Informed Consent for Ketamine Infusion Therapy

Mindfield Wellness provides psychiatric treatment services using telehealth and in-person IV ketamine treatments. 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 for use with children and adults for anesthesia and as a pain reliever during medical procedures.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), eating disorders, 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.

Why ls Ketamine Being Recommended?

Numerous studies have shown that a series of 6 IV ketamine treatments over 2-3 weeks can provide relief for weeks to months after your final treatment for depression, anxiety, PTSD, suicidal ideation, substance use disorders, eating disorders, OCD, BiPolar Disorder, and acute and chronic pain. Prior to your initial treatment, you and the Mindfield Wellness clinician will determine the initial treatment regimen that has the greatest likelihood of achieving your treatment goals. While the goal is improvement of symptoms, individual results cannot be guaranteed.

Excluded Conditions From Ketamine Therapy

1. Ketamine allergy
2. Active psychotic symptoms, manic symptoms, or a history of a primary psychotic disorder (e.g., schizophrenia, schizoaffective disorder)
3. Untreated high blood pressure
4. Congestive heart failure or other serious heart problems
5. Severe breathing problems (e.g., COPD)
6. Unstable thyroid disease
7. Elevated intraocular pressure (e.g., glaucoma)
8. Elevated intracranial pressure
9. Other serious medical illness not listed above
10.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.

What Safety Precaution Must You Take?

Inform your Mindfield Wellness clinician about all medications you are taking, especially narcotic pain relievers, benzodiazepines, barbiturate and muscle relaxers.
Continue to take most morning medications, especially antihypertensive medications.
Avoid stimulants on the day of treatment, they may cause mild agitation or high blood pressure during the treatment.
Avoid benzodiazepines on the day of treatment if this doesn’t pose any risks to your health or safety, these medicines may diminish your response to ketamine.
Avoid alcohol use 24 hours prior-to and following ketamine administration because it may diminish your response to ketamine.
Refrain from eating 3 hours before your treatment to mitigate the risk of nausea (your Mindfield Wellness physician may prescribe anti-nausea medication, if appropriate).
Refrain from drinking 3 hours before your treatment to prevent the need to interrupt your treatment.
Set aside at least 2 hours after your treatment to relax. Avoid moving around until you return to your normal physical and mental states.
Avoid driving a car, operating hazardous equipment, or engaging in hazardous activities until you’ve had a full night’s sleep.
Refrain from making important decisions until you’ve had a full night’s sleep.
If you experience a minor side effect while you are at home, you should contact call 911 or Mindfield Wellness immediately.

Ketamine Treatment – The Mindfield Wellness Experience

Once you’ve completed signing these Inform Consent forms, you’ll be able to make an appointment for your initial video consultation with a clinician. During your consultation, your clinician will conduct a psychiatric evaluation, determine whether you have a diagnosis that qualifies you for treatment using this medication. 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.

You will be receiving ketamine by IV Infusion over a period of 40 minutes up to 4 hours (called an infusion or treatment), ketamine may help improve symptoms rather quickly. During your treatment an IV catheter will be inserted into a vein of your band or arm and a ketamine fluid will be dripped into the vein. During the infusion your level of sedation, blood pressure, heart rate, oxygen concentration, heart rhythm and respiration will be monitored. After the treatment, you will need time to recover at home or in the office and may sip fluids during the recovery period. For depression and anxiety, current research recommends that you receive 6 treatments over two to three weeks as the primary treatment episode. Additional maintenance treatments may or may not be suggested, their occurrence will be determined by you and our clinician. For pain, the frequency of Ketamine infusions is based on your specific type of pain and response to therapy.

What Are the Possible Side Effects of Ketamine?

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 Mindfield Wellness’ treatment guidelines, which are designed to minimize the risk of adverse outcomes associated with the use of ketamine and to maximize its potential benefits.

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.

Possible Side Effects May Include and are Not Limited to:

fast or irregular heart beats
increased or decreased blood pressure
vivid dreams
confusion
irritation or excitement
floating sensation (“out-of-body”)
twitching, muscle jerks, and muscle tension
urinary frequency
increased saliva or thirst
lack of appetite
headache
metallic taste
constipation
blurry or double vision
nausea or vomiting
memory change

Rare side effects of ketamine are:

allergic reactions
pain at site of injection
increase in pressure inside the eye
increased frequency of urination, urinary incontinence, pain urinating, passing blood in the urine, or reduced bladder size
respiratory complications
hallucinations
euphoria
involuntary eye movement
low mood or suicidal thoughts

Side effects of receiving an IV are:

mild discomfort at the site of placement
bruising
infiltration
infection

Is Ketamine Addictive?

While ketamine has not been shown to be physically addictive, it has been shown to cause psychological dependency in some frequent recreational users

Coaches

As part of your program you may work with a Coach who is affiliated with Mindfield Wellness. Your Coach can help you prepare for your treatment, set intentions, and develop your integration plan. Coaches are trained in 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 or other licensed mental healthcare provider you may work with outside of this treatment.

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

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 Mindfield Wellness platform by their 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 progress surveys; (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 Mindfield Wellness harmless against any information or data that is lost due to technical failures.

Mindfield Wellness’ 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.

Expected Benefits:

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
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 doctor
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.

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 Mindfield Wellness 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.

By electronically signing this document, I confirm that:

1. 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 treatment providers affiliated with MindfieldWellness.
2. I will abide by all of MindfieldWellness’ guidelines and requirements outlined in this document and/or those that have been communicated by my clinician.
3. 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.
4. I understand that MindfieldWellness 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.
5. I understand it is up to the MindfieldWellness clinician to determine whether or not my specific clinical needs are appropriate for a telehealth encounter. MindfieldWellness’ 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.
6. I understand that my healthcare information may be shared with other individuals for the purposes of treatment, scheduling, billing, and other healthcare operations.
7. 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.
8. I give MindfieldWellness permission to access information regarding my historical medical data through their electronic health record system.
9. 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.
10. I understand that I may register any complaints regarding my provider to the applicable state professional licensing board.
11. I understand that I may withdraw my consent from treatment and/or the use of telehealth at any time by providing notice to info@mindfieldwellness.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 MindfieldWellness while the consent was in effect.
12. 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 11 located above.