Psychiatry · Medical Literature
Standardizing care for agitation in Alzheimer's disease, results from a randomized controlled trial of an integrated care pathway versus usual care - the StaN trial.
Abstract
Adherence to treatment guidelines for agitation in dementia is suboptimal and inconsistent. We designed and evaluated an Integrated Care Pathway (ICP) for the management of agitation in dementia. This was a double-blind randomized controlled trial at 12 inpatient units and long-term-care homes (LTCHs) across Canada. Participants were randomized 1:1 to the ICP or treatment-as-usual (TAU). Primary outcomes were Cohen Mansfield Agitation Inventory (CMAI) and psychotropic polypharmacy at 12 weeks. We randomized 185 participants (93 inpatients, 92 in LTCHs). For CMAI, there were no significant time-by-treatment-group interactions among inpatients (F4, 299.3 = 1.7, p = 0.14) or LTCH residents (F4, 296.0 = 0.87, p = 0.48). For polypharmacy, there were significant time-by-treatmentgroup interactions among both inpatients ( χ 7 2 = 15.3, p = 0.032) and LTCH residents ( χ 7 2 = 30.0, p < 0.001), with lower rates of polypharmacy in the ICP group at certain time points, but not at week 12. Standardizing care for agitation in dementia may result in lesser polypharmacy without affecting efficacy. Future studies should assess the ICP in the broader community and outpatients.
Clinical relevance
Agitation is one of the most prevalent and clinically challenging neuropsychiatric symptoms in Alzheimer's disease and related dementias, yet adherence to evidence-based treatment guidelines remains suboptimal across inpatient and long-term care settings. This trial directly addresses the translational gap between guideline recommendations and real-world prescribing practice by evaluating a structured, Integrated Care Pathway (ICP) in a Canadian multicenter, double-blind RCT. The findings are immediately relevant to geriatric psychiatrists, neurologists, and long-term care clinicians who manage dementia-related agitation and face ongoing pressure to reduce inappropriate psychotropic polypharmacy.
Key findings
1. 185 participants were randomized 1:1 (ICP vs. treatment-as-usual [TAU]) across 12 inpatient units and long-term care homes (LTCHs) in Canada, with 93 inpatients and 92 LTCH residents included in the analysis. 2. Primary outcome — Cohen Mansfield Agitation Inventory (CMAI): No statistically significant time-by-treatment-group interaction was observed among inpatients (F4, 299.3 = 1.7, p = 0.14) or LTCH residents (F4, 296.0 = 0.87, p = 0.48), indicating the ICP did not significantly outperform TAU in reducing agitation severity at 12 weeks. 3. Primary outcome — Psychotropic polypharmacy: Statistically significant time-by-treatment-group interactions were detected in both inpatients (χ²7 = 15.3, p = 0.032) and LTCH residents (χ²7 = 30.0, p < 0.001), favoring the ICP arm at certain time points. 4. The polypharmacy benefit observed in the ICP group at interim time points was not sustained at the 12-week primary endpoint in either setting, indicating attenuation of effect over the study duration. 5. The ICP demonstrated an ability to reduce psychotropic polypharmacy without a corresponding decrement in agitation control (non-inferior CMAI scores), suggesting a potential safety and tolerability advantage without loss of efficacy. 6. The study was limited to inpatient and long-term care settings; generalizability to community-dwelling patients and outpatient dementia clinics has not yet been established.
Practice implications
Clinicians managing agitation in dementia across inpatient and long-term care settings should consider implementing structured integrated care pathways as a mechanism to reduce psychotropic polypharmacy — a key driver of adverse drug events in this vulnerable population — without compromising agitation control. Patient selection should prioritize those in institutional settings (inpatient psychiatry, LTCHs) where ICP implementation is most feasible, while recognizing that the polypharmacy-reduction benefit may require active reinforcement beyond 12 weeks to be sustained. Future adoption should be accompanied by longitudinal monitoring of both agitation metrics (e.g., CMAI) and polypharmacy burden, and trials in outpatient and community dementia populations are needed before broader generalization of these findings.