Study setting and sample
Cambridge Health Alliance (CHA) is a Primary Care Practice-Based Research Network (PBRN)[25
] including 15 community health centers. The health centers predominantly serve a multi-cultural, low-income population in Cambridge, Somerville, and Everett, MA. We selected one health center to pilot-test the intervention, and a demographically similar health center to serve as the control health center. The CHA institutional review board approved the study protocol. The institutional review board provided a waiver of informed consent, since the study was promoting an established screening standard and primary care providers (PCPs) were able to identify patients who were not appropriate to contact.
Using an electronic clinical data system (Meditech), we identified patients aged 52–80 who appeared to be unscreened for colorectal cancer. We included patients age 75–80 because at the time of the study, age 80 was considered to be the upper age limit of screening by the U.S. Preventive Services Task Force. We chose to begin at age 52 instead of age 50 (the age at which guidelines suggest that screening begin), because we sought consistency with the Healthcare Effectiveness Data and Information Set (HEDIS) measure on colorectal cancer screening. [26
] The unscreened patient report used in our study also served as the basis for our ambulatory quality improvement colorectal cancer screening measure. We based eligibility for colorectal cancer screening on a modified version of the most recent HEDIS measure. US health plans utilize HEDIS measures to assess performance on important dimensions of care, including cancer screening. We modified the denominator of the measure to include any patient aged 52–80 who had one visit to a primary care physician in a community health center in each of the two previous years. The numerator included any patient who received colonoscopy in the past 10 years, sigmoidoscopy or barium enema in the past five years, or fecal occult blood testing (FOBT) during the prior year. Using this definition, 47% of eligible patients in our network of community health centers received colorectal cancer screening in the year 2006. Since the data report did not capture tests performed outside of Cambridge Health Alliance, or FOBT cards that were not billed, we suspect that the true screening rate was higher than 47%.
We limited our intervention group to patients who spoke English, Portuguese, Spanish or Haitian Creole and who received care at one center in Somerville, MA. We excluded patients of two primary care providers (PCPs) at the intervention center: one PCP who was a study investigator (KEL), and one PCP who was leaving the health center at the time of the study. The control group consisted of a random sample of similarly defined patients (speaking the same languages and unscreened for colorectal cancer based on the abovementioned definition) at another health center in Somerville.
Because the electronic data system did not capture diagnostic tests performed outside of the health center network, one investigator (KEL) reviewed the medical records of all patients at both the intervention and control health centers who appeared unscreened in the data report to confirm that they were, in fact, unscreened. After reviewing 196 medical records at the intervention center and 191 medical records at the intervention center, we identified 93 intervention patients and 90 control patients who had not received colorectal cancer screening according to the criteria specified above.
We asked each of the eight PCPs at the intervention center to review their list of unscreened patients and to identify any patient who they deemed inappropriate for telephone outreach, based on the following criteria: 1) patient has a medical contraindication to screening or a short life expectancy so that they do not warrant screening[25
] 2) the patient will be out of the country continuously for at least three months during the period of navigation 3) the patient had severe cognitive or mental impairment, and no one who can be identified as a caretaker or proxy and 4) other reason as designated by the PCP.
Of the 93 unscreened patients, PCPs deemed 38 (41%) to be inappropriate for outreach for the following reasons: patient has a long history of refusing screening (n = 16), patient with medical comorbidity (n = 7), gastrointestinal symptoms or gastrointestinal workup in progress (n = 6), mental illness or substance abuse (n = 5), other reasons (n = 4; patient uninsured, out of the country, or moving). Fourteen of the 38 patients deemed ineligible for outreach were uninsured.
The remaining 55 patients were eligible to receive the intervention. We sent letters by first-class mail, signed by each PCP, notifying patients that they were overdue for colorectal cancer screening, and that a patient navigator would be calling them. The mailing also included a colorectal cancer screening brochure designed by the Harvard Center for Cancer Prevention and the Massachusetts Colorectal Cancer Working Group ("Take Control: Get Tested for Colorectal Cancer"). The brochure, written at a sixth-grade reading level, offered patient-oriented information about the reasons for screening, the different screening modalities, and lifestyle changes to lower risk of colorectal cancer. We sent brochures to patients in English, Portuguese, Spanish, or French (for Haitian Creole-speaking patients).
The study patients were also eligible to receive navigation from navigators speaking English and Spanish, Portuguese, and Haitian Creole, respectively. The navigators were based in the hospital's Department of Community Affairs; they did not have a presence at the intervention health center. The navigator who worked with English and Spanish-speaking patients was originally from Nicaragua, had completed college, and had extensive experience doing community health outreach. She was also a trained certified nurse's assistant (CNA). The Portuguese-speaking navigator had been a masters-level clinical psychologist in Brazil, and was an experienced community health worker. The Haitian navigator was also an experienced community health worker, and worked as a medical assistant in a local community health center. All of the navigators were women, and were age 47, 42, and 37, respectively.
The navigators attended a two day training program in October 2007. The training program included lectures and interactive role plays about the following subjects: 1) the principles of motivational interviewing [28
] 2) colorectal cancer and how patients can be screened for it; 3) logistics ("how-to," pros, and cons) of FOBT cards and colonoscopy 4) prevention of colorectal cancer (including prevention by removal of adenomas) 5) use of open vs. closed questions, reflective listening, and summarizing; 6) assessment of patient's readiness for screening and 7) approaches for patients who refuse screening (pre-contemplation), are willing to think about it (contemplation), or are ready to act (action).[28
] We chose to frame the intervention around a "stages of change" model as other cancer prevention studies have successfully employed this model.[29
During the study implementation, the project manager (who also attended the training sessions) audited between one and five patient calls by each navigator for adherence to a calling script and for motivational interviewing techniques. The patient navigators and the project manager also met on a weekly basis to discuss challenges arising during the outreach calls and to review the use of motivational interviewing techniques.
Over a three week period in October 2007, the patient navigators made between 8 and 11 attempts to call each patient on different days (weekdays and weekends) and at different times (morning, afternoon, and evening) until they reached a patient. The navigators also left at least two messages for the patient, either on the answering machine or with a family member.
Once the navigator reached a patient, the navigator discussed the need for colorectal cancer screening with the patient, the screening options of colonoscopy vs. FOBT cards, and the advantages and disadvantages of each test. The navigators did not discuss other screening test options, such as flexible sigmoidoscopy and barium enema, since such options were not routinely offered to patients by their PCPs.
If a patient was interested in completing FOBT cards, the navigator reviewed the FOBT instructions with the patient and mailed FOBT cards and illustrated instructions to patients by first-class mail. The navigator also offered to review the FOBT instructions with the patient over the phone as soon as the patient received the FOBT cards. If a patient did not return the FOBT cards within four weeks, the navigator called the patient to provide support and to address barriers to completion.
For patients who were interested in pursuing colonoscopy, the navigators described the test in detail and the project manager contacted the patient's PCP to arrange a colonoscopy referral. Based on the patient's comorbid medical conditions, the PCP either referred the patient directly for colonoscopy or for a routine appointment with a gastroenterologist to discuss colonoscopy. Patients with any of the following conditions were not eligible for direct referral: sleep apnea, obesity (BMI > 30), previous history of anesthesia problems, congestive heart failure, presence of an automatic implanted cardiac defibrillator, renal failure (as defined by the PCP), and warfarin use for any reason. For patients referred directly to colonoscopy, a registered nurse (LV) called the patient, educated him/her about the procedure and the bowel preparation, and mailed instructions for the bowel preparation to the patient. The patient did not require a medical visit prior to the colonoscopy procedure. The gastroenterology office placed reminder calls to all patients one day prior to their procedure. Due to medico-legal concerns, the navigators did not escort patients home after the colonoscopy. In the event that a patient did not have someone to escort them home, the navigators advised them to complete FOBT cards instead.
At the control health center, patients eligible for colorectal cancer screening received usual care. PCPs offered patients screening on an ad-hoc basis during primary care visits. Unlike the PCPs at the intervention center, the PCPs at the control center did not review their lists of unscreened patients. At both health centers, PCPs had some decision support to promote colorectal cancer screening in the Epic electronic medical record. The electronic record includes a health maintenance grid which flags age-appropriate patients who have not received colorectal cancer screening. The PCPs at the control health center could also refer patients directly for colonoscopy at the time of the study, but they did not have access to patient navigators to advise patients on screening options or to assist them in completing the test.
The primary outcome of the study was completion of colorectal cancer screening at six months. While the intervention focused on the completion of colonoscopy or a set of three FOBT cards from home, patients who completed any of the following during the study period were considered to have been screened: colonoscopy, sigmoidoscopy or barium enema, or FOBT cards. One of the investigators (KEL) conducted a non-blinded chart review to determine completion of colorectal cancer screening tests.
During the study, the navigators maintained paper records in which they documented details of their interactions with patients, including the patients' readiness to be screened, barriers to screening, and actions that were taken to promote screening. The project manager entered these data into a Microsoft Access database.
We included all patients at the intervention center in an intention-to-treat analysis, regardless of whether they were designated by their PCP to receive navigation, or whether a navigator successfully reached the patient. Using the χ2 test, we compared screening rates at six months among intervention patients and control patients. We chose to analyze the data at six months because the wait for a screening colonoscopy at the time of the study was on the order of weeks, and we assumed that patients would have had sufficient time to complete their colonoscopy during the six-month period.