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

ABSTRACT: 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.To assess the impact of decision aid-assisted SDM on CRC screening uptake.RCT.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.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.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.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.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.This study is registered at www.clinicaltrials.govNCT00251862.

SUBMITTER: Schroy PC

PROVIDER: S-EPMC3966107 | biostudies-literature | 2012 Dec

REPOSITORIES: biostudies-literature

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

Schroy Paul C PC Emmons Karen M KM Peters Ellen E Glick Julie T JT Robinson Patricia A PA Lydotes Maria A MA Mylvaganam Shamini R SR Coe Alison M AM Chen Clara A CA Chaisson Christine E CE Pignone Michael P MP Prout Marianne N MN Davidson Peter K PK Heeren Timothy C TC

American journal of preventive medicine 20121201 6

<h4>Background</h4>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.<h4>Purpose</h4>To assess the impact of decision aid-assisted SDM on CRC screening uptake.<h4>Design</h4>RCT.<h4>Setting/participants</h4>The study was conducted at an urban, academic safety-net hospital and community health center between 2005 and ...[more]

PMID: 23159252

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Project description:BackgroundEliciting patient preferences within the context of shared decision making has been advocated for colorectal cancer (CRC) screening, yet providers often fail to comply with patient preferences that differ from their own.PurposeTo determine whether risk stratification for advanced colorectal neoplasia (ACN) influences provider willingness to comply with patient preferences when selecting a desired CRC screening option.DesignRandomized controlled trial.Setting/participantsAsymptomatic, average-risk patients due for CRC screening in an urban safety net health care setting.InterventionPatients were randomized 1:1 to a decision aid alone (n= 168) or decision aid plus risk assessment (n= 173) arm between September 2012 and September 2014.OutcomesThe primary outcome was concordance between patient preference and test ordered; secondary outcomes included patient satisfaction with the decision-making process, screening intentions, test completion rates, and provider satisfaction.ResultsAlthough providers perceived risk stratification to be useful in selecting an appropriate screening test for their average-risk patients, no significant differences in concordance were observed between the decision aid alone and decision aid plus risk assessment groups (88.1% v. 85.0%,P= 0.40) or high- and low-risk groups (84.5% v. 87.1%,P= 0.51). Concordance was highest for colonoscopy and relatively low for tests other than colonoscopy, regardless of study arm or risk group. Failure to comply with patient preferences was negatively associated with satisfaction with the decision-making process, screening intentions, and test completion rates.LimitationsSingle-institution setting; lack of provider education about the utility of risk stratification into their decision making.ConclusionsProviders perceived risk stratification to be useful in their decision making but often failed to comply with patient preferences for tests other than colonoscopy, even among those deemed to be at low risk of ACN.

Project description:BackgroundColorectal cancer (CRC) screening reduces mortality yet remains underutilized. Low health literacy may contribute to this underutilization by interfering with patients' ability to understand and receive preventive health services.PurposeTo determine if a web-based multimedia CRC screening patient decision aid, developed for a mixed-literacy audience, could increase CRC screening.DesignRCT. Patients aged 50-74 years and overdue for CRC screening were randomized to the web-based decision aid or a control program seen immediately before a scheduled primary care appointment.Setting/participantsA large community-based, university-affiliated internal medicine practice serving a socioeconomically disadvantaged population.Main outcome measuresPatients completed surveys to determine their ability to state a screening test preference and their readiness to receive screening. Charts were abstracted by masked observers to determine if screening tests were ordered and completed.ResultsBetween November 2007 and September 2008, a total of 264 patients enrolled in the study. Data collection was completed in 2009, and data analysis was completed in 2010. A majority of participants (mean age=57.8 years) were female (67%), African-American (74%), had annual household incomes of <$20,000 (76%), and had limited health literacy (56%). When compared to control participants, more decision-aid participants had a CRC screening preference (84% vs 55%, p<0.0001) and an increase in readiness to receive screening (52% vs 20%, p=0.0001). More decision-aid participants had CRC screening tests ordered (30% vs 21%) and completed (19% vs 14%), but no statistically significant differences were seen (AOR=1.6, 95% CI=0.97, 2.8, and AOR=1.7, 95% CI=0.88, 3.2, respectively). Similar results were found across literacy levels.ConclusionsThe web-based decision aid increased patients' ability to form a test preference and their intent to receive screening, regardless of literacy level. Further study should examine ways the decision aid can be combined with additional system changes to increase CRC screening.

Project description:ImportanceLung cancer screening with low-dose computed tomography lowers lung cancer mortality but has potential harms. Current guidelines support patients receiving information about the benefits and harms of lung cancer screening during decision-making.ObjectiveTo examine the effect of a patient decision aid (PDA) about lung cancer screening compared with a standard educational material (EDU) on decision-making outcomes among smokers.Design, setting, and participantsThis randomized clinical trial was conducted using 13 state tobacco quitlines. Current and recent tobacco quitline clients who met age and smoking history eligibility for lung cancer screening were enrolled from March 30, 2015, to September 12, 2016, and followed up for 6 months until May 5, 2017. Data analysis was conducted between May 5, 2017, and September 30, 2018.InterventionsParticipants were randomized to the PDA video Lung Cancer Screening: Is It Right for Me? (n = 259) or to EDU (n = 257).Main outcomes and measuresThe primary outcomes were preparation for decision-making and decisional conflict measured at 1 week. Secondary outcomes included knowledge, intentions, and completion of screening within 6 months of receiving the intervention measured by patient report.ResultsOf 516 quit line clients enrolled, 370 (71.7%) were younger than 65 years, 320 (62.0%) were female, 138 (26.7%) identified as black, 47 (9.1%) did not have health insurance, and 226 (43.8%) had a high school or lower educational level. Of participants using the PDA, 153 of 227 (67.4%) were well prepared to make a screening decision compared with 108 of 224 participants (48.2%) using EDU (odds ratio [OR], 2.31; 95% CI, 1.56-3.44; P < .001). Feeling informed about their screening choice was reported by 117 of 234 participants (50.0%) using a PDA compared with 66 of 233 participants (28.3%) using EDU (OR, 2.56; 95% CI, 1.72-3.79; P < .001); 159 of 234 participants (68.0%) using a PDA compared with 110 of 232 (47.4%) participants using EDU reported being clear about their values related to the harms and benefits of screening (OR, 2.37; 95% CI, 1.60-3.51; P < .001). Participants using a PDA were more knowledgeable about lung cancer screening than participants using EDU at each follow-up assessment. Intentions to be screened and screening behaviors did not differ between groups.Conclusions and relevanceIn this study, a PDA delivered to clients of tobacco quit lines improved informed decision-making about lung cancer screening. Many smokers eligible for lung cancer screening can be reached through tobacco quit lines.Trial registrationClinicalTrials.gov identifier: NCT02286713.

Project description:BackgroundClinicians face challenges in promoting colorectal cancer screening due to multiple competing demands. A decision aid that clarifies patient preferences and improves decision quality can aid shared decision making and be effective at increasing colorectal cancer screening rates. However, exactly how such an intervention improves shared decision making is unclear. This study, funded by the National Cancer Institute, seeks to provide detailed understanding of how an interactive decision aid that elicits patient's risks and preferences impacts patient-clinician communication and shared decision making, and ultimately colorectal cancer screening adherence.Methods/designThis is a two-armed single-blinded randomized controlled trial with the target of 300 patients per arm. The setting is eleven community and three academic primary care practices in Metro Detroit. Patients are men and women aged between 50 and 75 years who are not up to date on colorectal cancer screening. ColoDATES Web (intervention arm), a decision aid that incorporates interactive personal risk assessment and preference clarification tools, is compared to a non-interactive website that matches ColoDATES Web in content but does not contain interactive tools (control arm). Primary outcomes are patient uptake of colorectal cancer screening; patient decision quality (knowledge, preference clarification, intent); clinician's degree of shared decision making; and patient-clinician concordance in the screening test chosen. Secondary outcome incorporates a Structural Equation Modeling approach to understand the mechanism of the causal pathway and test the validity of the proposed conceptual model based on Theory of Planned Behavior. Clinicians and those performing the analysis are blinded to arms.DiscussionThe central hypothesis is that ColoDATES Web will improve colorectal cancer screening adherence through improvement in patient behavioral factors, shared decision making between the patient and the clinician, and concordance between the patient's and clinician's preferred colorectal cancer screening test. The results of this study will be among the first to examine the effect of a real-time preference assessment exercise on colorectal cancer screening and mediators, and, in doing so, will shed light on the patient-clinician communication and shared decision making 'black box' that currently exists between the delivery of decision aids to patients and subsequent patient behavior.Trial registrationClinicalTrials.gov ID NCT01514786.

Project description:BackgroundColorectal cancer screening participation is a preference-sensitive choice, in which trade-offs between benefits and harms must be made by individual citizens. Often the decision is made without any contact with healthcare professionals. Citizens with lower educational attainment tend to participate less in colorectal cancer screening than citizens with average educational attainment. Further, they tend to have lower levels of knowledge about colorectal cancer screening. Providing lower educational attainment citizens with a targeted decision aid embracing their diverse information needs might increase these citizens' ability to make informed decisions. The aim of this trial is to test the effectiveness of such a newly developed self-administered decision aid.MethodsThe LEAD (Lower Educational Attainment Decision aid) trial will be conducted as a two-arm randomized controlled trial among 10,000 50-74-year-old citizens, resident in the Central Denmark Region not yet invited to take up colorectal cancer screening. Citizens will receive a baseline questionnaire. Respondents will be allocated into the intervention or the control groups. Citizens in the intervention group will receive the decision aid whereas the control group will not. Those who return a stool sample within 45 days after receiving the screening invitation and those with medium or higher educational attainment are excluded. Both groups will receive a follow-up questionnaire 90 days after being invited to colorectal cancer screening. A historic cohort consisting of 5000 50-74-year-old citizens resident in the Central Denmark Region, having received their screening invitation in the beginning of 2017 will be included. This cohort will receive a follow-up questionnaire 6-9 months after they received the screening invitation. Informed choice will be evaluated by assessing levels of knowledge, attitudes, and screening uptake. Analyses will be conducted as intention-to-treat analyses. Additionally, differences between levels of worry and decisional conflict between groups will be assessed as secondary outcomes.DiscussionThis trial will evaluate whether a targeted decision aid is a feasible way of enhancing informed choice among lower educational attainment citizens in colorectal cancer screening. Further, it may guide decisions about providing information material in cancer screening in general.Trial registrationClinicalTrials.gov, NCT03253888 . Registered on 17 August 2017.

Project description:BackgroundIncidence of and mortality from colorectal cancer (CRC) can be effectively reduced by screening with the fecal immunochemical test (FIT) or colonoscopy. Individual risk to develop CRC within 15 years varies from <1% to >15% among people aged 50 to 75 years. Communicating personalized CRC risk and appropriate screening recommendations could improve the risk-benefit balance of screening test allocations and optimize the use of limited colonoscopy resources. However, significant uncertainty exists regarding the feasibility and efficacy of risk-based screening.ObjectiveWe aim to study the effect of communicating individual CRC risk and a risk-based recommendation of the FIT or colonoscopy on participants' choice of screening test. We will also assess the feasibility of a larger clinical trial designed to evaluate the impact of personalized screening on clinical outcomes.MethodsWe will perform a pilot randomized controlled trial among 880 residents aged 50 to 69 years eligible to participate in the organized screening program of the Vaud canton, Switzerland. Participants will be recruited by mail by the Vaud CRC screening program. Primary and secondary outcomes will be self-assessed through questionnaires. The risk score will be calculated using the open-source QCancer calculator that was validated in the United Kingdom. Participants will be stratified into 3 groups-low (<3%), moderate (3% to <6%), and high (≥6%) risk-according to their 15-year CRC risk and randomized within each risk stratum. The intervention group participants will receive a newly designed brochure with their personalized risk and screening recommendations. The control group will receive the usual brochure of the Vaud CRC screening program. Our primary outcome, measured using a self-administered questionnaire, is appropriate screening uptake 6 months after the intervention. Screening will be defined as appropriate if participants at high risk undertake colonoscopy and participants at low risk undertake the FIT. We will also measure the acceptability of the risk score and screening recommendations and the psychological factors influencing screening behavior. We will also assess the feasibility of a full-scale randomized controlled trial.ResultsWe expect that a total sample of 880 individuals will allow us to detect a difference of 10% (α=5%) between groups. The main outcome will be analyzed using a 2-tailed chi-squared test. We expect that appropriate screening uptake will be higher in the intervention group. No difference in overall screening uptake is expected.ConclusionsWe will test the impact of personalized risk information and screening recommendations on participants' choice of screening test in an organized screening program. This study should advance our understanding of the feasibility of large-scale risk-based CRC screening. Our results may provide insights into the optimization of CRC screening by offering screening options with a better risk-benefit balance and optimizing the use of resources.Trial registrationClinicalTrials.gov NCT05357508; https://www.clinicaltrials.gov/study/NCT05357508.International registered report identifier (irrid)DERR1-10.2196/46865.

Dataset Information

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

Publications

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

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