Traffic Lights Intervention Reduces Therapeutic Inertia: A Randomized Controlled Trial in Multiple Sclerosis Care.
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SUBMITTER: Saposnik G
PROVIDER: S-EPMC6589979 | biostudies-literature | 2019 Jan-Jun
REPOSITORIES: biostudies-literature
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Traffic Lights Intervention Reduces Therapeutic Inertia: A Randomized Controlled Trial in Multiple Sclerosis Care.
Saposnik Gustavo G Mamdani Muhammad M Montalban Xavier X Terzaghi Maria M Silva Berenice B Saladino Maria Laura ML Tobler Philippe N PN Caceres Fernando F
MDM policy & practice 20190101 1
<b>Background:</b> Therapeutic inertia (TI) is a common phenomenon among physicians who care for patients with chronic conditions. We evaluated the efficacy of the traffic light system (TLS) educational intervention to reduce TI among neurologists with MS expertise. <b>Methods:</b> In this randomised, controlled trial, 90 neurologists who provide care to MS patients were randomly assigned to the TLS intervention (<i>n</i> = 45) or to the control group (<i>n</i> = 45). The educational interventio ...[more]
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Project description:Background: Educational interventions are needed to overcome knowledge-to-action gaps in clinical care. We previously tested the feasibility and potential efficacy of an educational intervention that facilitates treatment decisions in multiple sclerosis care. A demonstration of the usability of such an intervention is crucial prior to demonstration of efficacy in a large trial. Objectives: To evaluate the usability of a novel, pilot-tested intervention aimed at neurologists to improve therapeutic decisions in multiple sclerosis (MS) care. Methods: We surveyed 50 neurologists from Chile, Argentina, and Canada randomized to an educational intervention arm of a pilot feasibility study using the System Usability Score (SUS) to assess the usability of a traffic light system (TLS)-based educational intervention. The TLS facilitates therapeutic decisions, allowing participants to easily recognize high-risk scenarios requiring treatment escalation. The SUS is a validated 10-item questionnaire with five response options. The primary outcome was the average and 95% confidence interval (CI) of the SUS score. Values above 68 are considered highly usable. Results: Of 50 neurologists invited to be part of the study, all completed the SUS scale and the study. For the primary outcome, the average usability score was 74.7 (95%CI 70.1-79.2). There was one outlier with a score of 35. The usability score excluding the outlier was 76.8 (95%CI 72.7-80.8). Multivariate analysis revealed no association between participants' characteristics and the SUS score. Conclusions: Our educational intervention has shown high usability among neurologists. The next step is to evaluate the effectiveness of this educational intervention in facilitating treatment decisions for the management of multiple sclerosis in a large trial.
| S-EPMC6048250 | biostudies-literature
Project description:BackgroundPhysicians 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.ObjectivesTo evaluate the feasibility and efficacy of an educational intervention compared to usual care among practicing neurologists caring for patients with multiple sclerosis (MS).MethodsWe 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.ResultsOf 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).ConclusionAn 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 registrationwww.ClinicalTrials.gov, identifier NCT03134794.
| S-EPMC5567059 | biostudies-literature
Project description:ImportanceTherapeutic inertia (TI) is the failure to escalate therapy when treatment goals are unmet and is associated with low tolerance to uncertainty and aversion to ambiguity in physician decision-making. Limited information is available on how physicians handle therapeutic decision-making in the context of uncertainty.ObjectiveTo evaluate whether an educational intervention decreases TI by reducing autonomic arousal response (pupil dilation), a proxy measure of how physicians respond to uncertainty during treatment decisions.Design, setting, and participantsIn this randomized clinical trial, 34 neurologists with expertise in multiple sclerosis (MS) practicing at 15 outpatient MS clinics in academic and community institutions from across Canada were enrolled. Participants were randomly assigned to receive an educational intervention that facilitates treatment decisions (active group) or to receive no exposure to the intervention (usual care [control group]) from December 2017 to March 2018. Participants listened to 20 audio-recorded simulated case scenarios as pupil responses were assessed by eye trackers. Autonomic arousal was assessed as pupil dilation in periods in which critical information was provided (first period [T1]: clinical data, second period [T2]: neurologic status, and third period [T3]: magnetic resonance imaging data). Data were analyzed from September 2018 to March 2020.InterventionsThe traffic light system (TLS)-based educational intervention vs usual care (unexposed). The TLS (use of established associations between traffic light colors and actions to stop or proceed) assists participants in identifying factors associated with worse prognosis in MS care, thereby facilitating the treatment decision-making process by use of established associations between red, green, and yellow colors and risk levels, and actions (treatment decisions).Main outcomes and measuresPupil assessment was the primary autonomic outcome. To test the treatment effect of the educational intervention (TLS), difference-in-differences models (also called untreated control group design with pretest and posttest) were used.ResultsOf 38 eligible participants, 34 (89.4%) neurologists completed the study. The mean (SD) age was 44.6 (11.6) years; 38.3% were female and 20 (58.8%) were MS specialists. Therapeutic inertia was present in 50.0% (17 of 34) of all participants and was associated with greater pupil dilation. For every additional SD of pupil dilation, the odds of TI increased by 51% for T1 (odds ratio, 1.51; 95% CI, 1.12-2.03), by 31% for T2 (odds ratio, 1.31; 95% CI, 1.08-1.59), and by 49% for T3 (odds ratio, 1.49; 95% CI, 1.13-1.97). The intervention significantly reduced TI (risk reduction, 31.5%; 95% CI, 16.1%-47.0%). Autonomic arousal responses mediated 29.0% of the effect of the educational intervention on TI.Conclusions and relevanceIn this randomized clinical trial, the TLS intervention decreased TI as measured by pupil dilation, which suggests that individual autonomic arousal is an indicator of how physicians handle uncertainty when making live therapeutic decisions. Pupil response, a biomarker of TI, may eventually be useful in medical education.Trial registrationClinicalTrials.gov Identifier: NCT03134794.
| S-EPMC7745101 | biostudies-literature
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.
| S-EPMC6194175 | biostudies-literature
Project description:As a molecular chaperone and activator of Toll-like receptor 2-mediated protective responses by microglia and macrophages, the small heat shock protein alpha B-crystallin (HspB5) exerts therapeutic effects in different animal models for neuroinflammation, including the model for multiple sclerosis (MS). Yet, HspB5 can also stimulate human antigen-specific memory T cells to release IFN-?, a cytokine with well-documented detrimental effects during MS. In this study, we explored in a Phase IIa randomized clinical trial the therapeutic application of HspB5 in relapsing-remitting MS (RR-MS), using intravenous doses sufficient to support its protective effects, but too low to trigger pathogenic memory T-cell responses. These sub-immunogenic doses were selected based on in vitro analysis of the dose-response profile of human T cells and macrophages to HspB5, and on the immunological effects of HspB5 in healthy humans as established in a preparatory Phase I study. In a 48-week randomized, placebo-controlled, double-blind Phase IIa trial, three bimonthly intravenous injections of 7.5, 12.5 or 17.5 mg HspB5 were found to be safe and well tolerated in RR-MS patients. While predefined clinical endpoints did not differ significantly between the relatively small groups of MS patients treated with either HspB5 or placebo, repeated administration especially of the lower doses of HspB5 led to a progressive decline in MS lesion activity as monitored by magnetic resonance imaging (MRI), which was not seen in the placebo group. Exploratory linear regression analysis revealed this decline to be significant in the combined group receiving either of the two lower doses, and to result in a 76% reduction in both number and total volumes of active MRI lesions at 9 months into the study. These data provide the first indication for clinical benefit resulting from intervention in RR-MS with HspB5.ClinicalTrials.gov Phase I: NCT02442557; Phase IIa: NCT02442570.
| S-EPMC4657879 | biostudies-literature
Project description:ObjectivesLimited information is available on physician-related factors influencing therapeutic inertia (TI) in multiple sclerosis (MS). Our aim was to evaluate whether physicians' risk preferences are associated with TI in MS care, by applying concepts from behavioral economics.DesignIn this cross-sectional study, participants answered questions regarding the management of 20 MS case scenarios, completed 3 surveys, and 4 experimental paradigms based on behavioral economics. Surveys and experiments included standardized measures of aversion ambiguity in financial and health domains, physicians' reactions to uncertainty in patient care, and questions related to risk preferences in different domains. The primary outcome was TI when physicians faced a need for escalating therapy based on clinical (new relapse) and magnetic resonance imaging activity while patients were on a disease-modifying agent.ResultsOf 161 neurologists who were invited to participate in the project, 136 cooperated with the study (cooperation rate 84.5%) and 96 completed the survey (response rate: 60%). TI was present in 68.8% of participants. Similar results were observed for definitions of TI based on modified Rio or clinical progression. Aversion to ambiguity was associated with higher prevalence of TI (86.4% with high aversion to ambiguity vs. 63.5% with lower or no aversion to ambiguity; p = 0.042). In multivariate analyses, high aversion to ambiguity was the strongest predictor of TI (OR 7.39; 95%CI 1.40-38.9), followed by low tolerance to uncertainty (OR 3.47; 95%CI 1.18-10.2).ConclusionTI is a common phenomenon affecting nearly 7 out of 10 physicians caring for MS patients. Higher prevalence of TI was associated with physician's strong aversion to ambiguity and low tolerance of uncertainty.
| S-EPMC5331032 | biostudies-literature
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.
| S-EPMC6647550 | biostudies-literature
Project description:BACKGROUND: Relaxation, mindfulness, social support, and education (RMSSE) have been shown to improve emotional symptoms, coping, and fatigue in multiple sclerosis (MS). Biofeedback was trialed as a psychological intervention, designed to improve self-control, in two groups of patients with MS. Both groups received RMSSE, and one group additionally received biofeedback. METHODS: Forty people with relapsing-remitting MS were recruited from three sites in Sydney, Australia. The mean disability score (Expanded Disability Status Scale; EDSS) was 2.41 ± 1.46 (95% confidence interval [CI], 1.46-3.36); the mean age in years was 45.9 ± 12.42 (95% CI, 41.92-49.87). Participants were randomly assigned to two active treatment groups (n = 20 per group). All participants received one 1-hour session per week for 3 weeks of RMSSE, while biofeedback equipment measured breathing rate and muscle tension. Members of one group used biofeedback screens to regulate physiological response. RESULTS: Whole-group pre- and post-treatment scores demonstrated a reduction of 38% for anxiety and 39% for depression scores (P = .007 and P = .009, respectively). A post-treatment comparison failed to demonstrate any significant difference between the two active treatment groups in anxiety and depression scores. The biofeedback group showed significant pre- to post-treatment improvement or trends toward improvement in anxiety, fatigue, and stress (P = .05, .02, and .03, respectively). Comparison of pre-post treatment results between groups showed improvements for the biofeedback group in breathing rate and muscle tension (P = .06 and .09). CONCLUSIONS: For relapsing-remitting MS patients receiving biofeedback in addition to RMSSE, there was a demonstrable reduction in anxiety, fatigue, and stress. There was also a trend toward significant reduction of breathing rate and muscle tension in favor of biofeedback.
| S-EPMC4455862 | biostudies-other
Project description:Poor handover between doctors is a recognised cause of error in hospitals.[1] Watford General Hospital is a busy acute trust in southern England, where high admission rates necessitate timely patient transfers from the acute admissions unit (AAU) to the medical wards. We found that doctors were infrequently informed of patient transfers, and they rarely handed over patient care when a patient was moved. Our aim was to minimise preventable harm to patients by prompting handover of clinically unstable patients, and patients with outstanding investigations or referrals, at the time of transfer. We introduced a traffic light tool to categorise patients on the medical take as red, amber, or green according to their clinical status at time of admission to AAU. The traffic light colour, which was assigned both on paper and electronically, was designed to prompt a verbal handover between doctors at the time of patient transfer from AAU.
| S-EPMC4645829 | biostudies-literature
Project description:Rapid advances are occurring in multiple sclerosis disease modifying therapies. Recent therapeutic advances include modifications to improve tolerability of existing products (e.g. interferon beta and glatiramer acetate), development of novel anti-neuroinflammatory medications (e.g. fingolimod, teriflunomide and dimethyl fumarate, daclizumab, alemtuzumab, ocrelizumab) and investigation of treatments in progressive MS (e.g. natalizumab, mastinib, natalizumab, siponimod). The impact of vitamin D supplementation on the disease course in relapsing MS patients is also being studied in several clinical trials. This article reviews the current state of the field with a forward look to the next phase of MS research that could focus on strategies to promote remyelination and provide neuronal protection.
| S-EPMC3975801 | biostudies-literature