Research article
Aid-Assisted Decision Making and Colorectal Cancer Screening: A Randomized Controlled Trial

https://doi.org/10.1016/j.amepre.2012.08.018Get rights and content

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.gov NCT00251862.

Introduction

Colorectal cancer remains a leading cause of cancer-related morbidity and mortality, despite recent declines in both incidence and mortality.1, 2 A compelling body of evidence has accumulated to suggest that screening is the most effective and rational strategy for further reducing the public health burden of this deadly yet potentially preventable disease. Consequently, screening is now endorsed by most, if not all, authoritative groups, including the U.S. Preventive Services Task Force, American Cancer Society, and U.S. Multi-society Task Force on Colorectal Cancer.3, 4 These endorsements, combined with more-widespread coverage by medical insurers and heightened public awareness efforts, have contributed to a steady increase in screening prevalence in recent years. Nevertheless, more than one third of age-eligible Americans have never been screened.5

Eliciting patient preference within the context of shared decision making (SDM) has been advocated as a potentially effective strategy for increasing patient acceptance and adherence to CRC screening recommendations.3, 4 Engaging patients to participate in the decision-making process when confronted with preference-sensitive choices related to CRC screening is also fundamental to the concept of patient-centered care.6, 7, 8 CRC screening is ideally suited for this approach given the availability of multiple options with distinct advantages and disadvantages, the lack of consensus regarding an optimal cost-effective strategy, and limited effectiveness of the more-traditional paternalistic approach in which providers assume full responsibility for the decision-making process. Further support is derived from studies finding that both patients and providers hold distinct preferences for the various screening options,9, 10, 11, 12, 13, 14 that providers often misperceive patient preferences,10 and that many patients endorse an SDM approach for CRC screening.15, 16

Despite a compelling rationale, SDM has been difficult to implement in routine clinical practice in part because of lack of time, resources, clinician expertise, and suitability for certain patients or clinical situations.17, 18 The use of patient-oriented decision aids has been proposed as a potentially effective strategy for circumventing several of these barriers.8, 19 Decision aids help patients make informed, value-concordant choices about a particular course of action based on an understanding of potential benefits, risks, probabilities, and scientific uncertainty.20 Studies to date have shown that decision aids for CRC screening enable users to identify a preferred screening option,11, 16, 21, 22, 23, 24, 25 reduce decisional conflict,22, 24 and increase interest in screening.21, 23, 25, 26 The authors recently have shown that decision aids also can facilitate SDM by increasing patient knowledge, increasing satisfaction with the decision-making process, enhancing screening intentions, and improving the quality and efficiency of the patient–provider encounter.16, 27

The extent to which decision aids increase CRC screening uptake, however, is less well defined.21, 22, 23, 24, 25, 28 Hence, the primary objective of the present study was to test the hypothesis that decision-aid users were more likely to complete a CRC screening test than non-users. Unlike previous such studies, effectiveness was evaluated within the context of a shared rather than informed decision-making framework.29 Based on evidence suggesting that individualized risk communication also might increase uptake of screening tests,30 a secondary objective was to test the hypothesis that a modified version of the decision aid that incorporated a validated personalized risk assessment tool for CRC would be more effective than the decision aid alone for increasing test completion.

Section snippets

Study Population and Recruitment Process

The study sample was made up of average-risk primary care patients cared for at Boston Medical Center or the South Boston Community Health Center. Patients were deemed eligible if they were aged 50–75 years and due for CRC screening.3, 4 Patients meeting any of the following criteria were excluded: (1) prior CRC screening by any method other than fecal occult blood testing (FOBT); (2) high-risk condition (personal history of colorectal cancer or polyps, family history of colorectal cancer or

Patient Characteristics

Of the 13,518 patients identified as potentially eligible for screening because of age, 7619 (56%) were deemed ineligible (mostly due to prior screening [n=6073]) and 5074 (38%) were excluded (Figure 1). Reasons for exclusion included inability to contact (n=4321); disinterest (n=290); scheduling conflict (n=305); and failure to keep appointment (n=158). The remaining 825 patients (52% of eligible subjects contacted) were enrolled and randomized to decision aid–alone (n=269); decision aid plus

Discussion

The current study provides new evidence that decision aid–assisted SDM is an effective strategy for increasing CRC screening. Test completion uptake was ∼8% higher among decision-aid users than controls at both 6 and 12 months, suggesting a very modest but sustained impact on screening uptake. Unlike previous such studies, the present study also explored the role of individual elements of SDM on screening behavior and found that the positive impact was mediated through activation of the

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