Aid-assisted decision making and colorectal cancer screening: a randomized controlled trial.

BACKGROUND: Shared decision making (SDM) is a widely recommended yet unproven strategy for increasing colorectal cancer (CRC) screening uptake. Previous trials of decision aids to increase SDM and CRC screening uptake have yielded mixed results. PURPOSE: To assess the impact of decision aid-assisted SDM on CRC screening uptake. DESIGN: RCT. SETTING/PARTICIPANTS: The study was conducted at an urban, academic safety-net hospital and community health center between 2005 and 2010. Participants were asymptomatic, average-risk patients aged 50-75 years due for CRC screening. INTERVENTION: Study participants (n=825) were randomized to one of two intervention arms (decision aid plus personalized risk assessment or decision aid alone) or control arm. The interventions took place just prior to a routine office visit with their primary care providers. MAIN OUTCOME MEASURES: The primary outcome was completion of a CRC screening test within 12 months of the study visit. Logistic regression was used to identify predictors of test completion and mediators of the intervention effect. Analysis was completed in 2011. RESULTS: Patients in the decision-aid group were more likely to complete a screening test than control patients (43.1% vs 34.8%, p=0.046) within 12 months of the study visit; conversely, test uptake for the decision aid and decision aid plus personalized risk assessment arms was similar (43.1% vs 37.1%, p=0.15). Assignment to the decision-aid arm (AOR=1.48, 95% CI=1.04, 2.10), black race (AOR=1.52, 95% CI=1.12, 2.06) and a preference for a patient-dominant decision-making approach (AOR=1.55, 95% CI=1.02, 2.35) were independent determinants of test completion. Activation of the screening discussion and enhanced screening intentions mediated the intervention effect. CONCLUSIONS: Decision aid-assisted SDM has a modest impact on CRC screening uptake. A decision aid plus personalized risk assessment tool is no more effective than a decision aid alone. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.govNCT00251862.

The Your Disease Risk Index for colorectal cancer is an inaccurate risk stratification tool for advanced colorectal neoplasia at screening colonoscopy.

Tailoring the use of screening colonoscopy based on the risk of advanced colorectal neoplasia (ACN) could optimize the cost-effectiveness of colorectal cancer (CRC) screening. Our goal was to assess the accuracy of the Your Disease Risk (YDR) CRC risk index for stratifying average risk patients into low- versus intermediate/high-risk categories for ACN. The YDR risk assessment tool was administered to 3,317 asymptomatic average risk patients 50 to 79 years of age just before their screening colonoscopy. Associations between YDR-derived relative risk (RR) scores and ACN prevalence were examined using logistic regression and χ(2) analyses. ACN was defined as a tubular adenoma ≥1 cm, tubulovillous or villous adenoma of any size, and the presence of high-grade dysplasia or cancer. The overall prevalence of ACN was 5.6%. Although YDR-derived RR scores were linearly associated with ACN after adjusting for age and gender (P = 0.033), the index was unable to discriminate "below average" from "above/average" risk patients [OR, 1.01; 95% confidence interval (CI), 0.75-1.37]. Considerable overlap in rates of ACN was also observed between the different YDR risk categories in our age- and gender-stratified analyses. The YDR index lacks accuracy for stratifying average risk patients into low- versus intermediate/high-risk categories for ACN.

The impact of a novel computer-based decision aid on shared decision making for colorectal cancer screening: a randomized trial.

BACKGROUND: Eliciting patients' preferences within a framework of shared decision making (SDM) has been advocated as a strategy for increasing colorectal cancer (CRC) screening adherence. Our objective was to assess the effectiveness of a novel decision aid on SDM in the primary care setting. METHODS: An interactive, computer-based decision aid for CRC screening was developed and evaluated within the context of a randomized controlled trial. A total of 665 average-risk patients (mean age, 57 years; 60% female; 63% black, 6% Hispanic) were allocated to 1 of 2 intervention arms (decision aid alone, decision aid plus personalized risk assessment) or a control arm. The interventions were delivered just prior to a scheduled primary care visit. Outcome measures (patient preferences, knowledge, satisfaction with the decision-making process [SDMP], concordance between patient preference and test ordered, and intentions) were evaluated using prestudy/poststudy visit questionnaires and electronic scheduling. RESULTS: Overall, 95% of patients in the intervention arms identified a preferred screening option based on values placed on individual test features. Mean cumulative knowledge, SDMP, and intention scores were significantly higher for both intervention groups compared with the control group. Concordance between patient preference and test ordered was 59%. Patients who preferred colonoscopy were more likely to have a test ordered than those who preferred an alternative option (83% v. 70%; P < 0.01). Intention scores were significantly higher when the test ordered reflected patient preferences. CONCLUSIONS: Our interactive computer-based decision aid facilitates SDM, but overall effectiveness is determined by the extent to which providers comply with patient preferences.

A cost-effectiveness analysis of subject recruitment strategies in the HIPAA era: results from a colorectal cancer screening adherence trial.

BACKGROUND: Changes in regulatory standards that restrict use of identifiable health information can reduce patient recruitment to clinical trials and increase recruitment costs. PURPOSE: To compare subject accrual rates and costs of three recruitment strategies that comply with new regulatory standards within the context of a clinical trial evaluating the impact of shared decision-making on colorectal cancer screening adherence. METHODS: Sequential cohorts of English-speaking, average-risk patients due for colorectal cancer screening were allocated to one of three recruitment strategies: (1) a provider-initiated electronic 'opt-in' referral (Click) method; (2) a provider-mediated 'opt-in' referral letter (Letter) method; and (3) an investigator-initiated direct contact 'opt-out' (Call) method. RESULTS: During distinct 6-month recruitment periods between March 2005 and April 2006, 100 potential subjects were identified using the Click method, 847 by the Letter method, and 758 by the Call method. After excluding ineligible prescreened patients, accrual rates were higher for the Call method (188 of 531 [35.4%]) than either the Click (12 of 72 [16.7%]; p = 0.002) or Letter (17 of 816 [2.1%]; p < 0.001) methods. The average cost per patient enrolled for the Call ($156) method was competitive with the Click ($129) and substantially lower than the Letter ($1967) methods; the Call method was least expensive if combined with automated patient identification ($99). Data extrapolation suggest it would take 2.4 years at an overall cost of $138,518 to recruit a target sample of 900 patients by the Call method, 40.5 years at $62,419 for the Click method and 27.9 years at $1,737,757 for the Letter method. LIMITATIONS: The study was nonrandomized and findings may not be generalizable to other research settings. CONCLUSION: The investigator-initiated direct contact 'opt-out' strategy is significantly more cost-effective and feasible than provider-initiated and provider-mediated 'opt-in' strategies for patient recruitment to clinical trials.

Has the surge in media attention increased public awareness about colorectal cancer and screening?

The Centers for Disease Control and Prevention's Screen for Life campaign in March 1999 followed by the creation of National Colorectal Cancer Awareness Month in March 2000 heralded a surge in media attention to promote awareness about CRC and stimulate interest in screening. Our objective was to assess whether these campaigns have achieved their goal of educating the public about CRC and screening. The study sample was comprised of mostly unscreened, average-risk, English-speaking patients aged 50-75 years seen in an urban primary care setting. Knowledge was assessed using a 12-item true/false questionnaire based primarily on the content of key messages endorsed by the National Colorectal Cancer Roundtable (Cancer 95:1618-1628, 2002) and adopted in many of the media campaigns. Multiple linear regression was performed to identify demographic correlates of knowledge. A total of 356 subjects (83% or=67%) were aware of who gets CRC, age to initiate screening, the goals of screening and potential benefits. Fewer were aware that removing polyps can prevent CRC and that both polyps and CRC may be asymptomatic. Knowledge scores were lower among Blacks and those with a high school degree or less. Race and education were independent correlates of knowledge. These data suggest that recent media campaigns have been effective in increasing public awareness about CRC risk and screening but important gaps in knowledge remain.