Open Access Highly Accessed Study protocol

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

Marjoleine JC Pieper12*, Wilco P Achterberg13, Anneke L Francke14, Jenny T van der Steen1, Erik JA Scherder5 and Christine R Kovach6

Author Affiliations

1 EMGO+ Institute for Health and Care Research, van der Boechorststraat 7, 1081 BT Amsterdam, The Netherlands

2 Department of Nursing Home Medicine, VU University Medical Center Amsterdam, van der Boechorststraat 7, 1081 BT Amsterdam, The Netherlands

3 Department of Public Health and Primary Care, Leiden University Medical Center, Postzone V0-P, PO Box 9600, 2300 RC Leiden, The Netherlands

4 Netherlands Institute for Health Services Research (NIVEL), PO Box 1568, 3500 BN Utrecht, The Netherlands

5 Department of Clinical Neuropsychology, VU University Amsterdam, van der Boechorststraat 1, 1081 BT Amsterdam, The Netherlands

6 University of Wisconsin-Milwaukee, Milwaukee, Wisconsin, USA

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BMC Geriatrics 2011, 11:12  doi:10.1186/1471-2318-11-12

Published: 24 March 2011

Abstract

Background

Pain (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/Design

The 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).

Discussion

The 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 registration

Netherlands Trial Register (NTR): NTR1967