ABSTRACT
BACKGROUND: Disparities in cervical cancer screening rates among marginalized groups is a driver of inequalities in cervical cancer. Self-sampling for human papillomavirus (HPV) testing is a newly emerging alternative to clinician-performed testing to screen for cervical cancer, and has high potential to reduce screening barriers in under-screened and marginalized groups. We study the acceptability in of HPV self-sampling and informational materials among Black/African American, Hispanic/Spanish speaking, American Indian/Alaska Native and transgender/nonbinary populations. METHODS: We conducted qualitative interviews with patients, ages 30-65, who were Black/African American, Hispanic, American Indian, and/or transgender/nonbinary individuals assigned female at birth. Telephone interviews were conducted in English or Spanish. Patients did not complete the test, rather were asked about the attractiveness, comprehensibility, and acceptability of the HPV self-test, instructions, and messaging. RESULTS: Among 23 completed interviews (5 American Indian/Alaska Native, 7 Hispanic [2 bilingual, 5 Spanish-speaking], 5 Black/African American, and 6 transgender/nonbinary), patients from all groups thought the test was straightforward and convenient, and they would complete the test at home or in clinic. The transgender/nonbinary patients preferred at-home testing. American Indian and transgender/nonbinary patients liked that the test might avoid pain, discomfort, and invasiveness. All patients liked the letter and instructions. All groups had specific suggestions for making the materials more culturally acceptable. CONCLUSIONS: The HPV self-test and the instructions and materials for use were acceptable for a diverse group of patients. Tailored outreach and messaging should be considered to reduce screening disparities among groups that have been historically underserved by the medical system.
Subject(s)
Papillomavirus Infections , Patient Acceptance of Health Care , Adult , Aged , Female , Humans , Middle Aged , Early Detection of Cancer/psychology , Early Detection of Cancer/methods , Human Papillomavirus Viruses/isolation & purification , Papillomavirus Infections/diagnosis , Papillomavirus Infections/virology , Patient Acceptance of Health Care/psychology , Qualitative Research , Specimen Handling/methods , Uterine Cervical Neoplasms/diagnosis , Uterine Cervical Neoplasms/virologyABSTRACT
INTRODUCTION: Recruiting organizations (i.e., health plans, health systems, or clinical practices) is important for implementation science, yet limited research explores effective strategies for engaging organizations in pragmatic studies. We explore the effort required to meet recruitment targets for a pragmatic implementation trial, characteristics of engaged and non-engaged clinical practices, and reasons health plans and rural clinical practices chose to participate. METHODS: We explored recruitment activities and factors associated with organizational enrollment in SMARTER CRC, a randomized pragmatic trial to increase rates of CRC screening in rural populations. We sought to recruit 30 rural primary care practices within participating Medicaid health plans. We tracked recruitment outreach contacts, meeting content, and outcomes using tracking logs. Informed by the Consolidated Framework for Implementation Research, we analyzed interviews, surveys, and publicly available clinical practice data to identify facilitators of participation. RESULTS: Overall recruitment activities spanned January 2020 to April 2021. Five of the 9 health plans approached agreed to participate (55%). Three of the health plans chose to operate centrally as 1 site based on network structure, resulting in 3 recruited health plan sites. Of the 101 identified practices, 76 met study eligibility criteria; 51% (n = 39) enrolled. Between recruitment and randomization, 1 practice was excluded, 5 withdrew, and 7 practices were collapsed into 3 sites for randomization purposes based on clinical practice structure, leaving 29 randomized sites. Successful recruitment required iterative outreach across time, with a range of 2 to 17 encounters per clinical practice. Facilitators to recruitment included multi-modal outreach, prior relationships, effective messaging, flexibility, and good timing. CONCLUSION: Recruiting health plans and rural clinical practices was complex and iterative. Leveraging existing relationships and allocating time and resources to engage clinical practices in pragmatic implementation research may facilitate more diverse representation in future trials and generalizability of research findings.
Subject(s)
Early Detection of Cancer , Primary Health Care , Rural Health Services , Humans , Early Detection of Cancer/methods , Primary Health Care/organization & administration , United States , Rural Health Services/organization & administration , Patient Selection , Rural Population , Colorectal Neoplasms/diagnosis , Medicaid , Community-Institutional RelationsABSTRACT
Patient navigation (PN) has been shown to improve participation in cancer screening, including colorectal cancer screening, and is now a recommended practice by the Community Preventive Services Task Force. Despite the effectiveness of PN programs, little is known about the number of contacts needed to successfully reach patients or about the demographic and healthcare utilization factors associated with reach. PRECISE was an individual randomized study of PN versus usual care conducted as a partnership between two large health systems in the Pacific Northwest. The navigation program was a six-topic area telephonic program designed to support patients with an abnormal fecal test result to obtain a follow-up colonoscopy. We report the number of contact attempts needed to successfully reach navigated patients. We used logistic regression to report the demographic and healthcare utilization characteristics associated with patients allocated to PN who were successfully reached. We identified 1,200 patients with an abnormal fecal immunochemical test result, of whom 970 were randomized into the study (45.7% were female, 17.5% were Spanish-speaking, and the mean age was 60.8 years). Of the 479 patients allocated to the PN intervention, 382 (79.7%) were reached within 18 call attempts, and nearly all (n = 356; 93.2%) were reached within six contact attempts. Patient characteristics associated with reach were race, county of residence, and body mass index. Our findings can guide future efforts to optimize the reach of PN programs. Prevention Relevance: The findings from this large study can inform clinic-level implementation of future PN programs in Federally Qualified Health Centers to improve the reach of patients needing cancer screenings, optimize staff resources, and ultimately increase cancer screenings.
Subject(s)
Colonoscopy , Colorectal Neoplasms , Early Detection of Cancer , Patient Navigation , Humans , Female , Male , Middle Aged , Colonoscopy/statistics & numerical data , Colonoscopy/methods , Patient Navigation/organization & administration , Patient Navigation/statistics & numerical data , Colorectal Neoplasms/diagnosis , Colorectal Neoplasms/prevention & control , Colorectal Neoplasms/epidemiology , Early Detection of Cancer/methods , Early Detection of Cancer/statistics & numerical data , Aged , Follow-Up Studies , Occult Blood , Mass Screening/methods , Mass Screening/statistics & numerical data , Mass Screening/organization & administration , AdultABSTRACT
BACKGROUND: Mailed fecal immunochemical test (FIT) outreach can improve colorectal cancer screening participation. We assessed the reach and effectiveness of adding notifications to mailed FIT programs. METHODS: We conducted secondary analyses of a stepped-wedge evaluation of an enhanced mailed FIT program (n = 15 clinics). Patients were stratified by prior FIT completion. Those with prior FIT were sent a text message (Group 1); those without were randomized 1:1 to receive a text message (Group 2) or live phone call (Group 3). All groups were sent automated phone call reminders. In stratified analysis, we measured reach and effectiveness (FIT completion within 6 months) and assessed patient-level associations using generalized estimating equations. RESULTS: Patients (n = 16,934; 83% Latino; 72% completed prior FIT) were reached most often by text messages (78%), followed by live phone calls (71%), then automated phone calls (56%). FIT completion was higher in patients with prior FIT completion versus without [44% (Group 1) vs. 19% (Group 2 + Group 3); P < 0.01]. For patients without prior FIT, effectiveness was higher in those allocated to a live phone call [20% (Group 3) vs. 18% (Group 2) for text message; P = 0.04] and in those who personally answered the live call (28% vs. 9% no call completed; P < 0.01). CONCLUSIONS: Text messages reached the most patients, yet effectiveness was highest in those who personally answered the live phone call. IMPACT: Despite the broad reach and low cost of text messages, personalized approaches may more successfully boost FIT completion.
Subject(s)
Colorectal Neoplasms , Text Messaging , Humans , Early Detection of Cancer , Reminder Systems , Mass Screening , Colorectal Neoplasms/diagnosis , Colorectal Neoplasms/prevention & control , Occult BloodABSTRACT
BACKGROUND: Mailed fecal immunochemical test (FIT) outreach and patient navigation are evidence-based practices shown to improve rates of colorectal cancer (CRC) and follow-up in various settings, yet these programs have not been broadly adopted by health systems and organizations that serve diverse populations. Reasons for low adoption rates are multifactorial, and little research explores approaches for scaling up a complex, multi-level CRC screening outreach intervention to advance equity in rural settings. METHODS: SMARTER CRC, a National Cancer Institute Cancer Moonshot project, is a cluster-randomized controlled trial of a mailed FIT and patient navigation program involving 3 Medicaid health plans and 28 rural primary care practices in Oregon and Idaho followed by a national scale-up trial. The SMARTER CRC intervention combines mailed FIT outreach supported by clinics, health plans, and vendors and patient navigation for colonoscopy following an abnormal FIT result. We applied the framework from Perez and colleagues to identify the intervention's components (including functions and forms) and scale-up dissemination strategies and worked with a national advisory board to support scale-up to additional organizations. The team is recruiting health plans, primary care clinics, and regional and national organizations in the USA that serve a rural population. To teach organizations about the intervention, activities include Extension for Community Healthcare Outcomes (ECHO) tele-mentoring learning collaboratives, a facilitation guide and other materials, a patient navigation workshop, webinars, and individualized technical assistance. Our primary outcome is program adoption (by component), measured 6 months after participation in an ECHO learning collaborative. We also assess engagement and adaptations (implemented and desired) to learn how the multicomponent intervention might be modified to best support broad scale-up. DISCUSSION: Findings may inform approaches for adapting and scaling evidence-based approaches to promote CRC screening participation in underserved populations and settings. TRIAL REGISTRATION: Registered at ClinicalTrials.gov (NCT04890054) and at the NCI's Clinical Trials Reporting Program (CTRP no.: NCI-2021-01032) on May 11, 2021.
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OBJECTIVES: Fecal immunochemical testing (FIT) is an effective screening tool for colorectal cancer. If an FIT is abnormal, a follow-up colonoscopy is necessary to remove polyps or find cancers. We sought to develop a usable risk prediction model to identify patients unlikely to complete a colonoscopy following an abnormal FIT test. METHODS: We recalibrated and then redeveloped a prediction model in federally qualified health centers (FQHCs), using a retrospective cohort of patients aged 50-75 with an abnormal FIT test and clinical data. Logistic and Cox regressions were used to recalibrate and then redevelop the model. RESULTS: The initial risk model used data from eight FQHCs (26 clinics) including 1723 patients. When we applied the model to a single large FQHC (34 clinics, 884 eligible patients), the model did not recalibrate successfully (c-statistic dropped more than 0.05, from 0.66 to 0.61). The model was redeveloped in the same FQHC in a cohort of 1401 patients with a c-statistic of 0.65. CONCLUSIONS: The original model developed in a group of FQHCs did not adequately recalibrate in the single large FQHC. Health system, patient characteristics or data differences may have led to the inability to recalibrate the model. However, the redeveloped model provides an adequate model for the single FQHC.
Subject(s)
Colorectal Neoplasms , Humans , Retrospective Studies , Colorectal Neoplasms/diagnosis , Colorectal Neoplasms/prevention & control , Early Detection of Cancer , Colonoscopy , Occult Blood , Mass ScreeningABSTRACT
PURPOSE: Colonoscopy can prevent morbidity and mortality from colorectal cancer (CRC) and is the most commonly used screening method in the United States. Barriers to colonoscopy at multiple levels can contribute to disparities. Yet, in rural settings, little is known about who delivers colonoscopy and facilitators and barriers to colonoscopy access through screening completion. METHODS: We conducted a qualitative study with providers in rural Oregon who worked in endoscopy centers or primary care clinics. Semistructured interviews, conducted in July and August, 2021, focused on clinician experiences providing colonoscopy to rural Medicaid patients, including workflows, barriers, and access. We used thematic analysis, through immersion crystallization, to analyze interview transcripts and develop emergent themes. FINDINGS: We interviewed 19 providers. We found two categories of colonoscopy providers: primary care providers (PCPs) doing colonoscopy on their own patients (n = 9; 47%) and general surgeons providing colonoscopy to patients referred to their services (n = 10; 53%). Providers described barriers to colonoscopy at the provider, community, and patient levels and suggested patient supports could help overcome them. Providers found current colonoscopy capacity sufficient, but noted PCPs trained to perform colonoscopy would be key to continued accessibility. Finally, providers shared concerns about the shrinking number of PCP endoscopists, especially with anticipated increased screening demand related to the CRC screening guideline shift. CONCLUSIONS: These themes reflect opportunities to address multilevel barriers to improve access, colonoscopy capacity, and patient education approaches. Our results highlight that PCPs are an essential part of the workforce that provides colonoscopy in rural areas.
Subject(s)
Colorectal Neoplasms , Humans , United States , Colorectal Neoplasms/diagnosis , Qualitative Research , Mass Screening , Colonoscopy , MedicaidABSTRACT
Promotion of colorectal cancer (CRC) screening can be expensive and unnecessary for many patients. The use of predictive analytics promises to help health systems target the right services to the right patients at the right time while improving population health. Multilevel data at the interpersonal, organizational, community, and policy levels, is rarely considered in clinical decision making but may be used to improve CRC screening risk prediction. We compared the effectiveness of a CRC screening risk prediction model that uses multilevel data with a more conventional model that uses only individual patient data. We used a retrospective cohort to ascertain the one-year occurrence of CRC screening. The cohort was determined from a Health Maintenance Organization, in Oregon. Eligible patients were 50-75 years old, health plan members for at least one year before their birthday in 2018 and were due for screening. We created a risk model using logistic regression first with data available in the electronic health record (EHR), and then added multilevel data. In a cohort of 59,249 patients, 36.1% completed CRC screening. The individual level model included 14 demographic, clinical and encounter based characteristics, had a bootstrap-corrected C-statistic of 0.722 and sufficient calibration. The multilevel model added 9 variables from clinical setting and community characteristics, and the bootstrap-corrected C-statistic remained the same with continued sufficient calibration. The predictive power of the CRC screening model did not improve after adding multilevel data. Our findings suggest that multilevel data added no improvement to the prediction of the likelihood of CRC screening.
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BACKGROUND: Mailed fecal immunochemical test (FIT) outreach can improve colorectal cancer screening rates, yet little is known about how to optimize these programs for effectiveness and cost. METHODS: PROMPT was a pragmatic, stepped-wedge, cluster-randomized effectiveness trial of mailed FIT outreach. Participants in the standard condition were mailed a FIT and received live telephone reminders to return it. Participants in the enhanced condition also received a tailored advance notification (text message or live phone call) and two automated phone call reminders. The primary outcome was 6-month FIT completion; secondary outcomes were any colorectal cancer screening completion at 6 months, implementation, and program costs. RESULTS: The study included 27,585 participants (80% ages 50-64, 82% Hispanic/Latino; 68% preferred Spanish). A higher proportion of enhanced participants completed FIT at 6 months than standard participants, both in intention-to-treat [+2.8%, 95% confidence interval (CI; 0.4-5.2)] and per-protocol [limited to individuals who were reached; +16.9%, 95% CI (12.3-20.3)] analyses. Text messages and automated calls were successfully delivered to 91% to 100% of participants. The per-patient cost for standard mailed FIT was $10.84. The enhanced program's text message plus automated call reminder cost an additional $0.66; live phone calls plus an automated call reminder cost an additional $10.82 per patient. CONCLUSIONS: Adding advance notifications and automated calls to a standard mailed FIT program boosted 6-month FIT completion rates at a small additional per-patient cost. IMPACT: Enhancements to mailed FIT outreach can improve colorectal cancer screening participation. Future research might test the addition of educational video messaging for screening-naïve adults.
Subject(s)
Colorectal Neoplasms , Early Detection of Cancer , Humans , Colorectal Neoplasms/diagnosis , Colorectal Neoplasms/prevention & control , Early Detection of Cancer/methods , Mass Screening/methods , Occult Blood , Reminder Systems , Telephone , Middle AgedABSTRACT
Colorectal cancer (CRC) is a leading cause of cancer death in the USA. Screening programs in federally qualified health centers (FQHCs) are essential to reducing CRC-related mortality and morbidity among underserved populations. Centralized, population-based mailed fecal immunochemical test (FIT) programs can improve CRC screening rates, but barriers to implementation remain. We qualitatively explored barriers and facilitators to implementation of a mailed FIT program at a large, urban FQHC that employed advance notification "primers" (live calls and texts) and automated reminders. We interviewed 25 patients and 45 FQHC staff by telephone about their experience with the program. Interviews were transcribed, coded, and content analyzed using NVivo.12. Patients and staff found advance notifications conveyed through live phone calls or text messages to be acceptable and motivational for FIT completion. Live phone primers were helpful in addressing patients' questions and misconceptions about screening, particularly for patients new to screening. Advance notifications sent by text were considered timely and useful in preparing patients for receipt of the FIT. Barriers to implementation included lack of receipt of primers, reminders, or the mailed FIT itself due to inaccurate patient contact information within the FQHC medical record; lack of systems for documenting mailed FIT outreach to coordinate with clinical care; and lack of local caller identification for primers and reminders. Our findings demonstrate that an enhanced mailed FIT program using primers and reminders was acceptable. Our findings can help other FQHCs implement and optimize their mailed FIT programs.
Subject(s)
Colorectal Neoplasms , Mass Screening , Humans , Colorectal Neoplasms/diagnosis , Colorectal Neoplasms/prevention & control , Health Facilities , Early Detection of Cancer , Occult BloodABSTRACT
INTRODUCTION: Colorectal cancer (CRC) incidence and mortality are disproportionately high among rural residents despite the availability of effective screening methods. Outreach activities can improve CRC screening rates but rely on accurate identification of patients due for screening. We report on data challenges in rural clinics and Medicaid health plans in Oregon in identifying patients eligible for CRC screening, in a large project implementing mailed fecal immunochemical tests (FIT) and patient navigation. METHODS: We analyzed data from clinic intake surveys and administrative claims. Clinics were asked to identify total population numbers relevant to CRC screening and follow-up. Health plans also identified enrollees eligible for CRC screening in Spring, 2021. Clinic staff validated patient lists for eligibility using their electronic health records (EHR). RESULTS: EHR features varied across the 29 participating and 28 responding clinics. Among the 28 responding clinics, 21 were able to report their Medicaid population (75%), 19 reported the number of patients aged 50 to 75 (68%) and the number screened for CRC in the last year (68%). Only 8 (29%) were able to report screening details such as number screened by FIT and 9 were able to report on patients with an abnormal FIT or colonoscopy completed after FIT (32%). Health plans had challenges properly identifying where enrollees received care and had missing data for race and ethnicity (range 22 to 34% unknown race, <1% to 24% unknown ethnicity). DISCUSSION: Most participating rural primary care clinics and Medicaid health plans experienced challenges identifying the population due for a CRC screening outreach program. Better EHR functionality and data reporting capabilities could help rural clinics apply population-based strategies and ultimately attenuate disparities in cancer screening and follow-up.
Subject(s)
Colorectal Neoplasms , Early Detection of Cancer , Humans , Mass Screening , Colorectal Neoplasms/diagnosis , Medicaid , Oregon , Occult Blood , Colonoscopy/methodsABSTRACT
PURPOSE: Human papillomavirus (HPV) and COVID-19 vaccination are both recommended for adolescents of ages 12-17. In May 2021, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices allowed the two vaccines to be administered concurrently. METHODS: We identified adolescents of ages 12-17 using electronic health records from a large integrated delivery system. We assessed associations between socio-demographic characteristics and uptake of HPV vaccination and COVID-19 vaccination, as well as the cumulative proportion of adolescents who obtained a COVID-19 vaccine over time by HPV vaccination status. RESULTS: We identified 40,819 adolescents; 65% had received any COVID-19 vaccination, and 79% had received any HPV vaccination. Adolescents who had initiated HPV vaccination had about 4-fold greater odds of having obtained a COVID-19 vaccine than those who had not (odds ratio = 4.02, 95% confidence interval = 3.81, 4.24). DISCUSSION: Patterns of vaccination uptake suggest possible advantages to co-promotion of adolescent vaccines.
Subject(s)
COVID-19 , Papillomavirus Infections , Papillomavirus Vaccines , Humans , Adolescent , COVID-19 Vaccines , Human Papillomavirus Viruses , Papillomavirus Infections/prevention & control , COVID-19/prevention & control , VaccinationABSTRACT
OBJECTIVE: Individuals with an abnormal fecal immunochemical test (FIT) result have an elevated risk of colorectal cancer, and the risk increases if the follow-up colonoscopy is delayed. Of note, rates of follow-up colonoscopy are alarmingly low in federally qualified health centers (FQHCs), US health care settings that serve a majority racial and ethnic minority patient population. We assessed factors associated with colonoscopy after an abnormal FIT result and used chart-abstracted data to assess reasons (including process measures) for lack of follow-up as part of an annual, mailed-FIT outreach program within a large, Latino-serving FQHC. METHODS: As part of the National Institutes of Health-funded PROMPT study, we identified patients with an abnormal FIT result and used logistic regression to assess associations between patient demographics and receipt of follow-up colonoscopy, controlling for patients' preferred language. We report on time (days) to referral and time to colonoscopy. For charts with an abnormal FIT result but no evidence of colonoscopy, we performed a manual abstraction and obtained the reason for the absence of colonoscopy. When there was no evidence of colonoscopy in a patient's electronic health record (EHR), we performed an automated query of the administrative claims database to identify colonoscopy outcomes. RESULTS: We identified 324 patients with abnormal FIT results from July to October 2018. These patients were mostly publicly insured (Medicaid 53.1%, Medicare 14.5%), 81.8% were aged 50 to 64 years, 55.3% were female, 80.3% were Hispanic/Latino, and 67.3% preferred to speak Spanish. We found that 108/324 (33.3%) patients completed colonoscopy within 12 months, and the median time to colonoscopy was 94 days (IQR: 68-176). Common barriers to colonoscopy completion, obtained from chart-abstracted data, were: no documentation following referral to gastrointestinal (GI) specialist or GI consultation (41.6%), no referral to GI specialist following abnormal fecal test (34.2%), and absence of a valid insurance authorization (6.5%). CONCLUSIONS: Multi-level strategies are needed to provide optimal care across the cancer continuum for FQHC patients. In order to reduce the risk of CRC and realize the return on fecal testing investment, concerted system-level efforts are urgently needed to improve rates of follow-up colonoscopy among FQHC patients and redress racial and ethnic disparities in CRC screening outcomes.
Subject(s)
Colorectal Neoplasms , Early Detection of Cancer , United States , Humans , Aged , Female , Male , Ethnicity , Minority Groups , Medicare , Colonoscopy , Colorectal Neoplasms/diagnosisABSTRACT
BACKGROUND: There is an urgent need for evidence on how interventions can prevent or mitigate cancer-related financial hardship. Our objectives are to compare self-reported financial hardship, quality of life, and health services use between patients receiving a financial navigation intervention versus a comparison group at 12 months follow-up, and to assess patient-level factors associated with dose received of a financial navigation intervention. METHODS: The Cancer Financial Experience (CAFÉ) study is a multi-site randomized controlled trial (RCT) with individual-level randomization. Participants will be offered either brief (one financial navigation cycle, Arm 2) or extended (three financial navigation cycles, Arm 3) financial navigation. The intervention period for both Arms 2 and 3 is 6 months. The comparison group (Arm 1) will receive enhanced usual care. The setting for the CAFÉ study is the medical oncology and radiation oncology clinics at two integrated health systems in the Pacific Northwest. Inclusion criteria includes age 18 or older with a recent cancer diagnosis and visit to a study clinic as identified through administrative data. Outcomes will be assessed at 12-month follow-up. Primary outcomes are self-reported financial distress and health-related quality of life. Secondary outcomes are delayed or foregone care; receipt of medical financial assistance; and account delinquency. A mixed methods exploratory analysis will investigate factors associated with total intervention dose received. DISCUSSION: The CAFÉ study will provide much-needed early trial evidence on the impact of financial navigation in reducing cancer-related financial hardship. It is theory-informed, clinic-based, aligned with patient preferences, and has been developed following preliminary qualitative studies and stakeholder input. By design, it will provide prospective evidence on the potential benefits of financial navigation on patient-relevant cancer outcomes. The CAFÉ trial's strengths include its broad inclusion criteria, its equity-focused sampling plan, its novel intervention developed in partnership with clinical and operations stakeholders, and mixed methods secondary analyses related to intervention dose offered and dose received. The resulting analytic dataset will allow for rich mixed methods analysis and provide critical information related to implementation of the intervention should it prove effective. TRIAL REGISTRATION: ClinicalTrials.gov NCT05018000 . August 23, 2021.
Subject(s)
Financial Stress , Neoplasms , Adolescent , Humans , Neoplasms/diagnosis , Quality of Life , Treatment OutcomeABSTRACT
BACKGROUND: Screening reduces incidence and mortality from colorectal cancer (CRC), yet US screening rates are low, particularly among Medicaid enrollees in rural communities. We describe a two-phase project, SMARTER CRC, designed to achieve the National Cancer Institute Cancer MoonshotSM objectives by reducing the burden of CRC on the US population. Specifically, SMARTER CRC aims to test the implementation, effectiveness, and maintenance of a mailed fecal test and patient navigation program to improve rates of CRC screening, follow-up colonoscopy, and referral to care in clinics serving rural Medicaid enrollees. METHODS: Phase I activities in SMARTER CRC include a two-arm cluster-randomized controlled trial of a mailed fecal test and patient navigation program involving three Medicaid health plans and 30 rural primary care practices in Oregon and Idaho; the implementation of the program is supported by training and practice facilitation. Participating clinic units were randomized 1:1 into the intervention or usual care. The intervention combines (1) mailed fecal testing outreach supported by clinics, health plans, and vendors and (2) patient navigation for colonoscopy following an abnormal fecal test result. We will evaluate the effectiveness, implementation, and maintenance of the intervention and track adaptations to the intervention and to implementation strategies, using quantitative and qualitative methods. Our primary effectiveness outcome is receipt of any CRC screening within 6 months of enrollee identification. Our primary implementation outcome is health plan- and clinic-level rates of program delivery, by component (mailed FIT and patient navigation). Trial results will inform phase II activities to scale up the program through partnerships with health plans, primary care clinics, and regional and national organizations that serve rural primary care clinics; scale-up will include webinars, train-the-trainer workshops, and collaborative learning activities. DISCUSSION: This study will test the implementation, effectiveness, and scale-up of a multi-component mailed fecal testing and patient navigation program to improve CRC screening rates in rural Medicaid enrollees. Our findings may inform approaches for adapting and scaling evidence-based approaches to promote CRC screening participation in underserved populations and settings. TRIAL REGISTRATION: Registered at clinicaltrial.gov ( NCT04890054 ) and at the NCI's Clinical Trials Reporting Program (CTRP #: NCI-2021-01032) on May 11, 2021.
ABSTRACT
PURPOSE: Mailed fecal immunochemical test (FIT) programs can facilitate colorectal cancer (CRC) screening. We sought to identify modifiable, clinic-level factors that distinguish primary care clinics with higher vs lower FIT completion rates in response to a centralized mailed FIT program. METHODS: We used baseline observational data from 15 clinics within a single urban federally qualified health center participating in a pragmatic trial to optimize a mailed FIT program. Clinic-level data included interviews with leadership using a guide informed by the Consolidated Framework for Implementation Research (CFIR) and FIT completion rates. We used template analysis to identify explanatory factors and configurational comparative methods to identify specific combinations of clinic-level conditions that uniquely distinguished clinics with higher and lower FIT completion rates. RESULTS: We interviewed 39 clinic leaders and identified 58 potential explanatory factors representing clinic workflows and the CFIR inner setting domain. Clinic-level FIT completion rates ranged from 30% to 56%. The configurational model for clinics with higher rates (≥37%) featured any 1 of the following 3 factors related to support staff: (1) adding back- or front-office staff in past 12 months, (2) having staff help patients resolve barriers to CRC screening, and (3) having staff hand out FITs/educate patients. The model for clinics with lower rates involved the combined absence of these same 3 factors. CONCLUSIONS: Three factors related to support staff differentiated clinics with higher and lower FIT completion rates. Adding nonphysician support staff and having those staff provide enabling services might help clinics optimize mailed FIT screening programs.
Subject(s)
Colorectal Neoplasms , Occult Blood , Colorectal Neoplasms/diagnosis , Early Detection of Cancer/methods , Humans , Mass Screening/methods , Postal ServiceABSTRACT
BACKGROUND: Health insurance plans are increasingly offering mailed fecal immunochemical test (FIT) programs for colorectal cancer (CRC) screening, but few studies have compared the outcomes of different program models (eg, invitation strategies). METHODS: This study compares the outcomes of 2 health plan-based mailed FIT program models. In the first program (2016), FIT kits were mailed to all eligible enrollees; in the second program (2018), FIT kits were mailed only to enrollees who opted in after an outreach phone call. Participants in this observational study included dual-eligible Medicaid/Medicare enrollees who were aged 50 to 75 years and were due for CRC screening (1799 in 2016 and 1906 in 2018). Six-month FIT completion rates, implementation outcomes (eg, mailed FITs sent and reminders attempted), and program-related health plan costs for each program are described. RESULTS: All 1799 individuals in 2016 were sent an introductory letter and a FIT kit. In 2018, all 1906 were sent an introductory letter, and 1905 received at least 1 opt-in call attempt, with 410 (21.5%) sent a FIT. The FIT completion rate was 16.2% (292 of 1799 [95% CI, 14.5%-17.9%]) in 2016 and 14.6% (278 of 1906 [95% CI, 13.0%-16.2%]) in 2018 (P = .36). The overall implementation costs were higher in 2016 ($40,156) than 2018 ($34,899), with the cost per completed FIT slightly higher in 2016 ($138) than 2018 ($126). CONCLUSIONS: An opt-in mailed FIT program achieved FIT completion rates similar to those of a program mailing to all dual-eligible Medicaid/Medicare enrollees. LAY SUMMARY: Health insurance plans can use different program models to successfully mail fecal test kits for colorectal cancer screening to dual-eligible Medicaid/Medicare enrollees, with nearly 1 in 6 enrollees completing fecal testing.
Subject(s)
Colorectal Neoplasms , Medicaid , Aged , Colorectal Neoplasms/diagnosis , Early Detection of Cancer , Humans , Mass Screening , Medicare , Middle Aged , Occult Blood , Postal Service , United StatesABSTRACT
Objectives: To develop and test a human papillomavirus (HPV) vaccination intervention that includes healthcare team training activities and patient reminders to reduce missed opportunities and improves the rate of appointment scheduling for HPV vaccination in a rural medical clinic in the United States. Methods: The multi-level and multi-component intervention included healthcare team training activities and the distribution of patient education materials along with technology-based patient HPV vaccination reminders for parents/caregivers and young adult patients. Missed vaccination opportunities were assessed pre- and post-intervention (n = 402 and n = 99, respectively) by retrospective chart review and compared using Pearson χ2. The patient parent/caregiver and young adult patient population (n = 80) was surveyed following the reminder messages and penalized logistic regression quantified unadjusted odds of scheduling a visit. Results: Missed opportunities for HPV vaccination declined significantly from the pre-intervention to the post-intervention period (21.6 vs. 8.1%, respectively, p = 0.002). Participants who recalled receipt of a vaccination reminder had 7.0 (95% CI 2.4-22.8) times higher unadjusted odds of scheduling a visit compared with those who did not recall receiving a reminder. The unadjusted odds of confirming that they had scheduled or were intending to schedule a follow-up appointment to receive the HPV vaccine was 4.9 (95% CI 1.51-20.59) times greater among those who had not received the vaccine for themselves or for their child. Conclusions: Results from this intervention are promising and suggest that vaccination interventions consisting of provider and support staff education and parent/caregiver and patient education materials, and reminders can reduce missed opportunities for vaccinations in rural settings.
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BACKGROUND: Colorectal cancer screening by annual fecal immunochemical test (FIT) with follow-up on abnormal results is a cost-effective strategy to reduce colorectal cancer incidence and mortality. Unfortunately, many patients with abnormal results do not complete a follow-up colonoscopy. We tested whether navigation targeted to patients who are unlikely to complete the procedure may improve adherence and long-term outcomes. METHODS: Study participants were patients at a large, integrated health system (Kaiser Permanente Northwest) who were ages 50 to 75 and were due for a follow-up colonoscopy after a recent abnormal FIT result. Probability of adherence to follow-up was estimated at baseline using a predictive risk model. Patients whose probability was 70% or lower were randomized to receive patient navigation or usual care, with randomization stratified by probability category (<50%, 50% < 60%, 60% < 65%, 65% ≤ 70%). We compared colonoscopy completion within 6 months between the navigation and usual care groups using Cox proportional hazards regression. RESULTS: Participants (n = 415; 200 assigned to patient navigation, 215 to usual care) had a mean age of 62 years, 54% were female, and 87% were non-Hispanic white. By 6 months, 76% of the patient navigation group had completed a colonoscopy, compared with 65% of the usual care group (HR = 1.35; 95% confidence interval, 1.07-1.72; log-rank P value = 0.027). CONCLUSIONS: In this randomized trial, patient navigation led to improvements in follow-up colonoscopy adherence. IMPACT: More research is needed to assess the value of precision-directed navigation programs.