Orthobiologic Consent Guidelines (Part 1)

Let's uncover the crucial elements of patient education, explore the nuances of off-label conversations, and dissect the intricacies of informed consent items and scripts. Don't miss out on the valuable insights shared by industry experts, guiding you towards a more profound understanding of the evolving orthobiologics landscape.

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Transcript

Intro

Hey, I'm Dr. Ariana DeMers. I'm an orthopedic sports medicine surgeon, and I have successfully integrated orthobiologics into my busy practice so that I can provide a continuum of care and treat patients who are in the gap. The gap is this gray area in orthopedics where standard conservative treatments have not been effective, but surgery may not be warranted. And we usually tell our patients, come back when it's worse. What? These are your patients coming to you for help. Orthobiologics is that solution that can fill the gap and help you treat your patients who are in your office looking to you for help. Orthobiologics can also be an excellent treatment for frustrating problems without good surgical outcomes. This podcast will help you create the orthobiologics business that will make you love your job again. We will focus on value of orthobiologics, patient selection, how to talk to your patients about money, office setup, and other logistics. If this is something you've always wanted but don't know where to start, join me in "The Business of Orthobiologics" podcast.

Dr. Ariana

Hi there. Welcome to The Bonus, Orthobiologic Consent Guidelines. Creating a consent form for orthobiologic treatments and educating your patients on the complex nature of these procedures is crucial for ensuring that they have the necessary information to make an informed decision. We will discuss physicians' responsibilities, recommendations for items to include in the consent form, and the best ways to educate your patients effectively and compliantly. I will also provide a couple of examples of scripts that could be used to talk to your patients. First off, I wanted to include physician responsibilities. So informed consent. When we're talking about this complex treatment, physicians should obtain consent from the patient explaining that this is an off-label use, evaluating and discussing potential benefits, risks, and available alternatives. It's essential to disclose any potential risks or side effects associated with orthobiologics therapies, and this helps patients make informed decisions and demonstrates a commitment to transparency. Also, we need to clearly state the limitations. You should provide clear and accurate information about the limitations and potential risks associated with orthobiologics, including PRP and cellular therapies. It's crucial to emphasize that the outcomes may vary for individual patients and that all conditions may not be suitable for orthobiologic treatments. You must use evidence-based information and ensure that any orthobiologic information that's presented is supported by credible scientific research and clinical studies. You can do this in the form of a bibliography or on your website, and you can reference that. Then referencing peer-reviewed publications and reputable sources helps establish the credibility of this information shared. For documentation, physicians should document the rationale for off-label use in the patient's medical record, including the reason for choosing this approach and any discussions with the patients. When it comes to off-label use, times when physicians are using off-label devices or off-label medications, make sure that you're documenting medical judgment. Physicians can use any approved device or medication off label if they believe based on their medical judgment and expertise, that is the best course of treatment for a particular patient's condition. Additionally, I would like to recommend that you document the lack of approved alternatives. Off-label use may be considered when there are no approved alternatives available for a specific condition or patient population. When you're using things off-label, make sure that you're monitoring the patient's response to the off-label treatment and adjust the treatment plan as necessary. Then obviously, stay current about the latest clinical evidence and guidelines related to the off-label use to ensure that the decisions are based on the most up-to-date information. Patient education should include a clear explanation and thoroughly discuss why you are recommending an off-label use of a medication or device. FYI, any musculoskeletal injection-based therapy use of the platelet-rich plasma 510(k) clear devices is off-label because the PRP devices were created to create PRP to make bone marrow and bone graft easier to use and apply. If you're not using it for bone grafting specifically, then you're using it off-label. Make sure that you document the potential risks and benefits and alternative options, including treatments that are FDA-approved, and explain why the off-label use is being considered the best course of action. Additionally, we're talking about informed consent, and this ensures that the patient understands the treatment, acknowledges off-label use, and provides informed consent in writing. The patient should have a clear understanding of the treatment and give their informed consent willingly. To effectively and compliantly educate the patients, there are a number of steps that need to be done. Really, this is not a one-time education. This should start with the initial consultation and discuss the orthobiologics treatments with the patient during this meeting, explain the procedure, its purpose, and potential risks and benefits. Next, I'm going to recommend you provide written materials that explain the procedure, its potential outcomes, risks, and alternatives. These materials can serve as a reference for patients to review at home. Next, an in-person discussion. I really, really, really recommend spending ample time to discuss the procedure with the patient, encouraging them to ask questions, and addressing any other concerns they may have. Then avoid using overly technical language. Use layman's terms to explain these complex medical concepts in simple, understandable terms. A lot of times, visual aids help, such as diagrams or videos, to help patients visualize this procedure and its potential impact. Then your informed decision is really going to culminate in providing this information, allowing them to ask questions, and then documenting their understanding in the patient's record. I always recommend you to encourage the patients to seek a second opinion if they have doubts or concerns, and then the consent form should only be signed after the patient has been able to ask all questions and they feel that they are informed and comfortable with their decision. Next, follow-up communication is always effective to communicate before and after the procedure to address any additional concerns that may arise throughout the process, and then compliance, making sure your educational materials and consent forms apply with the federal regulations, state and local regulations. Please remember, informed consent is an ongoing process, and patients should feel empowered to make decisions based on a thorough understanding of their orthobiologics treatments. This may change over time and this process, this ongoing process helps build trust and ensures patient safety. Items to include in your orthobiologics treatments. Number one, the patient information should have personal details including name, date of birth, and appropriate contact information. It should also include your name, medical license number, and contact details or location. Next is providing a clear description of the procedure with a concise description of the orthobiologic treatment, including the type of orthobiologic used, i.e., platelet-rich plasma, bone marrow concentrate, micro-fragmented adipose, and the purpose of the treatment. When you're outlining the purpose and risks, detail those potential benefits and risks associated with treatment, such as infection, pain at the site of injection, allergic reaction, and limited efficacy, and then also discuss alternatives. Alternative treatment options, including no treatment at all, and then the potential risks and benefits of each alternative option. Next, the recommendation is to explain the procedure itself and how it will be performed, the anesthesia or sedation options, and any post-treatment care requirements within the treatment, and then expected outcomes describing exactly what the patients can reasonably expect regarding pain relief, improved function, or any other desirable outcomes. Please outline clearly potential complications or side effects such as pain, swelling, bruising, infection, increased pain, and no guarantee of efficacy. Sometimes, though, there is recommended in the consent to clarify the cost of the procedure and whether it's covered by insurance and any out-of-pocket expense. Then a very clear area where they acknowledge their understanding of the procedure, understanding of the risks, and they consent to treatment. Then finally, the date and witness to include the witness to sign and date the form that the patient has voluntarily given consent and has not been coerced. Then the practitioner's signature also should be signed and dated that you have discussed the procedure and the patient has had the opportunity to answer any questions. A little bit more about this, I wanted to give you a script for possibly discussing these orthobiologic consent treatments. You know, I would say, "Hello, Sue. My name is Dr. DeMers, and today I want to discuss with you the orthobiologic treatment that we're considering for you. It's really important for you to understand that this treatment of what it entails and what to expect. The orthobiologic treatment involves using the biological substance of platelet-rich plasma or cellular therapy to promote healing and tissue repair in your body. The main purpose of this treatment is for you to have reduced pain and increased function, possibly through promoting tissue healing. Now, it's crucial that you be aware of all the potential risks associated with this procedure. These risks include the possibility of infection, allergic reactions, limited efficiency or efficacy, as well as common side effects like pain, swelling, and bruising at the injection site. Before we proceed, I wanted to also mention that there are alternatives to this treatment, such as physical therapy, anti-inflammatory medications, and FDA-approved injections, and we can help you discuss these alternatives to make an informed decision. The procedure itself will involve local anesthetic and under ultrasound guidance with injection-based therapy under ultrasound guidance, a limited downtime of 48 hours of taking it easy, and a gentle brace and range of motion, and then back to activities as you see fit".

Outro

This has been "The Business of Orthobiologics" podcast. Thank you so much for joining us today. If you want to know more, please join us on the website, "PRP-Now.com", and click on the FREE masterclass. Also, don't forget to "SUBSCRIBE" to this podcast to get more guidance on integrating PRP in your busy practice. Bye for now.