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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: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: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: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.

Project description:BackgroundA birth plan (BP) is a written document in which the pregnant woman explains her wishes and expectations about childbirth to the health professionals and aims to facilitate her decision-making. Midwives' support to women during the development of the BP is essential, but it's unknown if shared decision making (SDM) is effective in birth plan counselling. We hypothesized that women who receive counselling based on SDM during their pregnancy are more likely to present their BP to the hospital, more satisfied with the childbirth experience, and have better obstetric outcomes than women who receive standard counselling. We also aimed to identify if women who presented BP to the hospital have better obstetric outcomes and more satisfied with the childbirth experience.MethodsThis was a randomised cluster trial involving four Primary Care Units. Midwives provided BP counselling based on SDM to the women in the intervention group (IG) during their pregnancy, along with a leaflet with evidence-based recommendations. Women in the control group (CG) only received the standard birth plan counselling from midwives. The primary outcomes were birth plan presentation to the hospital, obstetrics outcomes and satisfaction with childbirth experience. The Mackey Satisfaction with Childbirth Scale (MCSRS) was used to measure childbirth satisfaction.ResultsA total of 461 (95.5%) pregnant women received BP counselling (IG n = 214 and CG n = 247). Fewer women in the intervention group presented their BP to the hospital compared to those in the control group (57.8% vs 75.1%; p <0.001). Mean satisfaction with childbirth experience was high in the IG as well as the CG: 150.2 (SD:22.6) vs. 153.4 (SD:21.8); p = 0.224). The information received about childbirth during pregnancy was high in both groups (95.1% vs 94.8%; p = 1.0). Fewer women in the IG used analgesia epidural compared to those in the CG (84.7% vs 91.7%; p = 0.034); women who combined non-pharmacological and pharmacological methods for pain relief were more in number in the IG (48.9% vs 29.5%; p = 0.001) and women who began breastfeeding in the delivery room were more in number in the IG (83.9% vs 66.3%; p = 0.001). Women who presented their BP had a greater probability of using combined non-pharmacological and pharmacological methods for pain relief aOR = 2.06 (95% CI: 1.30-4.30) and early skin-to-skin contact aOR = 2.08 (95% CI: 1.07-4.04).ConclusionThis counselling intervention was not effective to increase the presentation of the BP to the hospital and women's satisfaction with childbirth; however, it was related to a lower usage of analgesia epidural, a higher combination of pharmacological and non-pharmacological methods for pain relief and the initiation of breastfeeding in the delivery room. Presenting the BP to the hospital increased the likelihood of using pharmacological and non-pharmacological methods for pain relief, and early skin-to-skin contact.

Dataset Information

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

Publications

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

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