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 September 1, 2022 Peer reviewed DOI: 10.1016/j.jad.2022.06.036 via PubMed
Summary
Informed consent documents from 23 outpatient ketamine clinics were analyzed to assess their alignment with current evidence and identify areas for improvement. While most consent elements were addressed, there was significant variability at the item level. Key areas needing enhancement include communication about long-term adverse effects, treatment alternatives, and support during treatment. The readability of the documents was also poor, highlighting the need for better-informed consent processes as ketamine use in psychiatry grows.
Study at a glance
| Design | exploratory analysis |
|---|---|
| Sample size | 23 |
| Population | outpatient ketamine clinics in the United States |
| Key finding | Consent documents varied widely in addressing key elements, with notable deficiencies in communication about long-term effects and support during treatment. |
Abstract
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. 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. 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. Our study was limited by convenience sampling along with possible underestimation of verbal consent processes. 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.