The specific patient population being screened for ATTR-CM affects how simplified clinical criteria are developed and implemented, so the first step is choosing the right patient population to screen.²

First, look at patient populations that are at high risk for ATTR-CM. If the rate of those patients being diagnosed with ATTR-CM is lower than the rate reflected in current research, more screening may be needed to detect cardiac amyloidosis. For example, a physician at Duke Department of Medicine recommends broadly screening heart failure with preserved ejection fraction (HFpEF) patients for the presence of amyloid, as HFpEF is associated with cardiac amyloidosis.^3,4

Second, look for points along each patient care pathway where amyloidosis screening can be integrated using existing processes, technologies, and staff activities. For example, if patient data is already being reviewed centrally as part of a quality initiative, adding an ATTR-CM screening checklist to that review may require few additional resources but lead to high impacts on patient outcomes and increased efficiency.

Finally, develop a screening process that doesn’t add extra steps for patients. For example, incorporating amyloidosis screening into preexisting patient visits or post-op procedures will reduce the need for patients to make additional appointments.

Healthcare organizations can use existing simplified clinical criteria as-is, modify existing criteria, or create their own criteria.² Which simplified checklist, scorecard, or criteria to use for ATTR-CM screening will depend on the patient population’s clinical nuances and on its impact on provider and staff workflow. Consider the four questions below when choosing simplified clinical criteria.

Which patient touchpoints on the care pathway can reveal the clinical clues for ATTR-CM?

Organizations should develop simplified clinical criteria based on the information available at each patient touchpoint on the care pathway. For example, simplified clinical criteria embedded within the echocardiogram imaging department may be different than clinical criteria used by primary care providers (PCPs). Clinical clues available via echo might include imaging abnormalities or other visual indicators of disease, whereas the information available to PCPs might involve patient reports of symptoms or findings from an examination at a patient visit.

What are the clinical nuances of the screened population?

The clinical nuances of each patient population will determine how simplified clinical criteria are developed and implemented. For example, Prisma Health reviewed patients receiving treatment for ATTR-CM at their hospital to determine the commonalities among them. The resulting simplified clinical criteria thus were targeted to the unique traits of their own patient population with ATTR-CM. For example, Prisma’s patient population has a higher rate of diabetes than the national average, which means diabetic neuropathy is also common. For its simplified clinical criteria, Prisma had to distinguish neuropathy without diabetes — which raises suspicion of ATTR-CM — from diabetic neuropathy.² Neuropathy without diabetes became one of the simplified clinical criteria of ATTR-CM. Prisma also noticed that their patients with ATTR-CM were more likely to have the genetic version of ATTR-CM than average, which led them to put more emphasis on genetic testing during the diagnostic process.

What method of adding ATTR-CM screening to patient touchpoints will impact provider workflow the least?

The way that simplified clinical criteria is implemented can determine how much provider workflows are impacted. For example, paper checklists or decision trees that need to be evaluated manually are ideally easy for providers to memorize, reference, and apply. Clinical criteria that has been integrated into a centralized quality improvement process may have more room for complexity. Automating criteria in the electronic health record (EHR) or another system that can easily calculate results may create minimal impact on workflow, even as scoring complexity rises.

How many patients will the criteria flag?

Clinical criteria that flag too many patients can create system backlogs and clinical burden — but criteria that flag too few patients will miss cases of ATTR-CM. The right percentage of patients being diagnosed will depend on the specific patient population chosen for screening and should reflect current clinical literature.

Engaging providers early in the development of ATTR-CM clinical criteria will increase the likelihood of the process working from a clinical and workflow perspective. And involving providers early will also foster buy-in from key providers and staff. Consider involving:

• Heart failure specialists, who have insight into the best options for clinical criteria.
• Primary care doctors and general cardiologists, who are the front line of care for patients and are often involved in patients’ entry into screening.
• The clinical care team — such as nurse navigators, clinical coordinators, clinical pharmacists, genetic counselors, echo sonographers, radiologists, the cardiac MRI team, and the structural heart team — who can be ideal partners in implementing a new process and moving patients through the process, since these staff members often have multiple patient touchpoints along the patient journey. 
• Other specialists, including oncology, hematology, neurology, and orthopedics, who can be a source of referrals and/or a place to send patients.
• Quality improvement champions, service line leaders, and administrators, who can help get system buy-in and resources.

Thoughtfully designing how patients are notified and referred for further work-up can increase the chances that flagged patients follow up on the next steps, particularly if the screening process is automated or centralized.² Consider the three best practices listed below:

Entrust a familiar provider to talk to the patient about ATTR-CM.

Patients may be more responsive if their own PCP or cardiologist talks to them about ATTR-CM, partly because getting this information from someone who is not their provider can make some patients worry about privacy. If the patient’s provider isn’t familiar with ATTR-CM, equip them with resources and education.

Make sure patients understand next steps and why they are important.

For example, patient care navigators and similar roles may be well-positioned to talk to patients about the urgency of completing the recommended follow-up testing. Take-home patient education materials can also help patients to retain information.

Make it easy for providers to refer to the right specialists or tests.

For example, using prepopulated order sets in the EHR can ensure that once patients are flagged by the simplified clinical criteria, providers can easily and intuitively order the next steps. If prepopulated order sets are not an option, creating easy-to-reference one-pagers or assigning a patient care navigator to review order sets can help keep orders consistent across referring providers.

Provider education about clinical criteria doesn’t necessarily need to include every sign and symptom of ATTR-CM.² Instead, educate providers and staff about how to apply the simplified clinical criteria and the next steps in the process, which are easier to retain than an in-depth understanding of the disease. Be sure to include everyone who might initiate the simplified clinical criteria screening process, move patients through the process, or receive results of the process.

To optimize the impact of provider education, educational strategies should be:

• Simple: Distill new information into need-to-know criteria and next steps to avoid overwhelming providers and staff. For example, one health system teaches providers when and how to refer patients for imaging, rather than how to recognize a specific disease in the clinic.
• Convenient: Use preexisting training days or create protected time to make it convenient for providers and staff.
• Repeated: Deliver trainings several times and through different mediums so providers and staff have multiple opportunities to learn. Providers and staff will be more likely to retain information if they receive both an in-person training and an easy-to-read one-pager to refer to later.
• Supported by providers: Emphasize that simplified clinical criteria for ATTR-CM screening only supports provider expertise, rather than replaces it. If providers understand that clinical criteria make their workflow easier, they may be more likely to buy in.