Randomized, Controlled Trial of a Multimodal Intervention to Improve Cancer Screening Rates in a Safety-Net Primary Care Practice
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- Hendren, S., Winters, P., Humiston, S. et al. J GEN INTERN MED (2014) 29: 41. doi:10.1007/s11606-013-2506-1
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Cancer screening rates are suboptimal for low-income patients.
To assess an intervention to increase cancer screening among patients in a safety-net primary care practice.
Patients at an inner-city family practice who were overdue for cancer screening were randomized to intervention or usual care. Screening rates at 1 year were compared using the chi-square test, and multivariable analysis was performed to adjust for patient factors.
All average-risk patients at an inner-city family practice overdue for mammography or colorectal cancer (CRC) screening. Patients’ ages were 40 to 74 years (mean 53.9, SD 8.7) including 40.8 % African Americans, 4.2 % Latinos, 23.2 % with Medicaid and 10.9 % without any form of insurance.
The 6-month intervention to promote cancer screening included letters, automated phone calls, prompts and a mailed Fecal Immunochemical Testing (FIT) Kit.
Rates of cancer screening at 1 year.
Three hundred sixty-six patients overdue for screening were randomly assigned to intervention (n = 185) or usual care (n = 181). Primary analysis revealed significantly higher rates of cancer screening in intervention subjects: 29.7 % vs. 16.7 % for mammography (p = 0.034) and 37.7 % vs. 16.7 % for CRC screening (p = 0.0002). In the intervention group, 20 % of mammography screenings and 9.3 % of CRC screenings occurred at the early assessment, while the remainder occurred after repeated interventions. Within the CRC intervention group 44 % of screened patients used the mailed FIT kit. On multivariable analysis the CRC screening rates remained significantly higher in the intervention group, while the breast cancer screening rates were not statistically different.
A multimodal intervention significantly increased CRC screening rates among patients in a safety-net primary care practice. These results suggest that relatively inexpensive letters and automated calls can be combined for a larger effect. Results also suggest that mailed screening kits may be a promising way to increase average-risk CRC screening.
KEY WORDSbreast neoplasmscolorectal neoplasmscancer screeninghealthcare disparities
In the US, patients from racial minority groups and low income patients are less likely to receive cancer screening tests than other patients.1,2 Differential access to healthcare services, cultural and communication barriers, and competing health and economic priorities partially explain this disparity.3 Low rates of breast and colorectal cancer screening result in later stage at diagnosis and disparities in cancer survival.4
Effective interventions to improve cancer screening rates are needed, particularly those that are effective for low-income populations. Systematic review of the evidence for interventions to promote breast and colorectal cancer screening reveals that the most effective local interventions for increasing screening are those performed in the healthcare setting, as opposed to the community at large.5,6 Furthermore, patient navigation programs and other forms of tailored patient counseling that remove access barriers such as cost, transportation and appointment-scheduling have been proven successful.7–10 Unfortunately, expensive or complex strategies such as patient navigator programs may not be feasible in the under-resourced primary care practices in which many poor and minority patients receive care.10–12
By contrast, electronic physician reminders have little effect on screening rates, and solitary, lower-cost interventions (mailed patient reminders, automated phone calls) increase screening rates, but only modestly.6,13–17 However, several low-cost interventions might be combined to improve effect sizes. Stone et al. reviewed interventions to improve preventive healthcare services and showed an additive effect of combined interventions.18 Providing empirical support for this concept, several recent studies have reported on combined interventions to increase cancer screening.19,20
In this context, we sought to combine lower cost, feasible interventions into a multimodal cancer screening promotion for mammography and colorectal cancer screening for low income patients past due for screening.21 Using the Health Belief Model “cues to action” as a guiding framework, we employed repeated reminders and prompts at different times and through different modalities to prompt action.22 We selected the bundle of interventions to target the patient (based on the work of Stone et al) and to include both reminders (patient letters, phone calls to patients, provider prompts) and organizational change (mailed testing kits rather than opportunistic screening), because these have the greatest evidence supporting them, among lower-cost options.18
To avoid the selection bias often introduced by formally enrolling patients via an informed consent process, the current trial randomized all patients in the practice who were overdue for screening; waiver of informed consent was provided by the IRB. This design was employed to increase the generalizability of findings.
A large primary care practice in Rochester, New York, serving a large proportion of low-income and minority patients was recruited to participate. An electronic listing of all active patients was obtained, and eligibility criteria for patient inclusion were reviewed in the practice’s electronic health record (EHR). The study was approved by the Institutional Review Board of the University of Rochester.
Patients were eligible for randomization if they were overdue for the targeted cancer screening and average-risk for the cancer by EHR review. Age criteria were age 40–74 years for mammography (females) or 50–74 years for colorectal cancer (males and females) on the date of randomization. Patients were defined as overdue for mammography screening if more than 18 months from the last mammogram or past due for the follow-up interval specified at the prior mammogram. For colorectal cancer screening, patients were defined as overdue if >12 months from the last fecal occult blood testing or >5 or 10 years since last sigmoidoscopy or colonoscopy, respectively, or past the time recommended at last screening. Female patients could be eligible for both interventions. Patients were excluded if they did not have a visit to the practice during the past 2 years (in order to be considered an “active patient”). High-risk patients for breast or colorectal cancer were not randomized or included in the analysis, but received the intervention.
Patient data [race/ethnicity, zip code (mapped to median income), insurance status and type, name of the primary care physician and contact information] were imported into a secure, customized registry (Microsoft Access™). Most recent dates of screening were determined through manual review of the EHR by trained research assistants using data abstraction instruments. An offsite study statistician randomized participants to intervention or control groups using a random number algorithm stratified by the type of screening required (breast cancer, CRC or both). Healthcare and data abstraction personnel were blinded to group assignment.
Automated telephone message 1
Automated telephone message 2
Blinded chart review (if patient screened, stop intervention)
Blinded chart review
Letter 2 and FIT kit
Automated telephone message 3
Automated telephone message 4
Point-of-care prompt (if a primary care appointment occurred)
Stop intervention/usual care
Blinded chart review-final
Blinded chart review-final
An outreach worker mailed a personalized letter to each intervention patient. The letter was addressed from the patient’s primary care office and indicated the patient was overdue for mammography, CRC or both. The letter also indicated why screening was important and included information on how uninsured patients could obtain free cancer screening [i.e., through a local program supported by the National Breast and Cervical Cancer Early Detection Program (NBCCEDP)23 and the Colorectal Cancer Control Program (CRCCP)21]. The letter also gave the patient the opportunity to call the outreach worker with questions or for assistance, although only a small minority of patients did so.
A second letter was sent at week 12 of the intervention to patients who remained unscreened. Patients in need of CRC screening were mailed kits for stool testing [Fecal Immunochemical Test (FIT) kit] with the second letter.24 Interventions and screening were tracked in the database.
Automated Telephone Calls
An automated telephone reminder system (Televox® system) was utilized to deliver automated calls to the telephone number in the practice database for each intervention patient. The automated phone calls contained similar information to the letters, but in a brief form (approximately 25 s), with a phone number to call to arrange for screening. The automated calls were made on weeks 2 and 6 of the intervention period and repeated on weeks 14 and 25 for patients remaining unscreened on EHR review performed on week 11. Each call cost $0.09 to the program, which represents an institutional rate.
Written prompt sheets for providers and patients were developed as previously described.25 These were delivered to the practice each week for medical assistants to distribute at the time of an intervention-randomized patient appointment. The study ream did not attempt to confirm that the prompts were actually given to the patient and/or clinician. The prompt sheets reminded both the clinician and patient that the patient was past due for mammography and/or CRC screening. The back of each CRC prompt sheet briefly summarized the advantages and limitations for CRC screening modalities as a way of facilitating clinician-patient discussion. Because the research team hypothesized that the complex decision-making for CRC screening was a barrier to screening, the decision-making summarized in the prompt was dichotomized to colonoscopy versus high-sensitivity home stool testing. This is because preliminary interviews of primary care providers revealed that these were the predominant modes of testing utilized in the practice.
Medical Record Reviews
At week 12 of the intervention period, a review of the EHR was performed to determine whether each patient had undergone screening; if so, the intervention was stopped. To avoid bias in outcome ascertainment, these reviews were performed on both intervention and control group patients by research personnel unaware of the randomization group (the randomization group and intervention information were made electronically inaccessible to the personnel performing chart reviews).
Cost of Intervention
The cost per letter mailed was approximately $1.90, including material and labor costs. The total cost for the automated calls was about $0.92, including the preparation of each list of call recipients from the database and the monitoring of post-call status. The FIT kits cost about $25.12, including the Medicare reimbursement rate for the kit and the preparation for mailing/mailing costs. Finally, a small labor cost was incurred for using the point-of-care prompts. Medical assistant wages are about $14.48 per hour (http://www.bls.gov/oes/current/oes319092.htm). Using the prompts is estimated to take about 15 min per day of a medical assistant’s time, so for a practice about $3.62 per day in staff time would be needed to distribute the written prompts.
The primary outcome was documented mammography or colorectal cancer screening during the 52 weeks after randomization. This was measured using EHR review; a research assistant blinded to treatment assignment abstracted data from the EHR. A patient was considered ‘screened’ based on the EHR documentation of screening for breast cancer (mammography report) or colorectal cancer (fecal occult blood testing, colonoscopy, flexible sigmoidoscopy or double contrast barium enema reports).
Rates of screening were compared using a chi-square test and also using a logistic regression model that included age, sex, race/ethnicity, insurance and median household income by zip code from the 2000 US Census. An intention-to-treat analysis was performed; that is, all patient originally assigned to a group were analyzed. SAS 9.2 for Windows was used for analysis.
Baseline Characteristics of Mammography (a) and Colorectal Cancer Screening (b) Participants by Intervention Group
a. Mammography proportion by group
Intervention (n = 101)
Control (n = 90)
Other race—including Hispanic
b. Colorectal cancer screening proportion by group
Intervention (n = 114)
Control (n = 126)
Other race—including Hispanic
The fidelity of the interventions was informally tracked by the research team. Overall, the automated phone calls were answered in most cases; out of 670 calls to 183 subjects, 86 % of calls were “successful” and 96 % of subjects received at least one “successful” call. For the prompts delivered to the practice by research staff, the proportion that were actually given to the provider and/or patient was not formally tracked; anecdotally, there was a minority of instances in which the prompts were discovered “undelivered” at the end of the day.
These screening rates were assessed 1 year after randomization; however, an early assessment was also performed at 11 weeks after randomization. In the intervention group, 20 % of breast cancer screenings and 9.3 % of colorectal screenings were performed at the 11-week early assessment, while the remainder occurred after repeated interventions.
Within the CRC intervention group, 44 % of screened patients used a FIT kit, 44 % used colonoscopy and 12 % used a traditional fecal occult blood testing (FOBT) kit. By contrast, in the control group, 14 % used a FIT kit, 52 % used colonoscopy, and 33 % used a traditional FOBT kit. These results suggest that the mailed FIT kit portion of the intervention may have been particularly effective. Overall, of 92 FIT kits mailed, 19 were successfully used.
Adjusted Logistic Regression Model for Mammography (a) and Colorectal Cancer Screening (b)
Lower 95 % CI
Upper 95 % CI
a. Mammography effect
Other race—including Hispanic*
Non-Hispanic white (ref.)
b. Colorectal cancer screening effect
Other race—including Hispanic
Baseline Characteristics of Mammography (a) and Colorectal (b) Participants by Screening Status for Intervention Group
a. Mammography proportion by group
Screened (n = 30)
Not screened (n = 71)
Other race—including Hispanic
b. Colorectal screening proportion by group
Screened (n = 43)
Not screened (n = 71)
Other race—including Hispanic
This randomized trial tested a relatively low-cost, multimodal intervention to improve cancer screening rates for primary care patients at average risk for breast and colorectal cancer who were past due. The intervention was associated with in an increase in screening rates (to almost 30 % for mammography and almost 37 % for CRC) against a background of very low screening rates among patients not current with screening who received usual care (16.7 %), though the improvement in breast cancer screening did not quite reach statistical significance after adjustment [(OR 1.96 (95 % CI 0.87–4.39)]. This study is a significant contribution to the existing literature in two main ways: (1) it shows a larger effect size than most studies among patients past due, and (2) it highlights the potential for a mailed CRC screening kit, building on several recent studies.19,26
Decreasing healthcare disparities is a major public health goal in the US.27 For several reasons, cancer screening is an obvious target for addressing disparities. First, it has been shown that socioeconomically disadvantaged patients are disproportionately unscreened, and a lack of screening is one mechanism for decreased survival from breast and colorectal cancer.2,28 Second, financial barriers may be less prohibitive for cancer screening compared to other healthcare services, because cancer screening is generally covered by governmental and other healthcare insurers, and cancer screening programs for the uninsured are available.29
Nevertheless, improving rates of cancer screening for patients in safety-net primary care practices has proven difficult due in part to the stressed environment of the under-resourced primary care practices in which many disadvantaged patients receive care.11,30,31 These practices often lack adequate staffing and information systems to support tracking, reminders and counseling for preventive services. Furthermore, low socioeconomic status is associated with a higher burden of comorbid illnesses, leading to further difficulty in allocating time to preventive care within a rushed primary care visit.31,32
Other intervention trials have suggested that organizational change is a successful way to increase screening rates, such as designating non-physician providers to discuss screening, holding specific clinics for this purpose or employing patient navigators.10,33 However, dissemination of these resource-intensive interventions may not always be feasible in the safety-net primary care setting, in which personnel are often working at peak capacity and cannot take on additional tasks. Low-intensity interventions may be successful in practices with high baseline screening rates, but may not be successful among practices with low socioeconomic status and low screening rates.33,34 This trial was specifically designed for use in safety-net practices: a relatively low-cost intervention with low-literacy materials and a minimum of provider time required to implement it. Another unique feature of the trial was that all patients behind on screening were randomized, instead of approaching patients and obtaining informed consent, which in other studies has created selection bias in the study population.
These findings suggest a multiple-pronged strategy for reducing disparities in cancer screening. The first step is to target practices serving lower income and minority patients. The second step is to focus on those past due, and the third step is to use increasingly intensive interventions for non-responders, as this study did. We found that less than 20 % of patients who eventually were screened in the intervention group had completed screening at the early time-point assessment. Most of those eventually screened were screened only after multiple interventions, emphasizing the importance of repeated contacts. Finally, this study suggests a multimodal intervention may be superior to single interventions in practices serving patients of low socioeconomic status. Furthermore, we feel this intervention has potential for real-world implementation. As EHR systems become more functional in response to meaningful use criteria, it will become increasingly feasible to implement multimodal outreach to patients. Also, our low-literacy prompts could be implemented in any practice regardless of the presence of an EHR system.
The primary limitation of this trial is that these results may not be generalizable, as it was conducted in a single practice. The extremely low screening rates among usual care patients in the study reflect a primary care setting predominantly serving patients of low socioeconomic status, previously shown to be at risk for omission of cancer screening.35 As such, these results are most applicable to practices with low baseline rates of cancer screening. Also, the non-statistically significant result of the breast cancer intervention on multivariable analysis may reflect limited power, since the odds ratio approached two. Finally, a weakness of this study is that it did not incorporate a formal “implementation assessment” to allow the investigators to understand the details of which aspects of the intervention were implemented successfully, barriers to implementation and which aspects of the multimodal intervention actually “worked.” We hypothesize that “what works” varies by patient; that is, different patients respond to different processes, explaining why this multimodal intervention had a bigger effect than single interventions. This is consistent with the underlying Health Belief Model (specifically “cues to action”). In future research, we will seek to better understand the implementation and differentiate the effects of different components of the intervention.
In summary, a combination of letters, automated phone calls, patient prompts and home testing kit mailing resulted in increased cancer screening for patients in a safety net practice. We believe that implementing a combination of low-cost interventions such as these is feasible in safety-net practices, and this multimodal intervention does show a larger effect size compared to individual interventions. These results particularly highlight the promise of mailing a test kit directly to unscreened patients. Additional studies will be required to determine the “ideal” low-intensity intervention and to streamline the process for dissemination to primary care practices with low cancer screening rates.
This study was funded by the American Cancer Society (RSGT-08-077-01-CPHPS).
Conflict of Interest
The authors declare that they do not have any conflict of interest.