|- candidate number||24405|
|- NTR Number||NTR5872|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-mei-2016|
|- Secondary IDs||201600160 METc UMCG |
|- Public Title||Reduction of Inappropriate psychotropic Drug use in nursing home residents with dementia.|
Dutch: Beter af met minder: Bewust gebruik van psychofarmaca.
|- Scientific Title||Cluster randomized study on the effect of implementation of appropriate interventions at the department level to reduce inappropriate psychotropic drug use.
RID: Reduction of Inappropriate psychotropic Drug use in nursing home residents with dementia.
|- hypothesis||Implementation of complex interventions could be improved by acknowledging the local (nursing home) problems in the care process. The implementation of a facility tailored intervention will lead to a decrease in psychotropic drug use throughout the nursing homes .|
|- Healt Condition(s) or Problem(s) studied||Psychotropic medication, Elderly living in resdidential homes for the elderly, Dementia|
|- Inclusion criteria||Person with dementia: diagnosis dementia (DSM-IV criteria), informed consent of legal representative. |
|- Exclusion criteria||Terminal patients (life expectancy < 3 months). |
Acquired brain injury departments, regular somatic departments, Down's syndrome and Korsakov.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2016|
|- planned closingdate||1-feb-2018|
|- Target number of participants||800|
|- Interventions||The implementation of a facility tailored intervention: meaning that interventions vary depending on local problems of nursing homes in dealing with problem behavior. Possible interventions: systematic medication review, increasing knowledge and skills in dealing with problem behavior, training program for enhancing multi-disciplinary working. All interventions target the department level/health care professionals.
The study consists of 2 tranches, both of 8 months. The interventions group had 16 months to identify local problems and to start an intervention - implemenatation.
The 'controle group' delivers the first 8 months care as usual en starts in the last 8 months with the problem analysis + intervention (deferred treatment condition).
|- Primary outcome||Reduction of inappropriate psychotropic drugs (APID)|
|- Secondary outcome||Quality of life (VAS + RISE)|
Problem behavior / neuro=psychiatric symptoms (NPI-NH + CMAI)
|- Timepoints||baseline, 8 months, 16 months. |
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||PhD Claudia Groot Kormelinck|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. S.U. Zuidema|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|Ministry of Health, Welfare and Sports (VWS)|
|- Brief summary||Despite guidelines recommending psychosocial interventions as first choice in dealing with problem behavior, psychotropic drugs are still too often and too long being prescibed, while they are limited effective and potentially have severe side effects. Aim is to reduce the inappropriate use of psychotropic drugs by identifying local problems in nursing homes in dealing with problem behavior and by facilitating the implementation of a tailored intervention programme. |
|- Main changes (audit trail)|
|- RECORD||27-mei-2016 - 2-jul-2016|