Creating Learning Environments for Compassionate Care

ISRCTN	ISRCTN16789770
DOI	https://doi.org/10.1186/ISRCTN16789770
Protocol serial number	18140
Sponsor	University of Southampton
Funder	National Institute for Health Research

Submission date: 15/04/2015
Registration date: 15/04/2015
Last edited: 17/05/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
There is widespread public concern about the lack of compassion in hospital nursing care experienced by older people. This study aims to put CLECC (Creating Learning Environments for Compassionate Care) into practice and do the groundwork needed for a future study to test that it works. CLECC is a nursing practice development programme to promote compassionate care for older hospital patients. Education is often put forward as one solution to the problem, but the best approach is not known. Previous research indicates that workplace learning and a focus on ward nursing teams may be the best approach, but no research to date has looked at the impact of such programmes on the quality of care. This study aims to begin to address this gap.

Who can participate?
Staff and patients in either Southampton General Hospital or Queen Alexander Hospital, Portsmouth.

What does the study involve?
Participating wards are randomly allocated into one of two groups. CLECC is implemented in those wards in group 1. Wards in group 2 act as controls (that is, run as “business as usual”). CLECC is targeted at registered nurses (RNs) and care assistants (CAs) working in hospitals. The ward, rather than the classroom, is the main place for learning for staff and the learning is led by a senior nurse for education. CLECC focuses on creating ward manager and nursing team ways of working (“practices”) that support individual nurses and care assistants to be compassionate with patients. These team practices include regular discussions on improving compassionate care and responding to patient feedback. Each ward manager/sister attends learning groups with other managers to develop their compassionate care leadership role. “Care makers” volunteer from the ward team to receive additional training in doing observations of care and feeding back to colleagues. All nurses and care assistants also attend 8 hours of classroom learning, with patient input and a focus on understanding patient experiences. During and after the 4 months that CLECC takes to implement, we interview CLECC ward nursing staff, patients and visitors about CLECC. Interview data is then used to understand if CLECC can be easily put into practice and what factors influence its workability. This may lead to some changes to CLECC before it is used again.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
The trial is run by Southampton University (UK) and takes place at Southampton General Hospital (UK) and Queen Alexander Hospital, Portsmouth (UK).

When is the study starting and how long is it expected to run for?
March 2015 to October 2016

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

Who is the main contact?
Dr Lisa Gould

Contact information

Dr Jane Frankland
Scientific

University of Southampton
School of Health Sciences
University Road
Southampton
SO17 1BJ
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised; Interventional; Design type: Process of Care
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
Scientific title	Creating Learning Environments for Compassionate Care (CLECC): a feasibility study
Study acronym	CLECC
Study objectives	CLECC is a unit/ward-based implementation programme focused on developing leadership and team practices that enhance team capacity to provide compassionate care. This is a feasibility study and as such has no specific hypothesis however its objectives are to: 1. Create an expansive workplace learning environment that supports work-based opportunities for the development of relational practices across the work team; 2. Develop and embed sustainable manager and team relational practices such as dialogue, reflective learning and mutual support. 3. Optimise and sustain leader and team capacity to develop and support the relational capacity of individual team members; 4. Embed compassionate approaches in staff/service-user interaction and practice, and continue to improve compassionate care following the end of programmed activities
Ethics approval(s)	Social Care REC, 03/12.2014, ref: 14/IEC08/1018
Health condition(s) or problem(s) studied	Topic: Dementias and neurodegeneration, Ageing; Subtopic: Dementia, Ageing; Disease: Dementia, All Ageing
Intervention	CLECC has 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 a intervention which involves improving the workplace environment and the work team.
Intervention type	Behavioural
Primary outcome measure(s)	1. The quality of staff-patient interactions using QUISS, a time sampling tool that gives a measure of both the volume and quality of interactions; Timepoint(s): Timepoints 1 and 2 (pre and post intervention). 2. Patient-reported evaluations of emotional care measured using PEECH and PPE-15 2.1. The Patient Evaluation of Emotional Care during Hospitalisation (PEECH) survey tool focuses on the nature of interpersonal interactions with hospital staff and patient-reported assessment of the extent to which therapeutic emotional care has occurred. Questionnaires will be distributed to all eligible patients over a 4 week period at each assessment period and response rates will be assessed on an ongoing basis. 2.2. Nurses’ self-reported empathy will be established using the Jefferson Scale of Empathy (JSE)(Physician/HP version). All nursing staff currently working on each ward will be invited to complete the written questionnaires at each assessment period.
Key secondary outcome measure(s)	1. Climate for Care (CC) and Factors that Enable Climate for Care (FECC) questionnaires will be administered. 2. We will also assess nursing staff perceptions of workload using items from the International Hospital Outcomes Study battery (IHOS) 3. Perceptions of improved quality of care could also lead to higher job satisfaction and reduced burnout so we will measure levels of burnout using the 22 item Maslach Burnout Inventory (MBI). The target sample is 40 nurses per ward recruited, so a total of 120 per site. 4. Further all eligible carers/visitors on each ward over a four week period will be targeted and invited to complete a Carer Experiences of Care (CEC) questionnaire. The target sample is 16 carers/visitors per ward per assessment period.
Completion date	31/10/2018

Eligibility

Participant type(s)	Mixed
Age group	Adult
Sex	All
Target sample size at registration	1098
Total final enrolment	1038
Key inclusion criteria	1. Wards: The two adult medical inpatient wards in each NHS hospital trust with the highest proportion of patients aged 65+ years will be included in the study. These are likely to be medical wards specialising in older people's care. In addition we will include the medical/surgical ward with the highest proportion of older patients that is not a medicine for older people ward. This ward mix will enable us to explore feasibility in a mix of medicine for older people and nonmedicine for older people wards. 2. Staff: 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. For the observations, all interactions between patients and staff (of any discipline) working on the ward or visiting the ward will be recorded during the planned periods. 3. Patients: All adult patients on participating wards will be eligible to take part in the qualitative interviews, to be included in observations of care and to complete the questionnaires. Routine collection of age and cognitive status data will enable assessment of the relative participation rates of different groups. Only people who are able to complete a questionnaire in English with interviewer help (as assessed by the researcher and/or ward staff) will be invited to take part in the patient survey. The decision to focus on including people who understand English is a practical one, in that we anticipate some communication difficulties in relation to old age in a high proportion of the sample, and we are concerned that the likely small sample of people with language differences will not enable us to properly represent the views of people who have language difficulties. Ability to speak English will not determine whether or not patients are invited to have their care observed. Only people who speak English and who have the cognitive and communicative capacity to agree to take part in a research interview and to be interviewed (as assessed by the researcher and/or ward staff) will be invited to take part in the qualitative interviews. 4. Carers/visitors: Primary family carers of patients on participating wards or, where there is no primary family carer, regular visitors (visits 3+ times per week).
Key exclusion criteria	1. Wards: Critical care units will not be included. Wards will be excluded if departure of ward manager is anticipated in the subsequent 6 months of attempted recruitment 2. Staff: 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. Nursing students, bank and agency staff will not be eligible. For the observations, all interactions between patients and staff (of any discipline) working on the ward or visiting the ward will be recorded during the planned periods. 3. Patients: Patients will be excluded if they: 3.1. Are assessed by the recruiter or by clinical staff who know the patients as lacking capacity to decide about taking part in the research and/or unable to communicate their choices about taking part in the research AND 3.2. A consultee (as defined by the Mental Capacity Act) cannot be consulted (NB patients who lack capacity will be included if a consultee advises this is appropriate and the patient indicates that they are happy for data collection to proceed) 3.4. Patients who indicate either verbally or nonverbally that they do not wish to take part 3.5. Patients who are unconscious or where there are clinical concerns that may preclude them from being approached 3.6. Patients receiving continual clinical care that would impair their capacity to make a decision about taking part that is free from distraction 3.7. Patients with communication difficulties, including e.g. language differences, auditory impairments, that impair the recruiter's ability to communicate the research or the patient's ability to communicate their choice about taking part 3.8. Patients are unable to complete a questionnaire in English with or without interviewer help 3.9. People will be excluded from the qualitative interviews if the researcher and/or clinical staff assess them as lacking the cognitive and communicative capacity to be interviewed
Date of first enrolment	05/03/2015
Date of final enrolment	31/10/2016

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

Southampton University

University Road
Southampton
SO17 1BJ
United Kingdom

Southampton General Hospital

Tremona Road
Southampton
SO16 6YD
United Kingdom

Queen Alexander Hospital

Southwick Hill Road
Portsmouth
PO6 3LY
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	The datasets generated during and/or analysed during the current study are not expected to be made available due to there being no consent for sharing.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2017		Yes	No
Results article	results	22/02/2018		Yes	No
Results article		01/09/2018	17/05/2023	Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	version v4	30/10/2016	01/11/2017	No	No

Additional files

ISRCTN16789770_PROTOCOL_30Oct2016_v4.pdf: Uploaded 01/11/2017

Editorial Notes

17/05/2023: Publication reference and total final enrolment added.
11/09/2018: Publication reference added.
01/11/2017: Publication and dissemination plan, IPD sharing statement and publication reference added. Uploaded protocol v4 30/10/2016 (not peer-reviewed).
12/10/2017: The overall trial end date was changed from 31/10/2016 to 31/10/2018.