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Overcoming Therapeutic Inertia in Multiple Sclerosis Care: A Pilot Randomized Trial Applying the Traffic Light System in Medical Education.

ABSTRACT: BACKGROUND:Physicians often do not initiate or intensify treatments when clearly warranted, a phenomenon known as therapeutic inertia (TI). Limited information is available on educational interventions to ameliorate knowledge-to-action gaps in TI. OBJECTIVES:To evaluate the feasibility and efficacy of an educational intervention compared to usual care among practicing neurologists caring for patients with multiple sclerosis (MS). METHODS:We conducted a pilot double-blind, parallel-group, randomized clinical trial. Inclusion criteria included neurologists who are actively involved in managing MS patients. Participants were exposed to 20 simulated case-scenarios (10 cases at baseline, and 10 cases post-randomization to usual care vs. educational intervention) of relapsing-remitting MS with moderate or high risk of disease progression. The educational intervention employed a traffic light system (TLS) to facilitate decisions, allowing participants to easily recognize high-risk scenarios requiring treatment escalation. We also measured differences between blocks to invoke decision fatigue. The control group responded as they would do in their usual clinical practice not exposed to the educational intervention. The primary feasibility outcome was the proportion of participants who completed the study and the proportion of participants who correctly identified a high-risk case-scenario with the "red traffic light." Secondary outcomes included decision fatigue (defined as an increment of TI in the second block of case-scenarios compared to the first block) and the efficacy of the educational intervention measured as a reduction in TI for MS treatment. RESULTS:Of 30 neurologists invited to be part of the study, the participation rate was 83.3% (n?=?25). Of the 25 participants, 14 were randomly assigned to the control group and 11 to the intervention group. TI was present in 72.0% of participants in at least one case scenario. For the primary feasibility outcome, the completion rate of the study was 100% (25/25 participants). Overall, 77.4% of participants correctly identified the "red traffic light" for clinical-scenarios with high risk of disease progression. Similarly, 86.4% of participants correctly identified the "yellow traffic light" for cases that would require a reassessment within 6-12?months. For the secondary fatigue outcome, within-group analysis showed a significant increased prevalence of TI in the second block of case-scenarios (decision fatigue) among participants randomized to the control group (TI pre-intervention 57.1% vs. TI post-intervention 71.4%; p?=?0.015), but not in the active group (TI pre-intervention 54.6% vs. TI post-intervention 63.6%; p?=?0.14). For the efficacy outcome, we found a non-significant reduction in TI for the targeted intervention compared to controls (22.6 vs. 33.9% post-intervention; OR 0.57; 95% CI 0.26-1.22). CONCLUSION:An educational intervention applying the TLS is feasible and shows some promising results in the identification of high-risk scenarios to reduce decision fatigue and TI. Larger studies are needed to determine the efficacy of the proposed educational intervention. CLINICAL TRIAL REGISTRATION:www.ClinicalTrials.gov, identifier NCT03134794.

SUBMITTER: Saposnik G

PROVIDER: S-EPMC5567059 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Overcoming Therapeutic Inertia in Multiple Sclerosis Care: A Pilot Randomized Trial Applying the Traffic Light System in Medical Education.

Saposnik Gustavo G Maurino Jorge J Sempere Angel P AP Terzaghi Maria A MA Ruff Christian C CC Mamdani Muhammad M Tobler Philippe N PN Montalban Xavier X

Frontiers in neurology 20170821

<h4>Background</h4>Physicians often do not initiate or intensify treatments when clearly warranted, a phenomenon known as therapeutic inertia (TI). Limited information is available on educational interventions to ameliorate knowledge-to-action gaps in TI.<h4>Objectives</h4>To evaluate the feasibility and efficacy of an educational intervention compared to usual care among practicing neurologists caring for patients with multiple sclerosis (MS).<h4>Methods</h4>We conducted a pilot double-blind, p ...[more]

PMID: 28871238

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Project description:Importance: The prescription of generic (non-proprietary) compared to brand-name drugs is increasing worldwide. In many developing and emerging countries, generics companies market products at similar costs as brand-name competitors benefiting from more flexible compliance rules and regulations for marketing their products in the health system. Together, this phenomenon may influence prescriber's behavior (e.g., maintaining the same treatment despite guideline's recommendations or despite evidence of disease progression). Objectives: To compare the prevalence of therapeutic inertia (TI) between primary prescription of brand-name vs. generic drugs in the management of MS in Argentina. Design: We conducted a population-based online study comprising 117 neurologists with expertise in MS. Participants answered questions regarding their clinical practice, most commonly prescribed disease modifying agents, and therapeutic choices of 10 simulated case-scenarios that assessed TI. Inertia was defined as the lack of treatment initiation or escalation despite evidence of clinical and radiological activity (8 case-scenarios, 720 individual responses). We created the generic-brand name score (GBS) according to the 5 most frequently prescribed generic (n = 16) vs. brand-name (n = 9) drugs for MS, where scores higher than 1 indicated higher prescription of generic drugs and scores lower than 1 indicated higher prescription of brand-name agents. Candidate predictors of prescribing generic drugs included demographic data, MS specialist vs. general neurologist, practice setting, years of practice, volume of MS patients, risk preferences, costs of annual treatment. Participants and setting: population-based prospective study using including neurologists who care for patients with multiple sclerosis across Argentina. Exposure: prescription of generic vs. brand-name MS drugs Main outcome of interest: Therapeutic inertia (TI), defined as lack of treatment escalation when goals are unmet. Secondary outcomes included factors associated with generic drug prescription and costs of MS treatment. Results: Ninety participants completed the study (completion rate 76.9%). TI was observed in 153 (21.3%) of participants' responses. The evaluation of aggregate responses revealed a mean GBS score (SD) of 3.44 (2.1), with 46 (51.1%) participants having a GBS equal to or higher than 1. Older age (OR 1.19; 95% CI 1.00-1.42), being a general neurologist (OR 3.91; 95% CI 1.19-12.8), and being more willing to take risks in multiple domains (SOEP score OR 1.06, 95% CI 1.01-1.12) were associated with higher prescription of generic drugs in MS care. Costs of treatment were not associated with prescribing generic drugs. There was no difference in the annual costs of MS treatment for primary prescribers of brand-name vs. generic drugs (67,500 US$ vs. 67,496 US$; p = 0.99). The evaluation of individual responses revealed that participants with higher prescription of generics-reflected by a higher GBS-had higher incident risk of TI (mean GBS 3.61 for TI vs. 2.96 for no TI; p < 0.001). Multivariate analysis revealed that a prescription of generic agents was associated with an increased incident risk of TI (OR 1.56; 95%CI 1.07-2.29). There was no difference in the annual costs of MS treatment for participants that exhibited TI vs. those without TI (67,426 US$ vs. 67,704 US$; p = 0.66). Conclusions: General neurologist, older age, and willingness to take risks were associated with increased prescription of generic drugs despite similar costs compared to brand-name agents. In our study, the prescription of generic-MS drugs was associated with a higher incident risk of therapeutic inertia.

Project description:ImportanceThere is growing interest in understanding and addressing factors that govern the decision-making process in multiple sclerosis (MS) care. Therapeutic inertia (TI) is the failure to escalate therapy when goals are unmet. Limited data are available on the prevalence of TI and factors affecting therapeutic decisions in the management of patients with MS worldwide.ObjectivesTo compare TI across 4 countries (Canada, Argentina, Chile, and Spain) and to identify factors contributing to TI.Design, setting, and participantsProspective cohort study conducted between July 10, 2017, and May 4, 2018. Participants were exposed to behavioral experiments in which instruments were used to assess their risk preferences (eg, aversion to ambiguity) and therapeutic decisions in 10 simulated MS case scenarios. Mixed-effects linear and logistic regression analyses were performed to determine the association between the participants' baseline characteristics and TI. The association of unmeasured confounders was assessed by the E-value and a bootstrapping analysis. This multicenter study included neurologists practicing at academic and community centers in Canada, Argentina, Chile, and Spain who make therapeutic decisions for patients with MS.Main outcomes and measuresThe primary outcome was the prevalence of TI. The TI score was calculated by dividing the number of case scenarios in which participants showed TI by the number of case scenarios that measured TI. Higher TI scores indicated greater degrees of TI. The secondary outcome was the identification of factors that contributed to TI.ResultsOf 300 neurologists with expertise in MS care who were invited to be part of the study, 226 (75.3%) agreed to participate. Among those who initially showed interest in participating, 195 physicians (86.3%) completed the study, while 31 did not. The mean (SD) age of participants was 43.3 (11.2) years; 52.3% were male. Therapeutic inertia was present in 72.8% (142 of 195) of participants, leading to suboptimal decisions in 20.4% (318 of 1560) of case scenarios. The prevalence of TI among the Canadian group was the lowest compared with the other 3 countries (60.0% [33 of 55] vs 77.9% [109 of 140]; P = .01). For the primary outcome, the TI score in the Canadian group (mean [SD], 0.98 [1.15]) was significantly lower compared with groups from other countries (mean [SD], 1.70 [1.43] for Argentina, 2.24 [1.54] for Chile, and 2.56 [1.64] for Spain) (P = .001). The mixed-effects linear models revealed that participants from Argentina, Chile, and Spain (combined) had higher TI scores compared with their Canadian counterparts (β coefficient, 0.90; 95% CI, 0.52-1.28; P < .001). A higher number of patients with MS per week (OR, 0.44; 95% CI, 0.22-0.88), years of practice (OR, 0.93; 95% CI, 0.86-0.99), and participation from Canada (OR, 0.47; 95% CI, 0.23-0.96) were associated with a lower likelihood of TI. Aversion to ambiguity was associated with a 2-fold higher likelihood of TI (OR, 2.25; 95% CI, 1.02-5.00). All 95% CIs of the β coefficients of covariates were lower than the E-value of 2.35, making it unlikely for the results to be due to the association of unmeasured confounders.Conclusions and relevanceThis study showed that Canadian participants had the lowest prevalence and magnitude of TI. Higher TI scores were associated with a lower expertise in MS care and with a greater tendency for aversion to ambiguity.

Project description:BackgroundQuality improvement (QI) is an essential component of modern clinical practice. Front-line professionals offer valuable perspectives on areas for improvement and are motivated to deliver change. In the UK, all junior doctors are expected to participate in QI in order to advance to the next stage of their training. However, UK undergraduates receive no standardized training in QI methods. This is perpetuated within medical schools by a lack of teaching capacity and competing priorities, and may lead to tokenistic engagement with future QI projects.MethodsWe describe a near-peer teaching programme designed to introduce students to QI methods. This pilot study was conceived and delivered in full by junior doctors and used existing resources to ensure high quality teaching content. 111 fifth-year medical students from the University of Cambridge were taught in interactive, participative workshops that encourage them to develop their own QI change ideas and projects. Core topics included the model for improvement, driver diagrams, stakeholder engagement, measurement for improvement and analysing and presenting data. Students completed surveys before and immediately after this intervention to assess their understanding of and confidence in utilizing QI methods. Questionnaires were also completed by junior doctor tutors.ResultsAnalysis of questionnaires completed before and immediately after the intervention revealed statistically significant improvements in students' self-reported understanding of QI (p < 0.05) and confidence in applying techniques to their own work (p < 0.05). Students expressed a preference for QI teaching delivered by junior doctors, citing a relaxed learning environment and greater relevance to their stage of training. Tutors reported increased confidence in using QI techniques and a greater willingness to engage with QI in future.ConclusionsIn this single-centre study, near-peer teaching produced significant improvements in students' self-reported understanding of QI and confidence in applying QI methods. Near-peer teaching may constitute a sustainable means of teaching essential QI skills at undergraduate level. Future work must evaluate objective measures of student engagement with and competence in conducting QI.

Dataset Information

Overcoming Therapeutic Inertia in Multiple Sclerosis Care: A Pilot Randomized Trial Applying the Traffic Light System in Medical Education.

Publications

Overcoming Therapeutic Inertia in Multiple Sclerosis Care: A Pilot Randomized Trial Applying the Traffic Light System in Medical Education.

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