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

May 2, 2017 updated by: Gabriele Meyer, Martin-Luther-Universität Halle-Wittenberg

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1158

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Nordrhein-Westfalen
      • Witten Herdecke, Nordrhein-Westfalen, Germany, 58448
        • Universität Witten/Herdecke
    • Sachsen-Anhalt
      • Halle (Saale), Sachsen-Anhalt, Germany, 06110
        • Martin-Luther-Universität Halle-Wittenberg
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23562
        • University of Luebeck

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Person-centered Care
Medication Review + Person-centered Care
Other: Person-centered Care
Medication Review + Person-centered Care
Other: Optimised Treatment
Medication Review only
Active Comparator: Optimised Treatment
Medication Review
Other: Optimised Treatment
Medication Review only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of residents receiving at least one antipsychotic medication after 12 months
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Residents' quality of life
Time Frame: 12 months
Will be measured with the QoL-AD
12 months
Behavioural and psychological symptoms of dementia
Time Frame: 12 months
Will be measured with the CMAI
12 months
Costs within trial period
Time Frame: 12 months
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
Falls and fall-related medical attention
Time Frame: 12 months
12 months
Physical restraints within study period
Time Frame: 12 months
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
Median daily dose of antipsychotics in chlorpromazine equivalents within study period
Time Frame: 12 months
Each resident's daily dose of antipsychotic drugs will be translated into chlorpromazine daily equivalents.
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Process evaluation
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Martin-Luther-Universität Halle-Wittenberg

Collaborators

University of Luebeck
University of Witten/Herdecke

Investigators

  • Principal Investigator: Gabriele Meyer, Prof. Dr., Martin-Luther-Universität Halle-Wittenberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

November 12, 2014

First Submitted That Met QC Criteria

November 17, 2014

First Posted (Estimate)

November 20, 2014

Study Record Updates

Last Update Posted (Actual)

May 3, 2017

Last Update Submitted That Met QC Criteria

May 2, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPCentCare
  • 01GY1335A (Other Grant/Funding Number: German Federal Ministry of Education and Research)
  • 01GY1335B (Other Grant/Funding Number: German Federal Ministry of Education and Research)
  • 01GY1335C (Other Grant/Funding Number: German Federal Ministry of Education and Research)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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