Table 1 Overview of the evaluation of effects
Variable | Instrument | Description | Source | Time pointsa | Type of variable |
|---|---|---|---|---|---|
PEOPLE WITH COGNITIVE IMPAIRMENT | |||||
Length of hospital stay | Single item | Number of days people with cognitive impairment stayed in hospital during a single admission event [34] | Patient records | t5 | Primary outcome |
Prevalence of delirium | Confusion Assessment Method – short form (CAM) | The Confusion Assessment Method consists of 4 items on (1) acute onset and/or fluctuating course, (2) inattention, (3) disorganised thinking, and (4) altered level of consciousness. Delirium is indicated sensitively if item (1) and (2), and either (3) or (4) are scored positive [35,36,37] | Rating by research team | t1, t2, t3, t4, t5 | Secondary outcome |
Severity of delirium | Confusion Assessment Method – Severity (CAM-S) | Delirium severity is measured using the Confusion Assessment Method by rating the items in terms of severity (0 = absent, 1 = mild, 2 = marked). The item (1) acute onset and/or fluctuating course is only rated as 0 = absent or 1 = present. Overall, the scale ranges from 0—7 points, with higher values indicating a more severe degree [38] | Rating by research team | t1, t2, t3, t4, t5 | Secondary outcome |
Delirium subtype | Delirium Motor Subtype Scale (DMSS) | The Delirium Motor Subtype Scale consists of two subscales on hyperactive (4 items) and hypoactive (7 items) subtype, classifying four different motor subtypes: hypoactive, hyperactive, mixed or no motor subtype. Each item is scored dichotomously (present or absent) over the past 24 h. Hyperactive delirium is positive, when two items on the hyperactive subscale are present. Hypoactive delirium is positive, when either “decreased amount of activity” or “decreased speed of actions” in combination with at least one other item is present. Mixed type is positive, when both hyper- and hypoactive delirium was positive within the last 24 h [39, 40] | Rating by registered nurses | t1, t2, t3, t4, t5 | Secondary outcome |
Prevalence of pain | Numeric Rating Scale (NRS) | The Numeric Rating Scale is a 11-point scale ranging from 0 (no pain) to 10 (worst possible pain) [41]. A value ≥ 1 indicates pain | Self-rating by people with cognitive impairment | t1, t2, t3, t4, t5 | Secondary outcome |
Pain Assessment in Advanced Dementia (PAINAD-G) | If self-assessment is not possible with NRS, the Pain Assessment in Advanced Dementia (PAINAD-G) will be used. PAINAD-G consists of five items (breathing, negative vocalisation, facial expressions, body language, consolability) resulting in a score from 0 (no pain) to 10 (worst possible pain) [42, 43]. A score > 2 is defined as an indicator for pain [44] | Rating by research team | t1, t2, t3, t4, t5 | Secondary outcome | |
Prevalence of unrecognised pain | NRS / PAINAD-G | Unrecognised pain is defined by identified pain by the research team and, at the same time, no documentation of pain or administration of medication on demand in patient records | Discrepancy between rating by research team and patient records | t1, t2, t3, t4, t5 | Secondary outcome |
Prevalence of agitation | Cohen Mansfield Agitation Inventory (CMAI, hospital version) | The hospital version of the Cohen Mansfield Agitation Inventory consists of 9 items on a 7-point scale measuring frequency of agitated behaviour (including two subscales on aggressive and non-aggressive behaviour) with a time reference of one week. A score between 9 and 63 can be achieved, with higher scores reflecting a higher level of agitation [45, 46] | Retrospective rating by registered nurses | t3, t4, t5 | Secondary outcome |
Anxiety, stress, and depression | Depression Anxiety Stress Scales (DASS) – short form | The Depression Anxiety Stress Scales consist of 21 items, which are divided into 7 items each for the constructs depression, anxiety and stress. On a 4-point scale, the extent is rated from 0 = not at all true to 4 = very true or true most of the time. The time reference is a period of one week. A sum score is calculated for each subscale, with higher values indicating a higher degree of the negative emotional state. A score of 10 for depression and stress, as well as a score of 6 for anxiety can be assumed to indicate an increased expression of these characteristics [47] | Self-rating by people with cognitive impairment | t1, t3, t4, t5 | Secondary outcome |
Quality of sleep | Richards-Campbell-Sleep-Questionnaire (RCSQ) | The Richards-Campbell-Sleep-Questionnaire consists of 5 items on sleep depth, falling asleep, being awake, falling asleep again and sleep quality. The evaluation of the individual items refers to the previous night and is done using a visual analogue scale, with 0 mm representing the worst sleep and 100 mm the best sleep [48, 49] | Self-rating by people with cognitive impairment | t2, t3, t4, t5 | Secondary outcome |
Outcome-oriented nursing assessment AcuteCare (epa-AC ©b) | Sleep problems are described in epa-AC using two items, the presence of falling asleep and staying asleep as well as a disturbed sleep–wake rhythm [50] | Patient records | t2, t3, t4, t5 | Secondary outcome | |
Quality of life | Bath Assessment of Subjective Quality of Life in Dementia (BASQID) | The Bath Assessment of Subjective Quality of Life in Dementia includes 14 items divided into two subscales on life satisfaction and feeling of a positive quality of life. Both subscales are used with a 5-point Likert scale ranging from 0 = not at all satisfied or not at all to 4 = extremely satisfied or very satisfied. Overall, the scale results in a transformed score of 0—100 points, with higher values indicating a higher quality of life. Three additional questions provide a comprehensive assessment of quality of life, health, and memory performance and are evaluated separately [51, 52] | Self-rating by people with cognitive impairment | t5 | Secondary outcome |
QUALIDEM | The QUALIDEM uses 37 items to measure the quality of life of people with dementia, with a selection of 18 items being used for people with severe dementia. The 18-item version addresses the domains care relationship, positive affect, negative affect, restless and tense behaviour, social relationships, and social isolation. Responses are made using a 7-point Likert scale that asks for frequency. Although an analysis within domains is recommended, a total score of 0—168 points can also be calculated, with higher values representing a higher quality of life [53, 54] | Retrospective rating by registered nurses | t5 | Secondary outcome | |
Person-centred care | Individualised Care Scale (ICS) | The Individualised Care Scale consists of 17 items measuring the perspective of people with cognitive impairment on implementation of individualised care during hospitalisation. Items are rated with a 5-point Likert scale ranging from 1 = strongly disagree to 5 = strongly agree. A general score is calculated as mean value between 1 and 5, with higher values indicating more individualised care [55, 56] | Self-rating by people with cognitive impairment | t5 | Secondary outcome |
Falls | Single items | Number of falls documented | Patient records | t5 | Secondary outcome (safety outcome) |
Physical restraints | Single items | Occurrence of the use of physical restraints | Retrospective rating by registered nurses | t2, t3, t4, t5 | Secondary outcome (safety outcome) |
Prescription of antipsychotics | Predefined list | Newly prescribed antipsychotic medication during hospitalisation | Patient records | t5 | Secondary outcome (safety outcome) |
Mortality | Single items | People with cognitive impairment that died during data collection | Patient records | t6 | Secondary outcome (safety outcome) |
Stability of care arrangements | Single items | • Number of readmissions within 30 days • Perceived stability of care arrangement | Telephone interview with people with cognitive impairment and/or their relatives | t6 | Secondary outcome (safety outcome) |
Sociodemographic variables | Single items | • Age in years • Gender: Male, female, or divers • Care dependency levels ranging from 1 to 5 • Care situation before admission | Patient records | t1 | Control variable |
Admission diagnosis | Single items | Admission diagnosis as documented | Patient records | t5 | Control variable |
Type of admission | Single items | Emergency or planned admission | Patient records | t1 | Control variable |
Previous hospital admissions | Single items | Number of hospital admissions within the last seven days | People with cognitive impairment and/or their relatives | t1 | Control variable |
Admission diagnosis-related (diagnosis related groups) length of hospital stay | Single items | Mean stated length of stay of the patient's diagnosis-related group | Patient records | t5 | Control variable |
Or Ward-related length of hospital stay | Minimum length of stay of special wards, e.g., based on rehabilitation programmes | Ward managers | t0 | ||
Type of discharge | Single items | Discharge home, transfer | Patient records | t5 | Control variable |
Self-care ability | Self-care Ability Index (epa-AC ©b) | The Self-care Ability Index consists of 10 items: mobility, grooming and dressing (lower and upper body), eating and drinking, excretion, and cognition / consciousness. The items are rated every day on a 4-point Likert scale, with high scores reflecting a high self-care capacity. The scale ranges from 10 points (= impaired self-care ability) to 40 points (= full self-care ability) [50] | Patient records | t1 | Control variable |
Cognition | Montreal Cognitive Assessment (MoCA) | The Montreal Cognitive Assessment consists of 12 tasks on short-term memory recall, visuospatial abilities, executive functions, attention, concentration, working memory, language, and orientation. The maximum score achievable is 30 points. Scores between 28—25 indicate mild cognitive impairment, scores between 10—17 indicate moderate cognitive impairment, and scores < 10 indicate severe cognitive impairment [57] | Rating by research team | t1 | Control variable |
Comorbid disease status | Charlson Comorbidity Index (CCI) | The Charlson Comorbidity Index consists of 19 clinical conditions, each of which is weighted to produce a sum score. Higher scores indicate a greater risk of mortality and more severe comorbid conditions [58, 59] | Patient records | t5 | Control variable |
STAFF | |||||
Distress associated with difficult behaviour for people with cognitive impairment | Residents’ Challenging Behaviour related Distress Index | The Residents’ Challenging Behaviour related Distress Index includes 10 items that address altered behaviour such as hallucinations, instability, anxiety, depression, apathy, euphoria, limited communication skills, disinhibition, aggression, and impaired motor skills. All items are rated in terms of the degree of distress 1 = does not stress me at all, 2 = stresses me somewhat, and 3 = stresses me a lot. The score ranges from 0—100 points, with a higher score indicating higher distress [60] | Self-rating by staff | t0, t7 | Secondary outcome |
Person-centred care | Person-Centred Practice Inventory – Staff (PCPI-S) | The Person-Centred Practice Inventory—Staff includes 59 items covering 17 different constructs of person-centredness with respect to 3 domains: prerequisites, care environment, and person-centred processes. The items are measured on a 5-point Likert scale from 0 = strongly disagree to 4 = strongly agree. Overall, the scale shows a sum score of 0—100, with higher scores representing greater agreement with person-centredness [61, 62] | Self-rating by staff | t0, t7 | Secondary outcome |
Sociodemografic variables | Single items | • Age in years • Gender | Self-rating by staff | t0, t7 | Secondary outcome |