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.

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.

Reasons for Lack of Diagnostic Colonoscopy After Positive Result on Fecal Immunochemical Test in a Safety-Net Health System.

BACKGROUND: Effective colorectal cancer screening depends on timely diagnostic evaluation in patients with abnormal results on fecal immunochemical tests (FITs). Although prior studies suggest low rates of follow-up colonoscopy, there is little information among patients in safety-net health systems and few data characterizing reasons for low follow-up rates. This study aimed to characterize factors contributing to lack of follow-up colonoscopy in a racially diverse and socioeconomically disadvantaged cohort of patients with abnormal results on FIT ("abnormal FIT" for brevity) receiving care in an integrated safety-net health system. METHODS: We performed a retrospective electronic medical record review of patients aged 50-64 years with abnormal FIT at a population-based safety-net health system between January 2010 and July 2013. Review of electronic medical records focused on patients without follow-up colonoscopy to characterize patient-, provider-, and system-level reasons for lack of diagnostic evaluation. We used logistic regression analysis to identify predictors of follow-up colonoscopy within 12 months of abnormal FIT. RESULTS: Of 1267 patients with abnormal FIT, 536 (42.3%) failed to undergo follow-up colonoscopy within 1 year. Failure was attributable to patient-level factors in 307 (57%) cases, provider factors in 97 (18%) cases, and system factors in 118 (22%) cases. In multivariate analysis, follow-up colonoscopy was less likely among those aged 61-64 years (odds ratio 0.63, 95% confidence interval 0.46-0.87) compared with 50-55 year olds. CONCLUSIONS: Nearly half (42%) of patients with abnormal FIT failed to undergo follow-up colonoscopy within 1 year. Lack of diagnostic evaluation is related to a combination of patient-, provider-, and system-level factors, highlighting the need for multilevel interventions to improve follow-up colonoscopy completion rates.

Mailed Outreach Program Increases Ultrasound Screening of Patients With Cirrhosis for Hepatocellular Carcinoma.

BACKGROUND & AIMS: Surveillance of patients with cirrhosis increases early detection of hepatocellular carcinoma (HCC) and prolongs survival. However, its effectiveness is limited by underuse, particularly among racial/ethnic minorities and individuals of low socioeconomic status. We compared the effectiveness of mailed outreach strategies, with and without patient navigation, in increasing the numbers of patients with cirrhosis undergoing surveillance for HCC in a racially diverse and socioeconomically disadvantaged cohort. METHODS: We performed a prospective study of patients with documented or suspected cirrhosis at a large safety-net health system from December 2014 through March 2016. Patients were assigned randomly (1:1:1) to groups that received mailed invitations for an ultrasound screening examination (n = 600), mailed invitations for an ultrasound screening examination and patient navigation (barrier assessment and motivational education for patients who declined screening; n = 600), or usual care (visit-based screening; n = 600). Patients who did not respond to outreach invitations within 2 weeks received up to 3 reminder telephone calls. The primary outcome was completion of abdominal imaging within 6 months of randomization. RESULTS: Baseline characteristics were similar among groups. Cirrhosis was documented, based on International Classification of Diseases, 9th revision, codes, for 79.6% of patients, and suspected, based on noninvasive markers of fibrosis, for 20.4%. In an intent-to-treat analysis, significantly greater proportions of patients who received the mailed invitation and navigation (47.2%) or the mailed invitation alone (44.5%) underwent HCC screening than patients who received usual care (24.3%) (P < .001 for both comparisons). However, screening rates did not differ significantly between outreach the outreach groups (P = .25). The effects of the outreach program were consistent in all subgroups, including Caucasian vs non-Caucasian race, documented vs suspected cirrhosis, Child-Pugh A vs B cirrhosis, and receipt of gastroenterology care. CONCLUSIONS: In a prospective study, we found outreach strategies to double the percentage of patients with cirrhosis who underwent ultrasound screening for HCC. However, adding patient navigation to telephone reminders provided no significant additional benefit. ClinicalTrials.gov no: NCT02312817.

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.

Validity of Single-Item Screening for Limited Health Literacy in English and Spanish Speakers.

OBJECTIVES: To evaluate 3 single-item screening measures for limited health literacy in a community-based population of English and Spanish speakers. METHODS: We recruited 324 English and 314 Spanish speakers from a community research registry in Dallas, Texas, enrolled between 2009 and 2012. We used 3 screening measures: (1) How would you rate your ability to read?; (2) How confident are you filling out medical forms by yourself?; and (3) How often do you have someone help you read hospital materials? In analyses stratified by language, we used area under the receiver operating characteristic (AUROC) curves to compare each item with the validated 40-item Short Test of Functional Health Literacy in Adults. RESULTS: For English speakers, no difference was seen among the items. For Spanish speakers, "ability to read" identified inadequate literacy better than "help reading hospital materials" (AUROC curve = 0.76 vs 0.65; P = .019). CONCLUSIONS: The "ability to read" item performed the best, supporting use as a screening tool in safety-net systems caring for diverse populations. Future studies should investigate how to implement brief measures in safety-net settings and whether highlighting health literacy level influences providers' communication practices and patient outcomes.

Developing a Tablet-Based Self-Persuasion Intervention Promoting Adolescent HPV Vaccination: Protocol for a Three-Stage Mixed-Methods Study.

BACKGROUND: Human papillomavirus (HPV)-related cancers are a significant burden on the US health care system that can be prevented through adolescent HPV vaccination. Despite guidelines recommending vaccination, coverage among US adolescents is suboptimal particularly among underserved patients (uninsured, low income, racial, and ethnic minorities) seen in safety-net health care settings. Many parents are ambivalent about the vaccine and delay making a decision or talking with a provider about it. Self-persuasion-generating one's own arguments for a health behavior-may be particularly effective for parents who are undecided or not motivated to make a vaccine decision. OBJECTIVE: Through a 3-stage mixed-methods protocol, we will identify an optimal and feasible self-persuasion intervention strategy to promote adolescent HPV vaccination in safety-net clinics. METHODS: In Stage 1, we will define content for a tablet-based self-persuasion app by characterizing (1) parents' self-generated arguments through cognitive interviews conducted with parents (n=50) of patients and (2) parent-provider HPV vaccine discussions through audio recordings of clinic visits (n=50). In Stage 2, we will compare the effects of the four self-persuasion intervention conditions that vary by cognitive processing level (parents verbalize vs listen to arguments) and choice of argument topics (parents choose vs are assigned topics) on parental vaccine intentions in a 2 × 2 factorial design randomized controlled trial (n=160). This proof-of-concept trial design will identify which intervention condition is optimal by quantitatively examining basic self-persuasion mechanisms (cognitive processing and choice) and qualitatively exploring parent experiences with intervention tasks. In Stage 3, we will conduct a pilot trial (n=90) in the safety-net clinics to assess feasibility of the optimal intervention condition identified in Stage 2. We will also assess its impact on parent-provider discussions. RESULTS: This paper describes the study protocol and activities to date. Currently, we have developed the initial prototype of the tablet app for English- and Spanish-speaking populations, and completed Stage 1 data collection. CONCLUSIONS: Our systematic collaboration between basic and applied behavioral scientists accelerates translation of promising basic psychological research into innovative interventions suitable for underserved, safety-net populations. At project's end, we plan to have a feasible and acceptable self-persuasion intervention that can affect key cancer disparities in the United States through prevention of HPV-related cancers. TRIAL REGISTRATION: ClinicalTrials.gov http://clinicaltrials.gov/ct2/show/NCT02537756 and http://clinicaltrials.gov/ct2/show/NCT02535845 (Archived by WebCite at http://www.webcitation.org/6e5XcOGXz and http://www.webcitation.org/6e5XfHoic, respectively).

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

BACKGROUND: 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. METHODS: Patients aged 50 to 64 years who were not up-to-date with CRC screening but used primary care services in a large safety-net health system were randomly assigned to mailed FIT outreach (2400 patients), mailed colonoscopy outreach (2400 patients), or usual care with opportunistic visit-based screening (1199 patients). Patients who did not respond to outreach invitations within 2 weeks received follow-up telephone reminders. The primary outcome was CRC screening completion within 12 months after randomization. RESULTS: Baseline patient characteristics across the 3 groups were similar. Using intention-to-screen analysis, screening participation rates were higher for FIT outreach (58.8%) and colonoscopy outreach (42.4%) than usual care (29.6%) (P <.001 for both). Screening participation with FIT outreach was higher than that for colonoscopy outreach (P <.001). Among responders, FIT outreach had a higher percentage of patients who responded before reminders (59.0% vs 29.7%; P <.001). Nearly one-half of patients in the colonoscopy outreach group crossed over to complete FIT via usual care, whereas <5% of patients in the FIT outreach group underwent usual-care colonoscopy. CONCLUSIONS: Mailed outreach invitations appear to significantly increase CRC screening rates among underserved populations. In the current study, FIT-based outreach was found to be more effective than colonoscopy-based outreach to increase 1-time screening participation. Studies with longer follow-up are needed to compare the effectiveness of outreach strategies for promoting completion of the entire screening process.

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.

Effectiveness of a community research registry to recruit minority and underserved adults for health research.

BACKGROUND: 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. METHODS: Ethnically diverse, bilingual staff attended health fairs, inviting adults to join a registry. We examined rates of successful contact, scheduling, and participation for studies that used the registry. RESULTS: Five studies queried 6,886 research registry members (48% Hispanic and 38% black) and attempted to contact 2,301 potentially eligible participants; eligibility criteria varied across studies. We successfully contacted 1,130 members, 51.9% were scheduled to participate and of those, 60.8% completed their study appointment. Non-Hispanic whites were less likely than Hispanics to be interested, but among those scheduling an appointment, participation did not differ by race/ethnicity. CONCLUSION: Community research registries are a feasible and efficient method for recruiting minority and underserved adults and may address disparities in access to and participation in health research.

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.