Wendy Pechero Bishop

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.

Community events as viable sites for recruiting minority volunteers who agree to be contacted for future research

Reaching out to medically underserved racial/ethnic groups is a key challenge in population research. To increase their participation opportunities, we asked adults attending community events to complete a survey about their health concerns and invited them to join a registry of individuals agreeing to future study invitation. Approximately 66% of the 2298 survey responders joined the registry. Multivariate analysis showed that Hispanics were more likely to agree to contact than Whites. Agreers endorsed a wider range of health concerns than non-agreers.

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.

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.

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.

Legitimate and Ethical: Distinguishing When and How Regulations Apply in Patient-Oriented Research

We read Schonfeld and colleagues’ article “You Don’t Know Me But. . .” with interest. The authors suggest a lacuna in patient privacy and confidentiality falling between protections extended by the HIPAA Privacy Rule and other parts of the Code of Federal Regulations (CFR) addressing research with human subjects and the purview of institutional review boards (IRBs) (a.k.a. the Common Rule), arguing that HIPAA’s “preparatory research provisions” permit use of protected health information (PHI) for screening and study recruitment without patient consent. Because this period is “preparatory to research,” the authors believe it falls before IRB oversight begins and, therefore, that patients’ PHI may be used without their consent and without IRB approval. However, this suggestion conflates several key distinctions fundamental to understanding regulatory codes that we elucidate here to illustrate how HIPAA and the Common Rule align to provide participant protections in an increasingly broad field of patient-oriented research. This discussion necessitates a clear distinction between processes of research (analysis intended to advance generalizable knowledge in a field) and quality improvement (QI) or assurance (analysis intended to improve patient care within a particular setting). Research, as distinct from QI, is intended to be generalizable to other settings. Often this is indicated by intent to publish results through peer review. By this definition, analyses to be disseminated beyond local settings are research, not QI. This is a means/ends distinction from which follow respective regulatory domains covered by HIPAA and the Common Rule. HIPAA covers the broad domain of PHI created via patient care. The Common Rule sections apply to the narrower domain of research, overlapping with HIPAA

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.