Background: Psychiatric applications of ketamine have gained traction in the last two decades, contributing to the FDA approval of esketamine (ketamine’s isomeric form) as an antidepressant and antisuicidal agent. However, many psychiatric uses of ketamine continue to be “off-label” (Wilkinson, Toprak, et al., 2017). Thus, providers must reconcile benefits with increasing risks of operating on regulatory margins. The informed consent process is important to mitigate these risks and promote shared decision-making (Paterick et al., 2008; Riley & Basilius, 2007). We examined informed consent documents (IC-Docs) from a convenience sample of outpatient clinics to identify areas of congruence with guidelines and opportunities for growth.
Methods: We conducted an exploratory analysis of IC-Docs from 23 U.S. clinics. Domains assessed included clinic characteristics, clinical content, procedures, and syntax.
Results: Clinics varied widely in their training and services. Common routes of administration were intravenous (65.2%), intramuscular (34.8%), intranasal (21.7%) and oral (21.7%). Indications included major depressive disorder (100%), post-traumatic stress disorder (91.3%), generalized anxiety disorder (60.9%), obsessive-compulsive disorder (56.5%), bipolar disorder (43.5%), and addiction (26.1%). IC-Docs addressed most consent elements, though did so variably on an item-level. Areas of improvement included noting long-term risks (incomplete in 30.4%), alternatives (missing in 52.2%), medical & psychiatric evaluation before treatment (incomplete in 78.3% & 70.0%), medical & psychological support during treatment (incomplete in 78.3% & 82.6%), adjunctive psychological interventions (missing in 56.2%), and dissociative-type effects (missing in 65.2%). All forms had poor readability.
Conclusions: As ketamine continues to emerge as a psychiatric intervention, there is need for careful supervision of its use (McIntyre et al., 2021; Sullivan et al., 2020). Patients and providers will benefit from a consent process informed by scientific, ethical, and pragmatic factors. Our findings provide orientation for improved informed consent of ketamine for psychiatric treatment.