Noel O. Santini

Outreach invitations for FIT and colonoscopy improve colorectal cancer screening rates: A randomized controlled trial in a safety-net health system.

The effectiveness of colorectal cancer (CRC) screening is limited by underuse, particularly among underserved populations. Among a racially diverse and socioeconomically disadvantaged cohort of patients, the authors compared the effectiveness of fecal immunochemical test (FIT) outreach and colonoscopy outreach to increase screening participation rates, compared with usual visit‐based care.

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

Patient navigation for lung cancer screening in an urban safety-net system: Protocol for a pragmatic randomized clinical trial

The National Lung Screening Trial demonstrated improved lung cancer mortality with annual low-dose computed tomography (CT) screening, leading to lung cancer screening endorsement by the United States Preventive Services Task Force and coverage by the Centers for Medicare and Medicaid. Adherence to annual CT screens in that trial was 95%, which may not be representative of real-world, particularly medically underserved populations. This pragmatic trial will determine the effect of patient-focused, telephone-based patient navigation on adherence to CT-based lung cancer screening in an urban safety-net population. 340 adults who meet standard eligibility for lung cancer screening (age 55-77years, smoking history≥30 pack-years, quit within 15years if former smoker) are referred through an electronic medical record-based order by physicians in community- and hospital-based primary care settings within the Parkland Health and Hospital System in Dallas County, Texas. Eligible patients are randomized to usual care or patient navigation, which addresses adherence, patient-reported barriers, smoking cessation, and psycho-social concerns related to screening completion. Patients complete surveys and semi-structured interviews at baseline, 6-month, and 18-month follow-ups to assess attitudes toward screening. The primary endpoint of this pragmatic trial is adherence to three sequential, prospectively defined steps in the screening protocol. Secondary endpoints include self-reported tobacco use and other patient-reported outcomes. Results will provide real-world insight into the impact of patient navigation on adherence to CT-based lung cancer screening in a medically underserved population. This study was registered with the NIH ClinicalTrials.gov database (NCT02758054) on April 26, 2016.

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 systems 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.

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

Introduction Guideline-recommended surveillance reduces the likelihood of colorectal cancer recurrence, yet surveillance rates are low in the United States. Little is known about colorectal cancer surveillance rates among patients without health insurance and their primary care clinicians/oncologists’ attitudes toward surveillance care. Methods A retrospective study of 205 patients diagnosed with Stage I–III colorectal cancer from 2008 to 2010 was conducted in an integrated system with a network of clinics and health care 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. Forty-four Parkland primary care physicians (PCPs) and 24 oncologists completed surveys to assess their attitudes and practices regarding colorectal cancer surveillance. Results Thirty-eight percent of colorectal cancer patients received guideline-concordant surveillance; those with early stage cancers were less likely to receive surveillance (odds ratio = 0.35; 95 confidence interval: 0.14, 0.87). PCPs and oncologists differed markedly on who is responsible for cancer surveillance care. Seventy-seven percent 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. Sixty-seven percent of oncologists said that 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 colorectal cancer surveillance. New models of shared care clearly delineating roles for oncologists and PCPs are needed to improve colorectal cancer survivorship care.

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.

Recommendation of colorectal cancer testing among primary care patients younger than 50 with elevated risk

In the era of precision medicine, efforts are needed to identify and tailor screening recommendations among elevated-risk patients. Individuals younger than 50years are an important target population, as they comprise 15% of colorectal (CRC) cases and often present with more advanced disease than their 50+ counterparts. In this large study, 2470 patients ages 25-49 used a tablet-based program that assessed risks, matched risks with screening guidelines, and generated tailored printed guideline-concordant recommendations for patients and their providers. The tablet-based program identified 121 (4.9%) patients with risk factors warranting screening before age 50. Likelihood of risk warranting screening was greater for ages 40-49 than <40years (OR: 2.38), females than males (OR: 1.82), and African Americans (OR: 1.69) and non-Hispanic Whites (OR: 2.89) compared to Hispanics. Most common risk factors were family history of polyps (23.1%), personal history of inflammatory bowel disease (19.8%), and combined family history of CRC+polyps (18.2%). Receipt of guideline-concordant screening within 6months of identification was low, including only 5.3% of those who needed colonoscopy and 13.3% for whom colonoscopy or FIT was recommended. Although elevated-risk patients younger than 50years can be readily identified, more than notification is necessary to facilitate screening participation.