What elements should be included in an informed consent for a Peripherally Inserted Central Catheter (PICC) line placement?

From the Guidelines

An informed consent for a Peripherally Inserted Central Catheter (PICC) line placement must include elements of patient capacity, voluntariness, disclosure of material information, recommendation of a plan, understanding, decision, and authorization, as outlined in the concept of shared decision-making 1. When writing an informed consent for a PICC line, several key elements should be included to ensure patients fully understand the procedure.

• The consent should explain the purpose of the PICC line, typically for long-term intravenous access for medications, fluids, or blood draws.
• It should describe the procedure itself, including that a thin, flexible tube will be inserted through a vein in the arm and advanced until the tip reaches a large vein near the heart.
• The document should outline potential benefits such as reduced need for repeated needle sticks and ability to receive treatments that cannot be given through peripheral IVs.
• Risks that must be disclosed include infection, bleeding, thrombosis (blood clot formation), catheter migration or breakage, pneumothorax (collapsed lung), cardiac arrhythmias, and air embolism.
• The consent should mention alternatives to PICC lines such as peripheral IVs, implanted ports, or tunneled catheters.
• Post-procedure care instructions should be included, covering dressing changes, flushing protocols, activity restrictions, and signs of complications requiring medical attention.
• The consent should also specify the expected duration of PICC line placement and acknowledge that the patient has had the opportunity to ask questions and has received satisfactory answers before giving consent, in line with the principles of informed consent 1. The process of obtaining informed consent should follow a model of shared decision-making, where clinicians and patients work together to decide on the best care options, especially when there are multiple reasonable options available 1.

From the Research

Elements of Informed Consent for PICC Line Placement

The informed consent for a Peripherally Inserted Central Catheter (PICC) line placement should include the following elements:

• Purpose and process of the procedure: Explain the reason for the PICC line placement, how it will be inserted, and what to expect during the procedure 2
• Risks and benefits: Discuss the potential risks, such as occlusion, rupture, accidental withdrawal, infection, and venous thrombosis, as well as the benefits of having a PICC line, including convenient vascular access for long-term antibiotic treatment, chemotherapy, parenteral nutrition, and blood draws 3, 4
• Alternatives: Inform the patient about alternative options, such as conventional central venous catheters, and the reasons why a PICC line is recommended 2
• Complications associated with PICC lines: Specifically for patients with chronic kidney disease, discuss the increased risk of complications, such as phlebitis/thrombophlebitis, venous thrombosis, catheter-related infection, wound infection, and central vein stenosis, and the importance of preserving venous real estate 4

Readability and Comprehension of Informed Consent

To ensure patient comprehension, the informed consent document should:

• Be written in plain language, avoiding technical jargon and complex medical terminology 2, 5
• Have a readability level that does not exceed the 6th grade level, as recommended by the American Medical Association (AMA) and the National Institutes of Health (NIH) 5
• Use clear and concise formatting, with bullet points and short paragraphs to facilitate understanding 6
• Be supplemented with audiovisual or multimedia materials, extended discussions, or test/feedback techniques to improve patient comprehension, if necessary 6

Patient Understanding and Decision-Making

The informed consent process should:

• Allow patients to ask questions and express concerns about the procedure 2
• Provide patients with sufficient time to review the informed consent document and make a decision about whether to proceed with the PICC line placement 2
• Ensure that patients understand the risks, benefits, and alternatives to the procedure, and are able to make an informed decision about their care 2, 6