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Risk Stratification and Shared Decision Making for Colorectal Cancer Screening: A Randomized Controlled Trial.

ABSTRACT: Eliciting 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.To determine whether risk stratification for advanced colorectal neoplasia (ACN) influences provider willingness to comply with patient preferences when selecting a desired CRC screening option.Randomized controlled trial.Asymptomatic, average-risk patients due for CRC screening in an urban safety net health care setting.Patients 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.The 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.Although 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.Single-institution setting; lack of provider education about the utility of risk stratification into their decision making.Providers 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.

SUBMITTER: Schroy PC

PROVIDER: S-EPMC4818180 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature

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Risk Stratification and Shared Decision Making for Colorectal Cancer Screening: A Randomized Controlled Trial.

Schroy Paul C PC Duhovic Emir E Chen Clara A CA Heeren Timothy C TC Lopez William W Apodaca Danielle L DL Wong John B JB

Medical decision making : an international journal of the Society for Medical Decision Making 20160119 4

<h4>Background</h4>Eliciting 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.<h4>Purpose</h4>To determine whether risk stratification for advanced colorectal neoplasia (ACN) influences provider willingness to comply with patient preferences when selecting a desired CRC screening option.<h4>Design</h4>Randomized controlled trial.<h4>Sett ...[more]

PMID: 26785715

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Project description:BackgroundShared 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.PurposeTo assess the impact of decision aid-assisted SDM on CRC screening uptake.DesignRCT.Setting/participantsThe 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.InterventionStudy 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 measuresThe 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.ResultsPatients 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.ConclusionsDecision 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 registrationThis study is registered at www.clinicaltrials.govNCT00251862.

Project description:BackgroundRisk communication is a core aspect of a physician's work and a fundamental prerequisite for successful shared decision-making. However, many physicians are not able to adequately communicate risks to patients due to a lack of understanding of statistics as well as inadequate management of conflicts of interest (COI).ObjectiveTo evaluate the effects of an integrated curriculum encompassing COI and shared decision-making on the participants' risk communication competence, that is, their competence to advise patients on the benefits and harms of diagnostic or therapeutic interventions.DesignA rater-blind randomized controlled trial with a 30 (± 1)-week follow-up conducted from October 2016 to June 2017 at two German academic medical centers.ParticipantsSixty-three medical students in their fourth or fifth year.InterventionsParticipants received either a newly developed 15-h curriculum or a course manual adapted from teaching as usual.Main measuresPrimary outcome: change in risk communication performance in a video-observed structured clinical examination (VOSCE).Key resultsParticipants were 25.7 years old on average (SD 3.6); 73% (46/63) were female. Increase in risk communication performance was significantly higher in the intervention group with post-intervention Cohen's d of 2.35 (95% confidence interval (CI) 1.62 to 3.01, p < 0.01) and of 1.83 (CI 1.13 to 2.47, p < 0.01) 30 (± 1) weeks later. Secondary outcomes with the exception of frequency of interactions with the pharmaceutical industry also showed relevant improvements in the intervention as compared with the control group (d between 0.91 and 2.04 (p < 0.001)).ConclusionsOur results show that an integrated curriculum encompassing COI and risk communication leads to a large and sustainable increase in risk communication performance. We interpret the large effect sizes to be a result of the integration of topics that are usually taught separately, leading to a more effective organization of knowledge.Trial registrationThe trial is registered in the International Clinical Trials Registry with the trial number DRKS00010890.

Project description:Clinicians 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.This 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.The 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.ClinicalTrials.gov ID NCT01514786.

Project description: To compare the effectiveness of shared decision making with usual care in choice of admission for observation and further cardiac testing or for referral for outpatient evaluation in patients with possible acute coronary syndrome. Multicenter pragmatic parallel randomized controlled trial. Six emergency departments in the United States. 898 adults (aged >17 years) with a primary complaint of chest pain who were being considered for admission to an observation unit for cardiac testing (451 were allocated to the decision aid and 447 to usual care), and 361 emergency clinicians (emergency physicians, nurse practitioners, and physician assistants) caring for patients with chest pain. Patients were randomly assigned (1:1) by an electronic, web based system to shared decision making facilitated by a decision aid or to usual care. The primary outcome, selected by patient and caregiver advisers, was patient knowledge of their risk for acute coronary syndrome and options for care; secondary outcomes were involvement in the decision to be admitted, proportion of patients admitted for cardiac testing, and the 30 day rate of major adverse cardiac events. Compared with the usual care arm, patients in the decision aid arm had greater knowledge of their risk for acute coronary syndrome and options for care (questions correct: decision aid, 4.2 v usual care, 3.6; mean difference 0.66, 95% confidence interval 0.46 to 0.86), were more involved in the decision (observing patient involvement scores: decision aid, 18.3 v usual care, 7.9; 10.3, 9.1 to 11.5), and less frequently decided with their clinician to be admitted for cardiac testing (decision aid, 37% v usual care, 52%; absolute difference 15%; P<0.001). There were no major adverse cardiac events due to the intervention. Use of a decision aid in patients at low risk for acute coronary syndrome increased patient knowledge about their risk, increased engagement, and safely decreased the rate of admission to an observation unit for cardiac testing.Trial registration ClinicalTrials.gov NCT01969240.

Project description:BackgroundShared decision making is a crucial component of evidence-based practice, but a lack of training in the "how to" of it is a major barrier to its uptake.ObjectiveTo evaluate the effectiveness of a brief intervention for facilitating shared decision making skills in clinicians and student clinicians.DesignMulti-centre randomized controlled trial.ParticipantsOne hundred and seven medical students, physiotherapy or occupational therapy students undertaking a compulsory course in evidence-based practice as part of their undergraduate or postgraduate degree from two Australian universities.InterventionThe 1-h small-group intervention consisted of facilitated critique of five-step framework, strategies, and pre-recorded modelled role-play. Both groups were provided with a chapter about shared decision making skills.Main measuresThe primary outcome was skills in shared decision making and communicating evidence [Observing Patient Involvement (OPTION) scale, items from the Assessing Communication about Evidence and Patient Preferences (ACEPP) Tool], rated by a blinded assessor from videorecorded role-plays.Secondary outcomesconfidence in these skills and attitudes towards patient-centred communication (Patient Practitioner Orientation Scale (PPOS)).Key resultsOf participants, 95 % (102) completed the primary outcome measures. Two weeks post-intervention, intervention group participants scored significantly higher on the OPTION scale (adjusted group difference?=?18.9, 95 % CI 12.4 to 25.4), ACEPP items (difference?=?0.9, 95 % CI 0.5 to 1.3), confidence measure (difference?=?13.1, 95 % CI 8.5 to 17.7), and the PPOS sharing subscale (difference?=?0.2, 95 % CI 0.1 to 0.5). There was no significant difference for the PPOS caring subscale.ConclusionsThis brief intervention was effective in improving student clinicians' ability, attitude towards, and confidence in shared decision making facilitation. Following further testing of the longer-term effects of this intervention, incorporation of this brief intervention into evidence-based practice courses and workshops should be considered, so that student clinicians graduate with these important skills, which are typically neglected in clinician training.

Project description:BACKGROUND:Pregnant women often find it difficult to choose from among the wide variety of available prenatal screening options. To help pregnant women and their partners make informed decisions based on their values, needs, and preferences, a decision aid and a web-based shared decision making (SDM) training program for health professionals have been developed. In Canada, nurses provide maternity care and thus can train as decision coaches for prenatal screening. However, there is a knowledge gap about the effectiveness of SDM interventions in maternity care in nursing practice. OBJECTIVE:This study aims to assess the impact of an SDM training program on nurses' intentions to use a decision aid for prenatal screening and on their knowledge and to assess their overall impressions of the training. METHODS:This is a 2-arm parallel randomized trial. French-speaking nurses working with pregnant women in the province of Quebec were recruited online by a private survey firm. They were randomly allocated (1:1 ratio) to either an experimental group, which completed a web-based SDM training program that included prenatal screening, or a control group, which completed a web-based training program focusing on prenatal screening alone. The experimental intervention consisted of a 3-hour web-based training hosted on the Université Laval platform with 4 modules: (1) SDM; (2) Down syndrome prenatal screening; (3) decision aids; and (4) communication between health care professionals and the patient. For the control group, the topic of SDM in Module 1 was replaced with "Context and history of prenatal screening," and the topic of decision aids in Module 3 was replaced with "Consent in prenatal screening." Participants completed a self-administered sociodemographic questionnaire with close-ended questions. We also assessed the participants' (1) intention to use a decision aid in prenatal screening clinical practice, (2) knowledge, (3) satisfaction with the training, (4) acceptability, and (5) perceived usefulness of the training. The randomization was done using a predetermined sequence and included 40 nurses. Participants and researchers were blinded. Intention to use a decision aid will be assessed by a t test. Bivariate and multivariate analysis will be performed to assess knowledge and overall impressions of the training. RESULTS:This study was funded in 2017 and approved by Genome Canada. Data were collected from September 2019 to late January 2020. This paper was initially submitted before data analysis began. Results are expected to be published in winter 2020. CONCLUSIONS:Study results will inform us on the impact of an SDM training program on nurses' intention to use and knowledge of decision aids for prenatal screening and their overall impressions of the training. Participant feedback will also inform an upgrade of the program, if needed. TRIAL REGISTRATION:ClinicalTrials.gov NCT04162288; https://clinicaltrials.gov/ct2/show/NCT04162288. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/17878.

Project description:Nonvalvular atrial fibrillation (AF) is a common ongoing health problem that places patients at risk of stroke. Whether and how a patient addresses this risk depends on each patient's goals, context, and values. Consequently, leading cardiovascular societies recommend using shared decision making (SDM) to individualize antithrombotic treatment in patients with AF. The aim of this study is to assess the extent to which the ANTICOAGULATION CHOICE conversation tool promotes high-quality SDM and influences anticoagulation uptake and adherence in patients with AF at risk of strokes.This study protocol describes a multicenter, encounter-level, randomized trial to assess the effect of using the ANTICOAGULATION CHOICE conversation tool in the clinical encounter, compared to usual care. The participating centers include an academic hospital system, a suburban community group practice, and an urban safety net hospital, all in Minnesota, USA. Patients with ongoing nonvalvular AF at risk of strokes (CHA2DS2-VASc score???1 in men, or???2 in women) will be eligible for participation. We aim to include 999 patients and their clinicians. The primary outcome is the quality of SDM as perceived by participants, and as assessed by a post-encounter survey that ascertains (a) knowledge transfer, (b) concordance of the decision made, (c) quality of communication, and (d) satisfaction with the decision-making process. Recordings of encounters will be reviewed to assess the extent of patient involvement and how participants use the tool (fidelity). Anticoagulant use, choice of agent, and adherence will be drawn from patients' medical and pharmacy records. Strokes and bleeding events will be drawn from patient records.This study will provide a valid and precise measure of the effect of the ANTICOAGULATION CHOICE conversation tool on SDM quality and processes, and on the treatment choices and adherence to therapy among AF patients at risk of stroke.ClinicalTrials.gov, NCT02905032 . Registered on 9 September 2016.

Dataset Information

Risk Stratification and Shared Decision Making for Colorectal Cancer Screening: A Randomized Controlled Trial.

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Risk Stratification and Shared Decision Making for Colorectal Cancer Screening: A Randomized Controlled Trial.

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