Pragmatic Trial of Hospitalization Rate in Chronic Kidney Disease.

BACKGROUND: Despite the availability of effective therapies for patients with chronic kidney disease, type 2 diabetes, and hypertension (the kidney-dysfunction triad), the results of large-scale trials examining the implementation of guideline-directed therapy to reduce the risk of death and complications in this population are lacking. METHODS: In this open-label, cluster-randomized trial, we assigned 11,182 patients with the kidney-dysfunction triad who were being treated at 141 primary care clinics either to receive an intervention that used a personalized algorithm (based on the patient's electronic health record [EHR]) to identify patients and practice facilitators to assist providers in delivering guideline-based interventions or to receive usual care. The primary outcome was hospitalization for any cause at 1 year. Secondary outcomes included emergency department visits, readmissions, cardiovascular events, dialysis, and death. RESULTS: We assigned 71 practices (enrolling 5690 patients) to the intervention group and 70 practices (enrolling 5492 patients) to the usual-care group. The hospitalization rate at 1 year was 20.7% (95% confidence interval [CI], 19.7 to 21.8) in the intervention group and 21.1% (95% CI, 20.1 to 22.2) in the usual-care group (between-group difference, 0.4 percentage points; P = 0.58). The risks of emergency department visits, readmissions, cardiovascular events, dialysis, or death from any cause were similar in the two groups. The risk of adverse events was also similar in the trial groups, except for acute kidney injury, which was observed in more patients in the intervention group (12.7% vs. 11.3%). CONCLUSIONS: In this pragmatic trial involving patients with the triad of chronic kidney disease, type 2 diabetes, and hypertension, the use of an EHR-based algorithm and practice facilitators embedded in primary care clinics did not translate into reduced hospitalization at 1 year. (Funded by the National Institutes of Health and others; ICD-Pieces ClinicalTrials.gov number, NCT02587936.).

Effect of Patient Navigation on Completion of Lung Cancer Screening in Vulnerable Populations.

BACKGROUND: Although low-dose, CT-based lung cancer screening (LCS) can decrease lung cancer mortality in high-risk individuals, the process may be complex and pose challenges to patients, particularly those from minority underinsured and uninsured populations. We conducted a randomized controlled trial of telephone-based navigation for LCS within an integrated, urban, safety-net health care system. PATIENTS AND METHODS: Patients eligible for LCS were randomized (1:1) to usual care with or without navigation at Parkland Health in Dallas, Texas. The primary endpoint was completion of the first 3 consecutive steps in a patient's LCS process. We explored differences in completion of LCS steps between navigation and usual care groups, controlling for patient characteristics using the chi-square test. RESULTS: Patients (N=447) were randomized to either navigation (n=225) or usual care (n=222). Mean patient age was 62 years, 46% were female, and 69% were racial/ethnic minorities. There was no difference in completion of the first 3 steps of the LCS algorithm between arms (12% vs 9%, respectively; P=.30). For ordered LCS steps, completion rates were higher among patients who received navigation (86% vs 79%; P=.03). The primary reason for step noncompletion was lack of order placement. CONCLUSIONS: In this study, lack of order placement was a key reason for incomplete LCS steps. When orders were placed, patients who received navigation had higher rates of completion. Clinical team education and enhanced electronic health record processes to simplify order placement, coupled with patient navigation, may improve LCS in safety-net health care systems.

Unsatisfactory Fecal Immunochemical Tests for Colorectal Cancer Screening: Prevalence, Reasons, and Subsequent Testing.

BACKGROUND: Fecal immunochemical test (FIT) is an effective colorectal cancer screening modality. Little is known about prevalence, reasons, and testing after unsatisfactory FIT, or a FIT that cannot be processed by the laboratory due to inadequate stool specimen or incomplete labeling. METHODS: Our retrospective cohort study examined unsatisfactory FIT among average-risk individuals aged 50-74 years in a large, integrated, safety-net health system who completed an index FIT from 2010 to 2019. We determined prevalence of unsatisfactory FIT and categorized reasons hierarchically. We used multivariable logistic regression models to identify factors associated with: (i) unsatisfactory FIT; and (ii) subsequent testing within 15 months of the unsatisfactory FIT. RESULTS: Of 56,980 individuals completing an index FIT, 10.2% had an unsatisfactory FIT. Reasons included inadequate specimen (51%), incomplete labeling (27%), old specimen (13%), and broken/leaking container (8%). Unsatisfactory FIT was associated with being male [OR, 1.10; confidence interval (CI), 1.03-1.16], Black (OR, 1.46; CI, 1.33-1.61), Spanish speaking (OR, 1.12; CI, 1.01-1.24), on Medicaid (OR, 1.42; CI, 1.28-1.58), and received FIT by mail (OR, 2.66; CI, 2.35-3.01). Among those with an unsatisfactory FIT, fewer than half (41%) completed a subsequent test within 15 months (median, 4.4 months). Adults aged 50-54 years (OR, 1.16; CI, 1.01-1.39) and those who received FIT by mail (OR, 1.92; CI, 1.49-2.09) were more likely to complete a subsequent test. CONCLUSIONS: One in ten returned a FIT that could not be processed, mostly due to patient-related reasons. Fewer than half completed a subsequent test after unsatisfactory FIT. IMPACT: Screening programs should address these breakdowns such as specimen collection and labeling to improve real-world effectiveness. See related In the Spotlight, p. 183.

Factors influencing implementation of a care coordination intervention for cancer survivors with multiple comorbidities in a safety-net system: an application of the Implementation Research Logic Model.

BACKGROUND: Under- and uninsured cancer survivors have significant medical, social, and economic complexity. For these survivors, effective care coordination between oncology and primary care teams is critical for high-quality, comprehensive care. While evidence-based interventions exist to improve coordination between healthcare teams, testing implementation of these interventions for cancer survivors seen in real-world safety-net settings has been limited. This study aimed to (1) identify factors influencing implementation of a multicomponent care coordination intervention (nurse coordinator plus patient registry) focused on cancer survivors with multiple comorbidities in an integrated safety-net system and (2) identify mechanisms through which the factors impacted implementation outcomes. METHODS: We conducted semi-structured interviews (patients, providers, and system leaders), structured observations of primary care and oncology operations, and document analysis during intervention implementation between 2016 and 2020. The practice change model (PCM) guided data collection to identify barriers and facilitators of implementation; the PCM, Consolidated Framework for Implementation Research, and Implementation Research Logic Model guided four immersion/crystallization data analysis and synthesis cycles to identify mechanisms and assess outcomes. Implementation outcomes included appropriateness, acceptability, adoption, and penetration. RESULTS: The intervention was appropriate and acceptable to primary care and oncology teams based on reported patient needs and resources and the strength of the evidence supporting intervention components. Active and sustained partnership with system leaders facilitated these outcomes. There was limited adoption and penetration early in implementation because the study was narrowly focused on just breast and colorectal cancer patients. This created barriers to real-world practice where patients with all cancer types receive care. Over time, flexibility intentionally designed into intervention implementation facilitated adoption and penetration. Regular feedback from system partners and rapid cycles of implementation and evaluation led to real-time adaptations increasing adoption and penetration. DISCUSSION: Evidence-based interventions to coordinate care for underserved cancer survivors across oncology and primary care teams can be implemented successfully when system leaders are actively engaged and with flexibility in implementation embedded intentionally to continuously facilitate adoption and penetration across the health system.

Improving Colorectal Cancer Screening in a Regional Safety-Net Health System over a 10-Year Period: Lessons for Population Health.

BACKGROUND: Despite national policy efforts to increase colorectal cancer (CRC) screening, rates in vulnerable populations remain suboptimal. Many types of interventions have been employed, but their impact on improving population-level rates of CRC screening over time is uncertain. OBJECTIVE: Assess the impact of 10 years of different in-reach and outreach strategies to improve CRC screening and identify factors associated with being screen up-to-date (SUTD). DESIGN: Observational cohort study. PARTICIPANTS: Patients aged 50-74 years from 12 community-based primary care clinics in an integrated, regional safety-net health system. INTERVENTIONS: Multiple system-level interventions were implemented over time (visit-based electronic health record [EHR] reminders, quality measurement, annual preventive service letters, and mailed fecal immunohistochemical stool tests [FIT]). MAIN MEASURES: CRC SUTD rates by calendar year among those with a primary care (PC) visit in the prior 1 and 3 years and their multivariable correlates. KEY RESULTS: The sample included 31,786-40,405 patients/year. In 2011, mean age was 58.9, 63.9% were women, 37.0% were Hispanic, 39.3% Black, 16.8% White, and 6.6% Asian/Other, and 60.5% were uninsured/Medicaid. Three-quarters of patients had ≥ 1 PC visit in the prior year. Lower-intensity interventions (EHR reminders, quality measurement, annual prevention letters) had limited impact on SUTD rates (2-3% rise). Implementing system-wide mailed FIT increased rates from 51.2 to 61.9% among those with a PC visit in the past year (40.5 to 46.8% with a PC visit ≤ 3 years). Stopping mailed FIT due to COVID wiped out these gains. Higher screening rates were associated with the following: older age; female; more comorbidities, PC clinic visits, and prior FITs; and better insurance coverage. Hispanics had the highest SUTD rates followed by Asians, Blacks, and Whites (p < 0.05). CONCLUSIONS: Implementation of a system-wide mailed FIT program had the greatest impact on SUTD rates. Lower-intensity interventions (EHR reminders, quality measurement, and patient letters) had limited effects.

Assessing Barriers and Facilitators to Lung Cancer Screening: Initial Findings from a Patient Navigation Intervention.

Low-dose computed tomography-based lung cancer screening represents a complex clinical undertaking that could require multiple referrals, appointments, and time-intensive procedures. These steps may pose difficulties and raise concerns among patients, particularly minority, under-, and uninsured populations. The authors implemented patient navigation to identify and address these challenges. They conducted a pragmatic randomized controlled trial of telephone-based navigation for lung cancer screening in an integrated, urban safety-net health care system. Following standardized protocols, bilingual (Spanish and English) navigators educated, motivated, and empowered patients to traverse the health system. Navigators made systematic contact with patients, recording standardized call characteristics in a study-specific database. Call type, duration, and content were recorded. Univariable and multivariable multinomial logistic regression was performed to investigate associations between call characteristics and reported barriers. Among 225 patients (mean age 63 years, 46% female, 70% racial/ethnic minority) assigned navigation, a total of 559 barriers to screening were identified during 806 telephone calls. The most common barrier categories were personal (46%), provider (30%), and practical (17%). System (6%) and psychosocial (1%) barriers were described by English-speaking patients, but not by Spanish-speaking patients. Over the course of the lung cancer screening process, provider-related barriers decreased 80% (P = 0.008). The authors conclude that patients undergoing lung cancer screening frequently report personal and health care provider-related barriers to successful participation. Barrier types may differ among patient populations and over the course of the screening process. Further understanding of these concerns may increase screening uptake and adherence. Clinical Trial Registration number: (NCT02758054).

Prevalence And Impact of Medical Comorbidities in A Real-World Lung Cancer Screening Population.

BACKGROUND: Lung cancer screening trials generally enroll motivated, relatively healthy, and adherent populations. We therefore evaluated the prevalence and effects of comorbidities in a real-world population undergoing low-dose computed tomography (LDCT) scans. PATIENTS AND METHODS: We calculated the Charlson Comorbidity Index (CCI) of patients for whom an initial low-dose computed tomography (LDCT) for lung cancer screening was ordered between February 2017 and February 2019 in an integrated safety-net healthcare system. We examined the association between CCI and initial LDCT completion using multivariable logistic regression, assessed the association between specific medical comorbidity and LDCT completion using Chi-square test or Fisher's exact test as appropriate, and examined the association between CCI and LDCT Lung-RADS results using Fisher's exact test. RESULTS: A total of 1358 patients were included in the analysis. Mean age was 63 years, 57% were women, and 50% were Black. Patients had moderate comorbidity burden (median CCI 3) with chronic pulmonary disease the most common comorbidity. Overall, 943 LDCT (70%) were completed. There was no difference in 30-day, 90-day, or 1-year completion rates of initial LDCT according to CCI. However, 30-day LDCT completion rates did increase over time (P < .001). Lung-RADS scores were not associated with CCI. CONCLUSION: In a real-world setting, patients undergoing lung cancer screening have moderate comorbidity burden. The degree and type of medical comorbidity are not associated with initial screening completion or results. Timeliness of LDCT completion may improve as program experience increases.

Cost Effectiveness of Mailed Outreach Programs for Colorectal Cancer Screening: Analysis of a Pragmatic, Randomized Trial.

BACKGROUND & AIMS: Clinical guidelines for colorectal cancer (CRC) screening suggest use of either stool-based tests or colonoscopy - modalities that differ in recommended screening intervals, adherence, and costs. We know little about the long-term cost differences in population-health outreach strategies to promote these strategies. METHODS: We conducted a cost-effectiveness analysis to compare 2 mailed outreach strategies to increase CRC screening from a pragmatic, randomized clinical trial: mailed fecal immunochemical test (FIT) kits vs invitations to complete a screening colonoscopy. We built a 10-year Markov chain Monte Carlo microsimulation model to account for differences in screening intervals, adherence, and costs. RESULTS: Mailed FIT kits had a lower 10-year average per-person cost of screening relative to colonoscopy invitations ($1139 vs $1725) but with 10.89 fewer months of compliance and 60 fewer advanced neoplasia detected (37 advanced adenomas and 23 CRC). Incremental cost effectiveness ratios for colonoscopy invitations compared with mailed FIT kits were $55.23, $15.84, and $25.48 per additional covered month, advanced adenoma, and CRC, respectively. Although FIT was the preferred strategy at low willingness-to-pay thresholds, the 2 strategies were equal at a willingness-to-pay threshold of $41.31 per covered month gained. CONCLUSION: Mailed FIT or colonoscopy invitations are both options to improve CRC screening completion and advanced neoplasia detection, and the choice of outreach strategy may differ by a health system's willingness-to-pay threshold. Mailed FIT kits are less expensive than colonoscopy invitations but result in fewer months of screening compliance and advanced neoplasia detected.

Thematic Analysis of Challenges of Care Coordination for Underinsured and Uninsured Cancer Survivors With Chronic Conditions.

Importance: Although a majority of underinsured and uninsured patients with cancer have multiple comorbidities, many lack consistent connections with a primary care team to manage chronic conditions during and after cancer treatment. This presents a major challenge to delivering high-quality comprehensive and coordinated care. Objective: To describe challenges and opportunities for coordinating care in an integrated safety-net system for patients with both cancer and other chronic conditions. Design, Setting, and Participants: This multimodal qualitative study was conducted from May 2016 to July 2019 at a county-funded, vertically integrated safety-net health system including ambulatory oncology, urgent care, primary care, and specialty care. Participants were 93 health system stakeholders (clinicians, leaders, clinical, and administrative staff) strategically and snowball sampled for semistructured interviews and observation during meetings and daily processes of care. Data collection and analysis were conducted iteratively using a grounded theory approach, followed by systematic thematic analysis to organize data, review, and interpret comprehensive findings. Data were analyzed from March 2019 to March 2020. Main Outcomes and Measures: Multilevel factors associated with experiences of coordinating care for patients with cancer and chronic conditions among oncology and primary care stakeholders. Results: Among interviews and observation of 93 health system stakeholders, system-level factors identified as being associated with care coordination included challenges to accessing primary care, lack of communication between oncology and primary care clinicians, and leadership awareness of care coordination challenges. Clinician-level factors included unclear role delineation and lack of clinician knowledge and preparedness to manage the effects of cancer and chronic conditions. Conclusions and Relevance: Primary care may play a critical role in delivering coordinated care for patients with cancer and chronic diseases. This study's findings suggest a need for care delivery strategies that bridge oncology and primary care by enhancing communication, better delineating roles and responsibilities across care teams, and improving clinician knowledge and preparedness to care for patients with cancer and chronic conditions. Expanding timely access to primary care is also key, albeit challenging in resource-limited safety-net settings.

Clinician Variation in Ordering and Completion of Low-Dose Computed Tomography for Lung Cancer Screening in a Safety-Net Medical System.

BACKGROUND: Less than 5% of eligible individuals in the United States undergo lung cancer screening. Variation in clinicians' participation in lung cancer screening has not been determined. PATIENTS AND METHODS: We studied medical providers who ordered ≥ 1 low-dose computed tomography (LDCT) for lung cancer screening from February 2017 through February 2019 in an integrated safety-net healthcare system. We analyzed associations between provider characteristics and LDCT orders and completion using chi-square, Fisher exact, and Student t tests, as well as ANOVA and multinomial logistic regression. RESULTS: Among an estimated 194 adult primary care physicians, 144 (74%) ordered at least 1 LDCT, as did 39 specialists. These 183 medical providers ordered 1594 LDCT (median, 4; interquartile range, 2-9). In univariate and multivariate models, family practice providers (P < .001) and providers aged ≥ 50 years (P = .03) ordered more LDCT than did other clinicians. Across providers, the median proportion of ordered LDCT that were completed was 67%. The total or preceding number of LDCT ordered by a clinician was not associated with the likelihood of LDCT completion. CONCLUSION: In an integrated safety-net healthcare system, most adult primary care providers order LDCT. The number of LDCT ordered varies widely among clinicians, and a substantial proportion of ordered LDCT are not completed.

Tracking the Nonenrolled: Lung Cancer Screening Patterns Among Individuals not Accrued to a Clinical Trial.

INTRODUCTION: For lung cancer screening, the available data are often derived from patients enrolled prospectively in clinical trials. We, therefore, investigated lung cancer screening patterns among individuals eligible for, but not enrolled in, a screening trial. PATIENTS AND METHODS: From February 2017 through February 2019, we enrolled subjects in a trial examining telephone-based navigation during low-dose computed tomography (LDCT) for lung cancer screening. We identified patients for whom LDCT was ordered and who were approached, but not enrolled, in the trial. We categorized nonenrollment as the patient had declined or could not be reached. We compared the characteristics and LDCT completion rates among these groups and the enrolled population using the 2-sample t test and χ2 test. RESULTS: Of 900 individuals approached for participation (mean age, 62 years; 45% women, 53% black), 447 were enrolled in the screening clinical trial. No significant demographic differences were found between the enrolled and nonenrolled cohorts. Of the 453 individuals not enrolled, 251 (55%) had declined participation and 202 (45%) could not be reached, despite up to 6 attempts. LDCT completion was significantly associated with enrollment status: 81% of enrolled individuals, 73% of individuals who declined participation, and 49% of those who could not be reached (P < .001). CONCLUSIONS: In the present single-center study, demographic factors did not predict for participation in a lung cancer screening trial. Lung cancer screening adherence rates were substantially lower for those not enrolled in a screening trial, especially for those who could not be contacted. These findings may inform the broader implementation of screening programs.

Outcomes associated with use of the Cancer Risk Intake System among primary care safety-net patients identified as needing colorectal cancer screening.

Despite demonstrated primary and secondary prevention benefits, screening for colorectal cancer (CRC) is sub-optimal. We implemented the Cancer Risk Intake System (CRIS) among a convenience sample of patients presenting for primary care in Dallas County safety-net clinics. CRIS, which assesses individuals' CRC risks and generates guideline-based screening recommendations for them and their providers, had been found in a randomized trial to facilitate risk-based screening, compared to usual care. Here, of 924 patients ages ≥50 who used CRIS, 699 were identified as needing screening, with 39.2% needing colonoscopy rather than FIT. However, following use of CRIS and patients' and providers' receipt of guideline-concordant recommendations, 20.9% elevated-risk patients received no screening orders, only 44.1% received guideline-concordant colonoscopy orders, and less than half of these (48.4%) completed colonoscopy. Guideline-concordant screening orders were more common for average-risk patients (62.5% received orders for FIT and 26.6% for colonoscopy). However, like their elevated-risk counterparts who received screening orders, more than half of average-risk patients in each order group (52.3% for FIT and 52.8% for colonoscopy) did not complete screening. We found no correlates for receiving screening orders, but higher comorbidity scores were associated with less screening completion among the average-risk group. We had hoped CRIS would facilitate risk-based screening but, although orders for and receipt of colonoscopy were more common for elevated- than average-risk patients, they were still suboptimal in this clinical setting with a "FIT-first" strategy. A stronger intervention may be necessary to increase guideline-concordant recommendations and screening among patients 50 and older.

Evaluation of a Multifaceted Intervention to Reduce Health Disparities in Hepatitis C Screening: A Pre-Post Analysis.

Hepatitis C virus (HCV) testing in persons born from 1945 to 1965 has had limited adoption despite guidelines, particularly among racial/ethnic minorities and socioeconomically disadvantaged patients, who have a higher prevalence of disease burden. We examined the effectiveness of a multifaceted intervention to improve HCV screening in a large safety-net health system. We performed a multifaceted intervention that included provider and patient education, an electronic medical record-enabled best practice alert, and increased HCV treatment capacity. We characterized HCV screening completion before and after the intervention. To identify correlates of HCV screening, we performed logistic regression for the preintervention and postintervention groups and used a generalized linear mixed model for patients observed in both preintervention and postintervention time frames. Before the intervention, 10.1% of 48,755 eligible baby boomer patients were screened. After the intervention, 34.6% of the 34,093 eligible baby boomers were screened (P < 0.0001). Prior to the intervention, HCV screening was lower among older baby boomers and providers with large patient panels and higher in high-risk subgroups including those with signs of liver disease (e.g., elevated transaminases, thrombocytopenia), human immunodeficiency virus-positive patients, and homeless patients. Postintervention, we observed increased screening uptake in older baby boomers, providers with larger patient panel size, and patients with more than one prior primary care appointment. Conclusion: Our multifaceted intervention significantly increased HCV screening, particularly among older patients, those engaged in primary care, and providers with large patient panels.

Screening initiation with FIT or colonoscopy: Post-hoc analysis of a pragmatic, randomized trial.

Screening with FIT or colonoscopy can reduce CRC mortality. In our pragmatic, randomized trial of screening outreach over three years, patients annually received mailed FITs or colonoscopy invitations. We examined screening initiation after each mailing and crossover from the invited to other modality. Eligible patients (50-64 years, ≥1 primary-care visit before randomization, and no history of CRC) received mailed FIT kits (n = 2400) or colonoscopy invitations (n = 2400) from March 2013 through July 2016. Among those invited for colonoscopy, we used multinomial logistic regression to identify factors associated with screening initiation with colonoscopy vs. FIT vs. no screening after the first mailing. Most patients were female (61.8%) and Hispanic (48.9%) or non-Hispanic black (24.0%). Among those invited for FIT, 56.6% (n = 1359) initiated with FIT, whereas 3.3% (n = 78) crossed over to colonoscopy; 151 (15.7%) and 61 (7.7%) initiated with FIT after second and third mailings. Among those invited for colonoscopy, 25.5% (n = 613) initiated with colonoscopy whereas 18.8% (n = 452) crossed over to FIT; 112 (8.4%) and 48 (4.2%) initiated with colonoscopy after second and third mailings. Three or more primary-care visits prior to randomization were associated with initiating with colonoscopy (OR 1.49, 95% CI 1.17-1.91) and crossing over to FIT (OR 1.63, 95% CI 1.19-2.23). Although nearly half of patients initiated screening after the first mailing, few non-responders in either outreach group initiated after a second or third mailing. More patients invited to colonoscopy crossed over to FIT than those assigned to FIT crossed over to colonoscopy.

Mailed Outreach Invitations Significantly Improve HCC Surveillance Rates in Patients With Cirrhosis: A Randomized Clinical Trial.

Hepatocellular carcinoma (HCC) surveillance is associated with early tumor detection and improved survival in patients with cirrhosis; however, effectiveness is limited by underuse. We compared the effectiveness of mailed outreach and patient navigation strategies to increase HCC surveillance in a racially diverse cohort of patients with cirrhosis. We conducted a pragmatic randomized clinical trial comparing mailed outreach for screening ultrasound (n = 600), mailed outreach plus patient navigation (n = 600), or usual care with visit-based screening (n = 600) among 1800 patients with cirrhosis at a large safety-net health system from December 2014 to March 2017. Patients who did not respond to outreach invitations within 2 weeks received reminder telephone calls. Patient navigation included an assessment of barriers to surveillance and encouragement of surveillance participation. The primary outcome was HCC surveillance (abdominal imaging every 6 months) over an 18-month period. All 1800 patients were included in intention-to-screen analyses. HCC surveillance was performed in 23.3% of outreach/navigation patients, 17.8% of outreach-alone patients, and 7.3% of usual care patients. HCC surveillance was 16.0% (95% confidence interval [CI]: 12.0%-20.0%) and 10.5% (95% CI: 6.8%-14.2%) higher in outreach groups than usual care (P < 0.001 for both) and 5.5% (95% CI: 0.9%-10.1%) higher for outreach/navigation than outreach alone (P = 0.02). Both interventions increased HCC surveillance across predefined patient subgroups. The proportion of HCC patients detected at an early stage did not differ between groups; however, a higher proportion of patients with screen-detected HCC across groups had early-stage tumors than those with HCC detected incidentally or symptomatically (83.3% versus 30.8%, P = 0.003). Conclusion: Mailed outreach invitations and navigation significantly increased HCC surveillance versus usual care in patients with cirrhosis.

Care coordination for complex cancer survivors in an integrated safety-net system: a study protocol.

BACKGROUND: The growing numbers of cancer survivors challenge delivery of high-quality survivorship care by healthcare systems. Innovative ways to improve care coordination for patients with cancer and multiple chronic conditions ("complex cancer survivors") are needed to achieve better care outcomes, improve patient experience of care, and lower cost. Our study, Project CONNECT, will adapt and implement three evidence-based care coordination strategies, shown to be effective for primary care conditions, among complex cancer survivors. Specifically, the purpose of this study is to: 1) Implement a system-level EHR-driven intervention for 500 complex cancer survivors at Parkland; 2) Test effectiveness of the strategies on system- and patient-level outcomes measured before and after implementation; and 3) Elucidate system and patient factors that facilitate or hinder implementation and result in differences in experiences of care coordination between complex patients with and without cancer. METHODS: Project CONNECT is a quasi-experimental implementation study among 500 breast and colorectal cancer survivors with at least one of the following chronic conditions: diabetes, hypertension, chronic lung disease, chronic kidney disease, or heart disease. We will implement three evidence-based care coordination strategies in a large, county integrated safety-net health system: 1) an EHR-driven registry to facilitate patient transitions between primary and oncology care; 2) co-locating a nurse practitioner trained in care coordination within a complex care team; 3) and enhancing teamwork through coaching. Segmented regression analysis will evaluate change in system-level (i.e. composite care quality score) and patient-level outcomes (i.e. self-reported care coordination). To evaluate implementation, we will merge quantitative findings with structured observations and physician and patient interviews. DISCUSSION: This study will result in an evaluation toolkit identifying key model elements, barriers, and facilitators that can be used to guide care coordination interventions in other safety-net settings. Because Parkland is a vanguard of safety-net healthcare nationally, findings will be widely applicable as other safety-nets move toward increased integration, enhanced EHR capability, and experience with growing patient diversity. Our proposal recognizes the complexity of interventions and scaffolds evidence-based strategies together to meet the needs of complex patients, systems of care, and service integration. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02943265 . Registered 24 October 2016.

Surveillance for colorectal cancer survivors in an integrated safety-net health system in the United States.

INTRODUCTION: Guideline-recommended surveillance reduces likelihood of colorectal cancer (CRC) recurrence, yet surveillance rates are low in the United States (US). Little is known about CRC surveillance rates among patients without health insurance and their primary care clinicians/oncologists' attitudes towards surveillance care. METHODS: A retrospective study of 205 patients diagnosed with Stage I-III CRC from 2008-2010 was conducted in an integrated system with a network of providers delivering care to patients lacking health insurance coverage. Surveillance patterns were characterized from medical records and logistic regression models examined correlates of guideline-concordant surveillance. 41 Parkland primary care physicians (PCPs) and 24 oncologists completed surveys to assess their attitudes and practices regarding CRC surveillance. RESULTS: 38% of CRC patients received guideline-concordant surveillance; those with early stage cancers were less likely to receive surveillance (OR=0.35; 95 CI: 0.14, 0.87). PCPs and oncologists differed markedly on who is responsible for cancer surveillance care. 77% of oncologists responded that PCPs evaluated patients for cancer recurrence while 76% of PCPs responded that these services were either ordered by oncologists or shared with PCPs. 67% of oncologists said they rarely provide a treatment and surveillance care plan to survivors and over half said that they infrequently communicate with patients' other physicians about who will follow patients for their cancer and other medical issues. DISCUSSION: Care coordination between PCP and oncologist is needed to improve CRC surveillance. New models of shared care clearly delineating roles for oncologists and PCPs are needed to improve CRC survivorship care.

Identifying quality improvement targets to facilitate colorectal cancer screening completion.

The colorectal cancer (CRC) screening process involves multiple interfaces (communication exchanges and transfers of responsibility for specific actions) among primary care and gastroenterology providers, laboratory, and administrative staff. After a retrospective electronic health record (EHR) analysis discovered substantial clinic variation and low CRC screening prevalence overall in an urban, integrated safety-net system, we launched a qualitative analysis to identify potential quality improvement targets to enhance fecal immunochemical test (FIT) completion, the system's preferred screening modality. Here, we report examination of organization-, clinic-, and provider-level interfaces over a three-year period (December 2011-October 2014). We deployed in parallel 3 qualitative data collection methods: (1) structured observation (90+ hours, 10 sites); (2) document analysis (n > 100); and (3) semi-structured interviews (n = 41) and conducted iterative thematic analysis in which findings from each method cross-informed subsequent data collection. Thematic analysis was guided by a conceptual model and applied deductive and inductive codes. There was substantial variation in protocols for distributing and returning FIT kits both within and across clinics. Providers, clinic and laboratory staff had differing access to important data about FIT results based on clinical information system used and this affected results reporting. Communication and coordination during electronic referrals for diagnostic colonoscopy was suboptimal particularly for co-morbid patients needing anesthesia clearance. Our multi-level approach elucidated organizational deficiencies not evident by quantitative analysis alone. Findings indicate potential quality improvement intervention targets including: (1) best-practices implementation across clinics; (2) detailed communication to providers about FIT results; and (3) creation of EHR alerts to resolve pending colonoscopy referrals before they expire.

Effect of Colonoscopy Outreach vs Fecal Immunochemical Test Outreach on Colorectal Cancer Screening Completion: A Randomized Clinical Trial.

Importance: Mailed fecal immunochemical test (FIT) outreach is more effective than colonoscopy outreach for increasing 1-time colorectal cancer (CRC) screening, but long-term effectiveness may need repeat testing and timely follow-up for abnormal results. Objective: Compare the effectiveness of FIT outreach and colonoscopy outreach to increase completion of the CRC screening process (screening initiation and follow-up) within 3 years. Design, Setting, and Participants: Pragmatic randomized clinical trial from March 2013 to July 2016 among 5999 participants aged 50 to 64 years who were receiving primary care in Parkland Health and Hospital System and were not up to date with CRC screenings. Interventions: Random assignment to mailed FIT outreach (n = 2400), mailed colonoscopy outreach (n = 2400), or usual care with clinic-based screening (n = 1199). Outreach included processes to promote repeat annual testing for individuals in the FIT outreach group with normal results and completion of diagnostic and screening colonoscopy for those with an abnormal FIT result or assigned to colonoscopy outreach. Main Outcomes and Measures: Primary outcome was screening process completion, defined as adherence to colonoscopy completion, annual testing for a normal FIT result, diagnostic colonoscopy for an abnormal FIT result, or treatment evaluation if CRC was detected. Secondary outcomes included detection of any adenoma or advanced neoplasia (including CRC) and screening-related harms (including bleeding or perforation). Results: All 5999 participants (median age, 56 years; women, 61.9%) were included in the intention-to-screen analyses. Screening process completion was 38.4% in the colonoscopy outreach group, 28.0% in the FIT outreach group, and 10.7% in the usual care group. Compared with the usual care group, between-group differences for completion were higher for both outreach groups (27.7% [95% CI, 25.1% to 30.4%] for the colonoscopy outreach group; 17.3% [95% CI, 14.8% to 19.8%] for FIT outreach group), and highest in the colonoscopy outreach group (10.4% [95% CI, 7.8% to 13.1%] for the colonoscopy outreach group vs FIT outreach group; P < .001 for all comparisons). Compared with usual care, the between-group differences in adenoma and advanced neoplasia detection rates were higher for both outreach groups (colonoscopy outreach group: 10.3% [95% CI, 9.5% to 12.1%] for adenoma and 3.1% [95% CI, 2.0% to 4.1%] for advanced neoplasia, P < .001 for both comparisons; FIT outreach group: 1.3% [95% CI, -0.1% to 2.8%] for adenoma and 0.7% [95% CI, -0.2% to 1.6%] for advanced neoplasia, P < .08 and P < .13, respectively), and highest in the colonoscopy outreach group (colonoscopy outreach group vs FIT outreach group: 9.0% [95% CI, 7.3% to 10.7%] for adenoma and 2.4% [95% CI, 1.3% to 3.3%] for advanced neoplasia, P < .001 for both comparisons). There were no screening-related harms in any groups. Conclusions and Relevance: Among persons aged 50 to 64 years receiving primary care at a safety-net institution, mailed outreach invitations offering FIT or colonoscopy compared with usual care increased the proportion completing CRC screening process within 3 years. The rate of screening process completion was higher with colonoscopy than FIT outreach. Trial Registration: clinicaltrials.gov Identifier: NCT01710215.