Buprenorphine Use in Opioid Dependency

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What do we need to transform this mayhem into a
legitimate medical procedure?
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Procedural Competency and Informed Consent
Orientation
Charles R. Albrecht III, MD Associate Program
Director, Hospital Medicine Section JHU/Sinai
Hospital Residency Program in Internal
Medicine Division Director, General Internal
Medicine
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Professional Responsibilities

• The medical profession
• Commitment to
• Professional Competence
• Honesty with Patients
• Patient Confidentiality
• Maintaining appropriate relationships with
  patients
• Improving Quality of care
• Improving Access to care
• A just distribution of finite resources
• Scientific Knowledge
• Maintaining trust by managing conflicts of
  interest
• Ann Intern Med 20021136243-246

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Basic Bioethical Compass
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Basic Bioethical Compass

• Autonomy
• Nonmaleficence
• Beneficence
• Justice

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History of Informed Consent

• Slater vs. Baker and Sapleton 1767
• It appears from the evidence of the surgeon that
  it was improper to disunite the callous without
  consent this is the usage and law of surgeons
  then it was ignorance and unskillfulness in that
  very particular, to do contrary to the rule of
  the profession, what no surgeon ought to have
  done.

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History of Informed Consent

• Salgo v. Leland Stanford Junior University Board
  of Trustees 1957
• Physicians have a positive legal obligation to
  disclose information about risks, benefits, and
  alternatives to patients.
• This decision popularized the term informed
  consent.

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Definition

• Informed consent is when a person autonomously
  authorizes a physician to undertake diagnostic or
  therapeutic interventions for him or herself.
• Three fundamental requirements are
• Disclosure
• Understanding
• Voluntariness

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Case presentation

• A 71 year old with PAD is admitted with gangrene
  of three toes. The residents explain to her the
  likelihood that, without amputation the infection
  will spread, leading to either amputation, or
  even death. She was able to recount everything
  she was told but refused to proceed with surgery.
  
• Thoughts????
• Disclosure, Understanding, Voluntariness

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6 fundamental elements of disclosure needed for
informed consent

• Diagnosis and prognosis
• Nature of the proposed intervention
• Alternative interventions
• Risks associated with interventions
• Benefits of each intervention
• Likely outcomes of each intervention
• Disclosure, Understanding, Volutariness

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Case presentation

• When asked why, she explained that, although she
  thought the doctors were sincere in their desire
  to help her, they were mistaken about her
  condition. Her toes were not gangrenous, but
  simply dirty. If the nurses would wash her toes,
  which she couldnt reach, they would no longer be
  black and she could go home. Washing her toes
  and informing her that they were still gangrenous
  did not change her view she continued to claim
  that it was dirt and not gangrene that was the
  cause of the problem. ---Thoughts now?????

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Background

• Capacity vs. Competence
• How are we doing?
• Studies show we infrequently communicate all
  relevant information
• 1057 consents, 11 provided alternatives, 8
  provided pros and cons, 1.5 assessed patients
  understanding of the information

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History of Physician Patient Relationship

• 1847 AMA- The obedience of a patient to the
  prescriptions of his physician should be prompt
  and implicit(the patient) should never permit
  his own crude opinions.
• 1953 JAMA 69 physicians never told their
  patients if they had cancer
• 1961 JAMA 90 physicians never told their
  patients if they had cancer
• 1979 JAMA 97 physicians preferred to tell
  patients of their diagnosis of cancer

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Risk prevails

• The nature of the risks
• Their magnitude
• The probability of each occurring
• When the consequence might occur

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Standards

• Physician Standard
• The physician should disclose information which
  a reasonable medical practitioner would make
  under the same or similar circumstances.
• Reasonable person Standard
• Physicians should disclose all information that a
  reasonable person in the patients circumstances
  would find material to their medical decision.

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Alternatives to Patient

• Reasonable Person Standard/ Emergency
• Advance Directives
• Health Care Proxy
• Surrogates
• Spouse?children?parents?siblings
• Two Physician Consent
• We hereby certify that this is an emergency, that
  the patient is unable to give consent, and there
  is no indication that the patient has withheld
  consent for this procedure

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Decision Making Capacity

• MMSE ?
• Functional Tests
• MacArthur Competence Assessment Tool-Treatment
• Making and communicating a choice
• Understanding relevant information in context
• Expression of ones values

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An Algorithm to assessing decision making
capacity (Miller and Marin. Emerg Med Clinic
North Am 200018233-241)

• Do the history and physical exam confirm that the
  patient can communicate a choice?
• Can the patient understand the essential elements
  of informed consent?
• What is your medical condition.
• What is the treatment being recommended?
• What might happen if you accept treatment?
• What might happen if you do not accept treatment?
• What are the alternatives and the probable
  consequences (including no treatment)?

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An Algorithm to assessing decision making
capacity (Miller and Marin. Emerg Med Clinic
North Am 200018233-241)

• Can the patient assign personal values to the
  risks and benefits of intervention?
• Can the patient manipulate the information
  rationally and logically?
• Is the patients decision making capacity stable
  over time?

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Issues of Competency/ Capacity

• Conflict between protecting patient from harm
  (beneficence/ nonmaleficence) and the duty to
  respect the wishes of a competent patient
  (autonomy) OR Although a physician shall
  respect the rights of patients (AMA Principles of
  Medical Ethics 2001) including self
  determination, does the right of the patient to
  decide for themselves extend to the right to make
  a bad decision?

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ABIM procedures

• Procedures required to be performed safely and
  competently by the ABIM
• The minimum number of procedures recommended is
  given in parenthesis. These procedures must be
  done under direct supervision of the attending
  physician and must have been successful
  procedures (not attempts).
• ACLS (1) (orientation)
• Drawing Venous Blood (5) (Floor rotations)
• Drawing Arterial Blood (5) (ICU rotation)
• Pelvic exam, Pap smear and endocervical culture
  (5) (Clinic)
• Placing a peripheral venous line (5) (Floor and
  ED rotation)

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Procedural Competency

• Cognitive stage- explain and demonstrate
• Performance erratic and broken into distinct
  stages
• Integration stage- practice and feedback
• Performance with fewer interruptions
• Automatic stage- little cognitive input
• Performance is efficient, fluid, precise

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Cognitive Competence

• Indications
• Contraindications
• Patient Preparation
• Pain management
• Sterile technique
• Proper handling
• Test result Interpretation

• Complications
• Recognize and manage
• Explanation
• To the patient for informed consent

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ICCE-T

• Indications
• Contraindications
• Complications
• Explanation
• Test Results

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Procedures to Know, Understand And Explain

• Abdominal Paracentesis (lecture)
• Arthrocentesis (lecture)
• Central Venous Line Placement (lecture)
• Incision and Drainage of an Abscess (ER)
• Lumbar Puncture (lecture)
• Nasogastric Intubation (lecture)
• Pulmonary artery catheter placement (CCU)
• Thoracentesis (lecture)

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Time out Policy

• The TIME OUT refers to mandated policy
  referring to the verification of site and patient
  prior to an invasive procedure including
  paracentesis, arthrocentesis, central line, LP,
  and thoracentesis. Before any invasive procedure
  that exposes the patient to more than minimal
  risk the healthcare team verifies
• Correct patient by 2 patient identifiers (name,
  mr, dob)
• Correct procedure (informed consent and
  documentation)
• Correct Site and Side
• A prefabricated sticker is available on the floors

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Post procedural note

• Required elements
• Pre/postop diagnoses
• Procedure
• Operator
• Estimated blood loss
• Complications
• Specimens
• A prefabricated note is available on intranet.

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Procedural Supervision

• May be supervised by someone who has attained
  competency to perform the procedure independently
• During working hours, you may call any of the
  academic hospitalists to supervise, preferably
  the team attending

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Supervision by Academic Hospitalists

• Try to have a set time in mind
• Obtain required labs
• If a patient of a private attending, discuss the
  procedure with the attending and let them know
  you are asking us to supervise
• Obtain informed consent