Remote Treatment & Psychedelic Integration Consent

Remote Treatment 

‍To promote positive outcomes and ensure your safety, we require confirmation that you’ll comply with all guidelines below:

Identify a Peer Support *PS (spouse, family member, roommate, friend, or other trusted individual) that will be present and prepared to support each of your ketamine treatments. 

Follow all of Better Us preparation for treatment requirements included in the members page. Log in here at: https://www.betterucare.com/sign-in

It is your responsibility to check your blood pressure and heart rate prior to each treatment.

Do not proceed with a treatment session if your blood pressure is above 150/100 or your heart rate is above 100 beats per minute.

Set aside at least 4-6 hours for your uninterrupted treatment, and refrain from moving around until you return to your baseline physical and mental state (if you need to get up for any reason, such as to use the bathroom, ensure that you are escorted by your Peer Support)

If you have any questions about your treatment, email info@betterucare.com or call/text your Guide for support. If it’s a medical emergency, call 911.

If you do not have someone in your network (friends/family) that can be your Peer Support, we do offer Virtual Peer Support for $59 per session.  Please send a text to 725.888.8992 to schedule your Virtual Peer Support for your sessions. 

Psychedelic Integration Coach

As part of your Better U program, you are responsible for scheduling and attending psychedelic integration appointments with a Better U Psychedelic Integration Coach. Better U Psychedelic Integration Coaches are not licensed therapists or clinicians.  They are not licensed to treat PTSD, anxiety, depression, or other diagnoses. That’s the role of your Better U clinician or other licensed mental health clinicians.  

Better U Integration Guides aim to reply to all texts, emails, and phone calls within 24 hours (or much sooner) but they do not provide 24/7 support.

Zero Tolerance Policy

If you do not comply with the Ketamine Treatment Informed Consent, you’ll be disqualified from continuing services with Better U. We believe that this policy is essential to ensure your safety and create the greatest likelihood of positive outcomes. 

Telemedicine Consent

Telehealth involves the use of electronic communications to enable healthcare providers at different locations to share individual patient medical information for the purpose of improving patient care. Telehealth services offered by Better U and affiliated clinicians may also include consultations by video or by phone, chart review, remote prescribing, appointment scheduling, health information sharing, and non-clinical services, such as patient education. The information you provide may be used for diagnosis, therapy, follow-up and/or patient education, and may include 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 store and portal; and (5) output data from medical devices and sound and video files; (6) email and text/SMS messages.

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The electronic communication systems we use will incorporate network and software security protocols to protect the confidentiality of patient identification and imaging data and will include measures to safeguard the data and to ensure its integrity against intentional or unintentional corruption.

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Expected Benefits:

Improved access to care

More efficient care evaluation and management

Expertise of affiliated Psychiatric Clinicians

Possible Risks: 

Delays in evaluation and treatment could occur due to deficiencies or failures of the equipment and technologies

In rare events, our provider may determine that the transmitted information is of inadequate quality, thus necessitating a rescheduled telehealth consult

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 adverse drug interactions or allergic reactions or other judgment errors

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.

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 treatments and receive services via telehealth from providers affiliated with Better U.

I will abide by all of Better U’s guidelines and requirements outlined in this document and/or those that have been communicated by Better U website, membership portal and affiliated licensed 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 understand that Better U 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 1-800-273-8255, call 911, or go to the nearest emergency room.

I understand it is up to the Better U  to determine whether or not my specific clinical needs are appropriate for a telehealth encounter.

I understand that my healthcare information may be shared with other individuals for the purposes of treatment, scheduling, billing, and other healthcare operations.

I give Better U's affiliated clinicians 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.

I understand that I may withdraw from treatment and/or the use of telehealth at any time. 

*We understand that circumstances can change and want to do our best to accommodate your needs while also being respectful of our clinicians' time. If you are unable to attend your appointment, please contact us at least 48 hours in advance to avoid a $200 fee no-show fee.

By electronically signing this document, I confirm that:

I have fully read and understand this agreement.  I will comply with all stipulations included in this agreement and use my medication only as directed by my assigned Better U affiliated clinician. If I break this agreement, I will be disqualified from future services with Better U.

Maintaining Results:

For continued results, you may require additional Ketamine Therapy treatments at intervals determined by your treatment provider in conjunction with your personal treatment plan.

No Guarantee of Results: In some situations, it may be possible to achieve optimal results. Should complications occur, additional or other treatments may be necessary.

Financial Responsibility:

I understand the regular charge applies to all subsequent treatments. I understand and agree that all services rendered to me are charged directly to me and that I am personally responsible for payment. I further agree in the event of non-payment, to bear the cost of collection and/or Court costs, fees and reasonable legal fees, should this be required.

Missed Appointments:

We understand that circumstances can change and want to do our best to accommodate your needs while also being respectful of our clinicians' time. If you are unable to attend your appointment, please contact us at least 48 hours in advance to avoid a $200 fee no-show fee.

I have read and understand I am financially responsible for services rendered. 

Disputes & Cancellations

In case, any dispute arises between the Users while communicating, we encourage our Users to contact Better U’s customer support department for assistance by reaching us at info@betterucare.com where users can reach out to for any assistance or by calling the office at 725.888.8992.

If the affiliated licensed clinician that you are referred to determines that the you are not eligible or a good candidate for the Better U program(s) prior to starting treatment, a refund will be issued as soon as the clinician informs Better U that the program is not right for you.

No refunds will be issued after the clinician sends the prescription(s) to a pharmacy to be filled.

We share results of our clients on social media and on www.betterucare.com but in no way does this guarantee you will receive the same results.

As with any medical treatment done with any medical doctor, our treatments are not guarantees for results as everyone's mental health is different.  For this reason, Better U does not offer refunds or guarantee results.

We understand that circumstances can change and want to do our best to accommodate your needs while also being respectful of our clinicians' time. If you are unable to attend the appointment you scheduled, text 725.888.8992 or email info@betterucare.com at least 48 hours in advance to avoid a $300 no-show fee.

*If you financed through a third-party financing partner, you are subject to the terms & conditions of your contractual agreement with the third-party financing partner.

Disclosure of Health History/Medications/Substance Abuse Use:

I agree to inform the staff of any know allergies to medications, foods and/or other substances and have disclosed any previous allergic reactions.

I further agree to inform staff of any/all medications/substances I am currently taking, including recreational or street drugs, and have disclosed all pertinent health history. I understand that failing to inform the staff about my medical issues and/or drug use can lead to serious complications.

CLIENT ACKNOWLEDGEMENT AND RELEASE

Treatment Liability Waiver

I acknowledge that elective supplementation therapies, including but not limited to, Ketamine Therapy, may be considered medically unnecessary. It may or may not mitigate, alleviate, or cure the condition for which it has been prescribed. This therapy has been recommended to you in the belief that it is of potential benefit in these circumstances and its use will quite probably improve the conditions for which you are under treatment and in your overall health. Based on the risks and potential benefits of the current medically indicated treatment(s) and of this proposed treatment, I have elected to forego or supplement the indicated treatment(s) and receive this proposed treatment providers, affiliated psychiatric clinicians, and staff at Better U, LLC.

I understand that I may suspend or terminate my treatment at anytime by informing my affiliated medical provider. I assume full liability for any adverse effects that may result from the non-negligent administration of the proposed treatment. I waive any claim in law or equity for redress of any grievance that I may have concerning or resulting from the procedure, except as that claim pertains to negligent administration of this procedure. The risks involved and the possibilities of complications have been explained to me. I fully understand and confirm that the nature and purpose of the aforementioned treatment to be provided may be considered unproven by scientific testing and peer-reviewed publications and therefore may be considered medically unnecessary or not currently indicated.

Therefore, in consideration for any treatment received, I agree to unconditionally defend, hold harmless and release from any and all liability the company and the individual that provided my treatment, the insured, and any additional insured’s, as well as any officers, directors, independent contractors, or employees of the above referenced companies for any condition or result, known or unknown, that may arise as a consequence of any treatment I may receive.

I understand and agree that any legal action of any kind related to any treatment I received will be limited to binding arbitration pursuant to the Arbitration Agreement.

KETAMINE INFORMED CONSENT

This is an informed consent document to provide written information about the above named treatment risks, benefits and alternatives. It is important that you understand the information provided to you prior to proceeding with this treatment, please ask your healthcare professional any and all questions prior to signing this informed consent.

Purpose of Ketamine Treatment and General Information:

Depression remains a leading cause of disability worldwide (WHO, 2017) affecting nearly 300 million individuals globally (Charlson et al., 2019; Herrman et al., 2019). Depression is also a major contributor to the global burden of disease, with high rates of career burden and rising socioeconomic and healthcare costs.

The majority of patients with depression are currently treated with monoamine-based antidepressants. However, these drugs have low success rates in long-term treatment, with meta-analysis of RCT trials showing that antidepressants are only effective for 42-51% of patients with major depressive disorder (MDD). Furthermore, approximately one-third of patients fail to achieve meaningful recovery (Corriger and Pickering, 2019). Although some will respond to a subsequent trial of a different medication, the likelihood of a patient benefiting from a medication decreases with the number of medications they have tried before (ref). 

Treatment-Resistant Depression (TRD) has been defined as a depressive illness of at least moderate severity that has not responded to at least two trials of appropriate medication (Al-Harbi, 2012). Up to a third of depression patients are thought to fall in this category, with remission rates reportedly being less than 15% among patients with two prior conventional treatment or augmentation failures. Consequently, there is an urgent need for effective treatments for treatment-resistant depression (TRD) (Shah, 2016).

The treatment landscape for TRD has changed with the discovery in 2000 that a single sub-anesthetic dose of intravenous ketamine have rapid and potent effect in reducing depressive symptoms in TRD. This has been a successful repurposing of a drug that was first introduced to the medical community as a surgical anesthetic more than 50 years ago and a paradigm shift for depression research and treatment. Since then, multiple RCT as well as meta-analysis have demonstrated the efficacy of ketamine in the treatment of TRD as well as of other disorders, such as post-traumatic stress disorder (PTSD).

Ketamine is a Schedule III medication that has been used safely as an anesthetic and analgesic since it was FDA-approved in 1970 solely as an anesthetic. It is not FDA approved for mental health conditions. It is increasingly prescribed “off-label” for the treatment of anxiety, depression, post-traumatic stress disorder (PTSD), chronic pain, and other indications. Off-label prescribing is both legal and common. One study shows that about one in five prescriptions is written for off-label use.  Most insurance companies do not reimburse for ketamine treatments. 

Ketamine is classified as a dissociative anesthetic that may produce a sense of disconnection from one’s ordinary reality and usual self. At the dosage level administered to you, you will likely experience mild anesthetic, anxiolytic, antidepressant and psychedelic effects. Relaxation from ordinary concerns and usual states of mind, while maintaining conscious awareness of the flow of mind under the influence of ketamine is characteristic. This can lead to a disruption of negative feelings and obsessional preoccupations. The dissociative effects of ketamine are short-lived, and most people return to their ordinary level of awareness and state of mind within 45-90 minutes following administration.

Ketamine has an extensive historical safety record and has been used at much higher doses for surgical anesthesia and procedural sedation. As with any medication, it is not without risks (discussed in more detail below), and these must be kept in mind when determining whether ketamine is the right treatment for you.

The aim of this protocol is to establish a treatment pathway, set of procedures and minimum standards for the safe delivery of ketamine for patients with TRD and other mental health disorders.  

I understand the treatment goal is to alleviate subjective symptoms and that there is no implied or stated guarantee of success or effectiveness of any treatment. 

Treatment Benefits:

Ketamine has been shown to alleviate symptoms across a variety of mental health issues, as listed above. For people who have responded to ketamine in clinical trials, the initial antidepressant effects are often detectable within hours of administration, with peak antidepressant effects occurring approximately 24 - 48 hours after session, on average. 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.

Prior to your initial treatment, you and your Better U affiliated clinician will determine the initial treatment regimen that has the greatest likelihood of achieving your treatment goals.

Alternative Treatments:

Infusions of Lanicemine, Nitrous Oxide, Mamantine, among others.

Possible Risks and Side Effects:

The possible side effects and risks of Ketamine Therapy include, but are not limited to:

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

Rare side effects include arrythmia, low blood pressure, cystitis of the bladder (typically only seen in recreational abuse at high doses frequently over an extended period of time) and an allergic reaction.  

Long-term ketamine usage is not recommended.  Typically people will start with 4-8 sessions per month for the first 2-3 months. Then moving to once per week or once or twice per month as "maintenance" sessions.  We also recommend taking 1 month off after 4 months to properly gauge lasting benefits. 

This list is not meant to be inclusive of all possible risks associated with Ketamine Therapy, as there are both known and unknown side effects associated with any medication or procedure.

Possible Interactions:

I understand that other controlled substances, certain herbal products, medications, and supplements may result in reduced efficacy of treatment and/or additional side effects when interacting with Ketamine.

Consult your clinician during the appointment about possible interactions with any medication(s) that you are currently taking.  

Medical Care:

I understand that Better U, LLC is not a medical facility, nor does it provide medical diagnostics or medical care. If I feel I need medical attention and/or am concerned about a new or ongoing medical condition, I agree to seek medical attention and care at a qualified medical facility.  The clinicians that we work with are a part of Better U Medical Group, P.C. and can provide additional guidance for your ketamine treatments. 

I have read and agree to the aforementioned medical care statement. 

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.

By electronically signing this document, I confirm that:

I have fully read and understand this agreement.  I will comply with all stipulations included in this agreement and use my medication only as directed by my assigned Better U affiliated clinician. If I break this agreement, I will be disqualified from future services with Better U.