The implementation of the serial trial intervention for pain and challenging behaviour in advanced dementia patients (STA OP!): a clustered randomized controlled trial

BMC Geriatrics

Study Protocol

Erik JA Scherder¹  Jenny T van der Steen²  Marjoleine JC Pieper³  Wilco P Achterberg⁴  Anneke L Francke⁵  Christine R Kovach⁶ 

[1] Department of Clinical Neuropsychology, VU University Amsterdam, van der Boechorststraat 1, 1081, Amsterdam, BT, The Netherlands;EMGO+ Institute for Health and Care Research, van der Boechorststraat 7, 1081, Amsterdam, BT, The Netherlands;EMGO+ Institute for Health and Care Research, van der Boechorststraat 7, 1081, Amsterdam, BT, The Netherlands;Department of Nursing Home Medicine, VU University Medical Center Amsterdam, van der Boechorststraat 7, 1081Amsterdam, BT, The Netherlands;EMGO+ Institute for Health and Care Research, van der Boechorststraat 7, 1081, Amsterdam, BT, The Netherlands;Department of Public Health and Primary Care, Leiden University Medical Center, PO Box 9600, Postzone V0-P, 2300, Leiden, RC, The Netherlands;EMGO+ Institute for Health and Care Research, van der Boechorststraat 7, 1081, Amsterdam, BT, The Netherlands;Netherlands Institute for Health Services Research (NIVEL), PO Box 1568, 3500, Utrecht, BN, The Netherlands;University of Wisconsin-Milwaukee, Milwaukee, Wisconsin, USA;

关键词: Dementia;    Nursing Home;    Psychotropic Drug;    Nursing Home Resident;    Behavioural Symptom;   

DOI  :  10.1186/1471-2318-11-12

 received in 2010-12-09, accepted in 2011-03-24,  发布年份 2011

来源: Springer

【 摘 要 】

BackgroundPain (physical discomfort) and challenging behaviour are highly prevalent in nursing home residents with dementia: at any given time 45-80% of nursing home residents are in pain and up to 80% have challenging behaviour. In the USA Christine Kovach developed the serial trial intervention (STI) and established that this protocol leads to less discomfort and fewer behavioural symptoms in moderate to severe dementia patients. The present study will provide insight into the effects of implementation of the Dutch version of the STI-protocol (STA OP!) in comparison with a control intervention, not only on behavioural symptoms, but also on pain, depression, and quality of life. This article outlines the study protocol.Methods/DesignThe study is a cluster randomized controlled trial in 168 older people (aged >65 years) with mild or moderate dementia living in nursing homes. The clusters, Dutch nursing homes, are randomly assigned to either the intervention condition (training and implementation of the STA OP!-protocol) or the control condition (general training focusing on challenging behaviour and pain, but without the step-wise approach). Measurements take place at baseline, after 3 months (end of the STA OP! training period) and after 6 months.Primary outcome measures are symptoms of challenging behaviour (measured with the Cohen-Mansfield Agitation Inventory (CMAI) and the Neuropsychiatric Inventory-Nursing Home version (NPI-NH)), and pain (measure with the Dutch version of the Pain Assessment Checklist for Seniors (PACSLAC-D) and the Minimum Data Set of the Resident Assessment Instrument (MDS-RAI) pain scale). Secondary outcome measures include symptoms of depression (Cornell and MDS-RAI depression scale), Quality of Live (Qualidem), changes in prescriptions of analgesics and psychotropic drugs, and the use of non-pharmacological comfort interventions (e.g. snoezelen, reminiscence therapy).DiscussionThe transfer from the American design to the Dutch design involved several changes due to the different organisation of healthcare systems. Specific strengths and limitations of the study are discussed.Trial registrationNetherlands Trial Register (NTR): NTR1967

【 授权许可】

CC BY   
© Pieper et al; licensee BioMed Central Ltd. 2011