Condition category
Not Applicable
Date applied
04/03/2019
Date assigned
21/03/2019
Last edited
21/03/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Hospital patients receive care and support to meet personal care needs (taking on enough fluids, skin care, toileting, keeping active and eating healthily). This is called ‘fundamental care’. Sometimes patients feel this care doesn’t take their needs into account and they don’t feel involved. When the researchers asked a range of patients, carers and members of the public about fundamental care, they said that making it more personalised and involving patients was crucial. However, research into making care more personalised shows patients can worry about seeming ‘difficult’ when asking for what they want.

Who can participate?
Patients aged 18 and over and nurses and care assistants working on participating wards

What does the study involve?
The study uses three things together that have worked separately in previous research to see if they can improve the personal care people receive in hospital: training for teams of nurses on hospital wards, a feedback card for patients to record what is important about their care, a tool to help patients understand and choose the care that is best for them. The study focuses on bedsores as a proxy for meeting a range of fundamental care needs. Care is compared between wards where this work is done (intervention wards) with wards where this work is not done (control wards). To test what difference these ideas make to patient care in the hospital wards, the researchers:
1. Ask patients and staff on the wards to complete surveys and participate in interviews
2. Watch how staff support patients and take notes
3. Collect documents like meeting notes and forms
4. Use information already collected by the ward about patient care
The researchers collect the following information before and after they use the new tools and way of working:
1. Quality of staff support for patients
2. Whether care is thought to be personalised
3. Patient and carer satisfaction with care, bedsore development, and development of other complications like falls and infections where good records are available.

What are the possible benefits and risks of participating?
The results from this study will be used to help plan a larger test of working in this way.

Where is the study run from?
1. Southampton General Hospital (lead site) (UK)
2. Queen Alexander Hospital (UK)

When is the study starting and how long is it expected to run for?
September 2017 to August 2018

Who is funding the study?
National Institute for Health Research (NIHR) Collaborations for Leadership in Applied Health Research and Care (CLAHRC) Wessex (UK)

Who is the main contact?
Dr Jo Hope
j.l.hope@soton.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lisa Gould

ORCID ID

http://orcid.org/0000-0002-4334-8061

Contact details

Office 3029
Building 67
Highfield Campus
University of Southampton
Southampton
SO17 1BJ
United Kingdom
+44 (0)2380 597590
l.j.gould@soton.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

33268

Study information

Scientific title

Assessing the feasibility and acceptability of a combined intervention to increase the delivery of patient-centred multiple fundamental care activities on adult wards in acute hospitals, specifically those related to pressure ulcer prevention (hydration, nutrition, mobility, continence and skin care)

Acronym

IFCH

Study hypothesis

This study aims to assess the feasibility and acceptability of a combined intervention to increase the delivery of patient-centred multiple fundamental care activities, specifically those related to pressure ulcer prevention (hydration, nutrition, mobility, continence and skin care). The combined intervention includes a patient feedback card and the Creating Learning Environments for Compassionate Care (CLECC) nursing staff intervention.

Ethics approval

Approved 25/04/2017, London - Harrow Research Ethics Committee, Education Centre, Northwick Park Hospital, HA1 3UJ, Tel: +44 (0)207 104 8057, Email: nrescommittee.london-harrow@nhs.net, ref: 17/LO/0365

Study design

Randomised; Both; Design type: Process of Care, Complementary Therapy, Complex Intervention, Qualitative

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Specialty: Health Services Research, Primary sub-specialty: Health Services Research; Health Category: Generic health relevance

Intervention

This study combines two existing interventions.
1. The Creating Learning Environments in Compassionate Care (CLECC) intervention - this been designed for use by ward nursing teams in inpatient settings for older people. The implementation programme takes place over a 4 month period but it is designed to lead to a longer-term period of service improvement. The behavioural intervention in this study aims to improve compassionate care by delivering an intervention which involves improving the workplace environment and the work team.
2. A modified version of the 'Tell Us' card, a patient card to elicit care preferences.

In each of two hospitals this intervention is run in two wards, with one ward serving as a control (no intervention as described above).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Pre- and post-intervention surveys and observations will be taken:
1. Patient-centredness of care measured using the patient version of the Individualised Care Scale (ICS) and the Person-centred Climate Questionnaire (PCCQ)
2. Nurses' perceptions of patient-centredness of care measured using the staff versions of the Individualised Care Scale (ICS) and the Person-centred Climate Questionnaire (PCCQ)
3. Quality of staff-patient interactions measured using the QUIS, a time sampling tool that gives a measure of both the volume and quality of interactions. Interactions between staff and patients are observed by independent raters and coded as positive social, positive care, neutral, negative protective and negative restrictive. Observations will be divided into ten 2 hour periods (per ward at each assessment period) to ensure representation of a range of patients, times of day, nurses and days of week.

Secondary outcome measures

Timepoint(s): Pre- and post-intervention surveys:
1. Carer experiences of care; all eligible carers/visitors on each ward over a six week period will be invited to complete a Carer Experiences of Care (CEC) questionnaire
2. Feasibility of study design to inform a future definitive trial, capturing levels of recruitment, recruitment difficulties and feasibility of intervention (through interviews with staff)
3. Pressure ulcer prevalence (as a proxy for fundamental care activities being carried out satisfactorily) measured using audit data

Overall trial start date

01/09/2016

Overall trial end date

01/05/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Staff (interviews, surveys):
1. All nurses and care assistants (CAs) (Health care assistants, assistant practitioner, nursing auxiliaries) working on participating wards during any data collection period will be invited to be interviewed and eligible to complete the nursing questionnaires.
2. Age: 18+
3. Gender: Both

Patients (interviews, surveys):
1. Age: 18+
2. Gender: Both
3. Only people who speak English and who have the cognitive and communicative capacity to participate in a research interview (as assessed by the researcher and/or ward staff) will be invited to take part

Care interactions (patients and staff):
1. Age: 18+
2. Gender: both
3. Patients who are able to consent OR if lacking mental capacity, advice will be taken from an appropriate consultee in deciding whether or not to include someone

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 732; UK Sample Size: 732

Participant exclusion criteria

Staff:
1. Nursing students, bank and agency staff will not be eligible to be interviewed nor to complete the nursing questionnaires

Patients
1. Reverse-barrier nursed, receiving palliative care or are critically ill (research team will be advised by the nurse-in-charge when coming onto the ward)
2. Lacking capacity to decide about taking part in the research and/or unable to communicate their choices about taking part in the research AND a consultee (as defined by the Mental Capacity Act) cannot be consulted (NB patients who lack capacity will be included in care interaction observations if a consultee advises this is appropriate and the patient does not show signs of dissent)
3. Indicate either verbally or non verbally that they do not wish to take part
4. Unconscious or where there are clinical concerns that may preclude them from being approached (we will check with the nurse-in-charge on arrival on the ward whom we should not approach)
5. Receiving continual clinical care that would impair their capacity to make a decision about taking part
6. Communication difficulties, including e.g. language differences, auditory impairments, impair the recruiter's ability to communicate about the research or the patient's ability to communicate their choice about taking part
7. Unable to complete a questionnaire in English with interviewer help
8. Qualitative interviews - lacking the cognitive and communicative capacity to be interviewed

Recruitment start date

06/09/2017

Recruitment end date

30/07/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Southampton General Hospital (lead site)
Tremona Road
Southampton
SO16 6YD
United Kingdom

Trial participating centre

Queen Alexander Hospital
Southwick Hill Road Cosham
Portsmouth
PO6 3LY
United Kingdom

Sponsor information

Organisation

University of Southampton

Sponsor details

University Road
Southampton
SO17 1BJ
United Kingdom
+44 (0)2380 595000
abc@email.com

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR CLAHRC Wessex

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Three articles will be published before Dec 2020, one on the feasibility of the IFCH trial, one on the qualitative analysis of the feasibility trial, and one on measuring person-centred care in acute care settings.

Planned publications:
The Quality of Interactions Schedule (QuIS): concurrent validity in acute hospital settings (Professor Jackie Bridges, Professor Peter Griffiths, Dr Lisa Gould, Dr Jo Hope, Professor Lisette Schoonhoven) - drafting
Do-it-yourself care and the total institution: the importance of staff responsiveness to person-centred care in the hospital ward (Dr Jo Hope, Professor Peter Griffiths, Dr Lisa Gould, Professor Lisette Schoonhoven, Professor Jackie Bridges) - drafting
Improving Fundamental Care: Lessons learned from a feasibility study into a complex intervention (Dr Lisa Gould, Dr Jo Hope, Professor Peter Griffiths, Professor Lisette Schoonhoven, Professor Jackie Bridges)

IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available due to the nature of the consent obtained from participants.

Intention to publish date

28/08/2021

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes