2.2. Study setting

The study setting is Group Health, which is a large, nonprofit, integrated delivery system that provides both medical coverage and care to more than 600,000 members in Washington State and Idaho. This study is being conducted at 21 Group Health-owned primary care medical centers in the Puget Sound Region. Family practitioners (90%) and internists (10%), over 95% of whom are certified by their respective boards, provide primary care for adults. Each full-time physician cares for a defined panel of 1900 patients on average. Medical centers are divided into teams, which consist of three to four physicians, registered nurses (RNs), licensed practical nurses (LPNs), medical assistants (MAs), and a physician assistant or nurse practitioner. Almost all patients age 65 and older are Medicare patients, while most patients under age 65 are in commercial plans.

The demographic mix of Group Health enrollees is similar to the surrounding area, except that they are somewhat older (46% ≥ 45 years vs. 38% in the regional community), more likely to be employed, and more educated. African Americans 4%, Pacific Islander or American Indian 3%, and Hispanic 4%. Group Health is accredited by the National Committee for Quality Assurance (NCQA) and Healthcare Effectiveness Data and Information Set (HEDIS). CRCS rates in 2009 were 66.7% (FOBT in the measurement year, FS within 5 years, CS within 10 years, or barium enema within 5 years). However, HEDIS counts patients as screened if any code specific to FOBT submitted claim/encounter occurs, [9] regardless of the test being returned, so organizational estimates for CRCS are likely overestimated.

2.3 Participants

The Group Health Institutional Review Board (IRB) approved all study procedures. Participant recruitment began in July of 2008 and was completed in November of 2009. Subjects age 50 – 75 were eligible if continuously enrolled in Group Health for at least 2 years, and based on administrative data, also due for CRC screening (defined as no evidence of a FOBT in the last 8 months, no flexible sigmoidoscopy in the last 4 years, and no colonoscopy in the last 9 years). The recruitment sample pool was refreshed weekly to include or exclude potential participants based on their most recent CRC screening test. We also used administrative data to exclude patients with a history of the following: colorectal cancer, inflammatory bowel disease (Crohn's disease or ulcerative colitis), total colectomy, a myocardial infarction in the previous 3 months, and end stage or organ failure diseases (dementia, renal or liver failure, COPD on home oxygen, strokes, pacemakers or defibrillators), or active treatment for cancer with chemotherapy.

2.4 Telephone Recruitment

Figure 2 depicts recruitment and study flow. Those eligible based on automated data were sent recruitment letters to introduce the study. Research assistants then called potential participants to confirm eligibility, including their ability to converse in English over the telephone. Those no longer enrolled or planning to leave the health plan in the next year were excluded. Those reporting a flexible sigmoidoscopy in the prior 4 years or a colonoscopy in the prior 9 years were also excluded. Patients reporting a family history of colorectal cancer in a first degree relative age 60 or younger were also excluded and advised to discuss screening with their primary care physician. Patients who remained eligible and willing to participate (in both part 1 and 2 of the study) provide verbal consent (signed consent was not required). Then, they were sent a copy of the consent and a phone number to call if they decided not to participate after reading the form.

Approximately 25% of patients on the sample list were randomly pre-selected (prior to consent and randomization) to complete an additional survey with more detailed questions related to CRC screening knowledge, perceived risk for CRC, pros and cons of screening in general as well as for specific screening tests, and their self-efficacy and social support to complete screening. If their name is on this list and they consented to the longer questionnaire (20 minutes), they received $10 to thank them for their time. They did not need to complete the longer survey to participate in the trial. Participants completing the longer survey will be contacted again in 2 years to complete these questions again.

2.5 Study interventions

2.5.1. Study 1: Interventions to Increase CRC Screening Rates

Intervention components by study group are depicted in table 1. The components were selected based on the Chronic Care Model (figure 1) and its six domains: (1) evidence based guidelines (for CRC screening and follow-up and decision support tools); (2) information systems (electronic medical records, patient registries, automated mailings); (3) delivery design (the healthcare team and processes of care); (4) self-management support (patient information, informed decision making); (5) health care policy (insurance coverage, HEDIS measures [Health Employer Data Information Set]), and community resources (mass media, professional societies, worksite and community activities).

Table 1

Study 1 Intervention Components^*

	Group 1	Group 2	Group 3	Group 4
	UC	UC + Auto	UC + Auto + Assist	UC + Auto + Assist + Care Management
Evidence Based Guidelines and Decision Support
■ CRC screening guideline & Web based decision support for physicians	Yes	Yes	Yes	Yes
■ Academic detailing of CRC screening guidelines	No	No	Yes	Yes
Information Systems
■ Registry of patients current CRC screening status	No	Yes	Yes	Yes
■ Outreach screening and follow-up reminds tracking	No	Yes	Yes	Yes
Delivery System Design
■ Mailed FOBT screening kits with stamps and reminds	No	Yes	Yes	Yes
■ Medical Assistant	No	No	Yes	Yes
- Proactive
- Identifies Intent
- Assists with Action Plan
■ Nurse Care	No	No	No	Yes
- Proactive
- Decision Counseling/Preference Clarification
- Arranges Action Plan (clinical assessments, orders test, coordination of care)
Self-Management Support
■ Small media patient information (Web, paper)	Yes	Yes	Yes	Yes
■ Access to cancer screening resource line	No	Yes	Yes	Yes
■ Personalized screening schedule	No	Yes	Yes	Yes
■ Mailed FOBT with simplified instructions	No	Yes	Yes	Yes
■ Mailed reminds if screening not done	No	Yes	Yes	Yes
■ Medical Assistant intent clarification and action planning	No	No	Yes	Yes
■ Nursing care decision counseling/preference clarification, shared-decision making, assistance with preparation and completion of tests	No	No	No	Yes
Healthcare Policy and Community Resources
■ Workgroup of GH leaders, stakeholders, physicians, and researchers complete intervention protocols and processes of care	Yes	Yes	Yes	Yes
■ HEDIS/Group Health CRCS at health plan level	Yes	Yes	Yes	Yes
■ HEDIS/Group Health CRCS rates feedback at physician level	Yes	Yes	Yes	Yes
■ Mass Media promoting CRCS	Yes	Yes	Yes	Yes

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^*Intervention component specific to individual intervention groups are bolded

The Chronic Care Model does not specify a specific behavioral construct for optimizing patient self-management but often uses an “action plan” to help patients define their health goals and to make a plan to attain these. We use the Preventive Health Model to guide patient-level behavioral interventions (figure 3) [10-12]. The Preventive Health Model is based on the Health Belief and Theory of Reasoned Action Models and describes both moderators and mediators (modifiable behaviors) related to completion of cancer screening. Potential moderators of screening behavior include patient demographic characteristics. Modifiable factors might include patient perceived susceptibility and worry or concerns about CRC, knowledge of screening and the different tests, pros and cons of the different tests, social influence, and screening self-efficacy. We hypothesize that both individual behavioral and systems of care factors might influence patient CRC screening “intent” and “action.”

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Figure 3

Preventive Health Model of Adherence

Arm 1: Usual Care (UC)

Group Health recommends either yearly FOBT alone, FOBT yearly combined with flexible sigmoidoscopy every 5 years, or colonoscopy every 10 years. Usual care at Group Health already includes provider-level services to promote CRC screening including evidence based CRC screening guidelines, computer generated reports of patients who are not up to date for CRC screening and other quality measures. Usual care also includes patient-level paper information on CRC screening, online at a patient Web site, and in brochures in clinic. Additionally, all adult patients receive an annual letter from Group Health on their birthday listing dates of recommended immunization, screening tests, chronic condition care, and reminders if an item is due (including CRC screening).

Arm 2: Usual Care + Automated (Auto)

In addition to usual care, Arm 2 patients receive interventions delivered by a centralized automated registry system designed for the study. The registry is linked to Group Health clinical, laboratory, and claims databases and automatically tracks when screening is due and generates mailings accordingly. Approximately one week after randomization, Arm 2 patients receive a letter informing them they are due for CRC screening and a pamphlet with information on the different screening CRC tests and pros and cons of each. They are also informed FOBT cards will be mailed soon, but if they prefer another CRC screening test, they can call the SOS telephone line. Patients calling the SOS telephone line speak to a research assistant who informs them to make an appointment, call, or send a secure e-mail to their health care team to request an alternative to FOBT (entry of this information turns off subsequent year 1 mailings). Arm 2 patients not requesting alternative testing receive FOBT Hemoccult SENSA® cards (Beckman-Coulter Inc., Primary Care Diagnostics, Los Angeles, CA), simplified pictorial instructions for obtaining the specimens, and a postage-paid return envelope for returning them to the lab. FOBT results are entered into Group Health's laboratory databases with the SOS database capturing these results daily. If there is no evidence of FOBT completion after 3 weeks, a letter is sent to patients reminding them to complete the test or inquire about other types of CRC screening options. Automated systems are used to track interventions, record completion of CRC screening tests, and generate mailings. Quality processes are in place to assure proper labeling of the mailings and FOBT cards.

Arm 3: UC + Auto + Assisted (Assist)

In addition to automated support, Arm 3 patients receive telephone assistance from a medical assistant (MA) to complete the CRC test of their choice. The MA checks the registry database “to do list” to identify patients who have either called to request alternate screening or have not completed FOBT screening within 3 weeks of the mailings. She makes up to 3 attempts to contact the patient. Once she has contacted the patient, the MA determines the patient's CRC screening choice (such as planning to do the FOBT soon, prefers sigmoidoscopy or colonoscopy, or does not want to complete the test). If the patient needs assistance completing the cards or counseling related to making a screening choice, MAs can review the materials already sent to the patient (e.g. pictorial instructions for completing FOBTs and written information on risks and benefits of different screening tests). If the patient wants a flexible sigmoidoscopy or colonoscopy, the MA forwards an order to the patient's primary care physician. As per usual care, physicians may either sign and execute the order or refuse the order and suggest an alternate plan. If the patient still has clinical concerns or needs more information, the MA recommends making a telephone or in person appointment with their physician.

The MA documents all communications in the patient's electronic medical record (EMR) and updates the database. After the MA makes 3 attempts or contact is completed, a second code is used to remove the patient from the “to do” list. Quality of data entry and electronic medical records are monitored.

Arm 4: UC + Auto + Assist + Care Management

In addition to automated and assisted support, Arm 4 patients receive care management. Arm 4 patients who proactively call the SOS screening line with questions or requests for an alternative to FOBT are put directly in contact with an RN. Arm 4 patients not completing FOBT and not requesting an alternative to FOBT are initially contacted by the MA who makes up to 2 attempts to reach the patient and ascertain the patient's screening intent. The MA assists those who are still planning to do the FOBT (reminding, ordering more cards, or reviewing the pictorial instructions) and updates the database if the patient prefers not to do screening or an alternative test has been ordered by their physician. If the MA is unable to reach the patient after the second attempt, further attempts are made by the RN. The RN also contacts Arm 4 patients, who need assistance in making a screening choice, prefers an alternative to FOBT, or intend to do the FOBT, but after 3 weeks no FOBT laboratory results are in the database.

RN care management includes assessing patient risk for CRC and procedural risk; providing motivational counseling to assist with screening intent and completion of an action plan to complete this; assisting with referrals, appointments, and preparation for flexible sigmoidoscopy or colonoscopy; and tracking completion of the screening test. If the RN is unable to reach the patient, s/he sends the patient a secure e-mail (if they have secure access to the Group Health patient Web portal) or a letter (if they do not have or do not open their e-mails). The secure e-mail/letter reiterates the importance of completing CRC screening, gives brief information on the different options for screening, and provides the RN's phone number for assistance.

The RN uses the registry database “to do” list to track patients needing communication and to monitor completion of flexible sigmoidoscopy or colonoscopy. If the patient is waiting to have a colonoscopy, the RN can temporarily take the patient off the “to do” list until a time closer to testing. The RN also uses specific codes to document processes of care and an additional code to confirm that care has been completed. All communications and the assistance provided are documented in the patient's EMR.

Year 2 interventions (repeating annual FOBT screening)

Arms 2, 3, and 4 receive the same intervention in year 2 of the study as year 1. Exceptions to this include patients completing either a screening or diagnostic (after a positive screening test or for other reasons) colonoscopy in year 1.

2.6. Study 2: Interventions to Increase Follow-up After a Positive Test

2.7. Hiring and Training of the MAs and RNs

Both MAs and RNs were required to already be Group Health employees and show competence in their use of the electronic medical records prior to work on the project. In our hiring process, we found that Group Health had many more licensed practical nurses (LPNs) than MAs. Both had similar job descriptions, except the LPNs have a few additional care privileges (for instance, the ability to give immunizations in clinic). Because of the similarities, we hired both MAs and LPNs for Arm 3 interventions. To simplify discussion, we label both LPNs and MAs as having the MA role. RNs have much more training than LPNs or MAs and have a larger, more complex set of clinical privileges.

The MAs and RNs were trained separately to avoid contamination. MAs received 2 half days of training. These sessions included reviewing study procedures, basic information on CRC screening guidelines as well as the materials sent to patients (CRC screening pamphlet and FOBT instructions) and practicing delivery of the telephone-based intervention. They were trained to use the database “to do list” including the use of a limited set of coded tasks documenting attempted and completed telephone contacts and documentation of the patient's screening “intent” (figure 4). MA patient contact continues to be periodically observed. Queries and audits of the database and EMR are performed quarterly to assure MAs are adhering to protocols and documenting care accurately.

The RNs received 3 half days of training. These sessions included reviewing study procedures as well as Group Health and national CRC screening guidelines, identifying patients at high risk for CRC or at risk for complications from endoscopic procedures, and reviewing the preparations required for endoscopy and rules related to clinical concerns. They were trained to use the database including how to use the “to do” list, how to document completed tasks (for instance, screening intent) and how to track the completion of action plans (figure 4). One half-day session was dedicated to role playing using different vignettes (for example, patients who are too busy or resistant because of perceived lack of risk). The RNs are trained to use motivational interviewing (MI) techniques including using open-ended questions and clarifying statements, knowing how to handle resistance in a non-judgmental manner, and facilitating patient-centered action plans for completing screening [13]. The RNs, project manager, and principal investigator meet by phone every other week to review concerns related to the study and patient care and to review and practice MI techniques. To ensure fidelity to the behavioral approach, patient communications are directly observed each quarter.

2.8 Physician Participation

Prior to recruitment, the principal investigator contacted each medical center's medical and administrative directors to review the study design and procedures including potential impacts on physician practices. Physicians were informed there will be requests for screening flexible sigmoidoscopies ,colonoscopies and FOBT results in their EMR inboxes. They were instructed not to assume that their patients will be cared for by the study and to continue best practices to ensure CRC screening and follow-up after a positive FOBT. Physicians received no other interventions during the trial.

Aim #2

The primary objective for study 2 is to determine the proportion of participants with a complete diagnostic evaluation after a positive CRC screening test. Complete diagnostic evaluation (CDE) is defined as having either a colonoscopy (preferred) or a combination of flexible sigmoidoscopy and barium enema within 6 months of the date of the positive FOBT or flexible sigmoidoscopy. Automated data (procedure and claims codes) will be used to measure CDE receipt. There can be appropriate clinical reasons for patients not having a CDE including serious illness, frailty, death, or refusal. While we will describe these occurrences, these will be classified as non-receipt of a CDE.

Aim #3

Secondary aims include assessing patient behavioral components related to CRCS including: knowledge of CRC and CRCS, the pros and cons of CRCS testing, worries about and perceived risk of CRC, and self-efficacy for being able to complete testing. To measure psychosocial correlates related to screening, we use a questionnaire developed by Myers and Vernon based on the Preventive Health Model (which contains items related to pros, cons, social influence, and self-efficacy). Adaptations of this instrument have been used in diverse samples and have demonstrated good construct validity across different subgroups [12, 15-17].

8.2. Analysis of primary outcomes

10.2 Changes in national and local CRC screening guidelines

Over the course of the study, national and local CRC guidelines changed for patients at average risk for CRC. In 2008, 2 new sets of CRC guidelines were released. One set of guidelines was developed by the American Cancer Society, American College of Radiology, and American gastroenterology societies (the American College of Gastroenterology, The American Gastroenterological Association, and the American Society for Gastrointestinal Endoscopy) [32]. This guideline differentiates CRC screening tests into 2 groups: tests that identify early CRC (FOBT and stool DNA), and tests that identify both early CRC and premalignant adenomatous polyps (flexible sigmoidoscopy, optical colonoscopy, virtual CT colonoscopy, and double contrast barium enema). The second guideline was developed by the US Preventive Services Task Force, an independent panel of experts sponsored by the Agency for Health Care Research and Quality [33]. Based on their systematic review of the literature and economic modeling, they recommend CRC screening for adults age 50-75 either by “high sensitivity” FOBT annually (fecal immunochemical tests [FIT] or fecal guaiac Hemoccult SENSA©), flexible sigmoidoscopy every 5 years with a high sensitivity FOBT in between, or a colonoscopy every 10 years.

Prior to 2009, Group Health recommended screening for adults age 50-80 preferably by flexible sigmoidoscopy every 10 years combined with annual FOBT (Hemoccult SENSA©) or colonoscopy every 10 years as an alternative. In accordance with the USPSTF changes, beginning in the fall of 2009, Group Health's recommended CRC screening for average risk adults age 50-75 is annual FOBT as the preferred option, or combining this with flexible sigmoidoscopy every 5 years or colonoscopy alone every 10 years. Most of these changes have little impact on the SOS protocols, as we already limited eligibility to adults age 50-75 and send patients the “high sensitivity” SENSA FOBT annually, unless they request an alternative. However, MA/LPN/RNs found these differences confusing and needed additional training and monitoring to master these changes.

10.3 Quality improvements in follow-up of positive screening tests

After the grant was awarded, other investigators at Group Health's Research Institute discovered that complete diagnostic evaluation rates after a positive FOBT were increasing at Group Health. These results were published in Medical Care in 2008 [34]. Miglioretti et al. found that in 2005, 82% of patients with a positive FOBT had a complete diagnostic evaluation within 1 year (almost exclusively colonoscopy), compared to our estimates of a 65% completion rate at 6 months used for our power estimates (based on older data). Group Health has a remind system to notify physicians of patients not completing a CDE after a positive FOBT (section 2.6). However, Group Health's quality initiative does not include RN care management. We hypothesize that RN care management might further increase rates, diagnostic testing will occur more quickly, and if a CDE was not done, documentation will be improved.

This research is funded by a grant from the National Cancer Institute: Grant R01 CA121125 ClinicalTrials.gov Identifier: NCT00697047