III. Intervention Steps and Tools

This section describes each of the six main intervention steps and then describes the optional assessment step. Each intervention and assessment step includes what the step entails, provides instructions for implementing it, and offers tips about it and how to avoid potential pitfalls (based on implementation lessons learned). This section also identifies possible alternative ways of carrying out various steps and what would be needed to make such alternatives practical. In addition, the text notes where various steps may be considered optional and under what circumstances a user may or may not want to apply one of those steps. After each intervention step is described, the appropriate corresponding intervention tools are provided (e.g., forms, letters to patients, academic detailing material).

The tools are based on the materials used for CNA's intervention, but they can be tailored and revised as appropriate for each organization that implements the intervention. In addition, some tools include language that was specific to CNA (e.g., participation was voluntary since it was part of a study) that may not be appropriate for each setting. Text in the tools indicates where materials can be personalized (e.g., insert your organization's name here). We suggest that you review the tools and make any appropriate changes.

Step 1: Recruit Practices

Description

The first step of the SATIS-PHI/CRC intervention is recruiting primary care practices to participate. This component consists of encouraging primary care practices affiliated with the central entity to participate by providing the practices information about:

The importance of CRC screening.
The nature of the intervention and the evidence it is based on.
The benefits to them and their patients of participating.
The intervention requirements for them and their patients.

As the central entity recruits the practices, it is important for the central entity to clearly explain to the practices what is involved with the intervention and what is expected of the practices. Presenting the practices with a step-by-step process guide (Tool 1.a-1) can help them better understand the SATIS-PHI/CRC intervention.

In addition to recruiting practices, the central entity needs to consider whether it wants to involve a stool test kit supplier. This decision will likely vary depending on the type of organization that acts as the central entity. The central entity can choose to bear the upfront cost or negotiate with a clinical laboratory or other supplier to bear the cost of supplying kits for either all eligible patients or only those patients who request them through an enclosed request card. As a third alternative, the central entity can send the kit to patient groups it especially wants to target and send request cards to all other eligible patients. While insurance companies usually reimburse for the cost of kits when they are processed, unused or unprocessed kits are most likely not reimbursed by insurance companies.

Tips

Making sure practices are aware of their role. We suggest providing the practices with detailed written documentation of the practice's role in the intervention so that the practice office manager, staff, and clinicians understand who is supposed to do what and when. Therefore, we suggest using a step-by-step instruction packet to outline exactly what the practice and provider should do during each step of the process (Tool 1.a-1).
Sustaining practice involvement. We suggest staying engaged with the recruited practices during the time it takes to recruit all participating practices, identify eligible patients, and prepare the Invitation to Screen mailing to patients. While practice priorities will always be shifting and loss of practices from the intervention during this time may be inevitable, maintaining engagement with practices can help minimize this loss.
Sustaining support of a stool test kit supplier. When you recruit a stool test kit supplier, be sure that the supplier understands the financial implications of supplying kits. This is especially the case if the supplier is a clinical laboratory that expects to recoup the cost of supplying the tests by charging patients or their insurers for developing and processing returned kits. You should work with such a supplier to ensure that it has a realistic estimate of the proportion of supplied kits that are likely to be returned.

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Description

The practice/clinician educational component of the SATIS-PHI/CRC intervention consists of an academic detailing session at each participating practice conducted by staff of the central entity. The detailers use informational material, primarily consisting of PowerPoint® slides, for a presentation to practice clinicians and staff (Tool 2.b-1). The presentation describes the intervention and provides information about currently recommended CRC screening and followup guidelines (Tools 2.b-1 and 2.b-2).

Detailers also distribute and explain the use of a screening tracking sheet developed for this intervention to be used by practices that do not already have an effective means of tracking screening tests (Tool 2.b-3). Detailers stress the importance of tracking screening, notifying all patients of screening results whether normal or abnormal, and following up on positive screens.

As needed, the central entity can also conduct followup academic detailing. This need may arise from information collected from an optional survey and focus group of clinicians and other practice staff regarding their perceptions of and behavior performing CRC screening and followup. It also may arise from information found in record reviews (Step 3) or from current events (e.g., changes in guideline recommendations). Detailers can develop an academic detailing "booster" containing material targeted at clarifying misperceptions or nonrecommended screening and followup behaviors (Tool 2.c-1).

The optional practice survey should be distributed and collected prior before the academic detailing session, as the survey is intended to collect baseline information about the practices and should not be influenced by information disseminated during the detailing session (Tool 2.a-1). The optional focus groups should also be conducted before the central entity disseminates information about the intervention (Tool 2.a-2). If the focus group will be conducted during the same session as the academic detailing, it should be held at the beginning of the detailing session. Key informant interviews can also be conducted to obtain additional information not collected during the focus groups (Tool 2.a-3). The Assessment section has more information about these optional tools.

Tips

Understanding clinicians' preferences. Physicians may not agree with the new CRC screening guidelines. For example, a physician in CNA's intervention thought colonoscopy was the only acceptable screening method and that other methods recommended by the current guidelines were not correct, especially stool testing. If you find clinicians with similar preferences, talk with them about their concerns and stress the acceptability of all recommended screening modalities. We also suggest emphasizing the recommended screening modalities in the academic detailing session.
Setting expectations. It may not always be clear to practice staff, especially physicians, that agreeing to participate in the intervention includes agreeing to attend the academic detailing session (with its optional embedded focus group component) and to complete the optional survey of CRC beliefs and behaviors. We suggest reminding the practices and their physicians of this requirement when scheduling the academic detailing sessions. If you conduct the optional practice survey and focus group, we also suggest reminding clinicians and practice staff that you will need to collect the survey before the academic detailing session to avoid confounding of results.

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Step 3: Identify Eligible Patients

Description

Eligible patients are initially identified through a review of available electronic records. Such records can include claims records, billing records, electronic medical or health records, and patient registries. Ideally information in these records should be verified and made up to date by using a brief screening eligibility assessment (SEA) form of those patients identified as eligible through the records review (Tool 4.a-2).

This SEA form is optional, but we suggest using it, if possible. It helps ensure that the central entity only targets patients who are truly eligible and not those who may only appear to be eligible based on records with missing, incomplete, incorrect, or out-of-date information. Such patients may become annoyed if sent screening material in error or may decide to get screened even though they do not meet guidelines for screening.

The following are eligibility criteria for including patients in the SATIS-PHI/CRC intervention (Tool 3.a-1):

Being age 50 through 79.
Being a current patient of a participating practice (having had at least one visit to the practice within the previous 2 years).
Being of average risk for colorectal cancer (having no previous diagnosis of CRC, colorectal polyps, or inflammatory bowel disease and no family history of CRC diagnosed before age 60).
Having a complete mailing address on file.
Not being up to date in CRC screening according to prevailing guidelines. These guidelines currently include not having had (1) a colonoscopy within the previous 10 years, (2) a flexible sigmoidoscopy or double contrast barium enema x-ray within the previous 5 years, or (3) a stool test (e.g., a fecal occult blood test [FOBT], a fecal immunochemical test [FIT], or similar stool test) within the previous year.

Information about eligible patients should be entered into a "master patient database" (Tool 5.a-1). The format of this database can vary, depending on each organization's existing information technology infrastructure. At a minimum, it should include the following:

Patient's name and mailing address.
Unique patient identification number.ⁱⁱ
Patient's age or date of birth.
information indicating whether the patient would be ineligible for the intervention (e.g., evidence of prior diagnosis of CRC or polyps or inflammatory bowel disease, evidence of family history of CRC diagnoses before age 60, evidence of recent prior CRC screening test, not a patient of the practice).
Name of the practice the patient attends.

Additional patient information can also be entered in this database, such as the patient's gender and the patient's primary language. Recording the patient's primary language can especially be helpful if sending language-appropriate materials to patients. This information, as well as other demographic information, can be collected from the optional SEA form.

The master patient database will then be used for tracking patient screening, as described in greater detail in Step 5. Such tracking includes recording patient response to the intervention, screening results for those choosing to be screened, indications of patient notification of screening results, and indications of followup to screenings.

Followup electronic reviews are conducted before various subsequent steps in the intervention that require identifying patient response to the intervention material or results of screenings. These are described in more detail below under tracking patient response and screening results (Step 5).

Tips

Timing. Try not to schedule electronic record reviews during or in the weeks following open enrollment periods, because records may not be up to date for patients. During open enrollment, patients may be changing insurance plans or primary care practices. In addition, data system personnel at health plans, who may be required to assist with the record review, will likely be too busy updating records with open enrollment data to support the intervention during those times.
Complications of extracting data. You may need to build in extra time for electronic record reviews to accommodate inexperienced data system staff at practices or other entities from which information needs to be extracted. Staff responsible for managing and extracting data from the source data systems do not always have the necessary experience or expertise to easily identify and produce lists of patients eligible for the intervention. Further, these systems are not always set up to produce such lists or to provide the kinds of data needed (e.g., identifying which primary care practice a patient is affiliated with or finding evidence of prior colorectal cancer screening or other disqualifying conditions in the records) and require special programming. You may need to (1) accommodate competing demands on electronic data systems and on data management and programming staff, (2) supplement existing report generation programs with revised programs needed for the data extraction, (3) respond to Health Insurance Portability and Accountability Act (HIPAA) concerns of data management staff, and (4) accommodate and overcome missing data and data ambiguities, especially in electronic medical records. Roth (2009) and West (2009) both note that obtaining information from electronic health records is complicated and difficult. Roth found that quality indicator data for colorectal cancer are especially problematic. We suggest considering these potential complications when planning your record review.
Data cleaning. Regardless of all the precautions you take to ensure receiving clean data, you should plan to set aside time and resources to further clean them. Data cleaning may require a significant amount of additional manual effort. For example, the format of patient names received from different systems may be inconsistent or may not be compatible with producing mailing labels, requiring manual reformatting of names.
Staggered patient mailings. If you encounter delays in receiving and cleaning data for patients of some practices but have complete clean data for patients of other practices, you can consider staggering your patient mailings. You can mail material to patients of practices with complete data while continuing to obtain and clean data from other practices. If you choose this option, we suggest tracking in the master patient database which patients received the mailing and when to ensure that all patients received the mailing (as you will be sending patients the mailings at various intervals). In addition, you may want to track which patients received the mailings and when, regardless of whether you have to send the mailings with a staggered start.

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Step 4: Mail Screening Information and Materials

Description

This step consists of several mailings to patients:

Optional screening eligibility assessment (SEA) survey form.
Invitation to screen.
Followup reminder (including an optional second reminder).

Recent studies have found that minorities are more likely to be screened when the information is presented in a manner they can read and understand (Carcaise-Edinboro, 2008; Natale-Pereira, 2008). Therefore, if the intervention is to be implemented in a community that has a significant population that speaks or reads a non-English language, we highly recommend that all mailed material be sent in both English and the other languages. The CNA implementation of the SATIS-PHI/CRC had a large Spanish-speaking population, so most of the patient mailing materials included in this toolkit are in both English and Spanish.

In addition, recent studies have found that receiving information and recommendations for CRC screening from a health care provider can be a predictor of patient screening (Carcaise-Edinboro, 2008; Griffith, 2008; Sarfaty, 2007). Therefore, although the central entity mails the patient letters (on behalf of the practice), we suggest that the provider sign all mailings so that the patient clearly identifies this effort with his or her provider. In addition, all mailings should be printed on practice letterhead.

Optional SEA Form

As noted, use of the SEA form is optional, although it is recommended. Its primary intent is to identify patients who appear to be eligible based on the initial record review but who are, in fact, ineligible. SATIS-PHI/CRC includes this step to help compensate for the current state of most electronic records. The information contained in them required to determine eligibility is often incomplete, inaccurate, or not up to date. The SEA form gives patients an opportunity to identify themselves as ineligible and to report the reason for their ineligibility.

The central entity conducting the intervention can then change the status of such a patient in the master patient database from eligible to ineligible and indicate the reason. The central entity can also inform the practice with which such a patient is affiliated of the need to update its records on this patient or to further confirm with the patient the validity of the self-identified ineligibility. If a patient identifies himself or herself to be ineligible due to above-average risk for CRC (e.g., through a family history of CRC), the central entity should inform that patient's practice. The practice can then initiate a conversation with that patient to be diligent about receiving CRC testing more often than recommended for average-risk patients.

If the central entity is willing to accept the results of the initial electronic record review as determinative, it can omit the SEA form. The central entity may have great confidence in the validity of the electronic records from which it determines eligibility or it may decide that the cost and effort involved in mailing and processing the SEA form outweigh the benefit. We do not recommend this plan but leave it to the central entity adopting the intervention to make this choice.

If the central entity decides to use the SEA, all patients who are identified as being potentially eligible by the initial electronic record review should be sent the optional first mailing consisting of the following two items:

Letter from the primary care practice with which they are affiliated explaining the importance of CRC screening and informing them of the practice's participation in a screening program (Tool 4.a-1).
SEA form, requesting information about their eligibility and demographics (Tool 4.a-2).

The SEA form asks patients to indicate whether they consider themselves to be ineligible for the intervention (i.e., identify themselves as ineligible by checking one or more listed reasons that would make them ineligible). The form also requests demographic information about the patient not otherwise ascertainable through the available electronic records. Such information includes race/ethnicity, preferred language, marital status, educational level, and perceived health status. The SEA form also provides a check box for patients to indicate that they do not want to participate in the intervention (i.e., that they do not want to receive subsequent information about CRC screening or this screening program). A telephone number is provided (for the central entity) for opting out of the screening program intervention if a patient does not want to respond by the SEA form.

Invitation to Screen Mailing

The central entity next sends an invitation to screen to all patients deemed to be eligible by electronic record review and possibly the SEA mailing (note that if the central entity omits the SEA mailing, the invitation becomes the first rather than the second mailing). The invitation consists of:

A letter from the patient's primary care practice inviting the patient to be screened (Tools 4.b-1 and 4.b-2).
Educational material regarding CRC and screening (a brochure that describes the benefits of CRC screening and the alternative screening modalities consistent with the 2008 Multi-Society and USPSTF guidelines) (Tool 4.b-3).
A list of colonoscopy providers to whom clinicians in the patient's practices refer, along with those providers' addresses, phone numbers, and other contact information (additional information such as type of insurance accepted may be included if it is available).
Either a stool test kit or a request card that the patient can mail back to request a kit (Tool 4.b-4).
A self-addressed stamped envelope for returning either the kit or the card to the practice.

Depending on the relationship between the central entity and the laboratory, patients may be able to mail completed stool test kits directly to the laboratory for processing, or they may have to send the kits to the practice (who in turn send them to the lab).

If the invitation is the first mailing (i.e., the SEA mailing is omitted), the invitation should also include language from the introductory letter from practice clinicians (Tool 4.a-1).

The central entity should also tailor the invitation letter to whether a stool test kit or a request for a kit is enclosed with this mailing (we refer to these options as Versions 1 and 2, respectively). If the central entity decides to send kits only to those requesting one through a mail-back request card for all or some of the patients in the screening program, it should periodically mail kits to patients requesting them at short enough intervals that patients do not have to wait too long to receive them (Tool 4.c-1). The central entity can also update its master patient database to indicate which patients have requested a kit and when it was mailed to them. When the central entity sends patients the stool test kits, it should include instructions for completing the kit that are specific to the type of kit used.

Reminder Mailings

In conjunction with tracking patient responses and screening, the central entity sends one or more reminders to patients in the database who remain eligible for screening (i.e., those for whom no disqualifying information has been received) and no evidence of screening is found (Tools 4.d-1 and 4.d-2). The central entity can decide to stop after only one reminder or send one or more subsequent reminders. This decision should be based on considerations of cost and expected increased screening response.

Tips

Preparation of mailing materials. It was time and labor intensive to conduct the patient mailings. Depending on the size of the patient population and the staff resources available from the central entity, we suggest using a separate contractor who specializes in large-scale mailings to send and track the patient mailings. HIPAA issues should be considered when making this decision as well.
Use of SEA. The SEA form can be very useful for identifying patients who are not eligible and who do not want to participate. Some patients can also use the SEA form as a way to indicate their sometimes strong desire to not continue receiving any additional screening information.
Patient response. Patients do not always return requested information (e.g., SEA form) in a timely manner. In addition, patients can be frustrated by receiving information when they indicate they do not want to participate. If you choose to use the SEA form, we suggest waiting a sufficient amount of time before sending the invitation to screen. You can judge what a "sufficient amount of time" is by monitoring the rate of return of SEA forms and waiting until that rate drops off significantly. We also recommend adding a suggested timeline in patient mailing materials, indicating a deadline for patients to respond.

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Step 5: Track Patient Screening and Results

Description

After a reasonable period of time and periodically thereafter, the central entity conducts a followup electronic record review to look for evidence of screening (in particular, a stool test or colonoscopy, but evidence of screening by other guideline-supported modalities should be looked for as well). The central entity also reviews reports received from the clinical lab processing stool test kits for evidence of screening and results and updates its master patient database accordingly (Tool 5.a-1). Results from this tracking are used for sending out reminders and preparing feedback reports to the practices.

The intervention also uses two other tracking mechanisms. First, practices track the screening of their own patients and periodically generate reports that the central entity can use to update the master patient database. Tracking can be done with the screening tracking sheet provided at the academic detailing sessions (Tool 2.b-3) or with internal tracking mechanisms already in place.

Second, especially for practices without electronic medical records, central entity staff may request access to select patient charts to conduct audits looking for evidence of screening and possible needed followup (Tool 5.d-1). Such chart audits would only be performed in instances where electronic evidence of screening and followup is inconclusive and only if the audits would not violate HIPAA requirements. Audits can also be performed on electronic charts, especially when screening information may be entered in various text fields in the record that require a manual review.

Tips

Using a clinical champion. To help encourage practices to track their patient screening and to help instill the importance of CRC screening and tracking, we feel that it may be helpful to have a clinical "champion" at each practice to help ensure that the clinical tracking tools are used. This champion, along with a practice management staff member, can also serve as a liaison between the practice and the central entity.
Recording SEA data. It can be time and labor intensive to code and capture SEA results for the master patient database. We suggest establishing a codebook or exploring the use of a scannable SEA form. A scannable form will help minimize manual data entry and increase the speed, and perhaps accuracy, of data entry.
Tracking Screening and Followup. Practices may not use the screening tracking sheet. Each practice may have its own methods of tracking patient screening or may not be able to maintain additional records. In addition, it is difficult to determine from electronic records whether a followup colonoscopy (i.e., complete diagnostic exam was performed on stool test-positive patients. A screening colonoscopy and a diagnostic colonoscopy are not easily distinguishable in electronic records. The central entity may need to conduct a manual review of the record and chart notes to distinguish between them. Because tracking patient screening is important, we suggest working with the practices to determine how they can best monitor their patient screening.
Arrange lab record review. As mentioned, we suggest establishing an agreement with the clinical laboratory processing the stool tests so that they will be able to inform the central entity directly of the stool test screening result. This helps the central entity track patient screening and screening results. The central entity should consider potential HIPAA issues when establishing this agreement.

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Step 6: Provide Feedback to Practices

Description

The central entity notifies participating practices of positive (abnormal) and negative (normal) stool test screenings and coaches them on notifying patients about screening results and how to follow up on them (Tools 6.a-1 and 6.a-2, respectively). The central entity also provides a form to practices for tracking and documenting followup complete diagnostic examinations (CDEs)ⁱⁱⁱ for patients with positive (abnormal) stool test screening results (Tool 6.b-1).

The stool test abnormal and normal forms inform the practices and clinicians about how they are expected to respond to the respective results. Practices are expected to respond to a positive stool test by recommending a CDE for the patient (i.e., a followup colonoscopy). Practices are expected to respond to negative stool tests by notifying patients and informing them that the guidelines recommend that they be rescreened every 12 months.

In addition, the CDE feedback form facilitates tracking and followup of positive screens. The CDE feedback form identifies patients in need of a CDE and reminds providers of recommended CDE procedures. It also requests that providers document (1) that patients have been advised to have a CDE and what type of modality was recommended, (2) the date the CDE was scheduled and completed, and (3) the results of the CDE as well as any additional comments. This information can then become part of the patient's record.

Tips

Encouraging use of CDE feedback form. It can be difficult to get clinicians to complete and return the CDE feedback form. As previously noted, we suggest that in the future the central entity have a clinical "champion" at each practice, in addition to the office manager. If each practice has a clinical point of contact, he or she may be better suited to encourage fellow clinicians to use these clinical tracking tools.

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Assessment

Description of Optional Assessment Step

As previously noted, central entities may decide to assess their implementation of the SATIS-PHI/CRC intervention. To conduct such an assessment, we suggest that you use an evaluation framework that has both process evaluation and outcome evaluation components such as the Practical, Robust Implementation and Sustainability Model (PRISM) (Feldstein and Glasgow, 2008).

PRISM contains a contextual domain that allows you to gain a better understanding of the context in which the intervention takes place and how that context likely affected your ability to implement SATIS-PHI/CRC with fidelity and achieve intended outcomes. This contextual domain includes such factors as the external environment of your implementation setting, the organizational characteristics of that setting, and the setting's implementation and sustainability infrastructure. It also contains an outcome domain that allows you to assess whether and to what degree you achieved the intervention's intended outcomes of:

Reaching eligible patients,
Being adopted by target practices,
Being implemented with fidelity, and
Improving screening and followup rates.

PRISM incorporates the RE-AIM outcome factors of reach, effectiveness, adoption, implementation, and maintenance (Glasgow, et al., 1999). Please refer to CNA's final report to see how they used this framework in their assessment of implementing SATIS-PHI/CRC (Harris and Borsky, 2010).

Several optional tools may be useful for this assessment. These tools include the following data collection instruments:

A practice survey.
Practice interview guide.
Focus group guides for both practices and patients.

These tools can be useful for better understanding the perspectives of the clinicians, practice staff, and patients regarding CRC screening and their experience with the SATIS-PHI/CRC intervention.

Fielding these instruments and analyzing their results requires additional staff time and is not directly related to implementing the intervention. However, if your organization has the additional personnel and wants to better understand the effectiveness of your implementation, we suggest using these tools. If your organization conducts an assessment, we also recommend reviewing some recommended research protocol and assessment techniques (Babbie, 2004; Campbell and Stanley, 1963; Perceman and Curran, 2006; Krueger and Casey, 2009).

Practice Assessment

These assessment tools can be fielded before the intervention to ascertain baseline perspectives, and they can also be fielded after the intervention. To collect the baseline information, we suggest conducting the practice surveys (Tool 2.a-1) and practice focus groups (Tool 2.a-2) prior to Step 2. However, the interviews (Tool 2.a-3) should be conducted after Step 2 to gather information about additional questions and information that was not uncovered during the focus groups.

To collect postintervention information, we suggest conducting the practice surveys, practice focus groups, and practice interviews after Step 6 is complete (Tools 2.a-1, A.1-2, and A.2-1, respectively). The central entity can then compare the pre and post data collections to ascertain whether perspectives, knowledge, and reported behavior have changed.

Patient Assessment

The central entity can also conduct patient focus groups postintervention (Tool A.3-1). Focus groups can be held separately with a sample of patients who were screened and had negative findings and with a sample of patients who were screened and had positive findings.^iv Focus groups can also be held with patients who were not screened (nonresponders). The central entity can also decide to combine groups and to use only appropriate parts of the guides as needed.

Using the PRISM and RE-AIM frameworks and data gathered from focus groups, key informant interviews, and practice surveys can be helpful for assessing the contextual domain of your implementation of SATIS-PHI/CRC. In addition, screening outcomes can be assessed by analyzing the master patient database. If you plan to conduct such an assessment, we suggest collecting the optional data elements listed in the Master Patient Database Elements Tool (Tool 5.a-1). These optional elements can be useful for analytical purposes. For example, you could calculate the screening rate (number of screens/number of eligible patients) separately for men and women, and separately for older and younger patients. You could also conduct analyses to predict which elements were significantly associated with screening (e.g., conduct logistic regression or other statistical analyses).

Tips

Obtaining assessment approvals. Be certain to obtain any Institutional Review Board (IRB) approvals required by your organization before undertaking any assessment data collections. Check with your IRB to see whether your assessment activities will require its prior approval. Check with your legal department as well regarding HIPAA requirements.
Encouraging practice respondents. Clinicians and practice staff may be less likely to respond to the postintervention survey than the preintervention survey. We suggest maintaining communication with clinicians and practice staff and establishing expectations for participation to encourage them to remain engaged throughout the duration of the intervention.
Encouraging patient respondents. It may also be difficult to recruit patients for focus groups, especially patients who did not respond to the intervention. We suggest starting patient recruitment early and considering combining various types of patients into a single focus group, if needed.
Collecting analytical data. If you conduct an assessment of the SATIS-PHI/CRC intervention, we suggest that you collect the additional optional data elements and others relevant to your setting, listed in the Master Patient Database Elements tool (Tool 5.a-1). If conducting an assessment, it will be important to track which patients received what mailing and when, and it will also be important to track more demographic-related information. We also suggest collecting additional information about each patient's practice so that you can assess what practice-related factors influenced patient screening (e.g., presence of an electronic medical record, size of the practice, practice geographic setting, practice affiliation, and practice specialty).

ⁱⁱ Assigning a unique patient identification number to patients can be useful for confidentiality and Health Insurance Portability and Accountability Act (HIPAA) concerns.
ⁱⁱⁱ Also referred to as followup colonoscopy to a positive stool test screen.
^iv If conducting a focus group with positive screen patients, we suggest making sure that all such patients had a subsequent negative followup colonoscopy or CDE. We also suggest making sure that patients understand that this is a focus group for an intervention and not part of a support or therapeutic group.

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