Expanded nursing roles for person-centred care for people with cognitive impairment in acute care
| ISRCTN | ISRCTN81391868 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81391868 |
| Secondary identifying numbers | 01GY2005 |
- Submission date
- 11/06/2023
- Registration date
- 12/06/2023
- Last edited
- 15/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
People with cognitive impairment often experience hospital stays as negative stress. They feel ignored, helpless, and/or threatened. Hospital staff are often conceptually inadequately prepared for the care of people with cognitive impairment. This can lead to unmet needs, such as unrecognised pain, thirst or itching, resulting in changed behaviour, complications, such as falls, or the occurrence of delirium. Person-centred care is a promising care model to meet the needs of people with cognitive impairment. To successfully implement and establish person-centred care approaches, experienced nurses acting as "change agents" are needed.
The aim of this study is to develop, implement and evaluate a complex intervention on person-centred care for people with cognitive impairment in acute hospitals. Person-centred principles are promoted on the wards by nurses in expanded roles (expanded practice nurses).
Who can participate?
Patients aged 65 years and above with cognitive impairment or at risk for cognitive impairment who are admitted to non-ICU wards at the University Hospital Cologne that care for at least 30 people with cognitive impairment per month
What does the study involve?
The study is conducted at the University Hospital Cologne on six non-ICU wards. The complex intervention is implemented in three intervention wards. The intervention consists of 14 components that reflect the role and tasks of the expanded practice nurses. Each ward receives two expanded practice nurses, who have acquired in-depth knowledge of person-centred care for people with cognitive impairment through 200 hours of training. The intervention is performed over a period of 6 months. Three control wards receive written and oral information on person-centred care. The length of hospital stay of people with cognitive impairment in the intervention and control wards will be compared.
What are the possible benefits and risks of participating?
Participants in the intervention group may benefit from the study as it aims to foster person-centred care for people with cognitive impairment. In addition, the study will extend the understanding of the effects of the newly developed intervention. There will be no medical risk of participating for people with cognitive impairment and/or staff.
Where is the study run from?
University of Cologne (Germany)
When is the study starting and how long is it expected to run for?
March 2021 to February 2024
Who is funding the study?
Federal Ministry of Education and Research (Germany)
Who is the main contact?
Dr Martin Nikolaus Dichter, martin.dichter@uk-koeln.de
Contact information
Principal Investigator
Gleueler Straße 176-178
Cologne
50935
Germany
 ORCID ID |
0000-0002-5094-3723 |
|---|---|
| Phone | +49 (0)221 478 34640 |
| martin.dichter@uk-koeln.de |
Study information
| Study design | Single-centre non-randomized controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available as web format, please use the contact details to request a patient information sheet |
| Scientific title | Expanded nursing roles for person-centred care for people with cognitive impairment in acute care |
| Study acronym | ENROLE-acute |
| Study objectives | The study aims to implement a complex intervention for person-centred care of people with cognitive impairment on non-ICU wards by nurses in expanded roles. By introducing person-centred principles, individual needs of people with cognitive impairment can be identified in time and thus complications can be reduced or avoided. This contributes to a reduction in the length of hospital stay. |
| Ethics approval(s) |
Approved 09/06/2023, Ethics Committee of the Medical Faculty of the University of Cologne (Office of the Ethics Committee, University of Cologne, Cologne, 50931, Germany; +49 (0)221 478 87916; ek-med@uni-koeln.de), ref: 23-1009_1 |
| Health condition(s) or problem(s) studied | People with cognitive impairment in acute hospitals |
| Intervention | The complex intervention consists of a total of 14 components that reflect the role and tasks of expanded practice nurses in person-centred care: 1. Screening for cognitive impairment 2. Expanded nursing assessment 3. Planning person-centred interventions 4. Conducting person-centred interventions 5. Case conference discharge planning 6. Counselling significant others 7. Initiating consultations 8. Conducting consultations 9. Evaluating person-centred interventions 10. Training staff 11. Monitoring 12. Collaboration 13. Conceptual work 14. Nursing research The tasks are divided into patient-related (1 - 9) and system-related (10 - 14). In preparation for their role, six expanded practice nurses receive a 200-hour training and a 2-week internship in hospitals with established advanced nursing roles. Two expanded practice nurses are assigned to each intervention ward. During the intervention phase, the expanded practice nurses receive support in the form of bi-monthly coaching sessions. During a kick-off meeting, the members of the interprofessional team of the intervention wards receive information on the study process and principles of person-centred care for people with cognitive impairments as well as on expanded nursing practice. The control group consists of three non-ICU wards and receives optimised care in the form of an information session for nurses and physicians and written information on person-centred care. |
| Intervention type | Behavioural |
| Primary outcome measure | Length of hospital stay (from study inclusion to hospital discharge), obtained from medical records after patient discharge |
| Secondary outcome measures | Patient level: Measured at admission (t1), day 3 of hospital stay (t2), day 7 of hospital stay (t3), day 14 of hospital stay (t4), discharge (t5) and 30 days after discharge (t6): 1. Prevalence of delirium measured using the Confusion Assessment Method (CAM, short form), rated by the research team (t1, t2, t3, t4, t5) 2. Delirium subtype measured using the Delirium Motor Subtype Scale (DMSS-4), rated by nurses (t1, t2, t3, t4, t5) 3. Severity of delirium measured using the Confusion Assessment Method – Severity (CAM-S, short form), rated by the research team (t1, t2, t3, t4, t5) 4. Prevalence of pain measured using the Numeric Rating Scale (NRS), self-rated by patients. If the numeric rating scale is not feasible, the research team rates pain using the Pain Assessment in Advanced Dementia (PAINAD-G) (t1, t2, t3, t4, t5) 5. Undetected pain, defined as a discrepancy between the research team’s rating and nursing documentation of pain or administration of pain medication on demand (t1, t2, t3, t4, t5) 6. Prevalence of agitation measured using Cohen Mansfield Agitation Inventory (CMAI, hospital version), rated by nurses (t3, t4, t5) 7. Quality of sleep measured using Richards-Campbell-Sleep-Questionnaire (RCSQ), self-rated by patients (t2, t3, t4, t5) 8. Sleep problems measured using single items, obtained from medical records (t2, t3, t4, t5) 9. Anxiety, stress and depression measured using Depression Anxiety Stress Scales (DASS, short form), self-rated by patients (t1, t3, t4, t5) 10. Quality of Life – self-assessment using Bath Assessment of Subjective Quality of Life in Dementia (BASQID), self-rated by patients (t5) 11. Quality of Life – proxy assessment using QUALIDEM, rated by nurses (t5) 12. Person-centred care assessed using Individualised Care Scale (ICS), rated by patients (t5) 13. Falls assessed using single items, obtained from medical records (t5) 14. Physical restraints assessed using single items, reported by nurses (t2, t3, t4, t5) 15. Prescription of psychoactive medication assessed using a list of predefined psychoactive medication, obtained from medical records (t5) 16. Mortality measured using single items, obtained from medical records (t5) 17. Stability of care arrangements assessed using single items, rated by patients or relatives in a telephone interview (t6) Staff level: Measured at baseline and 6 months: 1. Burden caused by challenging behaviour of people with cognitive impairment measured using 9-item Residents’ Challenging Behaviour-related Distress Index (RCBI) 2. Perceived person-centred climate on wards measured using 59-item Person-Centred Practice Inventory – Staff (PCPI-S) Cost evaluation: In the economic evaluation, the mean total costs per group are compared. In addition, subgroup analyses according to gender, age groups, length of hospital stay and relative weight are conducted. Process-related outcomes: The accompanying process evaluation has three objectives: 1. To examine the implementation of the intervention components in terms of dose, reach, fidelity, and local adaptations 2. To examine the change processes in expanded practice nurses, interprofessional teams and patients as a result of the implementation of the intervention 3. To examine the contextual factors that influence the success of the implementation A mixed-methods design will be used, following the MRC guidance for process evaluations of complex interventions and Gant's framework for process evaluations in cluster randomised trials. Process outcome measures will be assessed at five time points: TP0 (before training, internship, and kick-off meeting), TP1 (after training, internship, and kick-off event), TP2 (start of the intervention period), TP3 (after transfer or discharge of patients) and TP4 (6 months after the start of the intervention period). |
| Overall study start date | 01/03/2021 |
| Completion date | 29/02/2024 |
Eligibility
| Participant type(s) | Patient, Health professional |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Sex | Both |
| Target number of participants | Six project wards (approx. 720 people with cognitive impairment in total) |
| Key inclusion criteria | Ward level: 1. Prevalence of at least 30 people with cognitive impairment per month according to data from hospital controlling 2. Non-ICU wards Staff level: 1. Nurses, nurse assistants and physicians working on project wards during the intervention period Patient level: 1. Patients aged 65 years and above 2. Patients with cognitive impairment or a risk for cognitive impairment, identified by: 2.1. Pre-existing diagnosis, defined by the following ICD-10 codes: F00.*, F01.*, F02.3, F02.8, F03, F05*, U51* 2.2. Need for clarification of neurocognitive disorder, assessed by outcome-oriented nursing assessment AcuteCare (ePA-AC ©) 1. Risk for delirium, defined by a combination of predetermined risk factors |
| Key exclusion criteria | Ward level: 1. Intensive care units, intermediate care units, psychiatric wards, palliative care wards, paediatric wards Staff level: 1. Other healthcare professionals Patient level: 1. Patients with insufficient German language skills 2. Patients without capacity to give consent and without legal guardianship 3. Patients with a planned hospital stay of <48 hours 4. Patients in the terminal phase (end of life) |
| Date of first enrolment | 13/06/2023 |
| Date of final enrolment | 30/11/2023 |
Locations
Countries of recruitment
- Germany
Study participating centre
Cologne
50937
Germany
Sponsor information
University/education
Institute of Nursing Science
Gleueler Straße 176-178
Cologne
50935
Germany
| Phone | +49 (0)221 478 65451 |
|---|---|
| frank.jaeger@uk-koeln.de | |
| Website | https://www.uni-koeln.de/ |
"ROR" |
https://ror.org/00rcxh774 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Federal Ministry of Education and Research, BMBF
- Location
- Germany
Results and Publications
| Intention to publish date | 01/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publications in peer-reviewed journals |
| IPD sharing plan | The datasets generated during the study will be available on reasonable request from Martin Dichter (Martin.Dichter@uk-koeln.de). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 14/12/2023 | 15/12/2023 | Yes | No |
Editorial Notes
15/12/2023: Publication reference added.
12/06/2023: Study's existence confirmed by the German Federal Ministry of Education and Research.
