Playing to our strengths in PAT

A proposal for improving psychedelic treatment through an interprofessional collaborative care model

I’ve teamed up to write this piece with fellow nurse practitioner Sandy Samberg, co-founder of the Joe and Sandy Samberg Foundation, which played a pivotal role in introducing psychedelic education into the nursing and social work programs at the University of Pennsylvania and Columbia University. Sandy is now working to expand this initiative to other nursing and social work schools nationwide.

Summary

• Within medical psychedelic administration, alternative pathways should be explored for safety and efficacy

• Each profession in the care team should contribute the expertise of their respective professions

• Nurses are well suited to attending to patients undergoing a psychedelic treatment

Introduction

The FDA’s recent denial of Lykos’ new drug application (NDA) for MDMA-Assisted Therapy (MDMA-AT) for PTSD has been met with understandable disappointment. The application faced a wide range of challenges, several related to the novel idea of combining medicine with therapy. While the FDA reviews and approves drugs and sets safety standards, it does not regulate the practice of medicine or therapy. Therefore, Lykos’ NDA necessitated the FDA’s Advisory Committee to opine on Psychedelic Assisted Therapy (PAT) which was, as several committee members stated, “out of their lane”.  Additionally, one of the critiques made by the Advisory Committee was the lack of clarity about the methods of psychotherapy in the treatment.

At this point, the minimum effective amount of psychotherapy in PAT is unknown. Some psychedelic pharmaceutical companies like Compass and MindMed have recognized the inherent challenges of co-mingling psychedelic medicine with therapy and have responded by decentralizing the therapeutic element. Both utilize the loosely defined “psychological support” rather than “psychotherapy”. While this supportive approach improves the ability to evaluate the stand-alone drug effects and reduces the issues related to the variability of psychotherapy, it raises concerns about potential harm to patients by allowing them to experience the vulnerable emotional state of a therapeutic psychedelic session without adequate therapy to help them process it. Psychedelic drug treatment alone, or with minimal support, also impedes patients from reaping the benefits of the psychotherapy component of PAT.

We’ve used the recent setback for medicalized* psychedelic treatments as an opportunity to envision a different approach. This ‘third way’ incorporates strengths from both models, leverages an interprofessional team, and maximizes safety, efficacy, access, and personalized care. In addition, it further integrates psychedelic care into our broader health care system, creating a framework that is similar to existing treatments and payment models, rather than leaving PAT as a carved-out luxury for those with the means to pay for it out of pocket.  Incorporating these suggestions into future studies and care delivery systems would bring PAT in line with how other medical treatments are delivered by different professionals. For example, a torn ligament might be referred from a primary care provider to an orthopedic surgeon who would perform a surgical repair and then refer to a physical therapist to complete the rehabilitation of the joint. The orthopedic surgeon does not provide the physical therapy, nor does the physical therapist perform the surgery.

A New Interprofessional Model of Psychedelic-Assisted Care

As nurses, we bring years of experience caring for patients and observing how health care is delivered, including one of us (AP) working at UCSF as a psychiatric nurse practitioner on a psychedelic research team for over 5 years, providing this treatment to dozens of study subjects. We would like to propose an alternative model that draws from the strengths of an interprofessional team optimizing the respective skills of each team member. We feel this model has the ability to provide safe, clinically viable, cost-effective, patient-centered care.

We posit that, for most psychedelics (MDMA may be an exception to this**), therapy is best delivered in the period before (preparation) and after (integration) the drug dosing session by those trained in psychotherapy, and what patients primarily need during the drug administration session is care.  As nurses, we believe our profession is ideally suited to delivering this care. Below, we outline our proposal from patient referral to aftercare, utilizing a multidisciplinary team.

A proposed pathway for PAT treatment

Proposed clinicians for a PAT treatment pathway

⁺All clinicians on the team would be psychedelic-assisted therapy (PAT) trained. If the patient chooses their own therapist for preparation/integration, that clinician would need to have PAT training.

1.        Referral and Screening: Following a referral from a medical or mental health care provider, the treatment process begins with a screening done by a clinician who is trained to assess both psychological and physiological contraindications to PAT, make decisions about what PAT modality is most appropriate for the patient, and  prescribes the medication and procedure.  A Psychiatrist (MD/DO), Psychiatric Mental Health Nurse Practitioner (PMHNP), or Psychiatric Physician Assistant (PA) serves in this role and identifies which team members are best suited to work with the patient. For example, a patient with a life-threatening illness could be matched with a therapist and nurse who have worked in palliative care; a patient with complex PTSD could be matched with a trauma-informed therapist and a nurse familiar with how psychedelic medicines impact PTSD; a patient from an underrepresented community could be matched with a therapist or nurse with a similar background, if desired and available. The screening clinician places the orders for the psychedelic medicine, the procedure (i.e.. the dosing day), and any medications that might be needed in case of an emergency (i.e. a beta blocker for elevated blood pressure or an albuterol inhaler for an asthma attack).

2.        Preparation: Following successful screening, the patient then begins the preparation phase of the treatment, led by a therapist. The preparation/integration therapist could be any licensed independent practitioner or chaplain with appropriate therapy and psychedelics training (see chart above).  Alternatively, if a patient’s current therapist has appropriate training in psychedelic-assisted therapy, this therapist could serve in this role, similar to the model that Journey Clinical uses to provide ketamine for patients who are already working with a therapist. The preparation session focuses on the process and goals of the treatment and addresses any concerns the patient might have. The psychedelic trained Registered Nurse (RN) or Licensed Practical Nurse (LPN) who would be in the room with the patient throughout the dosing day meets with the patient for part of the preparation session to establish a rapport, share additional details about the dosing day, and answer any questions. Whether additional preparation sessions are indicated or desired could be a shared decision between the patient and therapist.

3.        Treatment: For safety and practical purposes, a nurse-led dyad, consisting of the RN or LPN and an assistant (ideally, a trainee clinician who could be a pre-licensed student nurse, physician, psychotherapist, or a chaplain), is present for the entirety of the dosing session, administers the prescribed drug, monitors and manages any adverse events or side effects, and documents the patient’s response to the treatment. At the end of the day, the nurse ensures that the patient gets home with a designated support person and does not drive. Finally, the nurse debriefs with the therapist over the phone or via videoconferencing about anything significant that emerged for the patient during the dosing session and shares any written notes. If video and/or AI transcription are utilized during the session, a summary and time-stamped footage are sent to the therapist prior to the first integration session.

4.        Integration and Next Steps: Soon after the dosing session (ideally, the next day), the therapist and patient meet (in-person or via telehealth) to review the session, with the help of the information provided by the nurse and the AI-generated summary (if available). If indicated, a second integration session could follow, with the timing determined by the therapist and patient using a shared decision-making model. Following these integration sessions, the treatment team (the referring clinician, screening clinician, dosing nurse, and therapist) meet with the patient via telehealth to determine what additional integration support is needed and whether further dosing(s) are indicated. Supplementary integration resources such as groups, peer support, and the patient’s ‘integration toolkit’ (initially mentioned during the preparation phase and includes tools such as meditation, journaling, breathwork, nature, somatic practices, music, community, art), are discussed at this meeting and incorporated into the aftercare plan.

Benefits of This Model

Similar to other multidisciplinary teams in acute medical and surgical care, this interprofessional model incorporates roles and opportunities for all members of the treatment team to play to their greatest strengths while optimizing patient safety and efficacy. Like other procedural treatments in psychiatry (e.g. transcranial magnetic stimulation, ketamine infusions, or electroconvulsive therapy), this would allow psychotherapy to be disentangled from the medicine component, the inclusion of which appeared to be a stumbling block for MDMA-AT approval by the FDA. By taking the therapy component out the dosing session, not only would the FDA not need to opine on the therapy aspect of treatment when reviewing the NDA, it would allow therapists greater freedom to personalize the care by utilizing the modality of evidence-based psychotherapy that is best suited for the patient (i.e. prolonged exposure, EMDR, cognitive processing therapy, etc.) before and after the dosing day.  The use of therapies with a more limited evidence base in the Lykos protocol was also critiqued by the FDA Advisory Committee. Future studies could also serve to create an evidence base for these emerging therapeutic modalities when paired with psychedelic medicines.

A study designed with the model we are suggesting would enable the drug effects to be more readily separated from the care that is delivered when the FDA reviews a future NDA. Similar to buprenorphine (Subutex) for opiate use disorder, where the FDA label states that the drug “should be used as part of a complete treatment plan to include counseling and psychosocial support”, a future psychedelic NDA to the FDA could incorporate similar language to permit greater latitude in therapeutic approaches when treating a patient with a psychedelic.

(The FDA label for Subutex encourages counseling and psychological support, but does not dictate what kind of therapy or the duration).

During the dosing sessions, depending on the psychedelic medicine being used, there are often long stretches of quiet reflection for the patient. When needed, nurses can assist in taking care of basic needs such as eating, drinking, going to the toilet, and managing situations that might arise such as vomiting, incontinence or agitation. In some psychedelic dosing sessions, basic medical measurements such as vital signs need to be monitored regularly, and may be required as part of a future FDA label.   This part of the treatment is best supported by the presence and care of nurses. There is significant historical precedent for this practice, as well. Kay Parley was a nurse working with Dr. Humphrey Osmond in Weyburn, Saskatchewan, Canada in the early 1960’s. She and her fellow nurses would sit all day for patients undergoing LSD treatment for alcohol use disorder at Weyburn Hospital. Dr. Osmond would join towards the end of the session, but for most of the day, the patient was cared for independently by a psychedelic trained nurse. Parley wrote about her experiences in a 1964 American Journal of Nursing article entitled, “Supporting the Patient on LSD Day.”

(Andrew Penn and Erika Dyck interviewing Kay Parley in Regina, Sask, Canada, February 2024 – from a forthcoming documentary) Picture courtesy of Zoe Dubus)

Parley, K (1964) American Journal of Nursing

Utilizing a nurse-led dyad during the dosing session brings several other strengths to this model. It is worth pointing out that most nurses (with the exception of PMHNP’s and psychiatric clinical nurse specialists) are not trained in psychotherapy, which, in this model is actually a strength since most of the psychotherapy will be delivered by a trained psychotherapist before and after the dosing session, leaving the care needed during the dosing session to be safely supported and led by the nurse. Rescue medications, if needed, could be written as standing orders by the screening clinician and could be delivered by the nurse within their scope of practice. If the treatment is part of a clinical study requiring advanced monitoring (i.e. EKG or blood draws), this is also within the scope of a nurse’s practice. Patients undergoing psychedelic treatments who have complex medical conditions, (e.g.  cardiovascular disease, diabetes or feeding tubes), would best be managed by nurses.  Should a physical or psychological emergency arise that is beyond the nurse’s ability to manage, a physician/NP/PA and/or therapist could be available as backup. The primary role of the nurse in these dosing sessions would be to deliver supportive care, not to deliver psychotherapy.

From a safety standpoint, in addition to having two people in the room during the dosing session, using video recording and/or AI would provide additional protection for patients on a psychedelic and serve as valuable evidence in the event of an accusation of malpractice.  Regarding concerns about ethical boundary violations during dosing sessions, nurses have training in bioethics and are required to comply with the American Nursing Association’s professional code of ethics.

The use of physical touch in psychedelic sessions has been contentious. An incident of sexual abuse during a Phase 2 MAPS study was well publicized during the recent FDA Advisory Committee hearings and underscores the need to protect patients while in the vulnerable state of undergoing psychedelic treatment. Nurses routinely care for patients who are in similar vulnerable states, be it in an operating room or an intensive care unit, providing appropriate, safe touch when indicated and are consistently rated the most trusted profession in America. Reports of sexual abuse of patients by nurses are extremely rare, especially considering the volume of patients who are seen and touched by nurses each day and the number of nurses in the workforce.

This proposal would allow for all members of the psychedelic care team to play to their strengths in a way that is least impactful on an already overtaxed health care system. Therapists would focus on the psychotherapy portion of the treatment, before and after the dosing session, freeing them to continue to also see patients for non-psychedelic treatments. Given the dire shortage of therapists and current prolonged wait times for therapy, it is not the most efficient use of a therapist’s time to sit in day-long dosing sessions, as this will only exacerbate the current limitations on access to therapy. Additionally, if the patient has an ongoing relationship with their own (PAT trained) therapist, preparation and integration could be completed by this therapist, thus avoiding interruptions in that therapeutic relationship created by having to see other providers for PAT. Nurses would focus on the delivery of care during the dosing session, playing to their strengths of presence and allowing natural processes to unfold (as they do in childbirth and in the time leading up to death), while maintaining the safety and comfort of the patient.

This proposal also makes economic and workforce sense. Nurses are already the largest and most diverse profession within health care, with over 6 million RN’s and LPN’s in the United States. Training just 1% of nurses in the skills needed to provide psychedelic-assisted care would create a ready-made, already licensed workforce of 60,000 nurses that would make psychedelic treatments more accessible, affordable, and equitable. To have therapists provide the preparation and integration and nurses provide the care on dosing days also lowers the cost of the treatment, as hourly wages for nurses are typically less than that of therapists, an important consideration in a therapy day that can last 7-10 hours. The use of a trainee to assist the nurse during the dosing session further reduces costs and creates a unique opportunity to provide valuable training experience for future psychedelic clinicians from all relevant professions.

Modularizing the care delivered by the different professions also allows for a model that can be billed and reimbursed in a way that is more congruent with our current insurance systems. Psychotherapy, before and after the dosing day, could be billed using existing codes for therapy. The treatment itself (i.e. dosing day) could be billed as a medical procedure, and the drug itself could be billed as a separate cost. This would make the provision of psychedelic care more akin to other treatments in medicine, and therefore better positioned to be integrated into existing systems of care delivery and reimbursement.

This proposal also streamlines several concerns that have been raised about the regulation of this work. Each member of the psychedelic care team would be accountable to their respective professional governance board in that state, as they currently are for non-psychedelic practice. Respective professional organizations could develop certificates in psychedelic care that are appropriate to the ethos and skills of that profession (i.e. nursing credentialing organizations could certify nurses in psychedelic care and therapist credentialing organizations could certify therapists in psychedelic treatments, etc.).

Conclusion

The recent setbacks for medicalized psychedelic treatments, as disappointing as they are, present an opportunity for stakeholders – researchers, drug developers, regulators, insurers, clinicians, and patients - to reconsider how psychedelic-assisted treatments are delivered in a way that generates clear, interpretable data for purposes of FDA assessment and that provides safe, high-quality care for research subjects now and patients in the future. Nursing has always been a respected profession, and problem solving has been one of its strengths. We offer this proposal in an effort to safely and effectively bring these promising treatments to those who can benefit from them. In the words of Winston Churchill, “Never let a good crisis go to waste”.  We look forward to ongoing conversations with interested stakeholders about this proposal and other ways to improve psychedelic care.

* This proposal is based on the medical model of psychedelic care. While we recognize and appreciate growing regulated state-access, decriminalization, and religious practice models, they are outside the scope of this article.

** We recognize that different psychedelic medicines require different approaches to therapy. MDMA, which can be more relational and interpersonal, may require a different therapeutic approach than psilocybin, LSD, or DMT.

We’d like to extend our appreciation to our colleagues who read and provided feedback on this proposal: Wendy Marussich, Caroline Dorsen, Chuck Raison, Saundra Jain, Jeff Walker, Rakesh Jain, Dan Grossman, Ana LaDou, Andrew Chomer, and Mike Cotton.