A Physician Initiated Intervention to Increase Colorectal Cancer Screening in Chinese Patients

Abstract

Background

Among Chinese Americans only 42% of colorectal cancer (CRC) cases were diagnosed at an early stage, possibly because they were less likely than non-Hispanic whites to get CRC screening.

Methods

Primary care physicians (PCPs) were recruited from a local independent practice association serving Chinese Americans and randomized into Early and Delayed Intervention Groups. The Early Intervention Group PCPs received Continuing Medical Education (CME), and their patients received an intervention mailer, consisting of a letter with PCP’s recommendation, bilingual educational booklet, and FOBT kit in Year 1. The Delayed Intervention Group PCPs received no CME, and their patients received the mailers in Year 2.

Results

Twenty PCPs were assigned to the Early Intervention and 22 to the Delayed Intervention group. A total of 3,120 patients of these participating PCPs who had CRC screening due during the study period were included. A total of 915 mailers were sent in Year 1, and 830 mailers were sent in Year 2. FOBT screening rates increased from 26.7% at Baseline to 58.5% in Year 1 in the Early Intervention group vs. 19.6% to 22.2% in the Delayed Intervention group (p<.0001). The overall effect size of the mailer intervention with or without CME was estimated as 26.6 percentage points (95% CI: 22.0-31.2) difference from Baseline compared to usual care. The intervention had no impact on Colonoscopy/Sigmoidoscopy rates.

Conclusions

This pilot study demonstrated that a mailer that included educational materials and FOBT kits can increase CRC screening rates with or without CME for the PCPs.

INTRODUCTION

Chinese Americans are the largest Asian ethnic group, contributing to over one fifth of the total Asian American population.¹ Cancer is the leading cause of death among Asian Americans, with colorectal cancer (CRC) as one of the most common fatal malignancies.² The CRC incidence rates among Chinese American men and women are 54.0 and 40.2 per 100,000, respectively.³ Although the five-year survival rate is higher than 90% if CRC were diagnosed at a local stage,⁴ only 42% of CRC cases were diagnosed at an early stage among Chinese Americans.²

The United States Preventive Services Task Force (USPSTF) recommends stool-based tests such as the fecal occult blood test (FOBT) and fecal immunochemical test (FIT), sigmoidoscopy, and colonoscopy as screening tests for CRC.⁵ However, Asian Americans and Chinese Americans are 30-50% less likely than Non-Hispanic whites to participate in CRC screenings.^6,7 Barriers associated with low CRC screenings among Chinese Americans include lower educational attainment, limited English proficiency, recent immigration and lower acculturation, lack of health insurance,⁸ lack of physician recommendation,⁹ fear of abnormal results and lower perceived susceptibility.¹⁰ Additional barriers among Asian Americans for low CRC screening rates are lack of knowledge, language, transportation, time,⁸ and patient-physician language discordance.¹¹

Continuing Medical Education (CME) has been used as an educational strategy to change physician performance in their patients’ healthcare outcomes.¹³ Studies have demonstrated that physicians’ involvement in health promotion can influence patients’ health decision-making and behavior.¹⁴ CRC screening rates have shown to increase when physicians’ and patients’ language is in concordance.¹¹ Many doctors who are in solo practice or work in small groups may join an individual practice associations (IPA). Such network can bring these physicians together to deliver quality population-based care.¹⁵ This pilot study aimed to assess the efficacy of an intervention initiated by a physician network that included CME and mailed CRC information and FOBT kit to increase CRC screening rates among Chinese Americans.

MATERIALS AND METHODS

Academic-Community-Clinical Partnership

The pilot study was designed and implemented by partners within the Asian American Network for Cancer Awareness, Research and Training San Francisco site. The clinical partner was the Chinese Community Health Care Association (CCHCA), a non-profit IPA established in 1982 that provides San Francisco residents with culturally competent health care through its network of over 200 physicians serving primarily Chinese patients. The partnership also included academic researchers from University of California San Francisco and a community organization, Chinese Community Health Resource Center (CCHRC), a non-profit community-based organization that works closely with CCHCA in providing educational programs and services to their patients. CCHCA and CCHRC are part of the Chinese Hospital Health System, which also includes a community-based hospital and the Chinese Community Health Plan, a health insurer. For this study, the Chinese Hospital clinical laboratory conducted the CRC screening test analysis.

Study Population, Eligibility Criteria, and Enrollment

Primary care physicians (PCPs) were recruited from CCHCA to participate in the study. The physicians’ areas of specialty were Family Practice, General Practice, and Internal Medicine. Within CCHCA, there were 61 PCPs, with 54 being eligible because they had at least 1 eligible patient due for CRC screening during the intervention period from October 2007 to December 2009. A trained research staff from CCHRC visited each eligible PCP to explain the logistics of the study participation. Of the 54 eligible PCPs, 12 refused to participate resulting in 42 participating PCPs (78% participation rate). Additionally, CCHRC obtained a list of potential eligible patients from CCHCA and verified their eligibility with their enrolled PCPs. Eligible criteria for patients were: current member of the Chinese Community Health Plan; between the ages of 50-75; had an estimated life expectancy of 10 years or more; and were not up-to-date on CRC screening (no FOBT within one year, sigmoidoscopy within five years, or colonoscopy within 10 years) from September 2006 through December 2009, a study period during which CRC screening receipts were included in the analyses. The study protocols were approved by the University of California, San Francisco Institutional Review Board.

Study Design

The randomized controlled pilot trial was conducted at CCHCA with participating PCPs and their eligible patients were randomized into two groups: Early Intervention and the Delayed Intervention. In the Early Intervention Group, PCPs received three CMEs (2005 -2008) on CRC, and their eligible patients with CRC screening due during Year 1 received a mailer intervention packet in Year 1 of the study (October 2007- October 2008). PCPs assigned to the Delayed Intervention Group did not receive CMEs on CRC but their patients with CRC screening due in Year 2 received the mailer packet in Year 2 (December 2008 – December 2009). In addition, all patients received usual care by their PCPs during the study. During the time of the study, CCHCA’s usual care for CRC screening consisted of PCPs advising their patients who are over the age of 50 to complete one of the recommended CRC screenings.

Sample Size Justification

This sample size estimation of the trial was based on precision of the estimates. Conservatively assuming that the probability that a PCP’s patients will receive a particularly CRC screening test varies uniformly between 0 and 1, in a group of 20 PCPs, the standard error of the proportion of patients who receive the test is approximately 0.07. We considered a sample size of 20 participating PCPs per treatment group to provide sufficiently precise estimates for the pilot trial.

Theoretical Framework, Intervention Components and Implementation

Theoretical Framework

The intervention components affect different levels of the socio-ecological context as reflected in the Health Behavior Framework,¹⁶ an integrative conceptual model. At the individual level, CRC screening knowledge and communication with the provider, in a culturally-sensitive manner, was addressed through a bilingual letter from the PCP and a CRC booklet that was mailed directly to the patient. At the provider and health care system level, CRC screening structural factors were addressed by including in the mailing a FOBT kit, which could be sent directly back to the lab. Provider awareness was addressed in the CME seminars. The intervention design was guided by findings from a survey study of 51 primary care providers in solo practices or affiliated with Chinese Community Health Plan in 1995, which support these intervention strategies to help physicians overcome various barriers for increase CRC screening among their patients.¹⁷

Intervention Components

The intervention consisted of one component targeting to PCPs via CME seminars, and the other component for patients in a form of a mailer packet.

Physician-targeted component – CME seminars

PCPs in the Early Intervention group received a series of three CME seminars during 2005 through 2008. CME seminars for PCPs focused on the national recommendations on CRC screenings and treatments. Physicians from CCHCA with specialties in Colorectal Surgery, Gastroenterology and Oncology served as speakers.

Patient-targeted component - mailer packet

The mailer included six elements: (1) A bilingual (Chinese and English) letter from the patient’s PCP recommending CRC screening. (2) A bilingual booklet with information about CRC: The “Colorectal Cancer Booklet” was adapted from “A Lay Health Worker Training Guide on Colon Cancer Prevention” published by the Vietnamese Community Health Promotion Project at University of California, San Francisco and publications from the National Cancer Institute. The CRC booklet covered the following topics: a) What is cancer; b) What is CRC; c) Who gets CRC; d) Symptoms of CRC; e) Screening tests for CRC; f) What happens if a CRC screening test is not normal; g) Treatment for CRC; h) Commonly asked questions and answers; i) Where to get more information; j) Key Points Summary. The booklet was first developed in English by a CCHRC health educator and then reviewed by primary care physicians for clinical accuracy. Feedback was then incorporated into the English material and then finalized. The final English material was translated into Chinese by an experienced translator. The Chinese translation was at the 6th-grade reading level and then field-tested with a focus group of eight Chinese individuals from the target age group. The focus group provided feedback on the format, content, graphics, color scheme, literacy level and cultural appropriateness. Their feedback was incorporated into the final Chinese material. (3) A bilingual FOBT specimen instruction sheet provided by Chinese Hospital laboratory when patients receive FOBT test kit for CRC screening. (4) A Beckman Coulter 64151A Hemoccult II SENSA FOBT triple-slide kit pre-labeled with patient’s name and date of birth. (5) A completed lab order form; and (6) A pre-addressed and pre-paid postage return envelope to Chinese Hospital laboratory, with instruction to return the completed FOBT kit to Chinese Hospital laboratory. A copy of the FOBT laboratory result was sent to both patient’s PCP and the patient. Those patients with positive FOBT results were notified to follow-up with their PCPs.

Intervention Implementation

CME

During 2005 to 2008, CCHCA conducted three CME seminars in partnership with University of California, San Francisco researchers on CRC screenings and treatments. The CMEs aimed to raise physician awareness about the importance of CRC screening, with an emphasis on FOBT because it is low cost, non-invasive, and performed in the privacy of the patient’s home without anesthesia. CME attendance was not mandatory.

Mailer

CCHCA generated a monthly patient mailing list with patients due for CRC screening at the time when the list was generated for a randomly selected PCP from the corresponding treatment group (Year 1 for Early Intervention group and Year 2 for Delayed Intervention group). CCHRC staff obtained the patient list and verified with enrolled PCPs to confirm patients’ eligibility and whether patients could be mailed a mailer packet. PCP could choose to exclude individual patients from the mailing patient due to medical or other reasons deemed appropriate. CCHRC sent out approximately 150 mailer packets per month to eligible patients from October 2007 through December 2009. During Year 1 (Oct 2007-Oct 2008), the mailer packets were sent to patients of the PCPs assigned to the Early Intervention Group. During Year 2 (Dec 2008-Dec 2009), packets were sent to patients of the PCPs assigned to the Delayed Intervention Group.

Data Source for CRC Screening Rates

CCHCA provided aggregated data by PCP from electronic medical records. From each PCP, the number of eligible patients due for CRC screening and the number of these eligible patients who had FOBT, colonoscopy, or sigmoidoscopy performed during each of the 3 study periods were used in the analyses. The 3 study periods were: 1) Baseline (September 2006 to September 2007); 2) Year 1 (October 2007 to October 2008); and 3) Year 2 (December 2008 to December 2009).

Two primary outcome measures, computed at each study period (Baseline, Year 1 and Year 2), were: i) proportion of patients receiving FOBT screening (FOBT) among those who were due for CRC screening during the corresponding study period; and ii) proportion of patients receiving colonoscopy or sigmoidoscopy screening (COLSIG), excluding patients who had FOBT within the same year to avoid counting follow-up tests for a positive FOBT as screening. Because of the small number of sigmoidoscopies performed during the study periods (1 to 2 each study period among all PCPs combined), the screening rate of sigmoidoscopy was combined with colonoscopy.

Data Analysis

We created generalized linear marginal models using generalized estimating equations (GEE) with an identity working correlation matrix to account for within-PCP correlation of patient responses separately for each of the 2 screening outcomes: 1) receipt of FOBT; and 2) receipt of COLSIG.

For each GEE model, a binomial distribution of the binary response outcome (test receipt) with an identity link function was used so that the probability of receiving the test was a linear function of treatment group assignment (Early versus Delayed Intervention), study period (Baseline, Year 1, and Year 2), and a treatment group by study period interaction. First, the models were used to estimate the proportion of eligible patients who received FOBT and the proportion who received COLSIG along with their respective 95% confidence intervals (CIs) in each study period for both treatment groups; these are reported in Table 1, as well as the minimum and maximum proportion screened per PCP.

Table 1.

Colorectal Cancer (CRC) Screening Rates of Fecal Occult Blood Test (FOBT), and Colonoscopy or Sigmoidoscopy (COLSIG) by Intervention Condition and Study Period

Study Period	Fecal Occult Blood Test (FOBT)
	Early Intervention	Delayed Intervention
	% (95% CI)	% (95% CI)
	Range	Range
Baseline	26.7% (20.1%, 33.3%)	19.6% (12.4%, 26.9%)
	Range: 0% to 100%	Range: 0% to 44.4%
Year 1*	58.5% (49.5%, 67.6%)	22.2% (17.9%, 26.6%)
	Range: 0% to 92.9%	Range: 0% to 50.0%
Year 2**	19.2% (12.3%, 26.2%)	36.0% (29.8%, 42.3%)
	Range: 0% to 41.2%	Range: 0% to 58.3%
Study Period	Colonoscopy or Sigmoidoscopy (COLSIG)
	Early Intervention	Delayed Intervention
	% (95% CI)	% (95% CI)
	Range	Range
Baseline	10.5% (7.3%, 13.8%)	6.0% (2.3%, 9.8%)
	Range: 0% to 20.0%	Range: 0% to 15.2%
Year 1*	13.2% (10.8%, 15.8%)	9.5% (6.5%, 12.5%)
	Range: 0% to 35.1%	Range: 0% to 22.5%
Year 2**	6.1% (4.4%, 7.9%)	3.1% (2.1%, 4.2%)
	Range: 0% to 11.1%	Range: 0% to 25.0%

Note: 95% CI = 95% Confidence Interval.

^*In Year 1, Early Intervention group received CRC mailers while the Delayed Intervention group received usual care.

^**In Year 2, Delayed Intervention group received CRC mailers while Early Intervention group received usual care.

We then tested interaction terms to answer our primary and secondary research questions: 1) Was CME+mailer more efficacious than usual care alone? 2) Did the mailer-only (without providing CME to PCPs) improve CRC screening when compared to usual care? To answer the first question, we compared the treatment groups with respect to change from Baseline to Year 1 in FOBT and COLSIG screening rates. To estimate the impact on screening rates with the mailer alone, we compared the Delayed Intervention group with the Early Intervention group with respect to the difference in screening rates between Year 2 and Baseline. Then we compared the effect sizes of the two mailer interventions, and estimated the overall effect size of the mailer intervention with and without CME by averaging the effect sizes of the Year 1 and Year 2 mailer interventions. If the interaction terms were not statistically significant, we tested the main effects of study period and treatment group. Data were analyzed using SAS statistical software package (version 9.3, SAS Institute, Cary, NC). Statistical significance was assessed at the 0.05 level (2-sided).

RESULTS

Participating PCPs, Eligible Patients and Intervention Delivery

Of the 42 participating PCPs, 20 were assigned to the Early Intervention and 22 to the Delayed Intervention group. Of the 20 PCPs in the Early Intervention group, 1 PCP did not attend any of the CMEs. Figure 1 shows the patient flow of the number of eligible patients and PCPs involved by treatment group at each study period. The total number of eligible non-duplicate patients from the 42 participating PCPs were 3120 who had CRC screening due during one or more of the study periods: Baseline, Year 1 and Year 2. Among the 20 PCPs assigned to the Early Intervention, the number of patients due for CRC screening at Baseline, Year 1 and Year 2 were 896, 1051 and 1404, respectively. Mailer intervention packets were sent to 915 patients of the Early Intervention PCPs in Year 1. Among the 22 PCPs in Delayed Intervention, the number of patients due for CRC screening at Baseline, Year 1 and Year 2 were 433, 471 and 844, respectively. Mailer packets were sent to 830 patients of the PCPs in the Delayed Intervention group in Year 2. The reasons for some patients who were due for CRC screening not receiving the mailer packet for their corresponding treatment group assignment (Year 1 for Early and Year 2 for Delayed Intervention) were either because their PCP had excluded them from the mailing list due to individual medical situations or other reasons, or due to the timing when the mailing list was generated. Some patients who were due for CRC screening had already received screening right before the generation of the mailing list or their CRC screening was not due at the time of the mailing list generation (new patient, or existing patient becoming due after the mailing list generation during the same study year). Therefore, these patients were not sent the mailer.

Figure 1. CONSORT Diagram of Chinese American Patients in a Physician Initiated Early and Delayed Intervention to Increase Colorectal Cancer Screening.

Note: PCP = primary care provider. Eligible patient = patients of participating PCP and had CRC screening due during the study period (Baseline, Years 1 or 2). CME= Continuing Medical Education. Timing of mailer–A mailing list with patient due for CRC screening was generated for a specific PCP for the month when the mailer was sent out. Of note, the patient mailing list may not include all the patients listed as CRC screening due during the corresponding 13-month study period. Some patients had already received screening right before the generation of the mailing list of their CRC screening was not due at the time of the mailing list generation (new patients, or existing patient becoming due after the mailing list generation during the same study year). Thus these patients were not sent with the FOBT Mailer.

FOBT Screening

Screening rates for FOBT in each intervention group for each study period are shown in Figure 2 and Table 1. There was substantial variation in screening rates per PCP, ranging from 0 to 100% (Table 1). The change in screening rates from Baseline to Year 1 was significantly greater in the Early Intervention group (31.8 percentage points increase) than in the Delayed Intervention group (2.6 percentage points increase), a 29.2 percentage point difference (χ² = 35.3, p<.0001), providing evidence of the efficacy of the CME+mailer intervention.

Figure 2.

FOBT Screening Rates with 95% Confidence Intervals by Treatment Groups and Study Periods

The difference in FOBT screening rates between Year 2 and Baseline was significantly greater in the Delayed Intervention group (16.4 percentage points increase) than in the Early Intervention group (7.5 percentage points decrease), a 23.9 percentage point difference (χ² = 23.8, p<.0001), providing preliminary evidence that the patient-targeted mailer-only intervention improved CRC screening rates.

The effect sizes of the Year 1 and Year 2 mailer interventions did not differ significantly (29.2 vs. 23.9 percentage points, χ² = 0.4, p = 0.54), and the overall effect size of the mailer intervention with or without CME was estimated as 26.6 percentage points (95% CI: 22.0-31.2) difference from Baseline compared to usual care.

COLSIG Screening

Screening rates of patients in each intervention group for receiving either colonoscopy or a sigmoidoscopy (COLSIG) in each study period are shown in Figure 3 and Table 1. Again, there was substantial variation in screening rates per PCP, ranging from 0 to 35.1% (Table 1). There was no impact of CME+mailer (χ² = 0.1, p = 0.80), or the mailer-only (χ² = 0.4, p = 0.55) intervention on COLSIG screening rates. On average across the three study periods, the Early Intervention patients had higher COLSIG screening rates than patients assigned to the Delayed Intervention group (χ² = 4.5, p = 0.034), and there were significant differences among the study periods (χ² = 11.4, p = 0.0034).

Figure 3.

Colonoscopy or Sigmoidoscopy (COLSIG) Screening Rates with 95% Confidence Intervals by Treatment Groups and Study Periods

DISCUSSION

This pilot study illustrated a successful partnership among physicians’ network and academic and community-based organizations to implement cancer education outreach and prevention studies. The results from the first year of the study (Year 1) indicated that the intervention, consisting of CME for PCPs combined with a mailer containing a physician letter, a bilingual educational booklet, and a FOBT kits to their patients increased CRC screening rates compared to usual care among patients of physicians in a Chinese IPA. In the second year of the study (Year 2), the Delayed Intervention group received only the mailer but no CME. Nonetheless, that group had a larger difference in CRC screening between Year 2 and Baseline compared to the original CME + mailer intervention group, which had only usual care in Year 2, suggesting that the mailer was effective even without CME.

One factor that contributed to the successful implementation of this study was the building of a trusted partnership between academia, community and clinical entities through planning of the study. All partners became familiar with each other’s operational styles and developed a clear understanding of each partner’s responsibilities.

The partnership model not only enabled the research project to be executed but is also a prudent and practical way to approach health promotion in diverse communities. Since PCPs, particularly those in small private practices, have limited time and resources, they may not be able to send mailers to or be involved in health promotion activities for their patients. Involving a community-based organization like CCHRC in this effort can serve as an education resource for PCPs. PCPs can leverage community-based organization’s ’s cultural and linguistic expertise in community outreach, and their capacity in providing health education to improve patients’ clinical outcomes.

Another factor that may have led to increased screening was the letter from each patient’s PCP encouraging the patient to complete a CRC screening. Physicians are highly esteemed in the Asian community and are influential in patients’ health care decision-making,¹⁴ and the PCP’s recommendation and encouragement may have helped the patient to overcome other barriers. Sending the FOBT kit also addressed logistical barriers by minimizing the time and effort between the time a patient decides to have CRC screening and the time when a patient can be screened.

In year 2 when the mailers stopped, for the Early Intervention group, the CRC screening rates dropped below Baseline. However, there was a corresponding rise in screening rates in the Delayed Intervention group, which had only the mailer and no CME, suggesting that the mailer was the more important intervention component, and that the mailing needs to be sustained for continued effect on CRC screening rates. To achieve the American Cancer Society’s CRC screening goal for 2018 which is 80% among those age 50 and over and at average risk, changes must be made within the health system along with education to empower patients. Based on the results from this pilot study, CCHCA and Chinese Community Health Plan created a system change to adopt the mailer program as part of an annual CRC screening protocol and preventive education program for their patients which continues today.

This pilot study illustrates the power of partnerships in conducting research and improving quality of care in diverse populations. The findings confirm the efficacy of mailing FOBT kits and in-language educational materials along with PCP recommendation in increasing CRC screening rates among Chinese Americans. Future research could explore how partnerships between researchers, community organizations, and clinical entities can help to address health disparities.

LIMITATIONS

Study limitations were that the intervention was limited to only patients of a physician network, data on patients’ characteristics were limited, and that we were unable to evaluate the efficacy of each component in the intervention mailer packet. We are also unable to quantify the differential effect between the CME and mailer components in the Early Intervention group, although the results in the Delayed Intervention group suggest that the mailer is effective without the CME. One of the strengths of the study was that the CRC screening rates were validated by clinical service data, rather than self-reported data.