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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02295462
Recruitment Status : Completed
First Posted : November 20, 2014
Last Update Posted : May 3, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Dementia Other: Person-centered Care Other: Optimised Treatment

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Person-Centred-Care on Antipsychotic Drug Use in Nursing Homes: a Cluster-randomised Trial
Study Start Date : December 2014
Primary Completion Date : February 2017
Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Proportion of residents receiving at least one antipsychotic medication after 12 months [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Residents' quality of life [ Time Frame: 12 months ]
    Will be measured with the QoL-AD

  2. Behavioural and psychological symptoms of dementia [ Time Frame: 12 months ]
    Will be measured with the CMAI

  3. 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.

  4. Falls and fall-related medical attention [ Time Frame: 12 months ]
  5. 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.

  6. 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.


Other Outcome Measures:
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02295462


Locations
Germany
Universität Witten/Herdecke
Witten Herdecke, Nordrhein-Westfalen, Germany, 58448
Martin-Luther-Universität Halle-Wittenberg
Halle (Saale), Sachsen-Anhalt, Germany, 06110
University of Luebeck
Lübeck, Schleswig-Holstein, Germany, 23562
Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
University of Luebeck
University of Witten/Herdecke
Investigators
Principal Investigator: Gabriele Meyer, Prof. Dr. Martin-Luther-Universität Halle-Wittenberg
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gabriele Meyer, Prof. Dr., Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT02295462     History of Changes
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 )
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017

Keywords provided by Gabriele Meyer, Martin-Luther-Universität Halle-Wittenberg:
nursing homes
person-centered care
inappropriate prescriptions
cluster-randomised controlled trial
antipsychotic drugs

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs