Joanne M. Sanders

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

Promoting HPV vaccination in safety-net clinics: A randomized trial

OBJECTIVES: Evaluate effects of a multicomponent intervention (human papillomavirus [HPV] vaccine-specific brochure and recalls) on HPV vaccination and secondarily examine if race/ethnicity moderates effects. METHODS: Unvaccinated girls aged 11 to 18 years attending 4 safety-net pediatric clinics and their parent/guardian (n = 814 dyads) were randomized to (1) active comparison (general adolescent vaccine brochure), or (2) intervention consisting of a HPV vaccine-specific brochure, telephone recalls to parents who declined, and recalls to patients overdue for doses 2 and 3. HPV 1-dose and 3-dose coverages were assessed via electronic health records 12 months after randomization. Multivariate logistic regressions estimated adjusted odds and marginal predicted vaccine coverage by study arm and race/ethnicity. RESULTS: Intent-to-treat analyses found no main effect of the HPV vaccine-specific brochure on 1-dose coverage (42.0% vs 40.6%); however, secondary analyses found race/ethnicity was a significant moderator such that the intervention was effective only for Hispanic individuals (adjusted odds ratio [AOR] 1.43; 95% confidence interval [CI] 1.02–2.02), and not effective for black individuals (AOR 0.64; 95% CI 0.41–1.13). Recalls to parents who declined the vaccine during the index visit were not effective, but recalls to patients overdue for doses 2 and 3 were effective at increasing 3-dose coverage regardless of race/ethnicity (AOR 1.99; 95% CI 1.16–3.45). CONCLUSIONS: Educational materials describing only the HPV vaccine were effective for Hispanic but not black individuals. Future research should test mechanisms that may mediate intervention effects for different racial/ethnic groups, such as different informational needs or vaccine schemas (experiences, beliefs, norms).

Effectiveness of a Community Research Registry to Recruit Minority and Underserved Adults for Health Research

Recruiting minorities and underserved populations into population‐based studies is a long standing challenge. This study examined the feasibility of recruiting adults from a community research registry.

Impact of Risk Assessment and Tailored versus Nontailored Risk Information on Colorectal Cancer Testing in Primary Care: A Randomized Controlled Trial

Background: Colorectal cancer screening is effective but underused. Guidelines for which tests are recommended and at what intervals depend on specific risks. We developed a tablet-based Cancer Risk Intake System (CRIS) that asks questions about risk prior to appointments and generates tailored printouts for patients and physicians summarizing and matching risk factors with guideline-based recommendations. Methods: Randomized controlled trial among patients who: (i) used CRIS and they and their physicians received tailored printouts; (ii) used CRIS to answer questions but received standard information about cancer screening while their physicians received a standard electronic chart prompt indicating they were age-eligible but not currently adherent for colorectal cancer screening; or (iii) comprised a no-contact group that neither used CRIS nor received any information while their physicians received the standard prompt. Participation in testing was assessed via electronic medical record at 12 months. Results: Participation in any colorectal cancer testing was three times higher for those who used the CRIS and received any printed materials, compared with no-contact controls (47% vs. 16%; P < 0.0001). Among CRIS users ages 50 and older, participation in any testing was higher in the tailored group (53% vs. 44%, P = 0.023). Conclusion: Use of CRIS and receipt of any information facilitated participation in testing. There was more testing participation in the CRIS-tailored than nontailored group. Impact: Asking patients questions about their specific risk factors and giving them and their providers information just prior to an appointment may increase participation in colorectal cancer testing. Tailoring the information has some added benefit. Cancer Epidemiol Biomarkers Prev; 24(10); 1523–30. ©2015 AACR.

County-level outcomes of a rural breast cancer screening outreach strategy: a decentralized hub-and-spoke model (BSPAN2)

Rural mammography screening remains suboptimal despite reimbursement programs for uninsured women. Networks linking non-clinical community organizations and clinical providers may overcome limited delivery infrastructure in rural areas. Little is known about how networks expand their service area. To evaluate a hub-and-spoke model to expand mammography services to 17 rural counties by assessing county-level delivery and local stakeholder conduct of outreach activities. We conducted a mixed-method evaluation using EMR data, systematic site visits (73 interviews, 51 organizations), 92 patient surveys, and 30 patient interviews. A two-sample t test compared the weighted monthly average of women served between hub- and spoke-led counties; nonparametric trend test evaluated time trend over the study period; Pearson chi-square compared sociodemographic data between hub- and spoke-led counties. From 2013 to 2014, the program screened 4603 underinsured women. Counties where local “spoke” organizations led outreach activities achieved comparable screening rates to hub-led counties (9.2 and 8.7, respectively, p = 0.984) and did not vary over time (p = 0.866). Qualitative analyses revealed influence of program champions, participant language preference, and stakeholders’ concerns about uncompensated care. A program that leverages local organizations’ ability to identify and reach rural underserved populations is a feasible approach for expanding preventive services delivery.

Tailored information increases patient/physician discussion of colon cancer risk and testing: The Cancer Risk Intake System trial

Assess whether receipt of tailored printouts generated by the Cancer Risk Intake System (CRIS) – a touch-screen computer program that collects data from patients and generates printouts for patients and physicians – results in more reported patient-provider discussions about colorectal cancer (CRC) risk and screening than receipt of non-tailored information. Cluster-randomized trial, randomized by physician, with data collected via CRIS prior to visit and 2-week follow-up telephone survey among 623 patients. Patients aged 25–75 with upcoming primary-care visits and eligible for, but currently non-adherent to CRC screening guidelines. Patient-reported discussions with providers about CRC risk and testing. Tailored recipients were more likely to report patient-physician discussions about personal and familial risk, stool testing, and colonoscopy (all p < 0.05). Tailored recipients were more likely to report discussions of: chances of getting cancer (+ 10%); family history (+ 15%); stool testing (+ 9%); and colonoscopy (+ 8%) (all p < 0.05). CRIS is a promising strategy for facilitating discussions about testing in primary-care settings.

Cervical Cancer Burden and Opportunities for Prevention in a Safety-net Healthcare System

Background: The high prevalence of cervical cancer at safety-net health systems requires careful analysis to best inform prevention and quality improvement efforts. We characterized cervical cancer burden and identified opportunities for prevention in a U.S. safety-net system. Methods: We reviewed tumor registry and electronic health record (EHR) data of women with invasive cervical cancer with ages 18+, diagnosed between 2010 and 2015, in a large, integrated urban safety-net. We developed an algorithm to: (i) classify whether women had been engaged in care (≥1 clinical encounter between 6 months and 5 years before cancer diagnosis); and (ii) identify missed opportunities (no screening, no follow-up, failure of a test to detect cancer, and treatment failure) and associated factors among engaged patients. Results: Of 419 women with cervical cancer, more than half (58%) were stage 2B or higher at diagnosis and 40% were uninsured. Most (69%) had no prior healthcare system contact; 47% were diagnosed elsewhere. Among 122 engaged in care prior to diagnosis, failure to screen was most common (63%), followed by lack of follow-up (21%), and failure of test to detect cancer (16%). Tumor stage, patient characteristics, and healthcare utilization differed across groups. Conclusions: Safety-net healthcare systems face a high cervical cancer burden, mainly from women with no prior contact with the system. To prevent or detect cancer early, community-based efforts should encourage uninsured women to use safety-nets for primary care and preventive services. Impact: Among engaged patients, strategies to increase screening and follow-up of abnormal screening tests could prevent over 80% of cervical cancer cases.

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.