Expanded nursing roles for person-centred care for people with cognitive impairment in acute care

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

Length of hospital stay (from study inclusion to hospital discharge), obtained from medical records after patient discharge

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).