Abstract
BackgroundNearly all persons with dementia will experience neuropsychiatric symptoms (NPS) during the course of their disease. Clinicians and researchers emphasize the need for an evidence-informed standardized approach to managing NPS that integrates pharmacological and nonpharmacological treatments for real-world implementation. The Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms (TIME) represents such an approach and is a multicomponent intervention based on the theoretical framework of cognitive behavioural therapy.Methods/designThe trial is a 3-month cluster randomized trial conducted in 30 nursing homes including 168 participants with dementia and a high level of agitation. Each nursing home defined as a cluster will be randomized to receive either the TIME intervention (the intervention group) or a brief education-only intervention regarding dementia and NPS (the control group). TIME is a manual-based, multicomponent programme that includes a rigorous assessment, one or more case conferences and the treatment and evaluation of NPS. Patient-level measurements are taken at baseline (prior to randomization) and 8 and 12 weeks later. The primary outcome measure is the change in agitation, as defined by the Neuropsychiatric Inventory-Nursing Home Version, at 8 weeks from baseline. Secondary outcome measures include change in agitation at 12 weeks from baseline, and change from baseline at 8 and 12 weeks in other NPS, quality of life, and the use of psychotropic and analgesic medications. Mixed methods will be used to follow, measure and explore the implementation process and the effect of the intervention at the individual staff level and the organization level. Combining measurements of clinical effectiveness and implementation outcomes define this trial as an effectiveness-implementation hybrid trial.DiscussionMeasuring the implementation and effect of complex interventions aimed at reducing NPS in nursing homes is challenging. In this study protocol, we describe a multicomponent program, TIME, and discuss how an effectiveness-implementation cluster randomized hybrid trial can meet these challenges.Trial registrationClinicalTrials.gov identifier NCT02655003. Registered 6 January 2016.
Highlights
Most persons with dementia will experience neuropsychiatric symptoms (NPS) during the course of their disease
A systematic review by Reuther et al including 432 studies of case conferences performed as interventions to address challenging behaviour concluded that four of seven studies in the analysis showed a reduction in the challenging behaviour of people with dementia [11]
We found that approximately 12 % of patients had dementia and an Neuropsychiatric Inventory-Nursing Home Version (NPI-nursing homes (NH)) agitation item score of six or higher, which is our main criterion for inclusion
Summary
Most persons with dementia will experience neuropsychiatric symptoms (NPS) during the course of their disease. NPS like agitation, including physical or verbal aggression and excessive motor activity cause patients to experience profound suffering and a reduced quality of life and caregivers to experience increased burden [4]. These symptoms represent great challenges in the care of nursing home patients and are predictors of referral to specialist health care and hospitalization [2, 5]. In a review article published in 2014, a multidisciplinary expert panel emphasized the need to develop comprehensive models for the assessment and treatment of these symptoms Such models should enable the simple implementation of these recommendations in realworld settings [6]
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