What is the difference between a shared decision-making tool and an informed consent?

What is a shared decision-making tool?

A shared decision-making tool or SDM tool is an encounter that occurs between the patient and a physician or qualified nonphysician practitioner such as:

• Physician assistant
• Nurse practitioner
• Clinical nurse specialist
• Independent non-interventional physician

SDM tools are designed to help patients and clinicians participate in making specific choices among health care options. It describes options, benefits, harms, and areas of uncertainty for different health care treatments. The SDM tool should be an evidence-based decision tool such as the following and documented in the medical record, which tool was used:

• Anticoagulant Care Planning (ACP) AF Management Guide
• National Institute for Clinical Excellence (NICE) Patient Decision Aid on AF Treatment Options, American College of Cardiology (ACC) Cardiosmart’s AF Treatment Options
• SPARC — Stroke Prevention in Atrial Fibrillation Risk Tool
• Healthwise Decision Tool
• Idecide ICD — Cardiosmart

For cardiac procedures there are some differences on who can complete the SDM encounter. 

For the left atrial appendage closure or LAAC, the SDM encounter must occur between the patient and an independent non-interventional physician using an evidence-based decision tool on oral anticoagulation in patients with NVAF prior to the LAAC procedure. 

For Implantable Cardioverter Defibrillator (ICD), the SDM encounter must occur between the patient and a physician or qualified non-physician practitioner prior to the implantation.

What is an informed consent?

An informed consent is a process of communication between the patient or beneficiary and the health care provider that often leads to agreement or permission for care, treatment, or services. Every patient or beneficiary has the right to get information and ask questions before procedures and treatments. If adult patients are mentally able to make their own decisions, medical care cannot begin unless they give informed consent. The informed consent process makes sure that the health care provider has given the beneficiary/patient information about the condition(s) along with testing and treatment options before they decide what to do. Although, shared decision-making is part of the informed consent process, a signed consent form alone does not suffice for a SDM encounter or tool.

Resources

• Decision Memo for Implantable Cardioverter Defibrillators (CAG-00157R4)
• National Coverage Determination (NCD) for Implantable Automatic Defibrillators (20.4)
• Medicare Learning Network (MLN) Matters Article, MM 10865 — NCD 20.4 Implantable Cardiac Defibrillators (ICDs) (PDF)
• Medicare Learning Network (MLN) Matters Artile, SE 2006 — NCD 20.4 Implantable Cardiac Defibrillators (ICDs) (PDF)
• Medicare Coverage Database (MCD) Article: Billing and Coding: Implantable Automatic Defibrillators (A56343)
• Closing the Gap: Left Atrial Appendage Closure Module
  • JJ Part A
  • JM Part A
     
• NCD — Percutaneous Left Atrial Appendage Closure (LAAC) (20.34) 
• Shared Decisions | CardioSmart – American College of Cardiology website