Client Informed Consent to Ketamine Treatment

Background

Daydream MD provides medical and behavioral health treatment services using telehealth and potentially in-person services. As part of these psychiatric treatment services, you may be prescribed a medicine named ketamine, a Schedule III medication that has been used for various medical reasons since it was initially FDA-approved in 1970. This medication is not clinically appropriate for all people, but it has been shown to have positive effects for the treatment of anxiety, depression, suicidal ideation, post-traumatic stress disorder (PTSD), obsessive-compulsive disorder (OCD), alcohol use disorder, substance use disorder, chronic pain, and other indications. These uses are referred to as “off-label,” since they are not the purposes for which the medication was approved by the FDA. Off-label prescribing, when clinically appropriate, is both legal and common. As with any medication, ketamine is not without risks (discussed in more detail below), and these must be kept in mind when determining whether this treatment is right for you.
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Potential Benefits

Ketamine has been shown to alleviate symptoms across a variety of mental health issues. For people who have responded to ketamine in clinical studies, the initial antidepressant effects are often detectable within hours of administration, with peak antidepressant effects typically occurring approximately 24-48 hours after administration. The duration of ketamine’s antidepressant effect varies from person to person and can range from a few days to two weeks or longer following a single treatment.

While the benefits of ketamine have been demonstrated across modalities (e.g., sublingual, intravenous, intramuscular, oral), clinical studies have most often focused on intravenous (IV) administration. Studies have shown that a series of IV treatments over 2-3 weeks can extend the antidepressant effects of ketamine to anywhere from weeks to months after the final treatment. Prior to your initial treatment, you and the Practice’s clinician will determine the initial treatment regimen that has the greatest likelihood of achieving your treatment goals.
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Eligibility

Before participating in ketamine treatment, the Practice will carefully review your intake information (including medical history and assessment responses) and may require an in-person physical and/or psychiatric consult to confirm your diagnosis and eligibility for treatment. Clients must be at least 18 years old and cannot meet the exclusion criteria below:

• Ketamine allergy
• Ongoing alcohol or substance abuse or dependence
• History of opioid use disorder
• Active psychotic symptoms, manic symptoms, or a history of a primary psychotic disorder (e.g., schizophrenia, schizoaffective disorder)
• Active suicidal ideation with method, intent, or plan
• Suicide attempt within the past year
• Untreated high blood pressure
• Congestive heart failure or other serious heart problems
• Severe breathing problems (e.g., COPD)Unstable thyroid disease
• Elevated intraocular pressure (e.g., glaucoma)
• Elevated intracranial pressure
• For other purposes for Other serious medical illness not listed abovewhich we provide specific notice at the time the information is collected.
• Pregnant, nursing, or currently trying to become pregnant

Please notify your provider immediately and discontinue treatment if there are any changes to your physical or mental health that impact your eligibility for treatment.
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Client Requirements for Treatment

You are obligated to strictly comply with the guidelines below for all ketamine treatments.

• Identify a Peer Treatment Monitor (partner, family member, close friend, roommate, or other trusted adult) that will be present for your treatment
• Avoid stimulants on the day of treatment to avoid mild agitation and/or blood pressure elevation (these may be resumed following your ketamine session)
• Avoid benzodiazepines on the day of treatment if this doesn’t pose any risks to your health/safety, since these medications may diminish your response to ketamine
• Avoid alcohol or a hangover on the day of treatment to promote your safety and the likelihood of a strong clinical response
• Refrain from consuming food for 3 hours prior to treatment to mitigate the risk of nausea (your clinician may prescribe anti-nausea medication, if appropriate)
• Refrain from consuming liquids for 1 hour prior to treatment to avoid bathroom breaks that may disrupt your treatment
• Do not proceed with treatment if your blood pressure is above 150/100 or your heart rate is above 100 beats per minute (prior to treatment, we'll send you a Bloombox that contains a digital blood pressure monitor)
• Set aside at least 2 hours for your treatment and avoid moving around until you return to your baseline physical and mental states (ask your Peer Treatment Monitor to assist you if you need to get up for any reason, e.g., to use the restroom)
• Do not operate a vehicle (e.g., car, motorcycle, bicycle) or heavy machinery following treatment until you’ve had a full night of sleep

Ketamine Treatment

During your initial video consultation, your clinician will conduct a psychiatric evaluation, determine whether you have a diagnosis that qualifies you for treatment using this medication, and confirm that you do not meet any of the exclusion criteria listed above. If your clinician determines that you are eligible for treatment, they will review this Informed Consent with you and provide an opportunity for you to ask any questions.
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Your clinician may prescribe sublingual ketamine tablets. The tablets are administered by placing them under your tongue or in between your cheek and gums for 7 minutes without swallowing, and then any saliva that has accumulated is spit out. Clinicians advise against swallowing the ketamine because ketamine ingested orally may have a longer onset time, increase the adverse effects listed below, and/or extend the time required for you to return to your baseline physical and mental states.

The effects of the ketamine tablets can typically be observed about 10 minutes after administration, and the peak experience lasts approximately 30-45 minutes thereafter. About an hour after taking the medication, effects of ketamine will begin to diminish. The side effects of ketamine, such as dissociation, dizziness, headache, anxiety, or nausea, may persist for several hours following treatment.
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Side Effects & Risks Associated with Ketamine Treatment

Ketamine may cause adverse effects including, but not limited to: altered sense of time, anxiety, blurred vision, diminished ability to see/hear/feel, dizziness, dry mouth, elevated blood pressure and heart rate, elevated intraocular or intracranial pressure, excitability, loss of appetite, loss of balance or unsteady gait, mental confusion, nausea/vomiting, nystagmus (rapid eye movements), restlessness, slurred speech, synesthesia (a mingling of the senses). When these occur, they tend to resolve spontaneously as the acute effects of the ketamine wear off.

While ketamine has been reported to produce adverse outcomes including but not limited to those outlined below, lasting adverse side-effects are rare when medical protocols are carefully followed. By signing this informed consent document, you agree to adhere to Daydream MD’s treatment guidelines, which are designed to minimize the risk of adverse outcomes associated with the use of ketamine and to maximize its potential benefits.

• While ketamine has not been shown to be physically addictive, it has been shown to cause psychological dependency in some frequent recreational users
• In rare cases, frequent, heavy users have reported increased frequency of urination, urinary incontinence, pain urinating, passing blood in the urine, or reduced bladder size
• Ketamine may worsen problems in people with schizophrenia, severe personality disorders, or other serious mental disorders; users with a personal or family history of psychosis should be cautious using any psychoactive substance, including ketamine, and discuss potential risks with your clinician before proceeding with treatment
• The dissociative effects of ketamine may increase vulnerability and the risk of accidents
• People with a personal history of schizophrenia, schizoaffective disorder, or other primary psychotic illnesses are not eligible for ketamine therapy, due to the risk for ketamine to exacerbate psychotic symptoms in susceptible individuals

Ketamine-Assisted Therapy/Coach

As part of your program you may work with a Therapist or Coach who is affiliated with Daydream MD. Your Therapist or Coach can help you navigate your program, set intentions, and develop your integration plan. Therapists are trained mental health providers and adhering to scope of practice and licensure standard of their governing board. Coaches are trained in psychedelic preparation and integration coaching, best practices for working with psychedelic medicine, and how to best collaborate with your clinician to support your treatment.

While your Coach may be able to support you in changing unwanted thoughts or behaviors and achieve the goals you set for your program, Coaches are not licensed therapists, so they are not licensed to treat anxiety, depression, or other diagnoses. That’s the role of your clinician, therapist or other licensed mental healthcare provider you may work with outside of this treatment.

Guides aim to reply to client messages within 48 hours (or much sooner), but they do not provide 24/7 support.
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Consent to Telehealth

Telehealth involves the use of electronic communications to enable healthcare providers at different locations to share individual client medical information for the purpose of improving client care. Telehealth services offered through the Daydream MD platform by Practice’s clinicians may include consultations by video or by phone, chart review, remote prescribing, appointment scheduling, health information sharing, and non-clinical services, such as client education. The information you provide may be used for diagnosis, therapy, follow-up and/or client education, and may be provided through any combination of the following: (1) health records and test results; (2) images and asynchronous communications; (3) live two-way audio and video; (4) interactive audio with asynchronous communications; and (5) output data from medical devices and sound and video files.

The electronic communication systems we use will incorporate network and software security protocols to protect the confidentiality of client identification and imaging data and will include measures to safeguard the data and to ensure its integrity against intentional or unintentional corruption. It is possible, though unlikely, that your information or data may be lost due to technical failures. You agree to hold Daydream MD and Practice harmless against any information or data that is lost due to technical failures.

The Practice’s clinicians are an addition to, and not a replacement for, your primary care physician and/or primary mental health provider. Responsibility for your overall medical care should remain with your local primary care doctor, if you have one, and we strongly encourage you to locate one if you do not.
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Agreement for Self-payment of Services

• Improved access to care
• More efficient care evaluation and management

Possible Risks:

• Delays in evaluation and treatment could occur due to deficiencies or failures of the equipment and technologies
• More In rare events, a provider may determine that the transmitted information is of inadequate quality, thus necessitating a rescheduled telehealth consult or a visit with your local primary care doctorefficient care evaluation and management
• In very rare events, security protocols could fail, causing a breach of privacy of personal medical information
• In rare events, a lack of access to complete medical records may result in inaccurate and/or incomplete medical advice.

Alternative Treatments

Before deciding to proceed with ketamine treatment, you should consider the benefits and risks of available mood and anxiety disorder treatment options, such as other antidepressant and anti-anxiety medications, mood stabilizers, or psychotherapy. You should also consider alternatives to telehealth consultation, such as in-person services, before choosing to participate in a telehealth consultation. You can discuss these alternative treatments with your Practice clinician or with your local primary care doctor.
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Confidentiality

Your privacy is a priority and all treatment records will be kept confidential. They will be maintained with the same precautions as ordinary medical records. If you would like to provide other individuals or organizations with access to your records, contact us for a release form. You also understand that your healthcare information may be shared by Practice with Daydream MD and with other individuals for scheduling, treatment, and/or billing purposes, as well as in the event of a malpractice suit or other litigation, or for any other purpose to the extent permitted by law. Please refer to the Privacy Policy and Notice of Privacy Practices for additional details.
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By electronically signing this document, I confirm that:

• I have fully read and understand this agreement. I understand the potential benefits, risks, and alternative treatment options, and I freely give my consent to participate in ketamine treatment and receive services via telehealth from Practice providers affiliated with Daydream MD.
• I will abide by all of Daydream MD’s guidelines and requirements outlined in this document and/or those that have been communicated by my clinician.
• I meet the eligibility criteria and do not meet the exclusion criteria listed in the “Eligibility” section above. If there are any changes to my physical or mental health that impact my eligibility for treatment, I will notify my providers immediately and discontinue treatment, if necessary.
• I will be physically located in my state of residence, as identified in my new client registration, during my telehealth consultation. I will notify my Practice Clinician and Daydream MD immediately and no later than at the beginning of your telehealth consultation if I am located in a different state.
• I understand that Practice providers are not able to connect me directly to any emergency services. If I am in a life-threatening situation, I will call the National Suicide Prevention Line at 988 or +1-800-273-8255, call 911, or go to the nearest emergency room.
• I understand it is up to the Practice clinician to determine whether or not my specific clinical needs are appropriate for a telehealth encounter. The Practice’s clinician may deny care for potential misuse of the telehealth services or for any other reason if, in the professional judgment of the provider, the telehealth encounter is not medically or ethically appropriate.
• I understand that my healthcare information may be shared with other individuals for the purposes of treatment, scheduling, billing, and other healthcare operations.
• I understand that I have the right to object to the videotaping or other recording of a telemedicine visit, and I also agree not to record a telemedicine visit without my provider’s permission.
• I give Daydream MD and Practice permission to access information regarding my historical medical data through their electronic health record system.
• I understand that if I participate in a consultation, I have the right to request a copy of my medical records and to request that a copy of my medical records be sent to my local primary care physician or another medical provider.
• I understand that I may register any complaints regarding my provider to the applicable state professional licensing board.
• I understand that I may withdraw my consent from treatment and/or the use of telehealth at any time by providing notice to support@daydreammd.com. I understand that my revocation of consent may result in me no longer qualifying to receive services and that such consent will not impact the rights and actions of Daydream MD and Practice while the consent was in effect.
• I understand that I will have the opportunity to ask my clinician questions about this consent form at any time during my treatment. I understand that I may revoke this consent by following the process set forth in item 12 located above.

Note: we’ll send you a link to electronically sign this document prior to your first session.