The study protocol for a randomized, controlled trial of acupuncture versus a sham procedure versus standard care alone for the treatment of delirium in acutely hospitalized older adults with a medical illness

Background Many hospitalized older adults experience delirium, but treatment options are limited. Acupuncture has been shown to improve cognitive function and reduce agitation in dementia. We hypothesize that acupuncture, when compared with a sham intervention, will reduce the duration and severity of delirium, normalize delirium biomarkers, and improve clinical outcomes related to delirium in acutely hospitalized older adults with a medical illness. Methods This three-arm, prospective, randomized, clinical trial will evaluate adults aged over 65 years who are acutely hospitalized to an internal-medicine ward and diagnosed with delirium or subsyndromal delirium. The 288 patients (96 in each of three groups) will be randomly allocated to receive either daily true acupuncture with usual care, a daily sham procedure with usual care, or usual care only in a 1:1:1 distribution for up to one week or until the patient is delirium-free for over 48 h. Other delirium and clinical interventions will remain unchanged. Delirium will be diagnosed using DSM-5 criteria and its severity will be assessed using the long Confusion Assessment Method Severity (CAM-S) tool. Outcomes The primary study outcome will be the daily CAM-S score over 7 days between the three groups. Secondary outcomes will include time to first resolution of the delirium (over 7 days), the proportion of days spent delirium-free, daily antipsychotic use, daily pain scores, sleep quality, morning serum cortisol and T3 levels, and midnight urinary cortisol/creatinine ratio, all determined twice a week, and delirium-related complications. Hospital mortality, duration of hospital stay and functional status at discharge will also be compared between the three groups. Adverse events potentially related to acupuncture will be evaluated daily. The cost-effectiveness of acupuncture will be estimated. Conclusion This novel randomized study will evaluate both the specific and the non-specific effects of acupuncture on delirium, and related outcomes, and its safety. Potential mechanism(s) of action for acupuncture in reducing delirium will be explored and healthcare-related costs estimated. Positive study results may prove pivotal in facilitating a multimodal, non-pharmacologic, integrative approach to delirium treatment among older, medical inpatients.