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Table 3 Primary and secondary outcome measures

From: TIME – Targeted interdisciplinary model for evaluation and treatment of neuropsychiatric symptoms: protocol for an effectiveness-implementation cluster randomized hybrid trial

What is measured (scales/tools) Characteristics and psychometric properties of scales/tools
Primary outcome measure: The difference between the intervention group and the control group in change from baseline at 8 weeks
Agitation/aggression (single item from the NPI-NH) Change from baseline of agitation and aggression, as defined by the Neuropsychiatric Inventory-Nursing Home version (NPI-NH) item agitation/aggression. The NPI-NH assesses the frequency (0–4) and the severity (0–3) of 12 psychiatric and behavioural symptoms. An item score is generated by multiplying frequency and severity (0–12). A higher score indicates more frequent and severe presence of NPS.
Secondary outcome measures: The difference between the intervention group and control group in change from baseline at 8 and 12 weeks
Neuropsychiatric symptoms (NPI-NH) 12 items described in the Neuropsychiatric Inventory Nursing Home Version (NPI-NH). Range 0–12, as described above.
Subsyndrome of agitation (NPI-NH) The NPI-NH subsyndrome agitation is defined as the sum of the scores of the agitation/aggression, irritability, and disinhibition items. Range 0–36.
Subsyndrome affective symptoms (NPI-NH) The NPI-NH subsyndrome affective symptoms is defined as the sum of the scores of depression and anxiety items of the NPI-NH. Range 0–24.
Subsyndrome psychotic symptoms (NPI-NH) The NPI-NH subsyndrome psychosis is defined as the sum of the hallucinations and delusions items. Range 0–24.
Neuropsychiatric symptoms (NPI-10 NH sum score) The NPI-10 NH sum score is the sum of the first ten items in the NPI-NH, omitting the sleep disturbances and eating disorders (primarily vegetative symptoms) items. Range 0–120.
Caregiver occupational disruptiveness (NPI-NH) In NPI-NH, the caregiver must rate how disruptive they consider each behaviour or symptom on a five-point scale. Range 0–5. A higher score indicates a more disruptive behaviour.
Agitation (CMAI) The Cohen-Mansfield Agitation Inventory (CMAI), which measures 29 different types of agitation and the frequency at which they occur. Range for each item 1–7. Range total score 29–203. A higher score indicates more frequent agitation. Good validity and inter-rater reliability.
Depressive symptoms (Cornell) The Cornell Scale for Depression in Dementia, which measures the frequency of symptoms of depression.
Quality of life (QUALID) Quality of Life in Late-stage Dementia Scale, which measures 11 behaviours rated on a 5-point Likert scale. Range 11–55. A lower score indicates higher quality of life. Good validity and inter-rater reliability
Use and dosage of psychotropic and analgesic medication (defined as daily dosage (DDD)) Psychotropic and analgesic medication given both regularly and on demand. This will be assessed using a questionnaire and extracted from patients’ records. The assessment of the medication given on demand will be obtained from patients’ records at each visit and presented as the sum in mg used for the last 21 days. These drugs will be grouped according to the Anatomical Therapeutic Chemical Index.