Mapping consent practices for outpatient psychiatric use of ketamine

• Published in: Journal of affective disorders Vol. 312; pp. 113 - 121
• Main Authors: Mathai, David S., Lee, Scott M., Mora, Victoria, O'Donnell, Kelley C., Garcia-Romeu, Albert, Storch, Eric A.
• Format: Journal Article
• Language: English
• Published: 01.09.2022
• ISSN: 0165-0327; 1573-2517
• DOI: 10.1016/j.jad.2022.06.036

BACKGROUNDGiven 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. METHODSUsing 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. RESULTSParticipating 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. LIMITATIONSOur study was limited by convenience sampling along with possible underestimation of verbal consent processes. CONCLUSIONSAs 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.