Thank you very much for your interest in the Flu-FOBT Toolkit and Guide!

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1 Thank you very much for your interest in the Flu-FOBT Toolkit and Guide! The Colorado Colorectal Screening Program s (The Program) Flu-FOBT initiative assists community health clinics with increasing colorectal cancer (CRC) screening rates. With this goal in mind, The Program developed the Flu-FOBT toolkit. Please complete the following survey before you begin to use the toolkit so we can track its use and dissemination.

2 Flu-FOBT Toolkit & Guide 2

3 Table of Contents Introduction... 4 Background Information and Education CCSP.. 5 Flu-FOBT. 6 Why Do a Flu-FOBT Program... 7 Eligibility... 8 Colorectal Cancer Screening Recommendations.. 9 Patient Education 10 Setting Up Your Flu-FOBT Clinic Flu-FOBT Flow Chart.. 11 How to Set Up Your Flu-FOBT Program 13 Staff Training for Flu-FOBT. 17 Summary.. 20 Appendix A Flu-FOBT Logic Model Appendix B Colorado Clinical Guidelines Collaborative: Colorectal Cancer Screening Recommendations 22 Comparison of Screening Methods Appendix C Flu-FOBT Flow Chart 24 Appendix D FIT and FOBT Brands.. 26 Appendix E Flu-FOBT Program Checklist.. 27 Appendix F Advertising/Tracking Tools. 28 References. 32 3

4 Acknowledgements The Colorado Colorectal Screening Program would like to thank Michael Potter and his team for the development of this intervention, templates and materials utilized in this tool kit, focused on evidence-based practice, detecting colorectal cancer and reducing mortality. 4

5 Introduction The Colorado Colorectal Screening Program (The Program) Flu-FOBT initiative is intended to assist community health clinics in increasing access to colorectal cancer (CRC) screening to Colorado residents. It has been demonstrated in the literature that offering and providing take-home fecal occult blood tests (FOBTs) to patients at the time of their annual flu shot 1, 2, 4 increases CRC screening rates. Colorectal cancer (CRC) is the second leading cause of cancer death in the United States (US). 5 In 2008, almost 143,000 people were diagnosed with and more than 52,500 died from CRC. Regarding Colorado this same year, the CRC incidence rates were per 100,000 and death rates were per 100,000 people. 5 Compelling data from the Centers for Disease Control and Prevention (CDC) suggest that CRC screening reduces the incidence and mortality from colorectal cancer. The CDC detailed a study concerning CRC screening data gathered from the Behavioral Risk Factor Surveillance System surveys, in addition to incidence and mortality data gathered from the United States Cancer Statistics. Significant findings from this study were: CRC incidence and mortality rates declined 13% and 12% (approximately 66,000 cases and 32,000 deaths) respectively from 2003 to 2007 and screening prevented approximately half of the expected CRC cases (33,000) and deaths (16, 000) during this same time frame. 6, 7 Those screened for CRC increased 13% from 2002 to However, in 2010 one in three adults between the ages of 50 and 75 years were still not up-to-date with screening recommendations. 6 This study demonstrates that prevention and early detection of CRC through screening can decrease the incidence of and mortality from this disease. 7 The Colorado Colorectal Screening Program has developed this toolkit to include: Background and evidenced-based information/education of the Program and the benefits of Flu-FOBT Criteria for individuals eligible for colorectal cancer screening Patient education about colorectal cancer and the importance of screening Steps on setting up a Flu-FOBT program in your clinic Staff training regarding implementing a Flu-FOBT program for your clinic Tracking tools to manage your Flu-FOBT program Flu-FOBT Program for Community Health Centers Logic Model (Appendix A) 5

6 Colorado Colorectal Screening Program Background The Program is a statewide, competitive grant funded program that partners with health care providers to offer no-cost colorectal screening to the medically underserved. Coordinated through the University of Colorado Cancer Center, the Program is based in over 65 community health clinics across Colorado and partners with over 250 screening providers. What services are provided? Endoscopic screening services, referrals, follow-up and treatment Patient navigation and clinic outreach Provider and clinic education on systematic and evidence-based colorectal cancer screening How are services reimbursed? Providers are reimbursed at Medicare based rates The program is the payor of last resort and other coverage must be utilized first. Patient eligibility for no cost screening is as follows: Patient in a partnering clinic Household income at or below 250% of the federal poverty level Uninsured or have insurance that does not cover ANY cost for endoscopic colorectal screening Lawfully present Coloradans age 50 and older or those under 50 with personal or family history of colon cancer For more information visit our website at 6

7 Flu-FOBT Background The Flu-FOBT program is an efficient and effective way to increase colorectal cancer screening. Flu shot clinic staff provide take-home Fecal Occult Blood Test (FOBT) kits to patients due for colorectal cancer screening when they get their annual flu shot. Patients due for colorectal cancer screening through FOBT are 50 and older and have not had an FOBT in the last year or a colonoscopy in the last 10 years. The Flu-FOBT program is a population-based method, which has been shown to increase screening rates in a variety of settings, including low-income community health clinics. 1,2,3,4 An FOBT is a colorectal cancer screening test for patients 50 and older that must be done annually to be effective. 8 There are two types of FOBTs currently used for colorectal cancer screening, the guaiac-based FOBT and the immunochemical FOBT, more commonly known as a FIT. The Program will refer to both tests more broadly as FOBTs. Either a high sensitivity guaiac-based FOBT or a FIT test are appropriate for the Flu-FOBT Program. The patient completes the FOBT by collecting a small stool sample in the privacy of their home and returns the test to your office (or sends the kit to the lab) for processing. The test detects small amounts of blood in the stool that may result from colorectal cancer or pre-cancerous colon polyps. If the test is positive, a colonoscopy is then required to determine the source of the bleeding. The Program piloted the Flu-FOBT program with a small number of community health clinics in Fall 2011 and expanded this pilot in Fall The Program offered training for all clinic staff on how to run a Flu-FOBT program, provided tracking tools, aided in selecting an appropriate high sensitivity FOBT. This toolkit has been developed from this pilot intervention so that clinics not officially participating in a Flu-FOBT partnership can use this as a resource to inform the planning and implementation of an independent Flu-FOBT program. In 2011, the Program piloted the Flu-FOBT program with two clinics. Even in this short timeframe, the results indicated that a Flu-FOBT program is a worthwhile investment and a great way to increase screening rates in clinics. Because of lessons learned from the pilot, the Program decided to expand the Flu-FOBT program to include partnerships with clinics across the state and provide a toolkit for other clinics interested in implementing their own Flu-FOBT program. Results from the 2012 pilot are pending. 7

8 Why Do a Flu-FOBT Program? (Information in this section is provided with permission by Michael Potter, MD and flufit.org) Five Good Reasons to Try! 1. Annual colorectal cancer screening tests are underused. Colorectal Cancer is the second leading cause of cancer death in the United States. Most of these deaths could be prevented with routine screening. The least invasive, least expensive form of screening involves an annual home stool test, also known as fecal occult blood test (FOBT) or fecal immunochemical test (FIT). If done yearly and with good follow-up, FIT or FOBT can prevent colorectal cancer or catch it early when it can be cured. Colorectal cancer screening programs that emphasize the use of FIT and FOBT as initial screening tests can be similarly effective to programs that emphasize more invasive tests, such as colonoscopy. 2. Annual flu shot activities are an opportunity to reach many people who need colorectal cancer screening. Each fall, millions of Americans receive flu shots. Annual flu shot campaigns are an opportunity to reach people who are also due for colorectal screening. 3. FOBT kits can be given to patients by flu shot clinic staff. Many flu shot campaigns are run by nurses, pharmacists, or medical assistants. A prepared healthcare team can develop simple systems to provide a home FOBT kit to all eligible patients. 4. FLU-FOBT Programs increase colorectal cancer screening rates. FLU-FOBT Programs have been implemented successfully in a variety of clinical settings. They can be implemented and sustained with limited resources, are well accepted by patients, and lead to higher screening rates. 5. FLU-FOBT Programs can be a first step toward other innovative preventive health and screening interventions. Success with FLU-FOBT Programs can lead to other practice innovations. For example, once you are successful with a FLU-FOBT Program, you may decide to add other services to your flu shot activities, such as mammogram or smoking cessation referrals. 8

9 Colorectal Cancer Screening Eligibility Clinics will give FOBT kits to all patients coming in for their flu vaccine who are 50 years and older and have not been screened for colorectal cancer via colonoscopy in the last 10 years or FOBT in the past year. If an FOBT kit results in a positive test result, the patient will then need a colonoscopy as part of the screening process. When to offer an FOBT kit: Patient is 50 years and older No No FOBT Kit Given Yes Patient had had a colonoscopy in the past 10 years or FOBT test in the past year Yes No FOBT Kit Given No FOBT kit offered to patient 9

10 Colorectal Screening Recommendations The following is based on the American Cancer Society s recommendations for colorectal cancer early detection. More information can be found on their website. Average risk patients ages 50 and older should be routinely screened for colorectal cancer. There are several screening tests for colorectal cancer, that when done at recommended intervals, are effective at reducing colon cancer mortality, including: Colonoscopy every 10 years FOBT or FIT every year Flexible sigmoidoscopy every 5 years, preferably with FOBT every 1-3 years Double-contrast barium enema every 5 years CT colonography (virtual colonoscopy) every 5 years Stool DNA test If the results of an FOBT are positive, a colonoscopy should be done. For complete information on Colorectal Cancer Screening Recommendations, including guidelines for higher risk patients, refer to Appendix B: Colorado Clinical Guidelines Collaborative Recommendations. 10

11 Patient Education (Information in this section is provided with permission by Michael Potter, MD and flufit.org) Colorectal Cancer and FOBT: Facts and Talking Points to Use with Patients Facts about colorectal cancer and screening: 2 nd leading cause of cancer death in the United States More than 50,000 Americans die of colorectal cancer each year Colorectal cancer is often preventable with screening Early detection and treatment saves lives 70% of people diagnosed with colorectal cancer have no symptoms There are more than 1 million colorectal cancer survivors in the United States Colorectal cancer screening is recommended for adults 50 years and older Facts about FOBT and FIT kits They work by detecting small tiny amounts of blood that can come from colon polyps or early stage colorectal cancer If done every year, they can help find polyps and cancers before they become life threatening Studies have shown that high quality FOBT kits, if done correctly and followed up well, can be similarly effective to colonoscopy for most people to detect cancer They are done at home and mailed into the lab If the FOBT results are abnormal, you need to get a colonoscopy If you choose to get FOBT, you need to do it every year, just like a flu shot Useful Talking Points for Use with Patients We have something extra to offer you today! It looks like you are due for a home colon test Colon cancer screening can save lives Just like a flu shot, all our doctors and nurses recommend home colon tests It s very easy you can do it in the privacy of your home and mail it in We ll make sure the results get to your doctor Reminders After Giving the Kit to Patients Put the kit in the bathroom so it will be there when you need to use it Try to complete the kit in the next week if possible Write the collection dates on each completed kit Mail the kit in as soon as possible after you finish collecting the stool Call us if you have a problem with the kit Talk to your doctor if you have any other questions about FOBT 11

12 Setting Up Your Flu-FOBT Program Flu-FOBT Flow Chart (Appendix C) Patient arrives for flu vaccination Patient is 50 years and older No Yes Patient has had a colonoscopy in the past 10 years. No Yes Patient has had an FOBT test in the past year. No Yes Patient receives FOBT kit and explained the process of completing the kit. Patient receives flu vaccine. 12

13 **Patient returns FOBT kit within 14 days No Yes Place a reminder call and send post card to patient. Document FOBT kit return date in the EMR for yearly screen reminder. Record test result in patient s chart. Notify patient of test result. Negative Positive Repeat FOBT test in one year Provide referral for colonoscopy Colorado Colorectal Screening Program is able to provide follow-up colonoscopies for a positive FOBT to eligible patients only. **PLEASE REFER TO THE PROGRAM BACKGROUND FOR PATIENT ELIGIBILITY 13

14 How to Set Up Your Flu-FOBT Program (Information in this section is provided with permission by Michael Potter, MD and Setting up a Flu-FOBT Program is not hard, but it does require some careful planning and staff training before you start. 1. Put Your Flu-FOBT Team Together A. Select a Flu-FOBT Champion to coordinate your efforts This will usually be a nurse or other member of the medical team who works closely with the manager of your clinical site. B. Select your Flu-FOBT Team Members and Staffing Levels Flu-FOBT team members can be medical assistants or other health workers who enjoy working with patients and who can be trained to provide flu shots and/or FOBT kits to patients. Depending on your setup, you may have each team member carry out all aspects of the FLU-FOBT process with patients, or you may divide up the tasks. To implement a FLU-FOBT process, you may need to adjust your staffing levels. If you have a high volume clinical site, you may need to assign one or more additional persons above what you usually need for flu shot season to help assess patient eligibility and dispense FOBT kits. C. Help your Flu-FOBT Team to be Successful To make sure that the process runs smoothly, start your planning process early, and involve your team members in the planning process. Once you have settled on the details of your program and who will be involved, set up a date for a final training session. Usually this training should take place one or two weeks before the start of your program. Team members should arrive before the flu shot line opens to check their supplies and systems for assessing patient eligibility, and providing FOBT. Assign at least one experienced team member who knows all aspects of the program to be on hand each day to help supervise and offer guidance to team members who are less experienced. Develop a coverage system for lunch breaks and a back-up plan to solve logistical challenges as they arise. 2. Choose Times and Places for Flu-FOBT and Advertise Them A. When to Start The best time to start a Flu-FOBT Program is at the time when you usually begin dispensing flu shots. The first several days and weeks of flu shot activities can be busy, but this is also the time when you have the opportunity to reach the largest number of patients who may be due for colorectal cancer screening. 14

15 B. Where to do it You can do Flu-FOBT Programs wherever you provide flu shots, but the approach used may differ depending on the nature of your venue, your available resources, and your relationships with your patients. Flu-FOBT Programs are easiest to implement within integrated healthcare settings. For example, in settings with immediate access to documentation about prior screening history and with systems to provide test results to primary care physicians and to refer patients with abnormal tests to get follow-up. Flu-FOBT Programs can be implemented during dedicated Flu-FOBT Clinics or integrated within routine primary care office visits. Flu-FOBT Programs can be implemented outside of integrated healthcare settings, such as in commercial pharmacies or in non-clinical community health settings, but the logistics of doing this successfully are more complex, because of payment, processing, and test reporting issues. C. Advertise it The first step is to meet with the people who work within your organization, including managers and all of your staff members, and inform them that you are doing a Flu-FOBT Program so they can be ready to support you and so they can help you reach out to your patients. How you announce the program to your patients depends on your resources. If you are in a primary care setting, you may choose to pass out flyers to your patients announcing the Flu-FOBT Program dates, send postcards, provide an automated phone call announcement, or place information about the program on your website or in a clinic newsletter. Important information to give to patients can include the following: Dates and Times of your Program Who should come in for their flu shot Explain that patients aged 50 years and older who come in for flu shots will be offered a home colorectal cancer screening kit if they are due Provide a motivational message such as Yearly Prevention Saves Lives! 3. Design Patient Flow and Line Management Plan A. Offer Flu-FOBT in line BEFORE giving flu shot Planning patient flow issues in advance will help your program run smoothly. In busy settings, there may be a Flu-FOBT line. When there is a line, the most efficient way to reach everyone who needs colorectal cancer screening is usually to provide FOBT before providing flu shots. Waiting until after giving flu shots to offer FOBT may be less efficient, since patients usually expect to leave immediately after getting their flu shot. B. Assessing eligibility for FLU and FOBT Most experienced flu shot clinics already have established protocols for screening patients with allergies to egg 15

16 or poultry products or other contraindications to flu shots. Annual FOBT should be considered for all adults 50 years and older. Patients who have had a colonoscopy in the last 10 years will not usually need to get annual FOBT. Patients with other colorectal cancer screening tests, such as flexible sigmoidoscopy or barium enema usually can still benefit from annual FOBT. Therefore, the goal is to offer FOBT to the following patients: Age 50 years and older No colonoscopy in the last 10 years No FOBT in the last year In many cases, this information can be found in electronic medical records or in a health maintenance log sheet in the patient s paper medical chart. Team members who are unfamiliar with where to find this information may need training from a physician or clinic manager. When information about colorectal cancer screening is not available in the medical record, you can ask patients 50 years and older to tell you if they did a home stool test for colorectal cancer screening in the last year or a colonoscopy in the last 10 years, and offer FOBT who are due for screening based on their answers. If there is both no information in the medical record and patients are uncertain about when they had their last tests, you may still consider offering FOBT if it seems possible that they have not had testing in the recommended time intervals. One time-saving approach for clinics with electronic health records is to print out a list of patients who are due for FOBT at the beginning of the flu shot season, and use it as a reference to select appropriate patients for FOBT as they come in for their flu shots. 4. Develop Systems to Support Follow-Up of FOBT Kits Dispensed A. Consider ease of test completion when selecting a FOBT kit There are many FIT and FOBT tests kits on the market. When possible, select a test kit that does not require the patient to restrict their diet or medication regimen for several days before they collect their specimen. It is easiest for patients to complete a test that they can take home and complete without special preparation or delay (See Appendix D). B. Provide clear instructions for completing and returning kits Most test kits come with manufacturer recommended instructions, and they can be given to patients as part of the FOBT kit. You may want to insert additional instructions (such as multilingual instructions, simpler instructions for low literacy patients, a special reminders to date the kit when completed, and/or a phone number to call if they have questions) if you believe this would be helpful. C. Provide a return envelope for kits to be mailed back to your clinic or to the lab 16

17 Most test kits come with return envelopes to allow kits to be mailed back to your clinic for processing. Providing envelopes with paid postage will increase your return rates on FOBT kits dispensed. D. Reminder phone calls and/or postcards to encourage test completion by those who are given FOBT Typically, less than 50% of people who are given FOBT kits will return them without reminders. Providing reminders within 2 weeks of providing patients with a home FOBT kit can increase return rates. E. Assist patients with abnormal FOBT results to get colonoscopy and additional treatment when needed Develop a system for FOBT results to get to both the patient and their primary care physician. Patients with normal FOBT test results should receive the message that this is good news and that they should repeat the test in a year. Their primary care clinicians should also receive these results. Patients with abnormal FOBT test results should be called and told that they require colonoscopy to check for polyps or cancer. Their primary care clinician should also be called with this message so they can assist with arranging a colonoscopy for the patient. The Program is able to provide follow-up colonoscopies for positive FOBTs to eligible patients. Please refer to patient eligibility in the BACKGROUND section. Keep a log of patients with abnormal test results and check it periodically to verify that everyone on the list has gotten needed follow-up. 5. Implement Your Program: Final Preparations A. Gather Your Supplies Well in Advance Order flu shots and FOBT kits with return envelopes and/or stamps. Written patient education materials, posters, and algorithms for your team are available for duplication in this toolkit or downloadable from B. Two Weeks Before Flu- FOBT Activities Start Recheck to be sure you have all your supplies Do a walkthrough with your Flu-FOBT Team Consider doing a role-play with your Flu-FOBT Team, checking your workflow and procedures for providing flu shots and FOBT kits C. Your first day of your Flu-FOBT Program Whatever happens on the first day, don t give up Flu-FOBT programs get easier with experience. D. Flu-FOBT Checklist (See Appendix E) Congratulate yourselves for getting to this point! 17

18 Staff Training for Your Flu-FOBT Program (Information in this section is provided with permission by Michael Potter, MD and flufit.org) Setting up a FLU-FOBT Program requires training for the staff that will be interacting directly with your patients. The training that you provide will depend on the way you organize your program and the type of staff that are involved. For example, if your clinic site is already experienced in providing FOBT kits to patients without a doctor s order, your team may not need very much training at all. However, if your team has never provided FOBT in the past, more training will be needed. The 5 key elements to include in your training should include: 1. Information about the importance of both flu shots and colorectal cancer screening. Your staff should know a few facts about flu shots and colorectal cancer screening: Facts about Flu and Flu Shots: Flu is often mild, but can be a very serious illness Depending on the season, the CDC estimates that between 3,000 and 49,000 Americans die of complications from the flu each year Flu shots are one of the best tools we have to prevent people from getting flu Flu shots are safe when provided as directed Flu shots do not cause the flu Flu shots are recommended for everyone over the age of 6 months. More information about flu and flu shots can be found on the CDC s seasonal flu website: Facts about colorectal cancer and screening: Second leading cause of cancer in the United States More than 50,000 Americans die of colorectal cancer each year Colorectal cancer is often preventable with screening Early detection and treatment saves lives There are more than 1 million colorectal cancer survivors in the United States Colorectal cancer screening is recommended between the ages of 50 and 75 years More information about colorectal cancer and colorectal cancer screening can be found on the USPSTF website: 18

19 2. Information about how to organize your workflow efficiently. In most clinical settings, it is best to plan to offer FOBT either immediately before or during administration of flu shots. It is also important to give consideration to how your space is organized so that it will be comfortable for patients and staff. If you have a busy, high volume setting, you will want to have someone dedicated to managing the flu shot line to keep things running smoothly. You may also want to set up a separate station for FOBT several feet in front of the station where flu shots are being offered. If you are in an outpatient clinic that is providing the FLU-FOBT Program during primary care visits, or in a lower volume setting with limited space, you will likely want to provide FOBT and flu shots together at the same clinic station. Make sure to select all of your patient education materials in advance and have your work stations well stocked with FOBT kits and flu shots so that your team is well prepared for success 3. Assessing eligibility for flu shots and FOBT without waiting for a doctor s order. The CDC has developed detailed free training programs for health professionals and clinic staff who provide flu shots. These can be accessed at: Patients are eligible for colorectal cancer screening with FOBT if they are between the ages of 50 years and older also have had, No FIT or FOBT in the last year No colonoscopy in the last 10 years Patients with other colorectal cancer screening tests, such as flexible sigmoidoscopy or barium enema usually can still benefit from annual FOBT. Patients with an abnormal FOBT should be referred for colonoscopy to check for polyps or cancer. Eligibility for FOBT may be determined by reviewing clinic charts or your electronic health record. One time-saving approach for clinics with electronic health records is to print out a list of patients who are due for FOBT at the beginning of the flu shot season, and use it as a quick reference to select appropriate patients for FOBT as they come in for their flu shots. When clinic charts or electronic health records are not available, the clinic staff can ask the patient about prior FOBT and colonoscopy procedures. 19

20 As long as the patient is reasonably certain that he or she has not completed a recent FOBT kit and that they have not had a colonoscopy in the last ten years, it is reasonable to offer a FOBT kit with their flu shot. 4. Talking to patients about FOBT and how to complete the test. Colorectal cancer screening is a serious topic, but patients are usually receptive to hearing about it, especially when the conversation is kept simple and light. What you say to patients will depend on how your FLU-FOBT Program is set up and what type of kit you provide to patients. Effective points to make to patients may include phrases like this: We have something extra to offer you today! It looks like you are due for a home colon test! Colon cancer screening can save lives. Just like the flu shot, all our doctors and nurses recommend home colon tests. It s very easy and you can do it in the privacy of your home and mail it in. We ll make sure the results get to your doctor Patients who accept the kit should be given additional written material and instructions. If the patient is unfamiliar with FOBT, it is can be useful to take a moment to show the patient the kit and offer simple instructions with a visual aid or a brief instructional video. 5. Information about how to record your work and provide follow-up of FOBT kits provided to patients. For tracking purposes, you will want to keep a record of which patients were given FOBT (see Appendix F). This information can be recorded on a log sheet where flu shots are also recorded. This list can be useful to determine test return rates and to provide reminders to patients who have not yet returned kits that have been dispensed. The log sheet can be used to gather information to track and arrange follow-up of abnormal test results. 20

21 Summary Although a preventable disease, colorectal cancer (CRC) is the second leading cause of cancer deaths in the United States. 5 In addition, while unpredictable, flu-associated deaths in the US range from 3,000 to 49,000 people. 5 Screening for CRC and vaccination for flu both help reduce the incidence of these conditions. Together, research suggests that a Flu-FOBT program is an efficient and effective way to increase colorectal cancer screening and has demonstrated increased screening rates in a variety of settings. 1, 2, 4 FLU-FOBT Programs reach many patients who may otherwise not have an opportunity to receive screening. This toolkit will assist your clinic in setting up and implementing your Flu-FOBT Program with ease and great success. If you have any questions or concerns about the process please refer to or contact the Colorado Colorectal Screening Program at 21

22 Appendix A Flu-FOBT Components and Logic Model 22

23 Appendix B Clinical Guidelines Collaborative: Colorectal Screening Recommendations 23

24 24

25 Appendix C Flu-FOBT Flow Chart Patient arrives for flu vaccination Patient is 50 years and older No Yes Patient has had a colonoscopy in the past 10 years. No Yes Patient has had an FOBT test in the past year. No Yes Patient receives FOBT kit and explained the process of completing the kit. Patient receives flu vaccine. 25

26 **Patient returns FOBT kit within 14 days No Yes Place a reminder call and send post card to patient. Document FOBT kit return date in the EMR for yearly screen reminder. Record test result in patient s chart. Notify patient of test result. Negative Positive Repeat FOBT test in one year Provide referral for colonoscopy 26

27 Appendix D FIT and FOBT Brands We do not endorse any FIT or FOBT brand or product and we have not received any sponsorship from any FIT or FOBT manufacturer or supplier. We do however encourage use of high sensitivity tests to detect blood in the stool, per consensus guidelines. For your convenience, we are listing websites from some FIT and FOBT brands that are widely used in the United States. All of the brands listed are effective, but they differ somewhat in how they must be handled and processed. The websites listed all include information for health professionals and instructions for patients. For specific questions about individual tests, we recommend that you contact the manufacturers directly. Hemoccult Sensa (Beckman Coulter): This is a high sensitivity guaiac FOBT kit that requires samples from 3 consecutive bowel movements collected after dietary and medication restrictions. Each stool specimen is collected by using a collection stick to take samples from two different areas of stool from each bowel movement. The stool should be collected before it comes into contact with the toilet water. It is manually developed either in your clinic or in your clinic laboratory. Hemoccult ICT (Beckman Coulter): This is a FIT kit that is usually provided in a version requiring 2 stool samples and does not require any dietary or medication restrictions. Each stool specimen is collected by using a collection stick to take samples from two different areas of stool from each bowel movement. The stool should be collected before it comes into contact with the toilet water. It is manually developed either in your clinic or clinic laboratory. ype=render&wlpucm_renderer_path=%2fwsr%2fdiagnostics%2fclinical-products%2frapiddiagnostics%2fhemoccult-sensa%2findex.htm InSure FIT (Quest Laboratories): This test requires 2 stool samples and does not require any dietary or medication restrictions. It uses a collection method that involves the use of two long brushes to simplify stool collection. The brush is used to collect a sample of stool and toilet water which is then placed on a collection card. The InSure tests kits come in versions that can be sent to a commercial laboratory for automated development or that that can be developed on site by in your clinic or clinic laboratory. OC FIT-Check (Polymedco): This test can be provided as a 1-sample or 2-sample kit. The collection method involves poking the stool with a probe and placing the collection probe into a small tube which is mailed into the laboratory. The stool is probed before it comes into contact with the toilet water. The OC FIT-Check test kits come in versions that can be sent to a hospital laboratory for automated development or that can be developed on site by in your clinic or clinic laboratory. 27

28 Appendix E Checklist for Running a Flu-FOBT Program 1) Assemble Your Team & Involve Everyone in the Planning Process Designate a Champion/Coordinator Select Team Members Physicians Medical Assistants Nurses Health Workers who can be trained to provide flu shots and FOBT kits Plan specific roles and tasks for each member of the team 2) Plan and Implement Your Program Staff Training Educate staff on facts regarding the flu/flu shots & CRC/CRCS Familiarity with the procedure of completing the FOBT kit your program will distribute to patients Comfort with explaining the procedure of completing the FOBT kit to patients Organize and practice the workflow to become efficient Familiarity with eligibility and tracking Patient Flow Which staff will work with flu shot only patients and flu-fobt patients How patients will be guided to the flu shot only versus the flu-fobt areas Provide the FOBT before providing flu shots Assessing Eligibility Have eligibility algorithm posted Develop a system for easy access to patient records/emr You may still consider offering FOBT if it seems possible that the patient may not have received screening in the recommended intervals 3) Designate Dates, Times and Locations Advertise, Advertise, Advertise 4) Develop Systems to Support Tracking & Follow-Up Log Sheets Tracking Sheets for abnormal FOBT 5) Finish Preparations for Your Flu-FOBT Program Gather ample supply of flu shots and FOBT kits with return envelopes/stamps Gather ample patient education materials/directions for FOBT 6) Do not forget REMINDER CALLS to patients to return their FOBT kits 28

29 Appendix F Flu-FOBT Tools Telephone Script Hello. This is <Member Name> calling from <Clinic Name>. Our records indicate that you have received an FOBT test which has not yet been returned. Please complete your FOBT test and mail it back to us. An FOBT test screens for evidence of blood in your stool, which is an early detector for colon cancer. Finding cancer early is key to saving lives. If you would like another FOBT test kit mailed to you, please press one now. 29

30 Sample Patient Education Poster Flu is Preventable! Colon Cancer is Preventable! Just like the FLU, COLON CANCER is PREVENTABLE, TREATABLE & BEATABLE when found EARLY! Colon cancer screening is recommended for healthy men and women aged 50 and older. One recommended screening test is a yearly FOBT test that can be done at home. Other recommended colon cancer tests include: Colonoscopy every 10 years or Flexible Sigmoidoscopy every 5 years Yearly home stool tests are EASY TO DO! Yearly home stool tests COULD SAVE YOUR LIFE! If you are due for colon cancer screening today and have a regular doctor, WE WOULD LIKE TO OFFER YOU A FREE HOME TEST! 30

31 Sample Reminder Postcard REMEMBER! Greetings from [name of healthcare facility]! When you came in to get your flu shot, we gave you a home colon cancer screening test kit. If you already completed it, thank you! If you haven t done your home colon stool test yet, please do it and send it back to us as soon as possible. Thank you very much! [Insert signature of the patient s PCP or of the medical director of the clinic here] [Insert Clinic Address and Logo here] 31

32 Sample English/Spanish Poster 32

33 References 1 Potter, M.B., Phengrasamy, L., Hudes, E.S., McPhee,S.J., Walsh, J.M. (2009). Offering annual fecal occult blood tests at annual flu shot clinics increases colorectal cancer screening rates. Annals of Family Medicine, 7: Potter, M.B., Gildengorin, G., Wang, Y., Wu, M., Kroon, L. (2010). Comparative effectiveness of two pharmacybased colorectal cancer screening interventions during an annual influenza vaccination campaign. Journal of the American Pharmacists Association, 50: Potter, M. B. et al. (2011). Adaptation of the flu-fobt program for a primary care clinic a serving low-income Chinese American community: New evidence of effectiveness. Journal of Health Care for the Poor and Underserved, 22, Potter, M.B., Walsh, J.M., Yu, T.M., Gildengorin, G., Green, L.W., McPhee, S.J. (2001). The effectiveness of the FLU-FOBT Program in primary care: A randomized trial. American Journal of Preventative Medicine, 41: Centers for Disease Control and Prevention. (2012). Colorectal (Colon) Cancer. [Online]. 6 Centers for Disease Control and Prevention. (2011a). Vital signs: Colorectal cancer. [Online]. 7 Centers for Disease Control and Prevention. (2011b). Vital signs: Colorectal cancer screening, incidence, and mortality-unites States, , early release. [Online]. 8 American Cancer Society. (2011). Colorectal Cancer Facts & Figures Atlanta: American Cancer Society. 33

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