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U.S. Department of Health and Human Services
Health Resources and Services Administration

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Colorectal Cancer Screening

Part 1: Introduction

Part 2: Characteristics for Success: Colorectal Cancer Screening

Part 3: Implementation of Clinical Quality Measure: Colorectal Cancer Screening

Part 4: Improvement Strategies: Colorectal Cancer Screening

Part 5: Holding the Gains and Spreading Improvement

Part 6: Supporting Information


Part 3: Implementation of Clinical Quality Measure: Colorectal Cancer Screening 

Before following the steps in Part 3, an organization should first make a commitment to increase the number of adults screened for colorectal cancer and complete the initial steps outlined in the previous section that include:

  • Developing an aim statement
  • Creating an infrastructure for improvement
  • Obtaining commitment from leadership

Performance on this measure indicates how effectively all the steps of the processes used to deliver care work together so that colorectal cancer screening is optimized. Because there are so many factors that can have an impact on screening of patients, it helps to visualize how these steps are mapped. The next section defines Critical Pathway and illustrates the application of this concept to test improvements to improve colorectal cancer screening in patients.

The case study continues....

The Case Study: The Approach

Critical Pathway for Colorectal Cancer Screening

A critical pathway, also known as a clinical pathway, is a visual depiction of the process steps that result in a particular service or care. The sequence and relationship among the steps are displayed, which reveals a map of the care process. Additional information, including tools and resources regarding the mapping of care processes, can be found in the Redesigning a System of Care to Promote QI module. In an ideal world, the care process is reflective of evidence-based medical guidelines. Evidence-based medicine aims to apply the best available evidence gained from the scientific method for medical decision making. (20) A map of the care process steps that incorporates all of the known evidence and follows respected evidence-based medical guidelines can be considered the idealized critical pathway.

While the needs of individual patients should always be considered, clinical guidelines synthesize the best evidence into a pragmatic set of action steps that strive to provide the optimum health care delivery system. It is important to emphasize that clinical evidence and guidelines will evolve as knowledge progresses; therefore, the idealized critical pathway may evolve over time and not meet the needs of every individual. Clinical guidelines for Colorectal Cancer Screening for consideration include:

  • American College of Gastroenterology Guidelines for Colorectal Cancer Screening (21)
  • Screening and Surveillance for the Early Detection of Colorectal Cancer and Adenomatous Polyps (22)
  • Screening for Colorectal Cancer: U.S. Preventive Services Task Force Recommendation Statement (23)
Note: Please consider the following regarding critical pathways:
  • There can be more than one way to depict the idealized critical pathway.
  • Authorities vary on critical issues that have an impact on important decisions in medicine, and there is latitude within guidelines for variation related to less critical matters.
  • It is important that an organization agrees on the guidelines with which to align. There are no specific guidelines that address processes to improve Colorectal Cancer Screening, but a number of references provide available evidence. An organization may interpret the evidence that has an impact on Colorectal Cancer Screening differently than illustrated in Figure 3.1. If so, creation of a different schematic that reflects its interpretation of the best evidence is encouraged. References are located in Part 6: Supporting Information at the end of this module.

In Figure 3.1, the schematic for Critical Pathway for Colorectal Cancer Screening incorporates available evidence and represents an idealized critical pathway for care to optimize colorectal cancer screening. The boxes represent typical steps in care delivery. If these steps happen reliably and well, effective care is delivered.

Figure 3.1: Critical Pathway for Colorectal Cancer Screening.

Figure 3.1: Critical Pathway for Colorectal Cancer Screening

Walkthrough of the Idealized Critical Pathway

The steps illustrated in the schematic reflect a system that is working well. It is helpful to understand these steps in more detail and how they relate to improved Colorectal Cancer Screening:

1. Every patient encounter presents an opportunity for risk assessment and education.

2. Prescreening and education using the recommended clinical guidelines that are tailored toward the patient's risk serves as an opportunity for prevention. Prescreening and education can occur during a visit to the clinician, a preventative service visit, or during outreach to patients who have a history of not coming in for visits.

3. Determine if the patient meets the screening criteria using evidence-based guidelines. One useful tool to assist in risk assessment for patients 50 to 80 years of certain race/ethnicity categories has been the Colorectal Cancer Risk Assessment Tool. Although the Colorectal Cancer Screening clinical quality measure measures patients ages 50 to 80, patients younger than 50 years of age may warrant screening if they are at higher risk. Patients with the following conditions often require screening prior to age 50: ulcerative colitis, Crohn's disease, Familial adenomatous polyposis (FAP), Hereditary Nonpolyposis Colorectal Cancer (HNPCC), and personal history of colorectal cancer.

3a. Through the screening and risk assessment step, the provider determines if the patient meets the screening criteria. If the patient does not meet the screening guidelines, he or she is not screened; however, this provides an opportunity for ongoing education of the importance of screening should the patient's risk status change or when the patient matures in age. Interim and follow-up care is then discussed to ensure that the patient has what is needed to prevent colorectal cancer. Guidelines are emphasized so the patient understands what screening and examinations are to be done. Appropriate follow-up screening occurs in a timely manner and the cycle repeats.

3b. The provider collaborates with the patient to choose the appropriate screening, review pertinent instructions for effective preparation, and determine other tests needed in preparation for the screening. When a provider suggests a specific pathway for colorectal screening, the patient should be involved in the decision. The patient should be shown choices and receive information and advice on what the test can and cannot accomplish or prove. The patient should also be informed of what follow-up is involved after a positive or negative test result.

4. Ensuring that colorectal cancer screening has been completed is essential in the prevention of colorectal cancer. Often screening tests are ordered but not completed. Establishing a process to retrieve and review screening results is important to track the number of completed screenings and patient adherence to recommended guidelines.

5. Patient notification of the results provides an opportunity to involve the patient in his or her care plan and educate the patient about healthy behaviors to prevent colorectal cancer.

6. Positive results should be communicated to the patient in a culturally-sensitive manner. Treatment information and advice should be provided to the patient with an appropriate referral for those services.

6a. The patient should educated on the importance of timely treatment and then referred appropriately.

A quality improvement team benefits from mapping out how care is actually provided. Once it is able to evaluate where there are potential opportunities for improvement, it can use some of the improvement ideas that have worked for others, as outlined in Table 4.2: Sample Changes That Work.

A critical pathway can also be constructed to illustrate how screening is currently provided within an organization (the existing pathway). Understanding the gap between an organization's existing critical pathway (how you provide care now), and the idealized critical pathway (how to provide reliable, evidence-based care aligned with current guidelines), form the basis for improvement efforts.

Factors That Impact the Critical Pathway

In addition to understanding the steps for colorectal cancer screening for patients, factors that interfere with optimal care should be understood. As there may be several of these factors, a QI team may find it helpful to focus its attention on factors that interfere with ideal outcomes. This becomes especially useful as plans are developed to mitigate these factors.

Factors that have an impact on Colorectal Cancer Screening can be organized into those that are patient-related, relative to the care team, and a result of the health system. Overlaps exist in these categorizations, but it is useful to consider factors that have an impact on care processes from each perspective to avoid overlooking important ones.

Patient factors are characteristics that patients possess, or have control over, that have an impact on care. Examples of patient factors are age, race, diet, and lifestyle choices. Common patient factors may need to be addressed more systematically, such as, a targeted approach to address low health literacy, or a systematic approach to educate staff on the cultural norms of a new refugee population. Examples of how patient factors may increase a person's chance of developing colorectal cancer include:

  • Age-colorectal cancer increases after age 50
  • Family History-patients who have close relatives (parent, sibling, child) that had colorectal cancer have an increased risk
  • Lifestyle-diets high in animal fats, lack of exercise, and smokers have a 30 to 40 percent risk
  • Co-morbidity-individuals who are obese, have a history of inflammatory bowel disease, diabetes mellitus and insulin resistance, or certain types of polyps have a greater risk

Care team factors are controlled by the care team. These types of factors may include care processes, workflows, how staff follows procedures, and how effectively the team works together. Care team factors that may influence Colorectal Cancer Screening include:

  • Processes staff use to outreach to or educate patients to ensure periodic care based on level of risk
  • Procedures that provide culturally-competent care to address the patient's cultural norms about colorectal cancer screening
  • Processes that provide comprehensive care for patients who are seen regardless of reason for visit
  • Providers who may dislike doing colorectal cancer screenings

Health system factors are controlled at the high level of an organization and often involve finance and operational issues. Health system factors that may influence Colorectal Cancer Screening include:

  • Cost- co-pays and access to affordable screening methods
  • Scheduling systems-availability of evening and weekend appointments and wait time may have an impact on access
  • Location-no transportation or an unsafe location may present barriers to keeping appointments

These factors, when added to the critical pathway, create another dimension to the map as shown in Figure 3.2:

Figure 3.2: Care Factors That Have an Impact on the Critical Pathway for Colorectal Cancer Screening.

Figure 3.2: Care Factors That Have an Impact on the Critical Pathway for Colorectal Cancer Screening

Next, a team may identify specific factors that pertain to the way screening is provided for its patients. The team may look at Step 4: Colorectal cancer screening completed, and Step 5: Results received and routed to the designated person of the critical pathway. What factors have an impact on how effectively, timely, and reliably Step 5 follows Step 4? It is tempting to consider the first thoughts that come to mind, but a team is best served by systematically thinking through the potential impact of each category. Example 3.1 illustrates a team's output:

Example 3.1: A Team’s Brainstorming Session


The team brainstorms on factors that have an impact on the arrow (or opportunity) between Steps 4 and 5 of the critical pathway for Colorectal Cancer Screening.
Example 3.1: A Team’s Brainstorming Session.

Factor CategoryFactors pertinent to our organization - Steps 4 and 5
PatientPatients do not have a clear understanding of the disease and the consequences of not doing colorectal cancer screening
Care TeamNo staff, workflows, or prompts dedicated to developing self-management goals with the patient; available educational materials are not culturally appropriate for the population
Health SystemsPatients unable to access care due to conflicting work schedules

The team continues to look at different parts of the pathway to identify relevant impacts for each part. Once it is able to evaluate where there are potential opportunities for improvement, it can use this information to target its efforts. Additional examples of strategies to improve care for the measure, Colorectal Cancer screening, are described in the Part 4: Improvement Strategies section of this module.

Once the team visualizes the pathway and identifies opportunities for improved care, the next step is to collect and track data to test and document them. First, a QI team needs to determine how to collect data to support its improvement work. This step is essential for understanding the performance of its current care processes, before improvements are applied, and then monitoring its performance over time.

Data Infrastructure: Colorectal Cancer Screening

This section begins to address the critical role of data throughout the improvement process. It is important to recognize that different types of data are collected during the improvement project. First, data to calculate and monitor the Colorectal Cancer screening performance measure results is needed. Monitoring a performance measure involves calculating the measure over time and is used to track progress toward a numerical aim. This section provides an overview of what is needed. A detailed and stepwise approach follows to explain the types of infrastructure elements needed to gather data to support improvement. Second, changes an organization is making to improve care processes and their effects must be tracked. Tracking the impact of changes reassures the team that the changes caused their intended effects.

Data Infrastructure to Monitor the Performance Measure-An Overview

There are three major purposes for maintaining a data infrastructure for quality improvement work:

  • To know the starting baseline
  • To track and monitor performance as changes are implemented
  • To perform systematic analysis and interpretation of data in preparation for action

The first step to creating a data infrastructure for monitoring the performance measure is to determine the baseline. A baseline is the calculation of a measure before a quality improvement project is initiated. It is later used as the basis for comparison as changes are made throughout the improvement process. For the Colorectal Cancer Screening measure, an organization can determine the percentage of patients with an appropriate screening for colorectal cancer. Performance reflects the current organizational infrastructure and the patient's interactions with existing care processes and the care team.

Baseline data is compared to subsequent data calculated similarly to monitor the impact of quality improvement efforts. The details of how to calculate the data must be determined to ensure that the calculation is accurate and reproducible. The difference between how an organization provides care now (baseline) and how it wants to provide care (aim) is the gap that must be closed by the improvement work.

The next step of data infrastructure development involves a process in place to calculate the measure over time as improvements are tested. A QI team's work is to make changes, and it is prudent to monitor that those changes result in achieving the stated aim. This involves deciding how often to calculate the measure and adhering to the calculation methodology.

Finally, an organization's data infrastructure must include systematic processes that allow analysis, interpretation, and action on the data collected. Knowledge of performance is insufficient for improvement. It is important for an organization to understand why performance is measured and to predict which changes will increase the number of patients screened for colorectal cancer based on an organization's specific situation. Collecting data related to specific changes and overall progress related to achieving an organization's specified aim are important to improvement work. The next section describes in more detail how to develop a data infrastructure to support improvement. 

Implementation: Colorectal Cancer Screening
This section explores each step to create the data infrastructure used to improve performance on the Colorectal Cancer Screening clinical quality measure.
  1. Step 1 - Determine and Evaluate the Baseline

    As previously discussed, a baseline for improvement is a calculation that provides a snapshot of the performance of the systems of care for a measure before improvements are applied. The baseline is determined by calculating the measure and collecting the information for the numerator and denominator.

    Determination of a baseline is accomplished by actually calculating the measure and requires that the information for the numerator and denominator be collected. There are several methods to collect this information. While electronic methods are more efficient once established, manual chart audits using random sampling techniques are equally valid.

    Consistent data collection sources and methodologies are critical to ensure reliable data. Please note that the tables referenced in this section are from the NQF-Endorsed National Voluntary Consensus Standards for Physician-Focused Ambulatory Care, Appendix A- NCQA Measure Technical Specifications (April, 2008 V.7. Pages 20 – 23 and 26 – 28). The methodologies suggested are also from NQF and can be found here. Exit Disclaimer.

    The following tables and figure depict a decision algorithm for the measure, Colorectal Cancer Screening. The algorithm outlines the steps that an organization follows to determine its baseline and monitor improvements for Colorectal Cancer Screening.
     

    Identify the Denominator
    The denominator for this measure is the number of patients 51 through 80 years of age during the measurement year.
    a. Use a one-year date range, hereafter called the measurement year.
    b. Choose a selection methodClaim/Encounter Data—patients aged 51 to 80 years of age who had one office visit in the prior 12 months Note: Given the measurement look back period, adults 50 to 80 will be captured in this measure
    Denominator exclusionsPatients with a diagnosis of colorectal cancer or total colectomy.

    Identify the Numerator
    a. Based on an organization's systems, evaluate all of the individuals who remain in the denominator and choose an Electronic Method or the Medical Record Audit method to determine the numerator. For Electronic Method, use electronic data from an Electronic Medical Record or registry to identify patients in the denominator who have received one or more of the screenings for colorectal cancer. The patient should be included in the numerator if the patients 51 to 80 years of age are seen during the measurement year who have had one or more of the following:
    Numerator Inclusion: Appropriate screenings are defined by one or more of the appropriate screenings:
    1. Fecal occult blood test (FOBT) within the measurement year
    2. Flexible sigmoidoscopy within the measurement year or the four years prior to the measurement year
    3. Double contrast barium enema (DCBE) during the measurement year or the four years prior to the measurement year; air contrast enema is a clinical synonym
    4. Colonoscopy during the measurement year or the nine years prior to the measurement year
    b. Medical Record Audit: Audit all patients in the denominator or use valid sampling methodology. The records audited may be electronic or paper. Include the patient in the numerator if the
    1. Patients 51 to 80 years of age are seen during the measurement year and one or more of the appropriate screenings outlined in a. above.
    2. Documentation in the medical record must include both of the following:
      • a note indicating the date the colorectal screening was performed and
      • a notation in the progress notes of the result or finding (this ensures the screening was performed and not merely ordered)

    Calculate the Measure
    Divide the numerator by the denominator and multiply by 100 to get the percentage of the patients needing colorectal cancer screening.

    Compare an organization's performance to national benchmarks and other available data. The NCQA Web site Exit Disclaimer. updates performance on this measure annually. Note that there is considerable variation among practices reporting. Other opportunities for comparison data are from payers, State cancer control programs, State and regional quality improvement organizations.

    Decide if the performance is satisfactory based on available data from reliable sources. It is important to consider the organizational capacity and constraints, but it is recommended that an organization's aim is high. An organization with a low performance may want to allow a longer time to achieve excellence, but striving to reach a screening rate of 55 percent is feasible for most. If the performance is satisfactory, an organization may wish to choose another measure and focus on other systems of care.

    If the performance is unsatisfactory, consider adopting the measure and using it to monitor improvements to the care delivery system. An organization should understand that if a measure is adopted for improvement, ongoing and regular measurement is necessary to reach and sustain its organizational goals. More information regarding measurement can be found in the Managing Data for Performance Improvement module.

    Detailed specifications, including instructions to identify the denominator and numerator for the measure, Colorectal Cancer Screening, can be accessed on the HRSA Clinical Quality Performance Measures Web site.

    Evaluate the baseline. Initially, a team compares its baseline to the performance it hopes to achieve. It is important to remember this gap in performance is defined as the difference between how the care processes work now (baseline) and how an organization wants them to work (aim). An organization may often modify its aim or timeline after analyzing its baseline measurement and considering the patient population and organizational constraints.

    As an organization moves forward, the baseline is used to monitor and compare improvements in care over time. While it is important for an organization to stay focused on its aim, it is equally significant to periodically celebrate the interim successes.

  2. Step 2 - Create a reliable way to monitor performance over time as improvements are tested.

    An organization should standardize its processes and workflows to ensure the team collects and calculates performance data the same way over time. An organization should document exactly how the data is captured so staff turnover does not interfere with the methodology:

    1. Determine the frequency that performance will be calculated. Frequent data collection is often associated with higher levels of improvement. Monthly measurement is recommended if feasible, as it is associated with a higher level of team engagement and success. If it is infeasible, quarterly measurements may be obtained. Less frequent performance measurements are adequate for reporting purposes, but do not adequately support improvement efforts. An advanced discussion can be found in the Managing Data for Performance Improvement module.
    2. Chart and display results. A simple chart audit form is appropriate for manual audits and can be repeated frequently, as desired. Results of multiple audits can be presented in a graphic format to demonstrate trends.

    Note: The frequency of team meetings is not necessarily prescribed for success. Many successful teams meet once a week while others may meet bi-weekly when focusing their improvement efforts on any given measure. Success of these meetings is rather the output of the team members' active engagement in the meeting and being prepared to report on recent improvement findings. More information, including resources and tools supporting developing and implementing effective team meetings can be found in the Improvement Teams module.

  3. Step 3 - Create systematic processes that allow an organization to analyze, interpret, and act on the data collected.

    Having the data is not enough. Improvement work involves thinking about the data and deciding what to do based on that analysis. A QI team needs to put processes in place – team meetings, scheduled reports, and periodic meetings with senior leaders to use the data tracked. This section describes how a QI team may accomplish the work of creating actionable plans based on the data collected. In Example 3.2: The QI Team at Excelsior Health, the hypothetical scenario using a fictional health center illustrates how a team may use these concepts to act on its data:

    1. a. Analyze: What are the data trends?Tracking performance over time for the measure, Colorectal Cancer Screening, is critical to successful improvement, but calculation of performance is not enough. It is important for a team to meet to analyze the data on a regular basis. QI teams that are experienced in looking at data recognize these common patterns:
      • Performance is improving
      • Performance is decreasing
      • Performance is flat
      • Performance has no recognizable pattern
      Additional examples of common data patterns are provided with further explanation in the Managing Data for Performance Improvement module. It is typical for a team to see little movement in its data over the first several months. It is important that a QI team review performance progress regularly. A QI team that meets regularly and calculates performance monthly should spend part of one meeting each month reviewing its progress to date.
    2. Interpret: What do these data trends mean? A QI team needs to then interpret what these data trends mean within the context of its own organization. If performance is increasing, but has not yet reached the numerical aim, perhaps the changes in place are having the desired effect and the aim will be reached over time. If performance is decreasing, what has changed? Are there new care process changes, a failure of registry data input, or a large increase in those patients included in the registry? If performance is flat, did the organization maximize the benefits from changes implemented or was there some regression to the former way of doing things? Improvement trends that have reached a plateau may indicate that an organization needs to think differently about future changes. A few suggestions that an organization may consider when experiencing a plateau in improving are listed below:
      1. Consider looking at outliers to determine barriers to patient access to care for colorectal cancer screening, for example, lack of insurance, transportation, or language and cultural differences.
         

        Note: Asian-Americans, compared to non-Hispanic Whites, have lower rates of cancer screening (colorectal and breast), adjusting for access to care and socioeconomic status. Foreign-born Asians, on survey, believed that cancer screening should be a response to symptoms and declined tests because of lack of symptoms. (24)
      2. Consider changes in a different part of the framework to get improvement back on track. If using a critical pathway approach, an organization may look at the steps prior to where the problem seems to be. If a Care Model approach is used and the team worked hard on delivery system design issues, opportunities to better leverage the clinical information systems or engage the community may be considered.
      Interpretation of data over time is critical in determining where a team will target its efforts. Additional tools that can assist a team in understanding underlying causes for data trends are beyond the scope of this manual but are discussed in detail in a monograph that was published by the NQC, A Modern Paradigm for Improving Healthcare Quality. Exit Disclaimer.
    3. Act: Make decisions based on data. Once a QI team has a better understanding of what the data means, efforts should be targeted to further advance the performance toward the aim. Often the decisions are made at the team level about what to tackle first. Then small tests of change can be accomplished to determine what improvements could be implemented to enhance performance. The practice of using small tests of change actually allows multiple changes to be tested simultaneously.

      Note: An advanced discussion on how to use the data collected to advance an organization's improvement, including resources and tools to support improvement, can be found in the Managing Data for Performance Improvement module.

    Example 3.2: QI Team at Excelsior Health


    The Quality Improvement (QI) team at Excelsior Health worked diligently to improve colorectal cancer screening rates for patients over the last several months. The team focused on patient education, following screening guidelines, and streamlining those processes. But during the last three months, the performance remained the same at 30 percent, which was below its aim of having 55 percent of its patients with an appropriate screening for colorectal cancer.

    Analysis: The team noted improvement initially. Registry input, care processes, and patient volumes seemed to be stable but performance was flat for the last three months.

    The team leader asked for a list of those patients who did not have an appropriate screening for colorectal cancer. Further study of these specific cases found that over half of those patients were uninsured.

    Interpretation: Because there was initial improvement followed by several months of flat performance, the team leader looked for obvious changes in processes that would have an impact on performance, but found none. The team leader interpreted the data to mean that initial changes provided some improvement, but not enough to achieve its aim and have the desired impact. More work was needed. The team leader employed a common strategy to find additional opportunities; i.e., he looked at the population in compliance (the outliers) for a common cause to be addressed. In this case, a common thread was that patients were coming in for routine care and referred for screening, but were not able to follow through with the appropriate test.

    This information allowed the team to consider ways to assist uninsured patients with following through on colorectal cancer screening. They looked at Sample Changes that Worked (Table 4.2) for ideas then added suggestions based on its own patient population. The team decided to increase focus on access to screenings. A proposal was submitted to the organization leadership to purchase pre-stamped envelopes that would allow patients to easily mail in their fecal occult blood testing cards. A cost analysis was done that included cost of the postage and materials, as well as potential revenue. The purchase was approved and systems designed for implementing its use. The improvement team will continue to monitor its performance to determine if this change contributes to achieving its aim statement goals.

    Act: The information gathered from the analysis and interpretation of the data allowed the team to focus its next efforts. Since numerous patients were not following through with screening, the team targeted its efforts on improving access to affordable screenings. This enabled the team to focus on PDSAs to test changes specific to these areas and monitor its progress.

    A QI team leader needs to monitor the pace of the progress over time. If there is insufficient progress to meet the specified aim, reasons should be analyzed and addressed. One organization may choose to accelerate its improvement efforts; another may decide to extend its initial allotment of time to achieve its aim and consider other constraints within the organization.




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