Can the PROPER intervention reduce psychotropic drug prescription in nursing home residents with dementia? Results of a cluster-randomized controlled trial

Abstract

Objectives: To evaluate the effect of the PROPER intervention in nursing home residents with dementia on the prevalence of psychotropic drug use and neuropsychiatric symptoms. Design: A cluster-randomized controlled design with two parallel groups (intervention versus usual care) and assessments at 0, 6, 12, and 18 months. Setting: Thirty-one dementia special care units within 13 long-term care organizations in the Netherlands. Participants: Three hundred eighty nursing home residents with dementia Intervention: The PROPER intervention consisted of a structured and repeated multidisciplinary medication review, supported by education and continuous evaluation. Measurements: Prescriptions of antipsychotics, antidepressants, anxiolytics, and hypnotics, and occurrence of neuropsychiatric symptoms. Results: The prescription of any type of psychotropic drugs increased in the intervention group, and decreased in the control group, with an estimated difference of 3.9 percentage points per 6 months (p = 0.01). Effects for the individual drug groups were minor (differences of 1.6 percentage points and below per 6 months) and not statistically significant. The occurrence of neuropsychiatric symptoms remained stable in both the intervention and control groups during the follow-up of 18 months. Conclusions: The PROPER intervention failed to demonstrate effectiveness in reducing the prevalence of psychotropic drugs. It may be interesting to enrich the intervention with components that address personal attitudes and communication between nursing home professionals, not only with respect to the prescription of psychotropic drugs, but also to neuropsychiatric symptoms. The study has been registered in The Netherlands Trial Register (NTR3569).

What is more important, the appropriateness or the rate of psychotropic prescription in aged care homes?

“…No significant changes were observed for the occurrence of BPSD, using the Neuropsychiatric Inventory -Questionnaire, between the groups over time. Notably, albeit not statistically significantly, agitation and aggression, assessed with the Cohen-Mansfield Agitation Inventory (CMAI), was worse in the intervention than the control group (greater increase of CMAI scores with a small slope difference of 0.6 every 6 months) (Smeets et al, 2020).…”

“…One notable aspect of this paper (Smeets et al, 2020) is the conflict between its results and those of the authors' earlier report on the primary outcome of the PROPER II trial (van der Spek et al, 2018). The primary outcome was the appropriateness of psychotropic medication prescriptions for BPSD using the Appropriate Psychotropic drug use In Dementia (APID) index sum score, which showed a significant improvement for all types of psychotropic medication prescriptions in the intervention group compared with control ( − 5.28, P = 0.005).…”

“…This paper is a commentary on the paper by Smeets et al (2020), which reports results of the PROPER (Prescription Optimization of Psychotropic drugs in Elderly nuRsing home patients with dementia) II cluster-randomized controlled trial that aimed to establish the effectiveness of a multidisciplinary biannual medication review on improving the psychotropic medication prescribing practice in Dutch nursing homes (aged care homes hereafter). The paper reports the results for the secondary outcomes of the PROPER II trial: 1) the prevalence of psychotropic medication uses (e.g.…”

“…Given that the rationale for the psychotropic medication prescriptions was treatment of BPSD, it would have been helpful to investigate the role of individual BPSD in the prevalence of psychotropic medication prescriptions. This could have been particularly useful because agitation and aggression (assessed with CMAI) increased more in the intervention group than the control group (Smeets et al, 2020).…”

“…In addition, we note that analysis of the APID scores was performed "assuming no systematic difference between groups at baseline due to the randomisation" (van der Spek et al, 2018, p.434). This is an unusual way of examining the effectiveness of an intervention in a cluster trial with only 29 clusters, especially when the baseline APID scores for the two groups seem to have been quite different (van der Spek et al, 2018) and there were reported systematic differences between the two groups (Smeets et al, 2020). Furthermore, the assessment did not include pro re nata prescriptions, which is a critical omission if these were used as replacement.…”