Effect of Person-Centred-Care on Antipsychotic Drug Use in Nursing Homes: a Cluster-randomised Trial

Dementia Clinical Trial

— EPCentCare  

Official title:

Effect of Person-Centred-Care on Antipsychotic Drug Use in Nursing Homes: a Cluster-randomised Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02295462
• Other study ID #: EPCentCare
• Secondary ID: 01GY1335A01GY133
• Status: Completed
• Phase: N/A
• First received: November 12, 2014
• Last updated: May 2, 2017
• Start date: December 2014
• Est. completion date: February 2017

Study information

• Verified date: May 2017
• Source: Martin-Luther-Universität Halle-Wittenberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1158
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia

Intervention

Other:
• Person-centered Care
Medication Review + Person-centered Care
• Optimised Treatment
Medication Review only

Locations

Country	Name	City	State
Germany	Martin-Luther-Universität Halle-Wittenberg	Halle (Saale)	Sachsen-Anhalt
Germany	University of Luebeck	Lübeck	Schleswig-Holstein
Germany	Universität Witten/Herdecke	Witten Herdecke	Nordrhein-Westfalen

Sponsors (3)

Lead Sponsor	Collaborator
Martin-Luther-Universität Halle-Wittenberg	University of Luebeck, University of Witten/Herdecke

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Process evaluation	Different methods will be used for data collection: investigators documentation, questionnaires on staff knowledge and self-efficacy, structured interviews and in depth-interviews with staff.	12 months
Primary	Proportion of residents receiving at least one antipsychotic medication after 12 months		12 months
Secondary	Residents' quality of life	Will be measured with the QoL-AD	12 months
Secondary	Behavioural and psychological symptoms of dementia	Will be measured with the CMAI	12 months
Secondary	Costs within trial period	Cost parameters will be collected alongside the trial on intervention-related components as well as outcome-related components. Costs which are explicitly trial-associated will not be taken into account for cost analysis.	12 months
Secondary	Falls and fall-related medical attention		12 months
Secondary	Physical restraints within study period	Physical restraints will be assessed retrospectively by data extraction from residents' records- The following devices will be assessed: bilateral bedrails, belts, fixed tables, and other measures limiting free body movement.	12 months
Secondary	Median daily dose of antipsychotics in chlorpromazine equivalents within study period	Each resident's daily dose of antipsychotic drugs will be translated into chlorpromazine daily equivalents.	12 months