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By Dr. Eric Bricker MD

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ELECTRONIC SURGICAL INFORMED CONSENT FORMS FOR PODIATRISTS

CUSTOMIZABLE PROTOCOLS, CHECKLISTS & TEMPLATES

Courtesy: https://lnkd.in/gzhrqYP

e-Podiatry Consent Forms™ is an innovative new suite of software programs from the Institute of Medical Business Advisors [iMBA, Inc]. Our products solve your informed consent problems and enhance the education, discussion and documentation of the informed consent process for all podiatrists, orthopedists or other surgeons performing foot, ankle and leg reconstructive surgical procedures.

MORE: https://lnkd.in/eMbZnvA
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RELATED: www.PodiatryPrep.org

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About Consent Care.Net

The Case for Fully Informed Consent

By Dr. Martin Young

MBChB, FCS(SA)Otol.

martin@carespace.net

The issue of ‘informed consent’ is an ever present bugbear in all healthcare systems around the world, raising its head time after time in journals, weblogs, healthcare administration policies and, above all, medical malpractice lawsuits. Every mention emphasizes the need for improving this difficult issue, but in spite thereof little seems to change.  ConsentCare is a new initiative aiming at addressing the challenges of facilitating and enhancing informed consent.

Why the big deal?

Medical ethicists have long known that, if trust is indeed the cornerstone of the successful doctor-patient relationship, that subjecting a person to medical or surgical treatment without discussing all aspects thereof wherever possible, i.e. fully informed consent, constitutes a betrayal of that trust.

Common opinion asserts that good informed consent creates better mental preparation for surgery, decreased anxiety, shorter hospital stays, earlier recognition of complications by patients before they become serious, and a generally higher success rate and satisfaction rate for the surgery.

70% of the detail of discussion about surgical detail and risk held in doctors’ rooms is forgotten by patients by the time the consultation is over. Patients are ordinarily asked to consent to surgical procedures ‘on the spot’ without access to the detailed documentation of the risks of those procedures that they can consider in their own time and own comfortable environment.

A person knowing all the information about his or her procedure acts as another measure of control to avoid outright human error, such as the wrong operation, or operating on the wrong side.

Almost every case of litigation following surgery will address the adequacy of the consent process.

The right to full knowledge about medical or surgical interventions is entrenched as a human right, even legally enforceable by inclusion in the constitutions of some countries.

No longer is a successful surgical outcome adequate protection against litigation, particularly where the consent is deemed to have contained inadequate information.

In an environment where litigation is on the increase, and expectations, demands and knowledge by the public have heightened, adequate and fully informed consent is one of the few protections doctors can apply both to their own benefit and to that of their patients.

The challenges

Good informed consent is not just presentation of a form that demands the patient’s signature on the bottom.  The process is dependent on all aspects of a good doctor-patient interaction, i.e. positive and empathetic communication, good bedside manner, open and frank discussion of alternatives and costs, opportunity to ask questions, to seek independent advice, and to make decisions based on full disclosure of relevant facts.  The result can however be a valuable clinical record of benefit to all role-players in the process of having a surgical procedure.

The demands of taking fully informed consent are considerable.  No patient is the same, and a standard ‘one size fits all’ approach cannot take this into consideration. The same can be said for the doctor taking the consent.  All have individual approaches and styles that should facilitated by the consent process.  Again, ‘one size fits all’ is as inappropriate for doctors as it is for patients.  The challenge for doctors is in documenting the process for both their patients’ and their own benefit.  Without technological assistance this is impossible to do, for example, to the satisfaction of a medical malpractice lawyer hell-bent on proving medical negligence.

Solutions

ConsentCare was designed taking all these considerations into account, but preserving the traditional and familiar signed document as a final result .  A web-based platform was used, making the system accessible to both doctors and patients through a doctor portal and a patient portal, and opening the possibilities of direct doctor-patient communication around the specified procedure.  Call it if you like a ‘mini-Facebook’ around the consent process.

On logging in a doctor adds a new patient, and proceeds through progressive steps, selecting procedure name, adding or editing graphics, and having editorial control over the content at all stages.  An “editor’s” function allows preset information to be saved, speeding up the process for subsequent consents.

For all procedures a detailed consent document specific to the doctor, patient and procedure is produced in pdf form within a few minutes. This can be emailed to a patient beforehand, edited digitally using tablet PC’s, or printed out and discussed on the spot, leaving all options open as per the doctor’s preferences.

The potential

No other process leaves better evidence of a doctor’s ethical approach, transparency, patient care and responsibility than the informed consent process.  This is a document that should be in the patient’s possession as well as in the medical record, an ethical yardstick of due diligence.  It gives very little clinical detail away other than a patient’s name, the procedure, and likelihood of expected risks.  As such, this can assist the detailed case management of patients, warn nursing staff of anticipated complications, and allocate patients to different levels of post operative care.  It becomes a valuable nursing tool, not just a medicolegal hassle.

The record of a doctor’s approach to his patients in terms of attention to informed consent can be an ethical yardstick that raises that doctor’s profile above the rest.  In an era of doctor and hospital ratings, rising healthcare costs, rising litigation, and increasingly limited resources, all payers, i.e. patients, funders and insurers, could benefit from recognizing where their money is best spent.

The doctor’s excuse “I don’t have the time” should no longer be relevant. Technology takes care of that issue.  The consent process is so important, and with such cost-saving potential in the long term, that time considerations should be far secondary to ethical considerations.  In an era where low markups on doctors’ services promote the push to do high numbers of procedures, the consent process could be the one determinant to start reversing that process.

So, doctors, please make the time, cut the volumes, but, funders and insurers, make sure the doctor does not pay a financial penalty, and is remunerated properly for work done properly.  And malpractice insurers, please take note, and lower premiums for users.

Herein lies the true potential of facilitated informed consent, a ‘win-win’ for everyone involved.

Our position 

ConsentCare is a working proof-of-concept,  available for ‘reskinning’ to the designs of any users /institutions, with the same design elements applied to the final document, and can be hosted on private servers.

Interested users are invited to sign in on the website at www.consentcare.net for more information and a look around with basic functionality, and to contact me for more information.

Conclusion

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Conclusion

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New Medical Informed Consent Dilemma

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Emerging Problems

By Dr. David Edward Marcinko; MBA, CMP™

[Publisher-in-Chief]dem21

According to the Dictionary of Health Insurance and Managed Care, informed consent is the oral and written communication process between a patient and physician that results in the agreement to undergo a particular procedure, surgical intervention or medical treatment.

Unfortunately, a lack of standardization surrounding this process represents a major risk for patients and surgeons, and may lead to inaccurate patient expectations, lost or incomplete consent forms, missing encounter documentation and delays in critical surgeries and procedures.

History: Render S. Davis of Emory University [2008 recipient of the Health Care Ethics Consortium’s Heroes in Healthcare Ethics Award] writes for us in the Business of Medical Practice www.MedicalBusinessAdvisors.com that the concept of informed consent is rooted in medical ethics and codified as a legal principle. It is based on the assertion that a competent person has the right to determine what is done to him or her [self-regulated autonomy].

Rationale: The American Medical Association recommends that its members disclose and discuss the following with their patients:  

  • The patient’s diagnosis, if known,
  • The nature and purpose of a proposed treatment or procedure,
  • The risks and benefits of a proposed treatment or procedure,
  • Alternatives (regardless of cost or health insurance coverage),
  • The risks and benefits of the alternative treatments and,
  • The risks and benefits of not the procedure.

The requirements for informed consent are spelled out in statutes and case law in all 50 states. It is a necessary protocol for all hospitals, medical clinics, podiatry practices and ASCs.

Inadequacy of Traditional Consent Forms-to-Date

The typical informed consent process, particularly one that relies solely on traditional generic consent forms, is often inadequate, incomplete or offers the potential for not fully explaining and documenting a particular procedure to a given patient. 

Traditional consent forms are subject to errors and omissions, such as missing signatures (patient, provider or witness), missing procedure(s), and missing dates that place the validity of consent at risk. Lost or misplaced forms may result in delayed or postponed procedures often at the expensive of costly operating room time. Moreover, far too many forms are generic in nature and wholly unsuited for a specific patient or increasingly sophisticated medical procedure.

Patient Safety Background

According to the Institute of Medicine’s [IOM] repot, To Err is Human, more than 1 million injuries and nearly 100,000 deaths occur annually in the United States due to mistakes in medical care. Wrong patient, wrong-side, wrong-procedure and wrong-toe surgery are particularly egregious. In fact, these are among several other “never-events” that Medicare, and an increasing number of private insurance companies are refusing to reimburse.

Based on the need to make healthcare safer, the Agency for Healthcare Research and Quality (AHRQ) undertook a study to identify patient safety issues and develop recommendations for “best practices”.

AHRQ Evidence Report

The AHRQ report identified the challenge of addressing shortcomings such as missed, incomplete or not fully comprehended informed consent, as a significant patient safety opportunity for improvement.

The authors of the AHRQ report hypothesized that better informed patients “are less likely to experience errors by acting as another layer of protection.” And, the AHRQ study ranked a more interactive informed consent process among the top 11 practices supporting more widespread implementation.

General Accounting Office report found that malpractice insurance premiums were relatively flat for most of the 1990’s, but projections began to increase dramatically to 2010.

Results of Improper Informed Consent

Failure to obtain adequate informed consent, depending on state law, may place surgeons, resident, fellows, ambulatory and office surgery centers, medical clinics and hospitals at risk for litigation ranging from medical negligence to assault and battery.

Proceedings Involving Informed Consent

Informed consent is often a factor in medical malpractice litigation. Some attorneys note that physicians are liable, and that plaintiffs may be able to recover damages, in cases involving improper informed consent, even if the procedure is successful. Inadequate informed consent is often cited as a secondary cause in malpractice complaints and anecdotal evidence suggests this strategy may be especially pursued in podiatric malpractices cases.

Avoiding Litigation

The AMA advises its membership of the following regarding informed consent:  

“To protect yourself in litigation, in addition to carrying adequate liability insurance, it is important that the communications process itself be documented. Good documentation can serve as evidence in a court of the law that the process indeed took place. A timely and thorough documentation in the patient’s chart by the physician providing the treatment and/or performing the procedure can be a strong piece of evidence that the physician engaged the patient in an appropriate discussion.”

Impact of Comprehensive Informed Consent Forms

Another study found that providing informed consent information to patients in written form increased comprehension of the procedure. It was also hypothesized that: 

  • Better informed patients are more compliant with medical advice and recover faster.
  • Informed consent discussions strengthen physician-patient relationships and increase patients’ confidence in their doctor.
  • Well informed patients are more engaged in their own care, and are thus less likely to experience surgical errors than more passive, or less informed patients. 

Medical Ethics

The ethical foundation of informed consent is based on the creation of an environment that supports respect for patients and protects their right to autonomous, informed participation in all collaborative Healthcare 2.0 decisions. 

Assessment 

Thus, the essence of the informed consent problems of modern medicine today!

More: http://www.ePodiatryConsentForms.com 

Channel Surfing the ME-P

Have you visited our other topic channels? Established to facilitate idea exchange and link our community together, the value of these topics is dependent upon your input. Please take a minute to visit. And, to prevent that annoying spam, we ask that you register. It is fast, free and secure.

Conclusion

Your thoughts and comments on this ME-P are appreciated. Feel free to review our top-left column, and top-right sidebar materials, links, URLs and related websites, too. Then, subscribe to the ME-P. It is fast, free and secure.

Speaker: If you need a moderator or speaker for an upcoming event, Dr. David E. Marcinko; MBA – Publisher-in-Chief of the Medical Executive-Post – is available for seminar or speaking engagements. Contact: MarcinkoAdvisors@msn.com

OUR OTHER PRINT BOOKS AND RELATED INFORMATION SOURCES:

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