Informed Consent for Magnetic Resonance Imaging (MRI) in Patients with Coronary Artery Stents

Transcription

1 Informed Consent for Magnetic Resonance Imaging (MRI) in Patients with Coronary Artery Stents Introduction: Using the Outline and Tools for MRI Consent The appended outline is intended for use in developing a policy and procedure for consent to MRI services. The content emphasizes the importance of patient engagement, obtaining accurate history information to determine if the patient has coronary artery stents that could be impacted by exposure to certain types of MRI devices. A flowchart is provided to demonstrate the consent process sequence. The idea is to align the content of the policy and procedure with the flowchart to meet local needs at your facility. Sample consent documents are also part of the packet. It is emphasized that these are sample tools only. Input is encouraged from legal counsel to make certain that the final content is consistent with applicable state law. Finally, the consent documents are not intended to serve as a substitute for a consent communication process. Providing in-service education on this point may help to strengthen physician-patient engagement. 1

2 Outline for MRI Consent Policy and Procedure Content Intake Questions Cognitively Intact Patient Have you ever had any problems with your heart? If yes, please describe (record information in medical record). Do you have a cardiologist? Have you ever seen a cardiologist? If yes, for what reason? Have you ever had a heart attack? Yes No (Document in the medical record). Have you been treated for blockages in the (vessels) of the heart? If yes, what type of treatment did you receive? Have you ever had a cardiac catheterization (a procedure in which a tube was threaded into your wrist, arm or groin in order to take pictures of the arteries around your heart)? Did you have a coronary artery or cardiac stent(s) (tube in the vessels of the heart to keep them open) placed? If yes to cardiac stent placement, when you received your treatment in the past for your heart condition did you receive a card or other papers that provided information about the stent device? May I see the stent card or paperwork if you have it with you now? Please bring your stent card with you to your appointment. You say that you cannot remember all the details about how you were treated for your heart problem. Is there someone with you today or someone we may contact to get further details? If yes, who is the person and what is his/her relationship to you? Non-Cognitively Intact and/or Sedated Patient Requiring Immediate Care Check for cardiac stent information card in the patient s belongings If there is next of kin, duly authorized surrogate, or support person with the Patient: Ask for patient medical history, especially coronary artery stent placement or o Contact next of kin if known and inquire about past treatment including coronary artery stent placement Access patient EMR or EHR if available for medical history regarding coronary artery stents. Contact Primary Care (PCP), Cardiologist, if known and ask for stent information. Document why the situation constitutes a medical-legal emergency exception to obtaining consent. 2

3 Consent Communication Process with Patient or Duly Authorized Surrogate Explanation of the indications for MRI. Explanation of what is involved in the MRI. Explanation why questions were posed about previous medical history involving placement of stents in the coronary arteries We wanted to determine if you might have the type of stent that sometimes may cause some risks with the type of MRI we have available here. Present the probable benefits and probable risks associated with the MRI and in particular, potential risks associated with MRI examinations using local equipment with patients with some coronary artery stents Discuss the alternatives to having the MRI at this facility, including referral to another facility with an MRI that does not pose risks for those with some types of coronary artery stents. Describe the probable benefits and probable risks associated with the referral to another facility for the MRI including: o transfer costs o possible delay in testing and possible treatment o possibility that the patient s health plan considers the alternate site an out-of-network facility for which there is a higher co-pay. Discuss the probable consequences of refusing recommended and alternate diagnostic imaging tests. Answer questions, providing understandable responses. Complete a teach-back with patient/surrogate. Document informed refusal (when patient declines recommended or alternate imaging services) *Notify ordering provider when change in MRI scanner location or patient/surrogate refusal of MRI scan Accommodation Needs Language interpreter services, including American Sign Language Written explanatory information made available to the patient /surrogate in a language he/she prefers. 3

4 Sample Consent Tool Consent Documentation - See Addendum Emergency MRI Consent Exception Documentation The following would be recorded in the patient s medical record The patient, presented with a [life] [health] threatening event [describe here], and either due to an underlying condition or the acute event, was unable to participate in an informed consent process. A reasonable, good faith effort was made to obtain as much medical history information as possible regarding the patient from [select from the following choices: his/her EMR; EHR; MedicAlert; EMTs; relatives accompanying the patient; support person with the patient; legally authorized representative; primary care provider; specialist] Information obtained, if applicable: Based on the patient s acute status, a decision was made that the most prudent choice for [diagnosis} [treatment] was an MRI. The diagnostic imaging was completed at on. Signature Care Provider Date Time 4

5 Sample Consent Tool MRI Impracticality Consent Exception Documentation The patient, presented with a [life] [health] threatening event [describe here], and was able to participate in a brief conversation regarding his/her medical history. The patient was informed of the indications for an MRI and was provided with a brief explanation of the MRI procedure. A reasonable, good faith effort was made to obtain additional medical history information regarding the patient from [select from the following choices: his/her EMR; EHR; MedicAlert; EMTs; relatives accompanying the patient; support person with the patient; legally authorized representative; primary care provider; specialist] Information obtained, if applicable: Based on the patient s acute status, a decision was made that the most prudent choice for [diagnosis[ [treatment] was an MRI. The diagnostic imaging was completed at on. Signature Care Provider Date Time 5

6 Sample Tool MRI Consent Documentation The patient, presented with [ description of condition] for which an MRI is indicated. The patient was informed of: risks the MRI, including related probable benefits and probable alternatives to it. The patient was asked a series of questions to confirm his/her understanding of the MRI recommendation and alternatives to it. Based on the patient s responses, in my professional judgment the patient understood the information provided. The patient made this decision freely without any undue influence or coercion. Signature Care Provider Date Time 6

7 Sample Tool MRI Machine Choice Consent Documentation The patient, presented with [ description of condition] for which an MRI is indicated. The patient was informed of: ications for the MRI risks alternatives to it. Based on medical history information available regarding the patient, there is a possibility that the patient has one or more coronary artery stent(s). The patient was informed that while the presence of such stents is usually not a problem for those undergoing an MRI, one in ten patients may experience [explain risk of harm] due to stent exposure to the type of MRI available at this location. I discussed with the patient the option of having the MRI performed [name of facility] where the MRI device does not involve the [risk of harm]. Also discussed was the option of having a [name of test/treatment] in lieu of the MRI here. The patient was informed that there could be a delay in having the MRI at due to the need to arrange transportation and scheduling the MRI at. Further, the patient was encouraged to check whether transportation by ambulance to was a covered service under his/her health plan and also, whether the MRI completed at would be considered an out of network service increasing his/her out of pocket costs for the MRI. I discussed too, that the (e.g. office of patient relations) here is available to assist in obtaining answers to these coverage questions. The patient was asked a series of questions to confirm his/her understanding of the MRI recommendation and alternatives to it. Based on the patient s responses, in my professional judgment the patient understood the information provided. The patient made this decision freely without any undue influence or coercion. Signature Care Provider Date Time 7

8 Consent Note If the patient was receiving pain management medication during the consent process, this information should be noted in the consent document. The patient was receiving for pain management. Based on my clinical judgment, it did not appear that the presence of the pain management medication impaired the patient s ability to make a treatment decision. If a language interpreter was involved during the consent process, this information should be noted in the consent document. I,, a language interpreter, used [language] during the consent process. Based on questions posed to the patient and responses received in my clinical judgment, it appeared that the patient understood the information I provided through the use of the language interpreter. Information is provided for general informational purposes only and does not constitute legal, risk management, or other advice. Readers should consult their own counsel or other advisors for such advice. OneBeacon Professional Insurance (OBPI) and its parents and affiliates, The Rozovsky Group and consultants, contractors, and vendors of OBPI, The Rozovsky Group assume no responsibility or liability for the discovery or elimination of risks that possibly could cause accidents, injuries, or damages. Compliance with any strategies or opportunities for improvement provided in publications does not assure elimination of risks or the satisfaction of requirements of applicable law. Copyright The Rozovsky Group, Inc. and OneBeacon Professional Insurance. All Rights Reserved. Information may not be redistributed to non-obpi insured policy holders without OBPI s permission. 8

9 Information is provided for general informational purposes only and does not constitute legal, risk management, or other advice. Readers should consult their own counsel or other advisors for such advice. OneBeacon Professional Insurance (OBPI) and its parents and affiliates, The Rozovsky Group and consultants, contractors, and vendors of OBPI, The Rozovsky Group assume no responsibility or liability for the discovery or elimination of risks that possibly could cause accidents, injuries, or damages. Compliance with any strategies or opportunities for improvement provided in publications does not assure elimination of risks or the satisfaction of requirements of applicable law. Copyright The Rozovsky Group, Inc. and OneBeacon Professional Insurance. All Rights Reserved. Information may not be redistributed to non-obpi insured policy holders without OBPI s permission. 9

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