- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02295462
Effect of Person-Centred-Care on Antipsychotic Drug Use in Nursing Homes: a Cluster-randomised Trial (EPCentCare)
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Nordrhein-Westfalen
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Witten Herdecke, Nordrhein-Westfalen, Tyskland, 58448
- Universität Witten/Herdecke
-
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Sachsen-Anhalt
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Halle (Saale), Sachsen-Anhalt, Tyskland, 06110
- Martin-Luther-Universität Halle-Wittenberg
-
-
Schleswig-Holstein
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Lübeck, Schleswig-Holstein, Tyskland, 23562
- University of Luebeck
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Person-centered Care
Medication Review + Person-centered Care
|
Medication Review + Person-centered Care
Medication Review only
|
|
Aktiv komparator: Optimised Treatment
Medication Review
|
Medication Review only
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Proportion of residents receiving at least one antipsychotic medication after 12 months
Tidsramme: 12 months
|
12 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Residents' quality of life
Tidsramme: 12 months
|
Will be measured with the QoL-AD
|
12 months
|
|
Behavioural and psychological symptoms of dementia
Tidsramme: 12 months
|
Will be measured with the CMAI
|
12 months
|
|
Costs within trial period
Tidsramme: 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
Tidsramme: 12 months
|
12 months
|
|
|
Physical restraints within study period
Tidsramme: 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
Tidsramme: 12 months
|
Each resident's daily dose of antipsychotic drugs will be translated into chlorpromazine daily equivalents.
|
12 months
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Process evaluation
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Gabriele Meyer, Prof. Dr., Martin-Luther-Universität Halle-Wittenberg
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- EPCentCare
- 01GY1335A (Annet stipend/finansieringsnummer: German Federal Ministry of Education and Research)
- 01GY1335B (Annet stipend/finansieringsnummer: German Federal Ministry of Education and Research)
- 01GY1335C (Annet stipend/finansieringsnummer: German Federal Ministry of Education and Research)
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