform the design of a future multi-site study
TASK 3 Experiences and impacts from the viewpoint of the CSN and colleagues from different sectors
End of study interviews with the CSN and their line manager interviewed separately and focus groups with key colleagues from different sectors health social care and the voluntary sector will explore
the role experiences of delivering it or working alongside it
role activity eg activities with carers activities not directly with carers activities with colleagues
whether the CSN delivered the five Evidence-based Design Principles or whether they were modified and how and the impact of this
perceived impacts positivenegative
mechanisms of action how the role worked
barriers enablers and strategies influencing implementation of the role
learnings for the design of a future multi-site study
The line manager interview and cross-sector colleague focus groups will additionally explore
impacts on own or team members awareness of attitudes to and engagement with carers subsequent to the CSN starting in post
For Task 3 the CSN will already have been recruited at Task 1 The CSNs line manager will be invited to take part in Task 3 via an emailed recruitment pack from the study team The line manager is already in contact with the research team The recruitment pack will include an invitation letter and participant information sheet with reply by email directly back to the study team They will have an opportunity to ask any questions before informed consent is taken in person or online depending on interview mode The interviews will be topic guided and audio-recorded with permission and will either be conducted in person online or by phone
The focus groups two in total to enable people to take part but they will only attend one of them will involve health social and voluntary sector working partners up to nine participants in total across the two groups These key cross-sector colleagues will be identified first from the CSNs role activity in the preceding months and secondly through other stakeholders consulted during study work-up from across health settings social care voluntary sector and HealthWatch if needed to ensure representation of each sector These cross-sector colleagues will be invited to participate via an emailed recruitment pack an invitation letter participant information sheet with reply by email They will have an opportunity to ask any questions before informed consent is taken online or by email The focus groups will be topic guided and audio-recorded with permission and conducted online
The interview and focus group audio-recordings will be transcribed anonymised then analysed using framework analysis Ritchie et al 2003
TASK 4 Establishing mechanisms of action and effect and recommendations
The core team our Carer PPI group and Project Advisory Group will bring together the findings of Task 1-3 to explore whether and how the role worked The findings will also inform any suggestions for improving the CSN role going forward We will then work together to develop recommendations on whether and how to keep the role going and introduce it elsewhere This will also inform the design of a future multi-site study
FUTURE WORK
If the CSN role shows promise funding will be sought to further develop and evaluate the role in a future multi-site study informed by the feasibility data gathered
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None