Effectiveness and Cost of an Enhanced Mailed Fecal Test Outreach Colorectal Cancer Screening Program: Findings from the PROMPT Stepped-Wedge Trial.

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.

Comparing the clinical and cost-effectiveness of remote (telehealth and online) cognitive behavioral therapy-based treatments for high-impact chronic pain relative to usual care: study protocol for the RESOLVE multisite randomized control trial.

BACKGROUND: Cognitive behavioral therapy for chronic pain (CBT-CP) is an effective but underused treatment for high-impact chronic pain. Increased access to CBT-CP services for pain is of critical public health importance, particularly for rural and medically underserved populations who have limited access due to these services being concentrated in urban and high income areas. Making CBT-CP widely available and more affordable could reduce barriers to CBT-CP use. METHODS: As part of the National Institutes of Health Helping to End Addiction Long-term® (NIH HEAL) initiative, we designed and implemented a comparative effectiveness, 3-arm randomized control trial comparing remotely delivered telephonic/video and online CBT-CP-based services to usual care for patients with high-impact chronic pain. The RESOLVE trial is being conducted in 4 large integrated healthcare systems located in Minnesota, Georgia, Oregon, and Washington state and includes demographically diverse populations residing in urban and rural areas. The trial compares (1) an 8-session, one-on-one, professionally delivered telephonic/video CBT-CP program; and (2) a previously developed and tested 8-session online CBT-CP-based program (painTRAINER) to (3) usual care augmented by a written guide for chronic pain management. Participants are followed for 1 year post-allocation and are assessed at baseline, and 3, 6, and 12 months post-allocation. The primary outcome is minimal clinically important difference (MCID; ≥ 30% reduction) in pain severity (composite of pain intensity and pain-related interference) assessed by a modified 11-item version of the Brief Pain Inventory-Short Form at 3 months. Secondary outcomes include pain severity, pain intensity, and pain-related interference scores, quality of life measures, and patient global impression of change at 3, 6, and 12 months. Cost-effectiveness is assessed by incremental cost per additional patient with MCID in primary outcome and by cost per quality-adjusted life year achieved. Outcome assessment is blinded to group assignment. DISCUSSION: This large-scale trial provides a unique opportunity to rigorously evaluate and compare the clinical and cost-effectiveness of 2 relatively low-cost and scalable modalities for providing CBT-CP-based treatments to persons with high-impact chronic pain, including those residing in rural and other medically underserved areas with limited access to these services. TRIAL REGISTRATION: ClinicalTrials.gov NCT04523714. This trial was registered on 24 August 2020.

Bridge to Health/Puente a la Salud: a pilot randomized trial to address diabetes self-management and social needs among high-risk patients.

Social needs contribute to persistent diabetes disparities; thus, it is imperative to address social needs to optimize diabetes management. The purpose of this study was to determine determine the feasibility and acceptability of health system-based social care versus social care + behavioral intervention to address social needs and improve diabetes self-management among patients with type 2 diabetes. Black/African American, Hispanic/Latino, and low-income White patients with recent hemoglobin A1C (A1C) ≥ 8%, and ≥1 social need were recruited from an integrated health system. Patients were randomized to one-of-two 6-month interventions: (a) navigation to resources (NAV) facilitated by a Patient Navigator; or (b) NAV + evidence-based nine-session diabetes self-management support (DSMS) program facilitated by a community health worker (CHW). A1C was extracted from the electronic health record. We successfully recruited 110 eligible patients (54 NAV; 56 NAV + DSMS). During the trial, 78% NAV and 80% NAV + DSMS participants successfully connected to a navigator; 84% NAV + DSMS connected to a CHW. At 6-month follow-up, 33% of NAV and 34% of NAV + DSMS participants had an A1C < 8%. Mean reduction in A1C was clinically significant in NAV (-0.65%) and NAV + DSMS (-0.72%). By follow-up, 89% of NAV and 87% of NAV + DSMS were successfully connected to resources to address at least one need. Findings suggest that it is feasible to implement a health system-based social care intervention, separately or in combination, with a behavioral intervention to improve diabetes management among a high-risk, socially complex patient population. A larger, pragmatic trial is needed to test the comparative effectiveness of each approach on diabetes-related outcomes.

The Cancer Financial Experience (CAFÉ) study: randomized controlled trial of a financial navigation intervention to address cancer-related financial hardship.

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.

Barriers to family history knowledge and family communication among LGBTQ+ individuals in the context of hereditary cancer risk assessment.

Openness about identity as lesbian, gay, bisexual, transgender, queer, and other sexual orientations and gender identities (LGBTQ+) may cause strain on relationships between family members, which could lead to limited knowledge of cancer family history and reduced communication with family members. As a result, members of the LGBTQ+ community may have more difficulty accessing genetic counseling services for inherited cancer risk. We applied a mixed-methods approach to explore potential barriers to knowledge of cancer family history and family communication among participants of the Cancer Health Assessments Reaching Many (CHARM) study who self-identified as LGBTQ+. We assessed perceptions of family functioning and communication of genetic test results to family members using survey tools and supplemented these data with 20 in-depth interviews to further assess participant perspectives and experiences. LGBTQ+ participants were more likely to report unhealthy family functioning on the survey tool, and some interviewees endorsed that openness about their LGBTQ+ identity led to strained family relationships and reduced communication about their family history of cancer. Overall, this study identified barriers that may be faced by members of the LGBTQ+ community which could limit their ability to access genetic counseling services for inherited cancer risk.

Bridge to Health/ Puente a la Salud: Rationale and design of a pilot feasibility randomized trial to address diabetes self-management and unmet basic needs among racial/ethnic minority and low-income patients.

INTRODUCTION: Racial/ethnic and socioeconomic disparities in diabetes prevalence and management persist. Unmet basic needs such as food insecurity and unstable housing interfere with optimal diabetes self-management. Bridge to Health/Puente a la Salud is a randomized pilot trial designed to examine the feasibility of testing the effectiveness of addressing unmet basic needs via navigation services versus navigation plus diabetes self-management support (DSMS) on improving diabetes-related outcomes among racial/ethnic minority and low-income patients with uncontrolled diabetes. MATERIAL AND METHODS: We recruited and randomized 110 African American, Hispanic, and Medicaid patients (any race/ethnicity) with diabetes and recent hemoglobin A1C ≥ 8% to one of two 6-month interventions: 1) Navigation only; or 2) Navigation + DSMS. In both arms, practice-embedded patient navigators help participants navigate social services and community-based resources to address unmet basic needs. In Navigation + DSMS, participants are also assigned to a community health worker (CHW) embedded in a local community-based organization who provides additional navigation support and delivers DSMS. A1C and unmet basic needs data are collected via routine lab and survey, respectively, at baseline and 6-month follow-up. Qualitative interviews with participants, health system leaders, CHWs, and patient navigators are conducted to explore intervention acceptability and determinants of implementation in a health care setting. DISCUSSION: Findings from this pilot feasibility study will enhance understanding about acceptability, preliminary clinical effectiveness, and facilitators and barriers to implementation of the Navigation only and Navigation + DSMS interventions and inform refinements of the overall study design for the larger, randomized clinical trial.

Health plan adaptations to a mailed outreach program for colorectal cancer screening among Medicaid and Medicare enrollees: the BeneFIT study.

BACKGROUND: Promoting uptake of evidence-based innovations in healthcare systems requires attention to how innovations are adapted to enhance their fit with a given setting. Little is known about real-world variation in how programs are delivered over time and across multiple populations and contexts, and what motivates adaptations. METHODS: As part of the BeneFIT study of mailed fecal immunochemical tests (FIT) to increase colorectal cancer screening, we interviewed 9 leaders from two participating Medicaid/Medicare health insurance plans to examine adaptations to their health plan-initiated mailed FIT outreach programs in the second year of implementation. We applied an adaptation and modification model developed by Stirman and colleagues to document content and context modifications made to the two programs. RESULTS: Both health plans made substantial changes to their programs in the second year; adaptations differed substantially across health plans. In Health Plan Oregon, adaptations generally targeted health centers and member populations, most content adaptations involved tailoring program components, and the program was expanded to four additional health centers. In contrast, Health Plan Washington's second-year content adaptations were primarily at the level of members, and generally involved adding program components. Moreover, Health Plan Washington undertook large-scale context adaptations to the setting where the program was led (local vs. national), the personnel who administered the program (vendor and staffing), and the population selected for outreach (limiting outreach to dual-eligible members). CONCLUSIONS: Both programs implemented a variety of adaptations that reflected the values and incentives of the broader health plan contexts. Financial incentives for screening allowed Health Plan Oregon to expand but led Health Plan Washington to offer more targeted outreach to a subset of eligible enrollees. The breadth of changes made by each health system reflects the necessity of evaluating programs in context and adjusting to specific challenges as they are identified. Further research is needed to understand the effects of these types of adaptations on program efficiency and enrollee and health system outcomes.

First-year implementation of mailed FIT colorectal cancer screening programs in two Medicaid/Medicare health insurance plans: qualitative learnings from health plan quality improvement staff and leaders.

BACKGROUND: Colorectal cancer screening rates remain low, especially among certain racial and ethnic groups and the uninsured and Medicaid insured. Clinics and health care systems have adopted population-based mailed fecal immunochemical testing (FIT) programs to increase screening, and now health insurance plans are beginning to implement mailed FIT programs. We report on challenges to and successes of mailed FIT programs during their first year of implementation in two health plans serving Medicaid and dual eligible Medicaid/Medicare enrollees. METHODS: This qualitative descriptive study gathered data through in-depth interviews with staff and leaders at each health plan (n = 10). The Consolidated Framework for Implementation Research, field notes from program planning meetings between the research team and the health plans, and internal research team debriefs informed interview guide development. Qualitative research staff used Atlas.ti to code the health plan interviews and develop summary themes through an iterative content analysis approach. RESULTS: We identified first-year implementation challenges in five thematic areas: 1) program design, 2) vendor experience, 3) engagement/communication, 4) reaction/satisfaction of stakeholders, and 5) processing/returning of mailed kits. Commonly experienced challenges by both health plans related to the time-consuming nature of the programs to set up, and complexities and delays in working with vendors. We found implementation successes in the same five thematic areas as well as four additional areas of: 1) leadership support, 2) compatibility with the health plan, 3) broader impacts, and 4) collaboration with researchers. Commonly experienced successes included the ability to adapt the mailed FIT program to the individual health plan culture and needs, and the synchronicity between the programs and their organizational missions and goals. CONCLUSIONS: Both health plans successfully adapted mailed FIT programs to their own culture and resources and used their strong quality management resources to maximize success in overcoming the time demands of setting up the program and working with their vendors. Mailed FIT programs administered by health plans, especially those serving Medicaid- and dual eligible Medicaid/Medicare-insured populations, may be an important resource to support closing gaps in colorectal cancer screening among traditionally underserved populations.

Two Medicaid health plans' models and motivations for improving colorectal cancer screening rates.

Screening rates for colorectal cancer (CRC) remain low, especially among certain populations. Mailed fecal immunochemical testing (FIT) outreach initiated by U.S. health plans could reach underserved individuals, while solving CRC screening data and implementation challenges faced by health clinics. We report the models and motivations of two health insurance plans implementing a mailed FIT program for age-eligible U.S. Medicaid and Medicare populations. One health plan operates in a single state with ~220,000 enrollees; the other operates in multiple states with ~2 million enrollees. We conducted in-depth qualitative interviews with key stakeholders and observed leadership and clinic staff planning during program development and implementation. Interviews were transcribed and coded using a content analysis approach; coded interview reports and meeting minutes were iteratively reviewed and summarized for themes. Between June and September 2016, nine participants were identified, and all agreed to the interview. Interviews revealed that organizational context was important to both organizations and helped shape program design. Both organizations were hoping this program would address barriers to their prior CRC screening improvement efforts and saw CRC screening as a priority. Despite similar motivations to participate in a mailed FIT intervention, contextual features of the health plans led them to develop distinct implementation models: a collaborative model using some health clinic staffing versus a centralized model operationalizing outreach primarily at the health plan. Data are not yet available on the models' effectiveness. Our findings might help inform the design of programs to deliver mailed FIT outreach.

Patient randomized trial of a targeted navigation program to improve rates of follow-up colonoscopy in community health centers.

BACKGROUND: Colorectal cancer (CRC) screening by annual fecal immunochemical test (FIT) is an accessible and cost-effective strategy to lower CRC incidence and mortality. However, this mode of screening depends on follow-up colonoscopy after a positive FIT result. Unfortunately, nearly one-half of FIT-positive patients fail to complete this essential screening component. Patient navigation may improve follow-up colonoscopy adherence. To deliver patient navigation cost-effectively, health centers could target navigation to patients who are unlikely to complete the procedure on their own. OBJECTIVES: The Predicting and Addressing Colonoscopy Non-adherence in Community Settings (PRECISE) clinical trial will validate a risk model of follow-up colonoscopy adherence and test whether patient navigation raises rates of colonoscopy adherence overall and among patients in each probability stratum (low, moderate, and high probability of adherence without intervention). METHODS: PRECISE is a collaboration with a large community health center whose patient population is 37% Latino. Eligible patients will be aged 50-75, have an abnormal FIT result in the past month, and be due for a follow-up colonoscopy. Patients will be randomized to patient navigation or usual care. Primary outcomes will be colonoscopy completion within one year of a positive FIT result, cost, and cost-effectiveness. Secondary outcomes will include time to colonoscopy receipt, adequacy of bowel prep, and communication of results to primary care providers. Primary and secondary outcomes will be reported overall and by probability stratum. DISCUSSION: This innovative clinical trial will test the effectiveness and financial feasibility of using a precision health intervention to improve CRC screening completion in community health centers. TRIAL REGISTRATION: National Clinical Trial (NCT) Identifier: NCT03925883.

A Survey of Provider Attitudes, Beliefs, and Perceived Barriers Regarding a Centralized Direct-Mail Colorectal Cancer Screening Approach at Community Health Centers.

Background: Colorectal cancer screening (CRC) rates are low, particularly among individuals with low socioeconomic status. Organized CRC screening programs have demonstrated success in increasing screening rates. Little is known about provider attitudes, beliefs, and practices related to CRC screening or how they are influenced by an organized CRC screening program. Methods: In 2014 and 2016, providers from 26 safety net clinics in Oregon and Northern California were invited to complete baseline and follow-up online surveys for the Strategies and Opportunities to Stop Colon Cancer in Priority Populations (STOP CRC) study. The provider survey link was sent electronically to primary care providers serving adult patients. Providers were sent reminders every 2 weeks via email to complete the survey, up to 3 reminders total. In this article, we describe learnings about provider attitudes, beliefs, and practices related to CRC screening after implementation of the STOP CRC program. Results: A total of 166 unique providers completed baseline and/or follow-up surveys, representing 228 responses. Main themes included (1) favorable shifts in attitude toward fecal immunochemical test (FIT) and direct-mail cancer screening programs, (2) changes in provider perception of key barriers, and (3) growing interest in centralized automated systems for identifying patients due for CRC screening and eligible for population-based outreach. Discussion: Providers are interested in improved information systems for identifying patients due for CRC screening and delivering population-based outreach (ie, to distribute FIT kits outside of the clinic visit) to help reduce health system- and patient-level barriers to screening. Trial Registration: National Clinical Trial (NCT) Identifier NCT01742065.

The social and economic toll of cancer survivorship: a complex web of financial sacrifice.

PURPOSE: To assess the financial outcomes and associated social and economic effects on cancer survivors and their families. METHODS: We assessed the responses of 1656 cancer survivors to a survey with both closed- and open-ended questions about cancer-related financial sacrifices they and their family experienced and evaluated differences in financial sacrifice by reported levels of cancer-related debt. RESULTS: The most commonly reported financial sacrifices included cutbacks on household budgets, challenges with health care insurance and costs, career/self-advancement constraints, reduction/depletion of assets, and inability to pay bills. Survivors who incurred $10,000 or more in debt were significantly more likely to report social and economic impacts, including housing concerns and strained relationships. CONCLUSIONS: Our analysis demonstrates both the frequency with which cancer survivors and families must make financial sacrifices as a result of their cancer, and the variety of forms that this sacrifice can take, even for individuals who have health insurance. The many types of financial hardship create challenges that are unique to each survivor and family. IMPLICATIONS FOR CANCER SURVIVORS: Interventions that allow for personalized assistance with the specific financial and social needs of cancer survivors and their families have the potential to address a critical aspect of the long-term wellbeing of this important population.

Workflow Requirements for Cost-of-Care Conversations in Outpatient Settings Providing Oncology or Primary Care: A Qualitative, Human-Centered Design Study.

Background: Patients prefer to discuss costs in the clinical setting, but physicians and teams may be unprepared to incorporate cost discussions into existing workflows. Objective: To understand and improve clinical workflows related to cost-of-care conversations. Design: Qualitative human-centered design study. Setting: 2 integrated health systems in the U.S. Pacific Northwest: a system-wide oncology service line and a system-wide primary care service line. Participants: Clinicians, clinical team members, operations staff, and patients. Measurements: Ethnographic observations were made at the integrated health systems, assessing barriers to and facilitators of discussing costs with patients. Three unique patient experiences of having financial concerns addressed in the clinic were designed. These experiences were refined after in-person interviews with patients (n = 20). Data were synthesized into a set of clinical workflow requirements. Results: Most patient cost concerns take 1 of 3 pathways: informing clinical care decision making, planning and budgeting concerns, and addressing immediate financial hardship. Workflow requirements include organizational recognition of the need for clinic-based cost-of-care conversations; access to cost and health plan benefit data to support each conversation pathway; clear team member roles and responsibilities for addressing cost-of-care concerns; a patient experience where cost questions are normal and each patient's preferences and privacy are respected; patients know who to go to with cost questions; patients' concerns are documented to minimize repetition to multiple team members; and patients learn their expected out-of-pocket costs before treatment begins. Limitation: Results may have limited generalizability to other health care settings, and the study did not test the effectiveness of the workflows developed. Conclusion: Clinic-based workflows for cost-of-care conversations that optimize patients' care experience require organizational commitment to addressing cost concerns, clear roles and responsibilities, appropriate and complete data access, and a team-based approach. Primary Funding Source: Robert Wood Johnson Foundation.

Assessment of willingness to pay for expanded carrier screening among women and couples undergoing preconception carrier screening.

BACKGROUND: Expanded carrier screening can provide risk information for numerous conditions. Understanding how individuals undergoing preconception expanded carrier screening value this information is important. The NextGen study evaluated the use of genome sequencing for expanded carrier screening and reporting secondary findings, and we measured participants' willingness to pay for this approach to understand how it is valued by women and couples planning a pregnancy. METHODS: We assessed 277 participants' willingness to pay for genome sequencing reporting carrier results for 728 gene/condition pairs and results for 121 secondary findings. We explored the association between attitudes and demographic factors and willingness to pay for expanded carrier screening using genome sequencing and conducted interviews with 58 of these participants to probe the reasoning behind their preferences. RESULTS: Most participants were willing to pay for expanded carrier screening using genome sequencing. Willingness to pay was associated with income level and religiosity, but not risk status for a condition in the carrier panel. Participants willing to pay nothing or a small amount cited issues around financial resources, whereas those willing to pay higher amounts were motivated by "peace of mind" from carrier results. CONCLUSION: Women and couples planning a pregnancy value genome sequencing. The potentially high out-of-pocket cost of this service could result in healthcare disparities, since maximum amounts that participants were willing to pay were higher than a typical copay and related to income.

Time Costs for Genetic Counseling in Preconception Carrier Screening with Genome Sequencing.

Advances in technology and the promise of personalized health care are driving greater use of genome sequencing (GS) for a variety of clinical scenarios. As health systems consider adopting GS, they need to understand the impact of GS on the organization and cost of care. While research has documented a dramatic decrease in the cost of sequencing and interpreting GS, few studies have examined how GS impacts genetic counseling workloads. This study examined the time needed to provide genetic counseling for GS in the context of preconception carrier screening. Genetic counselors prospectively reported on the time spent in the results disclosure process with 107 study participants who were part of the NextGen study. We found that the median time for results disclosure was 64 min (ranged from 5 to 229 min). Preparation work was the most time-consuming activity. Qualitative data from journal entries, debrief interviews with genetic counselors, and detailed case conference notes provided information on factors influencing time for results disclosure and implications for practice. Results suggest that expanded carrier screening could require significant increases in genetic counseling time, unless we are able to generate new resources to reduce preparation work or develop other strategies such as the creation of new models to deliver this type of service.

Improving adherence to cardiovascular disease medications with information technology.

OBJECTIVES: Evaluate the utility of 2 electronic medical record (EMR)-linked, automated phone reminder interventions for improving adherence to cardiovascular disease medications. STUDY DESIGN: A 1-year, parallel arm, pragmatic clinical trial in which 21,752 adults were randomized to receive either usual care (UC) or 1 of 2 interventions in the form of interactive voice recognition calls-regular (IVR) or enhanced (IVR+). The interventions used automated phone reminders to increase adherence to cardiovascular disease medications. The primary outcome was medication adherence; blood pressure and lipid levels were secondary outcomes. METHODS: The study took place in 3 large health maintenance organizations. We enrolled participants who were 40 years or older, had diabetes mellitus or atherosclerotic cardiovascular disease, and were suboptimally adherent. IVR participants received automated phone calls when they were due or overdue for a refill. IVR+ participants received these phone calls, plus personalized reminder letters, live outreach calls, EMR-based feedback to their primary care providers, and additional mailed materials. RESULTS: Both interventions significantly increased adherence to statins and angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (ACEIs/ARBs) compared with UC (1.6 to 3.7 percentage points). Adherence to ACEIs/ARBs was also significantly higher for IVR+ relative to IVR participants. These differences persisted across subgroups. Among statin users, IVR+ participants had significantly lower low-density lipoprotein (LDL) levels at follow-up compared with UC (Δ = -1.5; 95% CI, -2.7 to -0.2 mg/dL); this effect was seen mainly in those with baseline LDL levels ≥ 100 mg/dL (Δ = -3.6; 95% CI, -5.9 to -1.3 mg/dL). CONCLUSIONS: Technology-based tools, in conjunction with an EMR, can improve adherence to chronic disease medications and measured cardiovascular disease risk factors.

Proton pump inhibitor and histamine 2 receptor antagonist use and vitamin B12 deficiency.

IMPORTANCE: Proton pump inhibitors (PPIs) and histamine 2 receptor antagonists (H2RAs) suppress the production of gastric acid and thus may lead to malabsorption of vitamin B12. However, few data exist regarding the associations between long-term exposure to these medications and vitamin B12 deficiency in large population-based studies. OBJECTIVE: To study the association between use of PPIs and H2RAs and vitamin B12 deficiency in a community-based setting in the United States. DESIGN, SETTING, AND PATIENTS: We evaluated the association between vitamin B12 deficiency and prior use of acid-suppressing medication using a case-control study within the Kaiser Permanente Northern California population. We compared 25,956 patients having incident diagnoses of vitamin B12 deficiency between January 1997 and June 2011 with 184,199 patients without B12 deficiency. Exposures and outcomes were ascertained via electronic pharmacy, laboratory, and diagnostic databases. MAIN OUTCOMES AND MEASURES: Risk of vitamin B12 deficiency was estimated using odds ratios (ORs) from conditional logistic regression. RESULTS: Among patients with incident diagnoses of vitamin B12 deficiency, 3120 (12.0%) were dispensed a 2 or more years' supply of PPIs, 1087 (4.2%) were dispensed a 2 or more years' supply of H2RAs (without any PPI use), and 21,749 (83.8%) had not received prescriptions for either PPIs or H2RAs. Among patients without vitamin B12 deficiency, 13,210 (7.2%) were dispensed a 2 or more years' supply of PPIs, 5897 (3.2%) were dispensed a 2 or more years' supply of H2RAs (without any PPI use), and 165,092 (89.6%) had not received prescriptions for either PPIs or H2RAs. Both a 2 or more years' supply of PPIs (OR, 1.65 [95% CI, 1.58-1.73]) and a 2 or more years' supply of H2RAs (OR, 1.25 [95% CI, 1.17-1.34]) were associated with an increased risk for vitamin B12 deficiency. Doses more than 1.5 PPI pills/d were more strongly associated with vitamin B12 deficiency (OR, 1.95 [95% CI, 1.77-2.15]) than were doses less than 0.75 pills/d (OR, 1.63 [95% CI, 1.48-1.78]; P = .007 for interaction). CONCLUSIONS AND RELEVANCE: Previous and current gastric acid inhibitor use was significantly associated with the presence of vitamin B12 deficiency. These findings should be considered when balancing the risks and benefits of using these medications.

More comprehensive discussion of CRC screening associated with higher screening.

OBJECTIVES: Examine association of comprehensiveness of colorectal cancer (CRC) screening discussion by primary care physicians (PCPs) with completion of CRC screening. STUDY DESIGN: Observational study in Kaiser Permanente Northwest, a group-model health maintenance organization. METHODS: A total of 883 participants overdue for CRC screening received an automated telephone call (ATC) between April and June 2009 encouraging CRC screening. Between January and March 2010, participants completed a survey on PCPs' discussion of CRC screening and patient beliefs regarding screening. PRIMARY OUTCOME MEASURE: receipt of CRC screening (assessed by electronic medical record [EMR], 9 months after ATC). Primary independent variable: comprehensiveness of CRC screening discussion by PCPs (7-item scale). Secondary independent variables: perceived benefits of screening (4-item scale assessing respondents' agreement with benefits of timely screening) and primary care utilization (EMR; 9 months after ATC). The independent association of variables with CRC screening was assessed with logistic regression. RESULTS: Average scores for comprehensiveness of CRC discussion and perceived benefits were 0.4 (range 0-1) and 4.0 (range 1-5), respectively. A total of 28.2% (n = 249) completed screening, 84% of whom had survey assessments after their screening date. Of screeners, 95.2% completed the fecal immunochemical test. More comprehensive discussion of CRC screening was associated with increased screening (odds ratio [OR] = 1.51, 95% confidence interval [CI] = 1.03-2.21). Higher perceived benefits (OR = 1.46, 95% CI = 1.13-1.90) and 1 or more PCP visits (OR = 5.82, 95% CI = 3.87-8.74) were also associated with increased screening. CONCLUSIONS: More comprehensive discussion of CRC screening was independently associated with increased CRC screening. Primary care utilization was even more strongly associated with CRC screening, irrespective of discussion of CRC screening.

Automated telephone calls to enhance colorectal cancer screening: economic analysis.

OBJECTIVES: To estimate the cost-effectiveness of an automated telephone intervention for colorectal cancer screening from a managed care perspective, using data from a pragmatic randomized controlled trial. METHODS: Intervention patients received calls for fecal occult blood testing (FOBT) screening. We searched patients' electronic medical records for any screening (defined as FOBT, flexible sigmoidoscopy, double-contrast barium enema, or colonoscopy) during follow-up. Intervention costs included project implementation and management, telephone calls, patient identification, and tracking. Screening costs included FOBT (kits, mailing, and processing) and any completed screening tests during follow-up. We estimated the incremental cost-effectiveness ratio (ICER) of the cost per additional screen. RESULTS: At 6 months, average costs for intervention and control patients were $37 (25% screened) and $34 (19% screened), respectively. The ICER at 6 months was $42 per additional screen, less than half what other studies have reported. Cost-effectiveness probability was 0.49, 0.84, and 0.99 for willingness-to-pay thresholds of $40, $100, and $200, respectively. Similar results were seen at 9 months. A greater increase in FOBT testing was seen for patients aged >70 years (45/100 intervention, 33/100 control) compared with younger patients (25/100 intervention, 21/100 control). The intervention was dominant for patients aged >70 years and was $73 per additional screen for younger patients. It increased screening rates by about 6% and costs by $3 per patient. CONCLUSIONS: At willingness to pay of $100 or more per additional screening test, an automated telephone reminder intervention can be an optimal use of resources.

Change to FIT increased CRC screening rates: evaluation of a US screening outreach program.

OBJECTIVES: To compare completion rates of colorectal cancer screening tests within a health maintenance organization before and after widespread adoption of the fecal immunochemical test (FIT). STUDY DESIGN: Retrospective cohort study. METHODS: Using electronic medical records of 113,901 patients eligible for colorectal cancer screening, we examined test completion during 2 successive time periods among those who received an automated screening outreach call. The time periods were: 1) the "guaiac fecal occult blood test (gFOBT) era," a 15-month period during which only gFOBT was routinely offered, and 2) a 9-month "FIT era," when only a new FIT was routinely offered. In addition to analyzing completion rates, we analyzed the impact of practice-level variables and patient-level variables on overall screening completion during the 2 different observation periods. RESULTS: The change from gFOBT to FIT in an integrated care delivery system increased the likelihood of screening completion by 7.7% overall, and the likelihood of screening with a fecal test by 8.9%. The greatest gains in screening completion using FIT were among women and elderly patients. Completion of FIT was not as strongly associated with medical office visits or with having a primary care provider as was screening with gFOBT. CONCLUSIONS: Adoption of FIT within an integrated care system increased completion of colon cancer screening tests within a 9-month assessment period, compared with a previous 15-month gFOBT era. Higher completion rates of the FIT may allow for more effective dissemination of programs to increase colorectal cancer screening through centralized outreach programs.