Formative evaluation of an emergency department clinical decision support system for agitation symptoms: a study protocol.

INTRODUCTION: The burden of mental health-related visits to emergency departments (EDs) is growing, and agitation episodes are prevalent with such visits. Best practice guidance from experts recommends early assessment of at-risk populations and pre-emptive intervention using de-escalation techniques to prevent agitation. Time pressure, fluctuating work demands, and other systems-related factors pose challenges to efficient decision-making and adoption of best practice recommendations during an unfolding behavioural crisis. As such, we propose to design, develop and evaluate a computerised clinical decision support (CDS) system, Early Detection and Treatment to Reduce Events with Agitation Tool (ED-TREAT). We aim to identify patients at risk of agitation and guide ED clinicians through appropriate risk assessment and timely interventions to prevent agitation with a goal of minimising restraint use and improving patient experience and outcomes. METHODS AND ANALYSIS: This study describes the formative evaluation of the health record embedded CDS tool. Under aim 1, the study will collect qualitative data to design and develop ED-TREAT using a contextual design approach and an iterative user-centred design process. Participants will include potential CDS users, that is, ED physicians, nurses, technicians, as well as patients with lived experience of restraint use for behavioural crisis management during an ED visit. We will use purposive sampling to ensure the full spectrum of perspectives until we reach thematic saturation. Next, under aim 2, the study will conduct a pilot, randomised controlled trial of ED-TREAT at two adult ED sites in a regional health system in the Northeast USA to evaluate the feasibility, fidelity and bedside acceptability of ED-TREAT. We aim to recruit a total of at least 26 eligible subjects under the pilot trial. ETHICS AND DISSEMINATION: Ethical approval by the Yale University Human Investigation Committee was obtained in 2021 (HIC# 2000030893 and 2000030906). All participants will provide informed verbal consent prior to being enrolled in the study. Results will be disseminated through publications in open-access, peer-reviewed journals, via scientific presentations or through direct email notifications. TRIAL REGISTRATION NUMBER: NCT04959279; Pre-results.

Medical Marijuana for Pain Management in Hospice Care as a Complementary Approach to Scheduled Opioids: A Single Arm Study.

Background: Opioid therapy is critical for pain relief for most hospice patients but may be limited by adverse side effects. Combining medical cannabis with opioids may help mitigate adverse effects while maintaining effective pain relief. Aim: This single-arm study investigated the impact of combined medical cannabis/opioid therapy on pain relief, opioid dose, appetite, respiratory function, well-being, nausea, and adverse events in hospice inpatients. Design: Adult hospice inpatients using scheduled oral, parenteral, or transdermal opioids for pain were administered standardized oral medical cannabis, 40 mg CBD/1.5 mg THC or 80 mg CBD/3 mg THC. Descriptive statistics detailed demographic and clinical baseline characteristics, the Mann-Whitney test compared outcomes, and the longitudinal mixed effects regression model analyzed longitudinal effects of combined therapy. Setting/Participants: Sixty-six inpatients at The Connecticut Hospital, Inc. were assessed over 996 treatment days; average age was 68.2 ± 12.9 years, 90.9% were white. Cancer was the most common diagnosis. Results: The medical cannabis/opioid combination showed a significant longitudinal reduction in pain intensity (P = .0029) and a non-significant trend toward lower opioid doses. Well-being, appetite, nausea, and respiratory function showed non-statistically significant changes. Three patients (4.5%) experienced minor, reversible adverse events potentially related to medical cannabis. No serious or life-threatening adverse events were seen. Conclusion: Combination medical cannabis/opioid therapy showed statistically significant pain relief and may have the potential for reducing opioid dose and mitigating opioid toxicity, offering a safe pain management alternative to opioids alone for patients in end-of-life care settings, and warrants further investigation in larger controlled trials.