Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effect of Person-Centred-Care on Antipsychotic Drug Use in Nursing Homes: a Cluster-randomised Trial
Brief Summary: Background: Up to 90% of nursing home residents with dementia experience behavioural and psychological symptoms like apathy, agitation, and anxiety. According to analyses of prescription prevalence in Germany, antipsychotic drugs seem to be prescribed as first line treatment of neuropsychiatric symptoms in persons with dementia. A huge number is prescribed for inappropriate reasons and too long without regular review. The use of antipsychotics is associated with adverse events like increased risk of falling, stroke, and mortality. This study aims to investigate whether a person-centered care approach developed in the United Kingdom can be adapted and implemented in German nursing homes. The aim of the investigators trial is to achieve a clinically relevant reduction of the proportion of residents with alt least one antipsychotic drug prescription.

Methods/Design: Cluster-randomised controlled trial comparing an intervention group (two-day initial skill training on person-centred care and on-going training and support programme) with a control group receiving optimised usual care. Both study groups will receive a medication review by an experienced psychiatrist with feedback to the prescribing physician. Overall, 36 nursing homes from East, North and West Germany will be included and randomised. The primary outcome is defined as the proportion of residents receiving at least one antipsychotic medication at 12 months. Secondary outcomes are residents' quality of life, behavioural and psychological symptoms of dementia as well as safety parameters like falls and fall-related medical attention. Cost parameters will be collected and process evaluation will be performed alongside the trial.


Options:
A: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Pimavanserin 40 mg; Type: EXPERIMENTAL; Interventions: Drug: Pimavanserin tartrate | Intervention Type: DRUG; Name: Pimavanserin tartrate; Assigned to Arm(s): Pimavanserin 40 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: Person-centered Care; Type: EXPERIMENTAL; Interventions: Other: Person-centered Care, Other: Optimised Treatment | Arm Label: Optimised Treatment; Type: ACTIVE_COMPARATOR; Interventions: Other: Optimised Treatment | Intervention Type: OTHER; Name: Person-centered Care; Assigned to Arm(s): Person-centered Care | Intervention Type: OTHER; Name: Optimised Treatment; Assigned to Arm(s): Optimised Treatment, Person-centered Care
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Behavioral: TREA (Treatment Routes for Exploring Agitation) | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Placebo Control Group | Intervention Type: BEHAVIORAL; Name: TREA (Treatment Routes for Exploring Agitation); Assigned to Arm(s): 1 | Intervention Type: BEHAVIORAL; Name: Placebo Control Group; Assigned to Arm(s): 2
D: Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Intervention; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Communication, Behavioral: Systematic Pain Assessment and Treatment, Behavioral: Medication Review, Behavioral: Occupational therapy, Behavioral: Safety | Intervention Type: BEHAVIORAL; Name: Communication; Assigned to Arm(s): Intervention | Intervention Type: BEHAVIORAL; Name: Systematic Pain Assessment and Treatment; Assigned to Arm(s): Intervention | Intervention Type: BEHAVIORAL; Name: Medication Review; Assigned to Arm(s): Intervention | Intervention Type: BEHAVIORAL; Name: Occupational therapy; Assigned to Arm(s): Intervention | Intervention Type: BEHAVIORAL; Name: Safety; Assigned to Arm(s): Intervention

Answer: B