Clinical trial NCT02295462: Effect of Person-Centred-Care on Antipsychotic Drug Use in Nursing Homes: a Cluster-randomised Trial
Official title: Effect of Person-Centred-Care on Antipsychotic Drug Use in Nursing Homes: a Cluster-randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: nursing homes
person-centered care
inappropriate prescriptions
cluster-randomised controlled trial
antipsychotic drugs
Lead sponsor: Martin-Luther-Universität Halle-Wittenberg
Sponsor class: OTHER
Collaborators: name: University of Luebeck
name: University of Witten/Herdecke
First posted: 2014-11-20
Enrollment: 1158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: On cluster level

Inclusion Criteria:

* nursing homes with at least 50 residents

Exclusion Criteria:

* other ongoing trial in the institution

On individual level

Inclusion Criteria:

* all residents within a cluster are eligible to participate in the study

Exclusion Criteria:

* diagnoses of schizophrenia, schizoaffective psychosis, or other forms of primary psychosis
* respite care

Primary outcomes:
measure: Proportion of residents receiving at least one antipsychotic medication after 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Residents' quality of life
timeFrame: 12 months
measure: Behavioural and psychological symptoms of dementia
timeFrame: 12 months
measure: Costs within trial period
timeFrame: 12 months
measure: Falls and fall-related medical attention
timeFrame: 12 months
measure: Physical restraints within study period
timeFrame: 12 months
measure: Median daily dose of antipsychotics in chlorpromazine equivalents within study period
timeFrame: 12 months
Other outcomes:
measure: Process evaluation
timeFrame: 12 months
Locations:
city: Witten Herdecke
country: Germany
facility: Universität Witten/Herdecke
state: Nordrhein-Westfalen
city: Halle (Saale)
country: Germany
facility: Martin-Luther-Universität Halle-Wittenberg
state: Sachsen-Anhalt
city: Lübeck
country: Germany
facility: University of Luebeck
state: Schleswig-Holstein
Study officials:
affiliation: Martin-Luther-Universität Halle-Wittenberg
name: Gabriele Meyer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Richter C, Fleischer S, Langner H, Meyer G, Balzer K, Kopke S, Sonnichsen A, Loscher S, Berg A. Factors influencing the implementation of person-centred care in nursing homes by practice development champions: a qualitative process evaluation of a cluster-randomised controlled trial (EPCentCare) using Normalization Process Theory. BMC Nurs. 2022 Jul 8;21(1):182. doi: 10.1186/s12912-022-00963-6.
citation: Richter C, Berg A, Langner H, Meyer G, Kopke S, Balzer K, Wolschon EM, Silies K, Sonnichsen A, Loscher S, Haastert B, Icks A, Wolf U, Fleischer S. Effect of person-centred care on antipsychotic drug use in nursing homes (EPCentCare): a cluster-randomised controlled trial. Age Ageing. 2019 May 1;48(3):419-425. doi: 10.1093/ageing/afz016.
citation: Dichter MN, Wolschon EM, Schwab CGG, Meyer G, Kopke S. Item distribution and inter-rater reliability of the German version of the quality of life in Alzheimer's disease scale (QoL-AD) proxy for people with dementia living in nursing homes. BMC Geriatr. 2018 Jun 19;18(1):145. doi: 10.1186/s12877-018-0834-z.
citation: Richter C, Berg A, Fleischer S, Kopke S, Balzer K, Fick EM, Sonnichsen A, Loscher S, Vollmar HC, Haastert B, Icks A, Dintsios CM, Mann E, Wolf U, Meyer G. Effect of person-centred care on antipsychotic drug use in nursing homes (EPCentCare): study protocol for a cluster-randomised controlled trial. Implement Sci. 2015 Jun 4;10:82. doi: 10.1186/s13012-015-0268-3.