Discussion
comorbidity, ’s disease, dementia, agitation
ADVERSE EFFECTS, DISEASE, STILL
This pragmatic, controlled trial focussed on improving the appropriateness of regular medication use among NH residents affected by severe dementia and aimed at showing whether knowledge exchange based on a continuous education session and specific medication revision guidance would contribute to such an improvement. Optimamed was derived from a pilot pre-post feasibility study that included 44 residents, where a similar intervention produced a 12% reduction in the mean number of regular medications per resident in 2014, in NHs of the same Health Network in greater Quebec City, Canada [First, the NHs that participated in both the pilot and the present study are, since April 2015, part of a large, publicly funded Quebec Integrated Health and Social Services University Network covering health and social services for mental health, rehabilitation, and geriatric services, both ambulatory and institutional, for a population of over 755 000 citizens within a geographic territory of 18 643 kmThis health board’s department of pharmacy employs 91 pharmacists of whom each may provide (part time) clinical pharmacy services in several NHs, including some forms of staff rotation. In other words, practice improvement measures experienced in a specific facility may affect practice in a different facility through contact between pharmacists and changing deployment schedules. This holds, to a lesser extent, for nurses and physicians employed by the health network and working in NHs.Second, in the time between the pilot and the present study, medication optimization in NHs became a priority in several countries, including Canada. In Quebec, two important initiatives took place between 2016 and 2019, which were both financed and endorsed by the Ministry of Health and Social Services and aimed at 1) the use of inappropriate antipsychotics in NHs, [Third, only 56.7% (161 of 284) of eligible residents could be included in the study. This rather low proportion of eligible residents whose families gave informed consent for study participation is certainly of concern. Reasons expressed during the conversations with the study nurse were most prominently distress about the family member’s disease state and hopelessness regarding disease evolution. In addition, there was apprehension regarding possible changes in the medication regimen. There remain important challenges to better inform families of NH residents affected by severe dementia on medication use for these persons, and to include them in shared decision making. Our leaflet for families (Additional file Fourth, while all residents in Quebec NHs are very frail, since a minimal SMAF score of 11 is needed for admission, related to high frailty, and all study participants were affected by severe dementia, residents in the intervention group were a mean of 3.4 years younger. Still, within a follow-up of over six months in the control sites, and of nearly 24 weeks in the intervention sites, 17 out of 59 residents died in the intervention sites and 20 out of 64 in the control sites, for a total of 37, or 29% in the intervention and 31% in the control sites, illustrating both the high level of frailty and the limited life expectancy of these residents. Despite the observation of similar mortality, there may have been clinical differences among residents in the different intervention and control sites, as visible in the differences in other resident characteristics in the intervention NHs, i.e. a lower proportion of women, lower comorbidity and somewhat higher mean scores for discomfort and agitation in the intervention NHs. Such differences may have affected decisions on medication prescribing, on adjustment and discontinuation differentially. Only a much larger multi-site cluster randomized trial may be able to avoid such mean baseline differences between intervention and control sites.Another specific point to note is that in one of the control sites, a quality improvement project regarding end-of-life care had been realized in 2014. This project included training for all care team members, including physicians and pharmacist, while one of the NH nurses acted as an agent of change and was trained by the study nurse (L Misson) of the present study [There may also exist a “ceiling effect”, meaning that it might be unlikely that mean numbers of regular medications for frail NH residents with advanced dementia, in the age group well above 80 years, can stay significantly and consistently below 6 or 7 regular daily medications. Thus, a French study from 2021 among 800 NH residents with a mean age of 86 years found a mean number of daily medications of 8.5 [Finally, we did assess the numbers of daily “as needed” medications in the participants’ files (but not the dispensed “as needed” doses, since this information is not on the computer files), which were and stayed lower in the intervention sites (daily mean of 8.2 medications if “as needed” ones are included, before, and of 7.8 after the intervention) than in the control sites (daily mean number of 10.7 before and 9.2 after the intervention). It is of note that during the process of deprescribing a phase of “as needed use” may facilitate this process for certain medications, by allowing to consider day-to-day variations in the residents’ health. The practice of including “as needed” medications in the NH resident’s files varies among NHs and depends largely on physician and nurse practices. Thus, if the “as needed” medications were given frequently in the control sites, the mean of 5.9 daily medications at the end of the follow-up might be an underestimation of the actual medication use. Unfortunately, it is very difficult to analyse which medications were given on a “as needed” basis in a multi-site study.It is important to stress that medication revision for NH residents suffering from severe dementia and aimed at reducing less appropriate medications stems from the desire to provide comfort care in the presence of severe dementia [Mean daily antipsychotics were well below 1 medication of this class per resident, in both intervention and control sites, at study beginning and the end of follow-up, but the intervention did not result in any decrease in the intervention site, whereas usage did decrease in the control NH of the same health board: among the 64 residents in the control NH there were 25 who had at least one regular prescription for antipsychotics, which are also part of the “sometimes appropriate” medications, and this number fell to 19 residents at the end of follow-up, while in the intervention NH these numbers were 38 out of 59 at the beginning and 34 at the end of follow-up. Against expectations, there was one control NH, where the number of residents who used at least one regular antipsychotic decreased from 11 residents (40%) among 27 who participated, to 3 residents (11%) at the end of follow-up. Although we were not able to include dispensed “as needed” doses and day-to-day dose variations, the intervention did not seem to have the intended overall impact on a decreased use of antipsychotic agents, despite their considerable risk of serious adverse effects [Our intervention built upon earlier work by Garfinkel et al. who incorporated evidence for medication indication, effectiveness, and adverse effects, as well as patient circumstances and continuation preferences into their approach [In a Dutch cluster randomized trial to discontinue inappropriate medications [