Informed Consent Part 1: General Principles Part 2: Risks and Alternatives Related to Central Venous Catheter Insertion Office of Graduate Medical Education Perelman School of Medicine University of Pennsylvania

Part 1: General Principles of Informed Consent

What is Informed Consent? The legal embodiment of the concept that each individual has the right to make decisions affecting his or her health. A dialogue between patient and physician about a potential treatment/procedure – When informed consent is done well, it strengthens the physician-patient relationship with shared authority, decision-making, and responsibility for outcomes Ethically, morally, and legally mandated. Many states have codified informed consent into statutory law

What is Informed Consent? “Consent is informed if the patient has been given a description of the procedure…and the risks and alternatives that a reasonably prudent patient would require to make an informed decision to that procedure…” * All Language on this slide is from Pennsylvania State MCARE law

Informed Consent is a Duty of Physicians* Except in emergencies, a physician owes a duty to a patient to obtain the informed consent of the patient or the patient’s authorized representative prior to conducting the following procedures: 1) Performing surgery, including administration of anesthesia 2) Performing any invasive procedure 3) Administering radiation or chemotherapy 4) Administering a blood transfusion 5) Inserting a surgical device or appliance. * All Language on this slide is from Pennsylvania State MCARE law

Principles of Informed Consent The physician directly involved in the proposed treatment or procedure should conduct the discussion. The informed consent discussion should include: – A discussion of the actual treatment/procedure – Risks and benefits of the treatment/procedure – Alternative therapies (with associated risks/benefits) – Both severe risks that occur rarely and less severe risks that occur more frequently – The most likely outcome with no treatment/procedure

Principles of Informed Consent Informed consent can be withdrawn at any time. When a physician allows a patient hours to reflect upon the decision, it validates the notion of informed consent. Can be enhanced through appropriate use of pamphlets, videos, or through involvement of support staff (advanced practice providers or nurses) Must be in a language that the patient understands

Documentation of Informed Consent Informed consent discussions must be documented on UPHS informed consent documents Must be: – Legible – Dated and timed – Authenticated (signature followed by credentials)

Who Signs Where? Signature: __________________________________ Date: _________ Time: _______ Patient Signature: ___________________________________ Date: _________ Time: ______ Authorized Healthcare Professional obtaining & witnessing patient’s signature Signature: ___________________________________ Date: _________ Time: ______ Attending Physician if applicable ***************************************************************************** ************************ Must be legible. If you need to correct an error on the document, make a single line through the error and initial, date, and time the correction.

Part 2: Risks and Alternatives to Central Venous Catheter Insertion

Risks* of Central Venous Catheter Placement Bleeding Localized Pain Infection: insertion site or bloodstream Blockage of blood vessel (clot) Damage to the local artery or vein Injury to chest or lungs including hemothorax or pneumothorax Other unexpected risks or complications including death Also consider and discuss risks specific to the individual patient (e.g. possible increased risk of infection in a patient with immunosuppression) *Risks listed on this slide are those that are included on the Penn Medicine Informed Consent for Central Venous Catheter Document

You Must Review Alternatives* to Central Venous Catheter Placement Alternatives: There may be other ways to monitor your condition or collect the information that is obtained by a central venous catheter (e.g. through non-invasive hemodynamic monitoring) There may be other ways to administer fluids, medications, nutrition (e.g. through a peripheral vein) *Alternatives listed on this slide are those that are included on the Penn Medicine Informed Consent for Central Venous Catheter Document