Mapping consent practices for outpatient psychiatric use of ketamine

Mapping consent practices for outpatient psychiatric use of ketamine
David S. Mathai, Scott M. Lee, Victoria Mora, Kelley C. O’Donnell, Albert Garcia-Romeu, Eric A. Storch
Journal of Affective Disorders, 1 September 2022; 312, pp 113-121
Abstract
Background
Given increasing community-based and off-label use of ketamine for psychiatric indications, we examined current informed consent processes from a convenience sample of outpatient ketamine clinics to identify areas of congruence with current evidence and opportunities for growth.
Methods
Using a rubric developed from existing practice guidelines, we conducted an exploratory analysis of informed consent documents (IC-Docs) from 23 American clinics offering ketamine as a psychiatric treatment. Domains assessed included clinical content, procedures, and syntax.
Results
Participating clinics (23/288) varied widely in their constitution, training, and services provided. We found that IC-Docs addressed a majority of consent elements, though did so variably on an item-level. Areas for improvement included communication around long-term adverse effects, treatment alternatives, medical/psychiatric evaluation prior to treatment, medical/psychological support during treatment, adjunctive psychological interventions, and subjective/dissociative-type effects. All forms were limited by poor readability.
Limitations
Our study was limited by convenience sampling along with possible underestimation of verbal consent processes.
Conclusions
As ketamine continues to emerge as a psychiatric intervention, both patients and providers will benefit from a deliberate consent process informed by scientific, ethical, and pragmatic factors toward the goal of shared decision-making regarding treatment.