PCORI RESEARCH PLAN Applicants are encouraged to refer to the contents of the PCORI Methodology Report in developing their Research Plan.

Transcription

1 PCORI RESEARCH PLAN Applicants are encouraged to refer to the contents of the PCORI Methodology Report in developing their Research Plan. RESEARCH STRATEGY (Use continuation pages as needed to provide the required information in the format shown below. Limit 15 pages for this section. Refer to the PCORI Application Guidelines and the PFA to which you are applying, found on the PCORI Funding Center, for additional guidance. ) RESPONSE TO REVIEWERS Project Summary. Comment 1: Provide more details about colorectal cancer (CRC) screening innovativeness. Response: CRC screening is widely accepted in preventive health care. Therefore, CRC screening is not novel. The proposed study will test the impact of an innovative decision support and navigation intervention (DSNI) on CRC screening adherence. The innovative nature of the multi-level DSNI as an intervention strategy is described in Sections and It is also novel that the DSNI will be tested among Hispanic primary care patients for the first time. Comment 2: Explain how patient experiences related to CRC screening will be improved. Response: Section describes steps that will be taken in the DSNI Group to improve patient knowledge about CRC screening, access to a preferred screening test, development of a patientcentered screening plan, navigation through the process of implementing the personalized screening plan, and communication with primary care providers. Criterion 1. Demonstrate that the condition imposes a significant burden on the health of individuals and populations Comment 1: Explain why increasing CRC screening is particularly important for Hispanics (R1). Response: CRC screening rates among Hispanics are significantly lower than screening rates among non-hispanic whites. This disparity contributes to the detection of more late-stage disease at time of diagnosis among Hispanics, which leads to higher mortality and lower survival. Reducing the persistent disparity in screening will help to mitigate related disparities in mortality and survival among Hispanics. 1,2 Comment 2: Explain how the issue of undocumented workers will be addressed (R2). Response: The research team is sensitive to the possible reluctance of undocumented immigrants to participate in a publically-funded study. In describing the study to prospective participants, we will explain that information related to their participation will be known only by members of the research team, and information related to screening will be shared only by with their health care provider. Criterion 2. Explain how the results of the study would likely improve health care and outcomes Comment 1: Provide evidence that patients or clinician groups have identified this type of research as a priority (R1). Response: Hispanic primary care patients and primary care provider stakeholders in the Lehigh Valley Health Network (LVHN) who participated in focus groups described in Section 4.1 of the application expressed concerns about CRC and support for efforts aimed at increasing knowledge about CRC, improving communication with primary care providers about CRC and screening, raising CRC PCORI Research Plan PFAs 1-4 1

2 screening rates in the Hispanic community, and reducing the disparity between Hispanics and nonhispanic whites in CRC screening. These reports are consistent with findings reported in various research studies referenced in the application and in the Latino Cancer Report. 3 Comment 2: Explain why a marginal change in screening is an important improvement (R1). Response: We estimate that the DSNI will generate a CRC screening adherence rate that is at least 15 percentage-points higher than the mailed standard intervention (SI), or 45% versus 30% screening rates, respectively. This level of impact is a conservative estimate of the proposed DSNI effect, and represents a 50% increase over the SI. This level of improvement, along with increased complete follow-up of participants who have an abnormal screening test result can substantially increase the likelihood of finding colorectal adenomas and early CRC, attenuate the screening disparity between Hispanics and nonhispanic whites, and reduce disparities in CRC mortality and survival. Comment 3: Explain the added value of decision support over and above navigation (R1) Response: An important aspect of the proposed DSNI is that bilingual Hispanic patient navigators (promotoras) will be trained to support both study participants and primary care providers. In terms of decision support for participants, the navigator will clarify each participant s preferred screening test; elicit personal, culturally-relevant barriers to and facilitators of performance of screening; develop a person-centered screening plan; and, send a copy of the plan to the participant. In terms of primary care provider support, the navigator will inform the provider of the participant s screening plan; will contact the practice office manager to ensure provider support for the screening plan; and, will act as an agent for the provider to facilitate screening plan implementation, including obtaining needed referrals and appointment-scheduling. Comment 4: Explain how research findings will translate to other locations (R2). Response: Study findings will be immediately relevant, not only to LVHN primary care practices, but also to primary care practices and health care systems that serve Hispanic patients. Intervention materials and methods will be available in English and Spanish. In addition, the research team will make the training manual developed in the project available for use in the LVHN and other health care systems. Effective intervention materials and methods will also be made available through an online National Institutes of Health-supported intervention dissemination website, known as Cancer Control Planet, which dedicated to disseminating Research Tested Intervention Programs. Comment 5: Clarify the role of patient navigator and justify 100% FTE (R2). Response: In the proposed study, the navigator will be a bilingual health educator with a bachelor s degree (or equivalent experience) in a healthcare related field. Initially the navigator will obtain certification for human subject protection and participate in training on study design and intervention implementation procedures. Once intervention delivery begins, the navigator will contact each participant randomized to the DSNI Group to establish the patient s decision regarding screening, and establish the participant s preferred method of screening. For those who prefer to complete a stool blood test (SBT), the navigator will assure that the participant has the appropriate screening kit and instructions for collecting and returning the specimen. For those who prefer colonoscopy, the navigator will obtain the needed specialist referral, schedule the screening appointment, explain procedure preparatory steps, arrange transportation where necessary, and make follow-up contact to assure completion of the procedure. The navigator will assure that all patients in the study who have a positive SBT test, whether intervention or control, will be scheduled for and complete a diagnostic colonoscopy. The navigator will also record and manage research data related to the position, and prepare reports for the patient and stakeholder advisory committee and the research team. Furthermore, the navigator will contact the office manager of each participating practice in order to ensure receipt of the screening plan developed for each DSNI Group participant and the screening record. We believe it is reasonable PCORI Research Plan PFAs 1-4 2

3 to expect that the navigator will devote 100% effort in Years 1 and 2, when patient and provider contacts are the most intensive, and will devote 50% effort in Year 3, when patient and provider contacts are less frequent. Comment 6: Indicate if the healthcare system has implemented prior findings from the research team (R1, R2). Response: The study team previously conducted CRC screening research sponsored by the Agency for Healthcare Research and Quality. 4 Findings from that earlier project have influenced the LVHN clinic system to make CRC screening more readily accessible to primary care patients. Specifically, the Community Health and Wellness Center (a community-focused outreach office that supports LVHN clinics) has initiated a centralized registry service for identifying and recruiting patients to participate in the current screening programs. The Center for Health and Wellness also added stool blood test kits to the choices made available for patients. Comment 7: Evaluate costs of intervention implementation (R1). Response: PCORI explicitly excludes cost analyses from being part of research studies it supports. The planned multi-level evaluation included in the proposed study will provide insights into barriers to and facilitators of screening intervention implementation, and resources needed for implementation. Criterion 3: Demonstrate the technical merit of the application (Previously Criterion 5: Rigorous research methods, Criterion 6: Inclusiveness of different populations and Criterion 7: Research team and environment) Comment 1: Explain why navigation wasn t chosen as the comparator, rather than mailed intervention (R1). Response: The use of mailed contacts to encourage screening has been shown to be effective in numerous published studies, and is endorsed by the Guide to Community Preventive Services. 5 According to reviews by Robinson-White et al. 6 and Robie et al., 7 few reports on patient navigation related to CRC screening among Hispanics have been reported in the literature; and those that have been reported enrolled patients at the time of a scheduled office visit. The few CRC screening navigation studies that have focused on Hispanics have offered stool blood testing as a screening test, and these studies have reported mixed results. Furthermore, no studies have reported on the impact of combined decision support and navigation versus a mailed standard intervention (SI) on CRC screening with stool blood testing and colonoscopy. Therefore, we believe that it is appropriate to compare the DSNI to the SI. Comment 2: Explain why the generalizability of findings will not be decreased by the use of charity care or other mechanisms to pay for screening (R1). Response: In the context of healthcare reform, Medicare, Medicaid, and private insurers will be required to cover A and B level screening recommendations from the United States Preventive Services Task Force (USPSTF). Importantly, USPSTF guidelines give CRC screening the highest level ( A ) recommendation. Also, healthcare organizations that aspire to become accountable care organizations will be required to promote population and community health, making programs like Reduced Cost Care in the Lehigh Valley Health Network more common in the United States. Comment 3: Provide more details on the data analysis plan (R2). Response: More details about the data analysis plan are provided in Section 3.4 of the application. Comment 4: Explain how patients will be selected for follow-up focus groups, and how balance will be achieved in gender, age, etc. (R2). PCORI Research Plan PFAs 1-4 3

4 Response: Participants who reflect the demographic (gender and age) composition of the study population will be invited to be in the focus groups. Comment 5: Describe who the navigators will be: lay vs. professional, ages or gender matched (R2). Response: The navigator(s) will be trained bilingual health educators whose language fluency and culture sensitivity are appropriate for the study population. A recent review of patient navigation in breast cancer screening 7 did not find evidence to support age- or gender-matching of navigators to patients. However, the study did conclude that it is important to ensure that navigators are adequately trained and supervised, and that they have good communication skills. As described in Section 3.3.2, the research team will hire, train, and supervise health educators from the Hispanic community in the Lehigh Valley to provide patient decision counseling and navigation services related to CRC screening. Furthermore, we will also assess the fidelity of intervention delivery throughout the study. Comment 6: Consider collecting information on income, insurance coverage, employment and assessing patient desires, approaches to decision making, health beliefs, etc. (R1) Response: The research team will add items to assess income level, employment status, level of acculturation, and preferred language on a planned 6-month survey. (See appendix) Data on insurance coverage will be obtained from medical records. We will also gather data on perceptions related to CRC screening on the 6-month survey. Information on patient decision factors and likelihood of screening will be collected as part of the decision counseling session described in Section These data will be used in data analyses described in Section 3.4. Comment 7: Determine the cultural make-up of the Hispanic population of the Lehigh Valley to identify unique cultural beliefs (R2). Response: While census data does not clearly delineate the percentages of people within each subculture of the Hispanic population of the Lehigh Valley, it is known that there are Puerto Rican, Dominican, Cuban, Mexican, and other Central or South American communities are represented in the Lehigh Valley. We will collect information on participant perceptions about CRC and screening on the 6- month survey. These data will be reviewed to identify participant psychosocial and cultural beliefs about CRC screening and to assess intervention impact on those beliefs. Inspection of these data will also provide insights into differences in subgroup perceptions about CRC screening. 8 Comment 8: Include patients other than focus groups in preparation of the proposal and include healthcare stakeholders in the research project (R1) Response: Section 4.3 explains that we have constituted a patient and stakeholder advisory committee (PASAC) that includes Hispanic patients and primary care providers. The committee and the research team have been engaged in planning the proposed study, will continue to work closely together during study implementation, and will collaborate on developing plans for intervention dissemination. We will also track these activities in planned committee meetings during the course of the study. Comment 9. Include letters of support from local organizations (R2). Response: Letters of support are provided in the appendix of the application. Criterion 4. Demonstrate the patient centeredness of the application Comment 1: Explain if Hispanics see the CRC screening disparity as a priority (R1) Response: See response to Criterion 2, Comment 1. PCORI Research Plan PFAs 1-4 4

5 Comment 2: Explain what happens to patients who are contacted by a DSNI Group navigator and decline or refuse CRC screening, and how the intervention will move patients along the continuum of readiness for change (R1 and R2). Response: Past research shows that when presented with an opportunity to screen with either SBT or colonoscopy, most individuals indicate a preference for one test over the other. Very few (~1%) indicate that they have decided against doing both tests. For participants in the former category, the DSNI Group navigator will generate a personalized screening plan for each participant that is keyed to the preferred test. For participants who decide against screening with either test at the time of navigator contact, the navigator will ascertain factors influencing the decision. This information will be noted in the participant s screening plan, along with a recommendation for follow-up contact within six months to assess screening decision stage and encourage screening adherence. Comment 3: Explain how the intervention will address outcomes other than screening (R2). Response: Aim 2 of the proposed study is to assess the impact of DSNI versus SI on change in participant CRC screening decision stage. Aim 3 of the study is to determine DSNI versus SI effects relative to participant test-specific screening adherence. Aim 4 is to find out if the DSNI and SI differ in terms of their impact on participant knowledge and psychosocial perceptions related to CRC screening. Comment 4: Provide more details about the PAPM (R3). Response: The Precaution Adoption Process Model (PAPM) specifies seven distinct stages in the journey from lack of awareness to adoption and/or maintenance of a behavior. In the first stage of the PAPM, an individual may be completely unaware of a risk (e.g. risk for CRC). The person may subsequently become aware of the issue but remain unengaged by it (Stage 2). Next, the person faces a decision about acting (Stage 3); may decide not to act (Stage 4), or may decide to act (Stage 5). The stages of action (Stage 6) and maintenance (Stage 7) follow. In the proposed study, we will use PAPM decision staging to identify CRC screening test-specific decision stage and overall CRC screening decision stage. Following methods used previously by the research team (see Sections and 3.2.3), we will elicit each participant s decision stage for colonoscopy and for stool blood test screening. By comparing participant responses, we will determine the participant s preferred screening test and overall screening decision stage. Criterion 5. Demonstrate the commitment to patient and stakeholder engagement Comment - This criterion did not exist when the initial application was reviewed. Response: See Section 5 of the application for details. Protection of Human Subjects Comment 1: Explain how patients who have an adverse reaction to screening will be managed. Response: See the Protections against Risk subsection of this part of application for details. PCORI Research Plan PFAs 1-4 5

6 1. Demonstrate that the condition imposes a significant burden on the health of individuals and/or populations (Criterion 1) In 2013, there will be an estimated 50,830 deaths from colorectal cancer (CRC) in the United States. 9 Many of these deaths will be due to missed opportunities to identify colorectal adenomas and early-stage CRC. It is well-known that CRC screening can find colorectal adenomas, which can be removed before they progress to CRC, and can detect early-stage CRC, when the disease can be cured. Guidelines of the United States Preventive Services Task Force (USPSTF), the American Cancer Society (ACS), and other organizations recommend CRC screening for persons who are 50 to 75 years of age and are at average risk for CRC. 10 Having a colonoscopy every 10 years or annual stool blood testing (SBT) are the CRC screening tests most frequently by primary care physicians. 11 CRC screening rates are rising in the general population, but are low among Hispanics. Unfortunately, Hispanics have a significantly lower CRC screening rate than non-hispanic whites and African Americans, and, as a consequence, are more likely to be diagnosed with late-stage CRC. Lower CRC screening rates among Hispanics translate into to relatively high mortality and low survival from CRC among Hispanics compared to nonhispanic whites and African Americans. In fact, CRC is the second leading cause of cancer deaths among Hispanics in this country. The disparities in CRC screening and mortality between Hispanics and non-hispanic whites persist, even when adjusting for education, income, and insurance status. 12,13 The potential gains associated with CRC screening can only be realized among Hispanics if screening rates rise in this segment of the population. 2. Explain how results of the study would likely improve health care and outcomes (Criterion 2) The Institute of Medicine (IOM) has encouraged research that addresses racial and ethnic disparities in health care. 14 The IOM s highest priority recommendations for areas of research include studies that focus on the comparative effectiveness of interventions (e.g., multi-level interventions versus single level methods of health education) to reduce disparities in major chronic diseases, including cancer. The IOM also has highlighted the need to compare the effectiveness of patient decision support tools, and to compare the effectiveness of different strategies to engage and retain patients in care and to delineate barriers to care, especially for members of populations that experience health disparities. In 2011, the Agency for Health Research and Quality (AHRQ) also called for research on the implementation of interventions that aim to reduce health disparities in priority populations, including racial and ethnic populations. 15 The proposed study is responsive to these IOM and AHRQ priorities in the context of primary care. Achieving high CRC screening rates in primary care can have a substantial, positive impact on CRC-related mortality and survival, along with related disparities, and can reduce economic costs associated with the disease. 16 In a recent analysis, Zauber et al. 17 estimated that by increasing CRC screening rates to 70% we could achieve a 53% reduction in CRC mortality. In economic terms, Bradley et al. 18 have projected that increased CRC screening could result in almost $15 billion in savings between 2005 and Raising CRC screening rates among Hispanics will have substantial benefits for this segment of the population and will contribute to societal gains related to CRC prevention and control. Effective, patient-centered interventions are needed, however, to increase screening 19 and reduce the unequal burden of the disease experienced by Hispanics. 3,8 According to reviews by Robie et al. 6 and Gonzalez et al., 20 however, few randomized, controlled trials of different interventions intended to increase CRC screening among Hispanics have been reported in the literature. Gonzalez found only four such studies in the literature, and most of those studies focused only on SBT screening, included Hispanic patients who presented for a primary care clinic office visit, and used mailed contacts and/or telephone reminders to boost screening rates. Few studies have intervened with Hispanic patients outside the context of an office visit and none have assessed the impact of decision support and navigation on SBT and colonoscopy screening rates. The proposed study will reach Hispanic patients outside the context of an office visit who are not up-to-date with CRC screening, are unlikely to have been informed about screening, and are unlikely to have received a physician referral for screening. In addition, we will test the impact of an integrated decision support and patient navigation intervention on CRC PCORI Research Plan PFAs 1-4 6

7 screening adherence. This strategy is intended to engage Hispanic primary care patients and their primary care providers in the screening process. Decision support, which has been shown to facilitate patient informed decision making in cancer prevention and control, and can be readily incorporated into patient navigation. In the proposed study, a bilingual health educator (promotora) trained in patient decision support and navigation will contact participants by telephone, provide information about SBT and colonoscopy screening, and identify the participant s preferred test. Following Motivational Interviewing (MI) principles, 24 the navigator then will elicit factors that are likely to influence performance of the preferred test ( pro and con factors), the importance each decision factor, and the likelihood of screening adherence. The navigator then will engage the participant in developing a personal screening plan, and will help to implement the individualized plan. For participants who prefer colonoscopy screening, the navigator will help the participant obtain a screening referral and screening appointment; and for patients who prefer SBT screening, the navigator will provide stepby-step instructions in test performance. Furthermore, the navigator will track participants through the screening process, inform their provider of progress, and encourage provider follow-up of non-adherers and those who have an abnormal screening test result. Consequently, we expect that increased screening adherence and complete follow-up will occur. The research team will also conduct a multi-level evaluation to identify patient, provider, and health system barriers to dissemination and implementation of the decision support and navigation intervention. To our knowledge, this multi-level evaluation will be the first that focuses on Hispanic patients in a set of primary care practices affiliated with a large, urban health care system. Findings from this aspect of the study will help to inform the development and implementation of preventive health care interventions in the context of patient-centered medical homes (PCMHs) and accountable care organizations (ACOs). 3. Demonstrate the technical merit of the application (Criterion 3) 3.1. Background and Significance. The literature on methods for increasing CRC screening adherence is growing. Much of this research has focused on single-level patient or provider contacts; and findings suggest that multi-level interventions which engage both patients and providers are likely to be more effective in raising screening rates than single-level interventions. Few studies have reported on the use of multi-level methods, however, and little is known about the impact of such strategies in Hispanic patient populations Mailed Contacts, Message Tailoring, and Preference. Recent reviews have found that generic patient contacts (e.g., print materials, mailed SBTs, reminder mailings) have produced a modest, positive impact on CRC screening, especially SBT screening Rawl et al. 28 also reported that mailed patientoriented, personalized print education materials may have a positive impact on CRC screening, especially in minority populations. However, Gonzalez et al. 20 found mailed patient materials had a modest positive impact on SBT screening among Hispanic primary care patients. Research on message tailoring in CRC screening in the general population is limited, and is almost nonexistent in Hispanic populations. Message tailoring refers to the delivery of educational messages that address personal barriers (i.e., cognitive needs and psychosocial concerns related to specific behaviors) and serves to minimize or remove psychosocial obstacles to action Educational message tailoring has been used successfully to promote smoking cessation, reduce dietary fat intake, increase cholesterol testing, physical activity, and mammography use To reduce disparities, Kreuter et al. 33,34 and Powe 35,36 have encouraged the delivery of tailored messages that address barriers relevant to population subgroups. Only a few research studies have reported on the use of message tailoring to address psychosocial barriers to CRC screening To date, these efforts have generated only modest effects at best. The use of message tailoring based on personal preference for different CRC screening tests may be more successful. However, no studies have been reported on the use of such methods among Hispanics. Wolf et al. elicited CRC screening test preferences among minority patients attending an urban health care clinic, and found that survey respondents commonly reported a preference for SBT screening. 40 Hawley et al. 41 reported that race was associated with differences in screening test preference among patients who visited a primary care practice. The literature also suggests that personal preference not only influences health PCORI Research Plan PFAs 1-4 7

8 behavior, but may also be related to observed disparities in preventive health behavior Shokar et al. 49 found that whites and African Americans tended to differ in terms of how they valued the attributes of different CRC screening tests. Recently, Inadomi et al. 50 reported that among patients in an urban health care clinic who were offered SBT and colonoscopy screening, adherence varied by race and ethnicity. Members of the research team have reported on the use of decision staging, based on the Precaution Adoption Process Model (PAPM), to identify an individual s preferred CRC screening test. 51,52 Findings from a recently-reported study conducted by the group showed that aligning patient preference for a given CRC screening test with access to that test boosted screening adherence in a diverse primary care clinic patient population Decision Support and Navigation for Patients and Providers. Patient navigation is recognized as a promising way to increase adherence to recommended health behaviors. Traditionally, patient navigators have been nurses who are assigned to help patients diagnosed with cancer to find their way through the complex and confusing diagnostic and treatment process Trained health educators and lay health advocates have also acted as patient navigators to effectively facilitate preventive health behaviors. 60 In terms of cancer screening, most navigation studies have addressed breast and cervical cancer screening, and a small number of studies were focused on CRC screening. 61 A few CRC screening studies have involved contacting the general primary care patient population residing in the community. In those studies, a patient navigator called patients by telephone and encouraged them to arrange colonoscopy screening. This strategy generated screening rates ranging from 27% to 41% ,62 In other CRC screening studies, primary care providers issued a colonoscopy screening referral for patients at the time of an office visit, and then handed off the patients to a navigator authorized to arrange a screening appointment. This approach produced screening rates ranging from 54% to 66% This interpretation is consistent with other reports suggesting that patient navigation has a greater impact on colonoscopy screening when the navigator is recognized as an agent of the primary care provider, and when the navigator assumes responsibility for appointment scheduling This type of CRC screening support is often not provided in primary care practices, however. Lebwohl et al. reported that the volume of screening colonoscopies among urban clinic patients at large urban hospital increased coincident with the initiation of a patient navigator program 69. In a small, randomized pilot study, Christie, et al. 62 showed that among low-income minorities, patients who received navigation were more likely to have CRC screening than controls (54% and 13%, respectively). Chen, et al. 63 reported that a cohort of patients using a patient navigator, including a subset of Hispanic patients, increased adherence. In a randomized trial using a single clinic, Percac-Lima et al. 37 found that those assigned to receive a patient navigator intervention were more likely to undergo CRC screening than control patients (27% vs. 12%). In a recent randomized trial that involved Hispanic patients who visited a university-based primary care clinic, 70 researchers found that adding targeted messages that were culturally-specific and sensitive to navigation contacts did not increase colonoscopy performance as compared to navigation alone. Findings from that study suggest that there is a need to identify a more effective, personalized way to enhance the impact of patient navigation among Hispanics. Recent reviews suggest that decision support interventions (DSIs) used in the context of patient navigation may offer a novel patient-centered strategy that can substantially improve CRC screening adherence, especially in minority populations. 20,71,72 To date, however, little research has been reported on the use of preference-based DSIs to increase CRC screening. 73, Preliminary Studies. The proposed study builds on and extends findings reported in the literature and those obtained from prior studies carried out by members of the research team A Low-Intensity Intervention Study in the Lehigh Valley Health Network (LVHN). In 2007, Thomas Jefferson University, Lehigh Valley Health Network, and CNA (a non-profit research and analysis company), formed the CNA Health ACTION Partnership. These partners worked together on a demonstration project intended to design an intervention that could be used to increase CRC screening and follow-up in primary care practices in the LVHN of Eastern Pennsylvania. The project was funded by the Centers for Disease Control and Prevention (HHSA ) between October 2007 and July The final report is available online at Key features of the intervention included educational outreach to primary care providers; use of an electronic medical records system to identify primary care practice patients eligible for CRC screening; delivery of a mailed immunochemical SBT kit to patients on PCORI Research Plan PFAs 1-4 8

9 request; tracking the performance of screening; and providing performance feedback on screening and followup rates to LVHN primary care providers. The study was conducted over the course of one year in 15 Intervention Group practices, beginning in CRC screening rates were monitored over the same time period in five additional matched Control Group practices. (None of these practices will be included in the proposed study). Twenty-eight percent of patients in Intervention Group practices requested an SBT kit. At endpoint, patients in Intervention Group practices had significantly higher CRC screening rates than patients in the Control Group practices, but rates were low (9% versus 4%). These findings suggested the need for a more intensive intervention approach. It should also be noted that data on patient race/ethnicity were not collected as part of the study. Therefore, intervention impact among Hispanic patients was not assessed A Randomized Trial of Mailed and Navigation Contacts in the General Patient Population. The research team recently completed an NCI-funded randomized, controlled trial titled, Tailored Navigation in CRC Screening (CA116576). 52 This trial involved primary care practices in Delaware and patients who were 50 to 74 years of age, were not previously diagnosed with CRC, and were not up to date with CRC screening. We enrolled 945 consenting participants, who were randomized to one of three study groups: a Control Group (n=317), Standard Intervention (SI) Group (n=316), and Tailored Navigation Intervention (TNI) Group (n=312). The Control Group received usual care. The SI Group received a mailed informational booklet on CRC screening; a personalized letter that included a nurse contact telephone number to call in order to arrange a colonoscopy, an SBT kit, and a mailed reminder at 30 days. Participants who called the nurse contact number were given the telephone number of a colonoscopy provider approved by their primary care practice, and were encouraged to schedule the procedure. The nurse was not authorized to schedule a colonoscopy appointment however all TNI Group participants initially were sent the CRC screening booklet and a personalized letter keyed to CRC screening test preference (i.e., preferred colonoscopy, equal preference for colonoscopy and SBT, or preferred SBT) assessed on the baseline survey. Those who preferred colonoscopy screening received a letter that included a navigator contact telephone number to call and discuss colonoscopy. Again, the navigator was authorized only to give the participant the telephone number of a gastroenterology practice affiliated with the participant s primary care practice. Those with an equal preference for colonoscopy and SBT screening received a letter, the navigator contact number, and an SBT kit. Persons preferring SBT screening received a letter and an SBT kit. After this initial mailing, a trained navigator called each participant; verified test preference; and encouraged test performance. Participants then received a reminder letter. Finally, a 6- month survey and 12-month medical records review were completed for all study groups. According to study protocol, all SI Group participants received both mailed colonoscopy instructions and an SBT kit. TNI Group participants who preferred SBT screening received only a mailed SBT kit, and those who preferred colonoscopy screening received only mailed colonoscopy instructions. TNI Group participants who preferred colonoscopy and SBT screening equally received both a mailed SBT kit and colonoscopy instructions. Furthermore, although navigators encouraged participants to complete their preferred test, but did not offer decision support, did not develop a screening plan, and did not engage the participant s primary care provider in screening plan implementation or follow-up. Overall 12-month screening rates were: Control Group (18%), SI Group (36%), and TNI Group (43%). Thus, both interventions increased CRC screening rates significantly over usual care (p<0.001), and telephone navigation had a stronger but nonsignificant effect than the mailed intervention (p=0.118). In secondary analyses, we have projected that if colonoscopy instructions and SBT kits had been sent to all TNI Group participants, the overall screening rate in that group would have been substantially higher. We believe that colonoscopy rates would also have been higher if navigators had been authorized to schedule colonoscopy appointments for participants who preferred that test. It is important to mention that there were very few Hispanic participants in this study. Thus, we could not determine intervention impact in this segment of the population. Furthermore, neither patients nor physicians were provided decision support Mailed and Navigation Contacts among African American Primary Care Patients. Members of the research team recently concluded an American Cancer Society-funded Research Scholar Award (RSGT CPPB) to determine the impact of a preference-based navigation intervention on CRC screening among African American patients in primary care practices. The study included African American patients who PCORI Research Plan PFAs 1-4 9

10 were years of age, had not been diagnosed with CRC, received medical care in a primary care practice setting (Jefferson Family Medicine Associates (JFMA) practice or Einstein Healthcare Network (AEHN) affiliated practices), and were eligible for CRC screening. In this study, 764 participants completed a baseline telephone survey and were randomly assigned either to a Standard Intervention (SI) Group (n=380) or a Tailored Navigation Intervention (TNI) Group (n=384). The SI Group received a mailed informational booklet on CRC screening; a personalized letter that included a colonoscopy contact telephone number, an SBT kit, and a mailed reminder at 30 days. TNI Group participants received preference-based contacts according to a protocol similar to the one described in Section The primary outcome of the study was adherence to CRC screening within 12 months after randomization. Participant background Table 1. CRC Screening Among African Americans by Intervention Group characteristics were as follows: Screening Status SI Group (n=380) TNI Group (n=384) male (36%), 60 years of age or older (33%), married (29%), and at least a high school education Screened, n (%) 122 (32) 137 (43) (40%). Final data analyses were completed in February Table 1 shows that adherence to screening was significantly higher among participants in the TNI Group than in the SI Group (43% and 32%, respectively, p=0.002). Thus, preferencebased navigation had a significantly greater positive impact on screening adherence than a standard mailed intervention among African Americans. As this study included only African American patients, we do not know the potential effect of tailored navigation on CRC screening adherence among Hispanic patients. Finally, neither patients nor physicians were provided decision support. The proposed study will provide needed information related to these matters Study Design. The proposed study will compare the effectiveness of a multi-level decision support and navigation intervention (DSNI) to a single-level mailed standard intervention (SI) in a randomized, controlled trial that involves Hispanic patients who are served by primary care practices in the Lehigh Valley Health Network (LVHN) Research Setting and Patient Population. The LVHN is a multi-center, non-profit healthcare delivery system with a National Community Cancer Center Program in Eastern Pennsylvania. LVHN s primary services areas include Lehigh and Northampton counties, which include over 645,000 residents, of whom 96,967 are Hispanic or Latino. The city of Allentown in Lehigh County is home to over 105,000 residents, 40% of which are Hispanic or Latino. Twenty-two percent of the population of Allentown lives below the poverty line, and 36% of people living in Allentown speak a language other than English at home. 75 The majority speak Spanish. The sampling frame for this proposed study will be patients from four (4) LVHN primary care clinic practices serving center city Allentown and a large LVHN community practice. The research team will engage patients and primary care providers in those practices, along with gastroenterology and colorectal specialists who perform screening colonoscopy in the LVHN system. Inspection of medical records shows that <35% of patients in the general patient population of LVHN practices are up-to-date with CRC screening guidelines. The CRC screening rate among potentially-eligible Hispanic patients in participating LVHN practices is <30%. In the proposed study, we will randomize equal numbers of Hispanic patients to one of two intervention arms, an SI Group (n=200) or a DSNI Group (n=200). The SI Group will receive a mailed CRC screening kit (colonoscopy instructions and a SBT kit) and a reminder. The DSNI Group will also receive a mailed screening kit and a reminder. In addition, a trained navigator will engage participants and providers in the process of performing the CRC screening test preferred by the participant. The relative effectiveness of these intervention strategies will be measured in terms of CRC screening adherence within 12 months. Choice of these two comparators has been informed by results from preliminary studies conducted by the research team and the screening literature which suggest that DSNI may be more effective than SI in boosting CRC screening minority populations. We have chosen not to include a usual care control group in the study design, because PCORI Research Plan PFAs

11 CRC screening is usually low in routine care, which is the case in LVHN practices. We believe that determining the impact of DSNI as compared to SI is more clinically meaningful than comparing DSNI or SI to usual care Navigator, Research Assistant, and Survey Interviewer Training/Supervision. Navigator and research assistant training will take advantage of an existing self-study manual developed in prior research. The manual, which will be adapted for use in this study, will include a copy of the study protocol, information on CRC screening and the diagnostic follow-up of patients with abnormal screening results; selected articles from the literature on patient navigation, message tailoring, preference clarification, and decision counseling. The Fox Chase Cancer Center Office of Health Communications & Health Disparities (OHCHD) will be responsible for translating all study print materials, text embedded in an online Decision Counseling Program (see Section 3.3.4), and the navigation telephone script into Spanish. Both bilingual project research assistants and patient navigators will complete the self-study manual. In addition, study navigators will complete a 2-day decision counseling and navigation training program. During this program, navigators will review the history and theory related to decision support and will receive instruction in decision counseling methods. In addition, the navigators will be provided current information on primary practices, providers and office managers; colonoscopy providers; and contacts and procedures for scheduling CRC screening. The navigators will conduct audio-recorded mock patient navigation calls with surrogate patients. During these calls, navigator adherence to study protocol will be evaluated by project staff. The study project manager and bilingual staff from OHCHD will review the audio recordings and complete a fidelity checklist that includes basic steps in the decision counseling and navigation process. Drs. Myers (Principal Investigator) and Sifri (Co-Investigator), along with the project manager will debrief the navigators and address any need for remediation. Specifically, barriers to effective interactions will be identified (e.g., inaccurate ascertainment of decision factors and related factor weights, incomplete development of an effective screening plan), and approaches for overcoming these barriers will be discussed and implemented. During the study, project leadership, the project manager, and OHCHD staff will listen to a sample of 10 navigation calls per year, assess intervention fidelity in an ongoing fashion, and provide remediation where necessary. Completeness of intervention delivery will also be documented in call contact logs. A bilingual LVHN research assistant will contact potential participants to assess eligibility for the study, obtain verbal consent, and administer a baseline survey described below. In addition, bilingual survey interviewers from Survey Technologies Research (STR), a professional survey company, will administer a 6-month Survey. In preparation for making these patient contacts, the research assistant and STR interviewers will review the self-study manual, which will include the respective questionnaires and describe procedures for survey administration. The research assistant and the survey interviewers will also conduct audio-recorded survey calls with surrogate patients, and will be debriefed to maximize contact quality. During the study, Drs. Myers and Sifri, along with the project manager and OHCHD staff will listen to 5 calls per month for the research assistant and the survey interviewers. The project manager will also train and supervise the research assistant in accessing electronic medical records and recording appropriate data Participant Recruitment, Baseline Survey Administration, and Randomization. Initially, Hispanic patients who are 50 to 75 years of age, have not been diagnosed with CRC, and have not had a recent CRC screening test will be identified via LVHN electronic records. These individuals will be mailed a study invitation letter in English and Spanish. The letter will describe the proposed research and provide information about ways to opt out of or register to participate in the study (i.e., complete and return a study registration card in an addressed postage-paid return envelope, or call a toll-free telephone number.) The letter will also inform recipients that a research staff member will call non-respondents. A trained bilingual research assistant will call patients within 15 days after the invitation letter mailing. The research assistant will conduct the call in the language preferred by the respondent. The research assistant will verify patient eligibility, describe the study, ascertain patient willingness to participate, obtain verbal consent, and administer a brief baseline survey to a total of 400 participants. As part of the survey, the research PCORI Research Plan PFAs

12 assistant will describe SBT and colonoscopy screening, and will ascertain the participant s overall and testspecific screening decision stage. Following procedures used in prior research sudies, 39,51,52 we will use the information to determine the participant s overall CRC screening decision stage and preferred CRC screening test. Data on sociodemographic background will also be collected. At the end of the baseline survey, the interviewer will ask participants to indicate a day(s) of the week and time(s) of the day when research staff can most conveniently speak to the participant by telephone. The interviewer will also ask for a telephone number and address for use in making contact. Finally, the research assistant will inform the participants that they will receive CRC screening materials in the mail, will determine whether the participant wants to receive study materials in English or Spanish, and will mention that the research team may contact them by telephone to discuss screening and will contact them to complete two follow-up surveys. As shown in Figure 1, research staff will randomly assign all consented participants either to a SI Group or a DSNI Group. Random assignment will be stratified by participant primary care practice. Figure 1. Study Design Baseline Survey Randomization Intervention Delivery Records Review (6,12 month) 6-Month Survey Standard Intervention (SI) (n = 200) Mailed contacts* Complete (n = 190) Complete (n = 160) Complete (N = 400) Stratify random assignment by primary practice Decision Support and Navigation Intervention (DSNI) (n = 200) Mailed contacts, Support/Navigation contacts** Complete (n = 190) Complete (n =160) * Mailed Contacts: Screening letter, informational booklet, colonoscopy instructions, SBT kit, and reminder letter. **Mailed Contacts: Screening letter, informational booklet, colonoscopy instructions, SBT kit, and reminder letter; Support/Navigation contacts: navigator calls to provide decision counseling, develop screening plans, support plan implementation, and deliver screening plan and status reports Intervention Implementation. Following randomization, SI Group participants will be mailed a set of standard materials (see Appendix). The materials will include a letter from the participant s primary care practice encouraging selection and performance of either (1) colonoscopy screening, or (2) stool blood test (SBT). Accompanying the letter will be instructions for arranging a colonoscopy appointment and instructions for completing an enclosed immunochemical SBT kit. Print materials and contacts will be provided in the language the participant as preferred (English or Spanish) at the time of the baseline survey. At 45 days following random assignment, research staff will send participants a reminder letter from the participant s primary care provider that endorses and encourages screening. Study participants assigned to the DSNI Group will also be mailed print materials, including a letter from the practice on CRC screening, an informational booklet, and instructions for arranging a colonoscopy appointment and instructions for completing an enclosed immunochemical SBT kit. Again, print materials will be provided in the language specified by the participant at baseline. Within 7 days after this mailing, DSNI Group participants will also receive a telephone call from a trained bilingual study navigator. In the call, the navigator initially will review the CRC screening materials and verify the participant s preferred CRC screening test. During this encounter, the navigator will PCORI Research Plan PFAs