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Teaching Conflicts of Interest and Shared Decision-Making to Improve Risk Communication: a Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Risk 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). OBJECTIVE:To 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. DESIGN:A 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. PARTICIPANTS:Sixty-three medical students in their fourth or fifth year. INTERVENTIONS:Participants received either a newly developed 15-h curriculum or a course manual adapted from teaching as usual. MAIN MEASURES:Primary outcome: change in risk communication performance in a video-observed structured clinical examination (VOSCE). KEY RESULTS:Participants 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)). CONCLUSIONS:Our 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 REGISTRATION:The trial is registered in the International Clinical Trials Registry with the trial number DRKS00010890.

SUBMITTER: Koch C

PROVIDER: S-EPMC7018798 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Teaching Conflicts of Interest and Shared Decision-Making to Improve Risk Communication: a Randomized Controlled Trial.

Koch Cora C Dreimüller Nadine N Weißkircher Janosch J Deis Nicole N Gaitzsch Eva E Wagner Stefanie S Stoll Marlene M Bäßler Franziska F Lieb Klaus K Jünger Jana J

Journal of general internal medicine 20191210 2

<h4>Background</h4>Risk 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).<h4>Objective</h4>To evaluate the effects of an integrated curriculum encompassing COI and shared decision-making on the participants' risk communication competen ...[more]

PMID: 31823309

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Project description:BackgroundInnovative interventions are needed to address gaps in preventive cancer care, especially in rural areas. This study evaluated the impact of clinical decision support (CDS) with and without shared decision making (SDM) on cancer-screening completion.MethodsIn this 3-arm, parallel-group, cluster-randomized trial conducted at a predominantly rural medical group, 34 primary care clinics were randomized to clinical decision support (CDS), CDS plus shared decision making (CDS+SDM), or usual care (UC). The CDS applied web-based clinical algorithms identifying patients overdue for United States Preventive Services Task Force-recommended preventive cancer care and presented evidence-based recommendations to patients and providers on printouts and on the electronic health record interface. Patients in the CDS+SDM clinic also received shared decision-making tools (SDMTs). The primary outcome was a composite indicator of the proportion of patients overdue for breast, cervical, or colorectal cancer screening at index who were up to date on these 1 y later.ResultsFrom August 1, 2018, to March 15, 2019, 69,405 patients aged 21 to 74 y had visits at study clinics and 25,198 were overdue for 1 or more cancer screening tests at an index visit. At 12-mo follow-up, 9,543 of these (37.9%) were up to date on the composite endpoint. The adjusted, model-derived percentage of patients up to date was 36.5% (95% confidence interval [CI]: 34.0-39.1) in the UC group, 38.1% (95% CI: 35.5-40.9) in the CDS group, and 34.4% (95% CI: 31.8-37.2) in the CDS+SDM group. For all comparisons, the screening rates were higher than UC in the CDS group and lower than UC in the CDS+SDM group, although these differences did not reach statistical significance.ConclusionThe CDS did not significantly increase cancer-screening rates. Exploratory analyses suggest a deeper understanding of how SDM and CDS interact to affect cancer prevention decisions is needed. Trial registration: ClinicalTrials.gov ID: NCT02986230, December 6, 2016.

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: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:BackgroundPoor patient-provider communication, among other reasons, is a notable barrier to contraceptive decision-making among Latinas. Patient-centered approaches to contraceptive counseling that optimize communication align with shared decision-making (SDM) -which is associated with satisfaction and continued contraceptive use among various populations.ObjectiveTo examine associations of patient-provider communication and importance of SDM tenets with consistent contraceptive use among a population of Latinas.Patient involvementFormative work for this study included prior qualitative and quantitative research with Latinas who expressed the importance of patient-provider communication during contraceptive counseling and therefore were instrumental in problem definition.MethodsCross-sectional surveys were administered to Latinas ages 15-29 years. Patient-provider communication, patient-reported importance of specific SDM tenets, and consistent contraception use were measured and analyzed for associations.Results103 Latinas (mean age = 21.4) participated. 33% of participants<21 years were using contraception consistently vs. 67% for those ≥ 21 (p = 0.003). Among participants ≥ 21, consistent users reported higher communication scores compared to inconsistent users and non-users (p = 0.042). For participants< 21, consistent users were more likely than inconsistent users and non-users to report that 2 SDM tenets (discussion of contraceptive preferences and avoidance of race/ethnic-based judgement) are important (p = 0.052, 0.028, respectively).DiscussionPatient-provider communication was especially important for Latinas ≥ 21 while using an SDM approach during counseling was highly valued by those<21. Patient-centered approaches to contraceptive counseling provide opportunities to optimize healthcare delivery for this vulnerable population.Practical valueResults from this research demonstrate that patient-centered communication is highly valued by Latina study participants and is an important consideration in their contraceptive counseling. Clinicians should consider employing techniques such as SDM as they seek to provide patient-centered care during contraceptive counseling for this patient population.

Project description:BackgroundThe Pre-Consultation Educational Group INTERVENTION pilot study seeks to assess the feasibility and inform the optimal design for a definitive randomized controlled trial that aims to improve the quality of decision-making in postmastectomy breast reconstruction patients.Methods/designThis is a mixed-methods pilot feasibility randomized controlled trial that will follow a single-center, 1:1 allocation, two-arm parallel group superiority design.SettingThe University Health Network, a tertiary care cancer center in Toronto, Canada.ParticipantsAdult women referred to one of three plastic and reconstructive surgeons for delayed breast reconstruction or prophylactic mastectomy with immediate breast reconstruction.InterventionWe designed a multi-disciplinary educational group workshop that incorporates the key components of shared decision-making, decision-support, and psychosocial support for cancer survivors prior to the initial surgical consult. The intervention consists of didactic lectures by a plastic surgeon and nurse specialist on breast reconstruction choices, pre- and postoperative care; a value-clarification exercise led by a social worker; and discussions with a breast reconstruction patient.ControlUsual care includes access to an informational booklet, website, and patient volunteer if desired.OutcomesExpected pilot outcomes include feasibility, recruitment, and retention targets. Acceptability of intervention and full trial outcomes will be established through qualitative interviews. Trial outcomes will include decision-quality measures, patient-reported outcomes, and service outcomes, and the treatment effect estimate and variability will be used to inform the sample size calculation for a full trial.DiscussionOur pilot study seeks to identify the (1) feasibility, acceptability, and design of a definitive RCT and (2) the optimal content and delivery of our proposed educational group intervention. Thirty patients have been recruited to date (8 April 2013), of whom 15 have been randomized to one of three decision support workshops. The trial will close as planned in May 2013.Trial registrationNCT01857882.

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:AimsTo assess the intervention effects of BREATHE (BRief intervention to Evaluate Asthma THErapy), a novel brief shared decision-making intervention and evaluate feasibility and acceptability of intervention procedures.DesignGroup-randomized longitudinal pilot study.MethodsIn total, 80 adults with uncontrolled persistent asthma participated in a trial comparing BREATHE (N = 40) to a dose-matched attention control intervention (N = 40). BREATHE is a one-time shared decision-making intervention delivered by clinicians during routine office visits. Ten clinicians were randomized and trained on BREATHE or the control condition. Participants were followed monthly for 3 months post-intervention. Data were collected from December 2017 - May 2019 and included surveys, lung function tests, and interviews.ResultsParticipants were Black/multiracial (100%) mostly female (83%) adults (mean age 45). BREATHE clinicians delivered BREATHE to all 40 participants with fidelity based on expert review of audiorecordings. While the control group reported improvements in asthma control at 1-month and 3-month follow-up, only BREATHE participants had better asthma control at each timepoint (β = 0.77; standard error (SE)[0.17]; p ≤ 0.0001; β = 0.71; SE[0.16]; p ≤ 0.0001; β = 0.54; SE[0.15]; p = .0004), exceeding the minimally important difference. BREATHE participants also perceived greater shared decision-making occurred during the intervention visit (β = 7.39; SE[3.51]; p = .03) and fewer symptoms at follow-up (e.g., fewer nights woken, less shortness of breath and less severity of symptoms) than the controls. Both groups reported improved adherence and fewer erroneous medication beliefs.ConclusionBREATHE is a promising brief tailored intervention that can be integrated into office visits using clinicians as interventionists. Thus, BREATHE offers a pragmatic approach to improving asthma outcomes and shared decision-making in a health disparity population.ImpactThe study addressed the important problem of uncontrolled asthma in a high-risk vulnerable population. Compared with the dose-matched attention control condition, participants receiving the novel brief tailored shared decision-making intervention had significant improvements in asthma outcomes and greater perceived engagement in shared decision-making. Brief interventions integrated into office visits and delivered by clinicians may offer a pragmatic approach to narrowing health disparity gaps. Future studies where other team members (e.g., office nurses, social workers) are trained in shared decision-making may address important implementation science challenges as it relates to adoption, maintenance, and dissemination. TRAIL REGISTRATION: clinicaltrials.gov # NCT03300752.

Dataset Information

Teaching Conflicts of Interest and Shared Decision-Making to Improve Risk Communication: a Randomized Controlled Trial.

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Teaching Conflicts of Interest and Shared Decision-Making to Improve Risk Communication: a Randomized Controlled Trial.

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