Condition category
Not Applicable
Date applied
03/06/2020
Date assigned
29/06/2020
Last edited
29/06/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
When people cannot get from one place to another by themselves, such as moving from their bed into a chair, they need help from another person and/or equipment. If equipment such as a mobile hoist is used within the home, or the moving procedure is complicated, 'double-hande'’ care is usually provided with two care workers attending every visit. Such care arrangements may start after an event such as a crisis at home or a hospital discharge and often stay in place for the long-term. Some local authorities are specifically undertaking assessments of an individuals’ care provision if it involves double-handed care. The aim is to assess whether two care workers are needed on a continuing basis or whether additional equipment might allow a single care worker to do the work instead of two.

There is limited research on the experiences of people receiving double-handed homecare or the review processes of such care. There is also limited research on the outcomes that are important to service users, their families and homecare workers. There is also widespread variation in whether authorities are reviewing double-handed homecare and how they are doing it.

We want to understand the things that the people involved in the reviews of double-handed homecare (whether receiving or delivering) believe should be included in those reviews, and to subsequently come up with a way of making those reviews better. Specifically, we want to:

1. Find out about the practices and procedures that local authorities in England currently use in reviewing double-handed homecare (or even if they even do such reviews at all).
2. Find out about the experiences, processes, facilitators and barriers for those delivering and receiving double-handed homecare and the reviews of it.
3. Produce recommendations for how double-handed homecare reviews are performed and then test these recommendations in practice.

Who can participate?
To find out about how local authorities in England currently review double-handed homecare, we aim to involve all 151 local authorities in England with social care responsibilities as participants.
To find out about the experiences, processes, facilitators and barriers for those delivering and receiving double-handed homecare and the reviews of it, we aim to involve 10-15 service users, 10-15 family members, 10-15 local authority reviewers, and 10-15 homecare workers as participants.
To test the recommendations for how double-handed homecare reviews are performed we aim to involve 10 service users, and an unspecified number of homecare workers and reviewing staff.
Finally, whilst not regarded as ‘participants’, we will also involve service users, family members, homecare workers, and practitioners in guiding the research process as part of a ‘working group’ that will meet periodically.

What does the study involve?
The first stage of the research process will involve sending an invite to local authorities for them to complete an online questionnaire that will gather information about practices and processes for double-handed homecare reviews within their local authority area.
The second stage will involve interviewing service users, family members, local authority reviewers, and homecare workers to find out about the experiences, processes, facilitators and barriers for those delivering and receiving double-handed homecare and the reviews of it.
The third stage will firstly involve the ‘working group’ assessing the research from the first two stages to identify and prioritise the aspects of the process that are important. These recommendations will then be tested within two local authority areas, involving feedback from people receiving the new reviews and the staff who carried them out. This will involve taking measurements of service users’ quality of life and independence before and after the new review process, interviews with service users, homecare workers, and reviewing staff, and through examining documents completed by reviewing staff and homecare workers about the new process.

What are the possible benefits and risks of participating?
There may be no direct benefit to participants, though we hope that any new recommendations for double-handed homecare reviews subsequently adopted by local authorities will improve the process for all those involved.
There is a possibility that some interview participants may find some of the topics discussed sensitive, embarrassing, or even upsetting. These topics will be discussed sensitively and in line with good research interview practice.
In testing the recommendations in the form of new review processes (the third stage of the study), participants will be monitored to ensure no harm or disadvantage occurs.

Where is the study run from?
The study is being run from Northumbria University, but the research team involves partners from Nottingham City Council, Sunderland City Council, and the Elders Council of Newcastle.

When is the study starting and how long is it expected to run for?
The study started in October 2019 and is expected to run until February 2022.

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

Who is the main contact?
Dr Phillip Whitehead, phillip.whitehead@northumbria.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Phillip Whitehead

ORCID ID

http://orcid.org/0000-0003-1310-4020

Contact details

Room B018
Coach Lane Campus
Northumbria University
Newcastle upon Tyne
NE7 7XA
United Kingdom
+44 (0)191 215 6564
phillip.whitehead@northumbria.ac.uk

Type

Scientific

Additional contact

Dr Leigh Rooney

ORCID ID

Contact details

Room G210
Coach Lane Campus
Northumbria University
Newcastle upon Tyne
NE7 7XA
United Kingdom
+44 (0)191 215 6327
leigh.rooney@northumbria.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 44580

Study information

Scientific title

Co-production of best practice recommendations for local authority reviews of double-handed homecare packages

Acronym

Study hypothesis

The purpose of this study is to co-produce best-practice recommendations for local authority reviews of double handed homecare packages. The aim is to produce the recommendations collaboratively with a range of key stakeholders (through an operational "working group") based upon evidence from current practices and procedures and exploration of the experiences and views of practitioners, people accessing services and their families.

Ethics approval

Approved 05/08/2019, Coventry and Warwick NRES Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)207 104 8009; coventryandwarwick.rec@hra.nhs.uk), ref: 19/WM/0224

Study design

MIxed methods

Primary study design

Observational

Secondary study design

Mixed methods assessment

Trial setting

Community

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Homecare practices

Intervention

Work Package 1 (WP1). We will carry out a national survey of all local authorities with social care responsibilities in England in order to identify, describe and evaluate current review processes and practices for double-handed homecare reviews.

Each local authority in England with social care responsibilities (n=151) will receive an email with a link to complete an electronic questionnaire. The questionnaire will gather information about practices and processes for double handed homecare reviews within that local authority area.

Work Package 2 (WP2). We will carry out interviews with people receiving on-going double-handed homecare packages and/or reviews (n=10-15) and their family members (n=10-15), reviewers of care packages (n=10-15) and homecare workers (n=10-15) in order to explore stakeholder views and experiences, facilitators and barriers.

Service user and family members who have received a double handed homecare review will be recruited from two local authority areas. Reviewing staff and homecare workers will be recruited from these areas. Each participant in the interview will take part in one interview.

Work Package 3 (WP3). We will use a nominal group technique with our working group in order to identify and prioritise aspects of good practice based on the findings from work packages 1 and 2. We will then co-develop recommendations for double-handed homecare reviews and test these in an iterative process including feedback from service users and staff.

Our working group will consist of recipients of double-handed homecare packages, their family members, social care practitioners and homecare workers. They will be involved throughout the study with particular input into the nominal group technique to identify the top priorities for 'best practice' reviews based on the findings from WP1 & WP2.

Feasibility Study - Part 1
Service users referred for double handed-homecare reviews will be screened consecutively at each of our sites and those who meet the eligibility criteria will be approached. Eligibility criteria are: a.) referral for first time review of double-handed care package and b.) capacity to provide informed consent. Exclusion criteria are: a.) being on an end-of life care pathway. Although this may be an important social-care intervention for service users who lack mental capacity, in this phase our purpose is to obtain feedback from people with experience in order to further shape and refine the recommendations and implementation process; we envisage that people who lack capacity would be involved in future research. Where the service user has a carer (friend or family member providing support) we will also approach the carer for informed consent. Recruitment will cease when five participants have been recruited at each site. Following consent, baseline measures will be completed prior to the double-handed homecare review. These will be repeated four weeks after the review process. We will collect measures of health and social care related quality of life (Adult Social Care Outcomes Toolkit (ASCOT); EuroQol EQ-5D-5L and independence in personal activities of daily living (Barthel Index)). These measures will be analysed using descriptive statistics in order to describe the characteristics of our sample. We will not conduct any inferential or before and-after analysis as this is not appropriate for feasibility work.

At the follow-up, participants (service users and carers) will also take part in informal qualitative interviews with our lead practitioners at site. They will use an adapted topic guide from WP2. The interviews will be informed by the framework developed in WP2 in order to facilitate the identification of similarities and differences in experiences of the review process following the implementation of the ‘best practice’ recommendations. The interviews will be targeted specifically on feedback from the review process in order to identify “what worked well” and “what didn’t work so well”. Findings will be linked to the findings from work package two we will seek direct feedback on those aspects which we aimed to alter seek views on whether and how this is working. We will also focus the interview on user and family perspectives on outcomes following the review process.

Reviewing staff and homecare workers will complete a purposely designed pro forma and a checklist after each double-handed homecare review which will detail the content of the review. The pro forma will include a freetext section for staff to record their comments on the updated review process including facilitators and barriers to delivery. To supplement the information recorded on the pro formas, our lead practitioners at site will conduct informal debriefing sessions with the staff involved in delivering the best practice reviews in order to explore and clarify any issues recorded on the pro formas.

Review of Recommendations
After five participants have been recruited at each site the working group will convene and determine whether any further alterations to the recommendations are required.

Feasibility Study - Part 2
In Part 2, the feasibility testing will continue with the updated recommendations and a further five participants will be recruited from each site, using the same procedure as in Part 1.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Work package 1: Processes and practices for double-handed homecare packages currently undertaken by local authorities with social care responsibilities in England, measured using a questionnaire at a single time point
Work package 2: Service user and practitioner experiences of double-handed homecare packages and local authority reviews of double-handed homecare packages, using qualitative interviews at a single time point
Work package 3:
3.1. Service user quality of life using the Adult Social Care Outcomes Toolkit (ASCOT) and EuroQol EQ-5D-5L at baseline and 4 weeks
3.2. Service user independence in personal activities of daily living using the Barthel Index at baseline and 4 weeks
3.3. Service user, homecare worker, and reviewing staff experiences of the updated review process using informal qualitative interviews at a single time point
3.4. Staff and homecare workers’ details of practice and experience using a purposely designed pro forma and a checklist at a single time point

Secondary outcome measures

There are no secondary outcome measures.

Overall trial start date

01/01/2019

Overall trial end date

01/02/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Survey: Local authority in England with social care responsibilities
2. Qualitative study: Service user, family member, social care professional or homecare worker with experience of double handed homecare review within previous six months
3. Feasibility study: Service user with double-handed homecare package about to undergo review; able to provide informed consent

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

Planned Sample Size: 232; UK Sample Size: 232

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/01/2020

Recruitment end date

01/11/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Northumbria University
Newcastle upon Tyne
NE7 7XA
United Kingdom

Sponsor information

Organisation

Northumbria University

Sponsor details

Pandon Building
Camden Street
Newcastle upon Tyne
NE2 1XE
United Kingdom
+44 (0)1912274257
laura.hutchinson2@northumbria.ac.uk

Sponsor type

University/education

Website

https://www.northumbria.ac.uk/

Funders

Funder type

Government

Funder name

NIHR Central Commissioning Facility (CCF); Grant Codes: NIHR200040

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Institute for Health Research (NIHR) (UK)

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

We will produce the following outputs:
• An NIHR report
• Best practice recommendations (synthesised findings from all three work packages) in the format of a protocol
• Academic papers for the survey, qualitative interviews with stakeholders, and development of the recommendations in high impact journals which will be made freely available via open access or the Northumbria University repository
• Presentations at a range of national and international conferences
• A key findings 'infographic' for older and disabled people, their families and carers
• A Plain English Policy & Practice Briefing explaining the findings to be widely disseminated through the research team’s extensive networks

It is intended that publications will be made throughout the research period as the various stages of the research reach maturity, as well as within around one year of the trial end date, but no firm dates have been established.

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

Intention to publish date

01/02/2023

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

03/06/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR)