The Problem

The Cedar Rapids provider community serves a growing elderly population. The Cedar Rapids Chamber of Commerce reported that in 2005 and 2006, within three area counties (Benton, Jones, and Linn), there were 15,370 adults aged 65 to 74 and an additional 15,320 over age 75. Combined, this represents 13 percent of the population of these three counties.⁴ The fastest-growing segment of the population is adults over age 80; patients in this group frequently make mistakes in taking their medications. In a 2004 Information Technology Association of America Teleconference titled Using a Patient-Based Information Technology Approach for Solving Prescription Medication Non-Compliance, it was reported that (1) up to 60 percent of all medications prescribed are taken incorrectly or not at all, (2) up to 90 percent of elderly patients make some medication errors, and (3) up to 35 percent of the elderly make potentially serious errors when taking their prescribed medications.⁵

Since anticoagulation therapy is particularly risky, patients need to be aware of the risks and must closely follow established treatment protocols. Health care providers must also make appropriate treatment decisions by monitoring patients regularly and following established protocols. However, because many variables can affect an individual’s anticoagulation levels and compliance is difficult to assess, it can be quite challenging for clinicians to consistently monitor outpatients on anticoagulation medication. In order to meet these challenges, many health care facilities have established outpatient anticoagulation clinics for their patients receiving warfarin.

The purposes of the CAT Clinic include:

• Provide consistent monitoring of patients taking warfarin.
• Ensure that the international normalized ratio (INR) levels are within target range.
• Decrease adverse drug events (ADEs).

Although the structure of anticoagulation clinics varies among institutions, most clinics share some of the following policies and work-related procedures:

• Identify the roles and duties of clinic staff and personnel.
• Identify which patients are viable anticoagulation clinic enrollees.
• Develop electronic systems to track patients due for lab tests, document results of lab tests, and document successful patient management.
• Develop protocols for managing patient results and for timely reporting of results to physicians and health care professionals.
• Develop and update resources for ongoing patient education.

The Solution: A Compliance-Assessment Tool

Many different factors can affect how warfarin affects patients and their INR levels, which are used to adjust the required warfarin medication dosage. Quite early in our experience, it became apparent that there was no established method to measure patient compliance with anticoagulation management. For this reason, the CAT Clinic staff designed and developed a compliance tool, the Warfarin Compliance Assessment Scale (WCAS), that assigns points to the following categories (see Table 1):

Table 1

Warfarin compliance-assessment scale.

• Medication use, such as the addition/discontinuance of antibiotics.
• Amiodarone.
• Herbal supplements, aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs).
• Dietary intake of foods high in vitamin K.
• Alcohol intake.
• Missed/extra doses.

Use of the WCAS assists the CAT clinic nurses when making dosage decisions and provides a simple way to monitor the effectiveness of overall warfarin management.

The Rockwell Collins improvement specialists provided guidance in the project team’s use of Lean and Six Sigma concepts in their analysis of the current anticoagulation system in two busy cardiology practices in Cedar Rapids. Their analysis produced valuable objective advice on ways to improve the warfarin management system.

Under their expert leadership, the CAT Clinic designed and developed a Web-based database to precisely document individual patient visits. Each patient is specifically identified in the database, which incorporates the WCAS compliance tool, assigning points to each item on the compliance assessment scale. After a CAT Clinic patient’s blood draw is completed and the CAT Clinic nurse has received the INR level results, the nurse can contact the patient and assess the patient’s compliance with each of the items on the WCAS. If the patient reports a change in any of the items, the nurse can easily update the patient’s individual record by clicking on the drop-down list and choosing the most appropriate item (Figure 1).

Figure 1

INRPro^© database WCAS page.

The database then calculates a score for the individual patient based on the number of visits and the total for each item selected from the compliance assessment. For instance, if a patient reported missing two doses of warfarin since the last INR, 2 points are assigned. If the patient had two INRs that month and a score of 2.0, the compliance score is calculated as 2.0 points divided by two visits, or 1.0.

Clinic nurses can use this information to help educate patients about certain important aspects of their medication compliance. In cases where patients may be consistently missing warfarin doses, the nurse and patient can work together to plan ways to improve compliance. In addition, patients’ compliance scores can be reviewed in aggregate. The patient’s score is tallied each month and plotted graphically. Figure 2 documents a decrease (i.e., improvement) in average compliance score over time, as patients become more educated about their individual dosing requirements, illustrating an increase in patients’ understanding and compliance with their warfarin therapy.

Figure 2

Average CAT compliance score, from April 2006 to July 2007.

The CAT Clinic has successfully implemented several interventions that might affect patients’ compliance scores. Each patient referred to the clinic receives comprehensive warfarin education, and the nurse conducts a “brown-bag” review of all their current medications. During this educational session, the nurse and patient review a booklet entitled, “My Guide to Warfarin Therapy,” which was developed by several nursing faculty members at Kirkwood Community College who were studying the issue of health literacy.⁶

Health literacy concerns are compounded by the high number of older adults living in the Cedar Rapids community who are taking warfarin. Many of these adults require intensive guidance in order to help them comply with their unique medication requirements. While this guide was in development, a group of participants at a local Cedar Rapids senior center reviewed the contents and provided valuable feedback that served to strengthen the guide. The nursing instructors reviewed the existing warfarin patient education materials and found that they were too difficult for patients to understand because they:

• Were written using medical language that was too technical.
• Were printed in a color other than black ink on white paper.
• Used too small a font and contained too few pictures (e.g., not enough “white space”).

The new guide is written at a fifth-to-sixth grade level and is printed in black ink on white paper using a larger size font. The guide uses numerous pictures and bullet points to explain important aspects of warfarin therapy.

During the “brown-bag” medication review, patients bring in their actual prescription pill bottles and all of their over-the-counter medications, as well as a list of medications they are currently taking. CAT Clinic nurses review each medication name, indication, dose, and frequency with the patient. If the patient has a question or does not understand something, the nurse uses this as an opportunity to educate the patient about his or her medication. If there is a discrepancy between the medication listed and the medication taken by the patient, the nurse contacts the patient’s primary care physician for clarification and confirms the correct medication and dosage with the patient.

Another intervention found to be useful in monitoring patient medication compliance and making dosage decisions is the control chart (Figure 3), which provides a statistical signal that a process might have gone awry, allowing the operator to make the necessary adjustments to bring the process back into control.⁷ The CAT Clinic utilizes the database mentioned above which displays a control chart of each patient’s historical INR values along with a histogram. This information allows the CAT Clinic nurse to make statistically based decisions on whether the patient needs a dose change, instead of basing decisions solely on the most recent readings. The compliance assessments, along with the use of the control chart, are simple techniques for making objective dosage decisions for the CAT Clinic patient.