Search

Background: Drug-eluting stents reduce the risk of restenosis in patients undergoing percutaneous coronary intervention, but their use necessitates prolonged dual antiplatelet therapy, which increases costs and bleeding risk, and which may delay elective surgeries. While >80% of patients in the United States receive drug-eluting stents, less than a third report that their physicians discussed options with them. Methods and Results: An individualized shared decision-making (SDM) tool for stent selection was designed and implemented at 2 US hospitals. In the postimplementation phase, all patients received the SDM tool before their procedure, with or without decision coaching from a trained nurse. All patients were interviewed with respect to their knowledge of stents, their participation in SDM, and their stent preference. Between May 2014 and December 2016, 332 patients not receiving the SDM tool, 113 receiving the SDM tool with coaching, and 136 receiving the tool without coaching were interviewed. Patients receiving the SDM tool + coaching, as compared with usual care, demonstrated higher knowledge scores (mean difference +1.8; P P P Conclusions: An SDM tool for stent selection was associated with improvements in patient knowledge and SDM only when accompanied by decision coaching. However, the SDM tool (with or without coaching) had no impact on stent selection or concordance between patients’ stent preference and stent received, suggesting that physician-level barriers to SDM may exist. Clinical Trial Information URL: https://www.clinicaltrials.gov . Unique Identifier: NCT02046902.

Background: Alteplase does not uniformly benefit patients with acute ischemic stroke (AIS). Variable times since symptom onset, age, comorbidities and symptom severity add much uncertainty to physicians’ ability to knowledgeably individualize clinical decision-making. This contributes to the recent controversy regarding ACEP-authored expert guidelines which support presentation of risks and benefits and a process of shared decision-making. We previously developed the RESOLVE decision support tool for generating personalized estimates of the benefits and risk of alteplase and developed implementation strategies for both the Emergency Department (ED) and Telehealth settings. This study was a survey of physicians in rural hospitals within a large stroke network to quantify physician’s satisfaction and confidence in treating AIS after having access to the RESOLVE tool. Methods: To provide rural ED physicians access to the RESOLVE decision support tool prior to the administration of alteplase for AIS, nurses at a centralized Telehealth system were trained to enter the data elements required to run the RESOLVE model and fax the tool to the rural hospital immediately, while the provider was waiting for a neurologist’s consultation from the comprehensive stroke center. We then conducted semi-structured interviews of rural hospital physicians who used the tool as soon as possible. We interviewed 14/28 physicians at 7 critical access hospitals, 6 rural community hospital and one urban public that used the RESOLVE tool in decision making during a 6 month pilot. Results: Providers strongly agreed the tool was helpful in discussing potential risks and benefits with the patient or family. Having the knowledge of the individualized patient risk of hemorrhage, and being able to inform the patient/family, was a theme that emerged from qualitative analyses of the interviews. “Knowing the risk of hemorrhage was only 3% made me more comfortable giving IV tPA” - ED Physician, Critical Access Hospital “[I] used it to discuss the risk of hemorrhage with the patient/family. That was very helpful.” - ED Physician, Urban Public Hospital “…used it to discuss the benefits and risks, having it helped me to know what to discuss with the patient/family.” - ED Physician, Rural Community Hospital Study limitations included the difficulty in interviewing physicians due to 12-hour work shift and those practicing as a locum tenens. Additionally, the timing and fax location was a limitation in some physicians seeing the tool prior to prior to treatment. Conclusions: The preliminary results showed the rural hospital providers saw value in the RESOLVE tool while discussing the risks and benefits with patient/family. Future strategies would include process changes to expedite the faxing of the RESOLVE tool.

Background— National guidelines endorse recombinant tissue-type plasminogen activator (r-tPA) in eligible patients with acute ischemic stroke to improve patients’ functional recovery. However, 23% to 40% of ideal candidates with acute ischemic stroke for reperfusion are not treated, perhaps because of the difficulty in explaining the benefits and risks of r-tPA within the frenetic pace of emergency department care. To support better knowledge transfer and creation of a shared decision-making tool, we conducted qualitative interviews to define the information needs and preferred presentation format for stroke survivors, caregivers, and clinicians considering r-tPA treatment. Methods and Results— A multidisciplinary team used qualitative research methods to identify informational needs and strategies for describing the benefits and risks of r-tPA in a clinical setting. Through focus groups (n=10) of stroke survivors (n=39) and caregivers (n=24) and individual interviews with emergency physicians (n=23) and advanced practice nurses (n=20), several themes emerged. Survivors and caregivers preferred a broader definition of a good outcome (independence, rather than no significant disability), simpler graphs as compared with detailed pictographs, and presentation of both population and individualized benefits (framed positively) and risk of receiving r-tPA. Some physicians expressed skepticism with the data and the ability to present risk/benefit information emergently, whereas other physicians and most advanced practice nurses thought such information would improve care. Physicians stressed the importance of presenting the risk of thrombolytic-related intracranial hemorrhage. Conclusions— This study suggests that a positively framed risk–benefit tool with graphical presentations of general and patient-specific risk estimates could support patients and providers in considering r-tPA for acute ischemic stroke. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01864928.

Background The foundation of precision medicine is the ability to tailor therapy based upon the expected risks and benefits of treatment for each individual patient. In a prior study, we implemented a software platform, e PRISM, to execute validated risk-stratification models for patients undergoing percutaneous coronary intervention and found substantial variability in the use of the personalized estimates to tailor care. A better understanding of physicians' perspectives about the use of individualized risk-estimates is needed to overcome barriers to their adoption. Methods In a qualitative research study, we conducted interviews, in-person or by telephone, with 27 physicians at 8 centers that used e PRISM until thematic saturation occurred. Data were coded using descriptive content analyses. Results Three major themes emerged among physicians who did not use e PRISM to support decision making: (1) "Experience versus Evidence," physicians' preference to rely upon personal experience and subjective assessments rather than objective risk estimates; (2) "Omission of Therapy," the perception that the use of risk models leads to unacceptable omission of potentially beneficial therapy; and (3) "Unnecessary Information," the opinion that information derived from risk models is not needed because physicians' decision making is already sound and they already know the information. Conclusions Barriers to the use of risk models in clinical practice include physicians' perceptions that their experience is sufficient, that models may lead to omission of therapy in patients that may benefit from therapy, and that they already provide good care. Anticipating and overcoming these barriers may improve the adoption of precision medicine.

Background: Cardiac arrest (CA) claims an estimated 300,000 lives in America each year even with cardio-pulmonary resuscitation (CPR) efforts. Additionally, of the patients who survive CPR and are discharged, many have suffered anoxic brain injury. Clinically, mild therapeutic hypothermia (TH) immediately post CA increases the odds of survival as well as improves neurological recovery and outcomes 6 months post-CA. Studies report that a small percent of CA patients recall their experience, but little is known regarding patient recall of hypothermia treatment post CA. This qualitative study seeks to understand the experience of survivors of CA and TH. Methods: A qualitative phenomenology study was conducted at a single center with survivors 12-24 months following CA and TH. Face-to-face or telephone interviews were audio recorded with each subjects’ permission and then transcribed verbatim. Transcripts were read in their entirety and searched for meaning-units that coalesced into themes. Consensus was achieved by all 3 nurse researchers and member-checked by being posed to a panel of survivors (1 was a subject of this study) which demonstrated thematic saturation yielding credible and trustworthy findings. Results: Six 6 survivors (67% [4 of 6] male, age 19-72 years) were interviewed. Four overall themes emerged: Memory gap - CA- “I can tell you what people told me, because I don’t remember it” and TH -“I don’t remember being cold or uncomfortable or anything like that” ; Filling in the gaps - “Several doctors, from what I understand, told my sister that I would have at least 70% brain loss if I was to wake up” “Everything was told to me”; and Misconceptions - “Even though I have a pacemaker/defibrillator it only operates one side; it doesn’t operate the whole heart. At least that’s what they told me anyway” “Of course, they told me if (my heart rate) got to 300, my heart would explode” ; and Divine coincidence - “My son had just taken a CPR course” “There was a nurse in the restaurant I was at” . Additionally, several patients provided unsolicited compliments of the staff - “I got absolutely outstanding care there ¼ I believe because they got me into hypothermia protocol so quickly, that was probably one of the contributing factors to my success” . Though one patient stated “I wish they’d left me alone” as he had unknowingly been resuscitated against his wishes. Conclusions: Survivors of CA and TH report memory gaps, and then strive to fill in the gaps by family and staff descriptions. Additionally, survivors easily identified an unexplained coincidence that they felt allowed them to successfully recover from their CA. Further study is warranted regarding whether the creation of a specific treatment plan to assist in the accurate recall and story would enhance survivors and family in recovery.

Background: During the early phase of ischemic stroke (IS), thrombolytic (recombinant tissue plasminogen activator; rt-PA) therapy has been shown to effectively reverse symptoms and improve outcomes. However, serious bleeding can occur, which has discouraged both patients and physicians from using rt-PA. The purpose of the overall study is to create a decision-making tool that accurately depicts the risk and benefits of rt-PA in a graphical format that effectively engages physicians, patients and their families. Methods: To better understand the most effective method for presenting the probabilities of outcomes we used eye-tracking technology (Applied Science Laboratories D-6 optics) to assess the manner in which participants studied graphs of varying formats. We recorded which components of the graphs that participants looked at, and how long they looked at these graph components. The graphs were developed from a series of qualitative studies and showed 3 representations rt-PA benefits drawn from the NINDS data: bar; stacked bar; and iconic (person outline figures) graphs. Each presented probabilities for outcomes ranging from little/no disability to severe disability/death and risk of bleeding with or without rt-PA use. Stroke survivors or family members were randomly presented with one of the graphs and asked to imagine they were consulting with a physician about using rt-PA for a family member who had just had a stroke. Comprehension was tested with questions assessing knowledge of the risk and outcome percentages presented in the graphs. Results: Participants (n=12) spent a longer time studying the iconic and bar graphs (mean = 64 seconds and 63 seconds, respectively) than the stacked bar graph (mean = 46 seconds). Study time in different graph regions varied by graph type. Participants spent 16%, 7.5 %, and 1.4 % of their study time looking at the key risk information in the stacked bar, bar, and iconic graphs, respectively. In addition, 4 out of 5 subjects who incorrectly identified the risk of bleeding on the comprehension test had studied the iconic graph. When shown all three formats, participants indicated the iconic graph to be confusing and the stacked bar to be most informative. Conclusions: Our preliminary data suggest that stacked bar graphs facilitate better understanding of the risks and benefits of rt-PA in acute IS. Presenting data in this format could better engage patients and families in making treatment decisions in the setting of IS.

Study Objectives: Multiple guidelines endorse recombinant tissue plasminogen activator (rt-PA) in eligible patients with acute ischemic stroke (AIS), but only 4-6% of patients are treated. Clinician doubts about treatment benefits or operational barriers may be among the reasons for not treating potentially eligible patients. Through qualitative interviews, we sought to better understand the issues and perspectives for AIS treatment from Emergency Medicine Physicians (EMP) and Neurology and Emergency based Advanced Practice Nurses (APN) looking for similarities and differences. Methods: A multidisciplinary research team conducted in-depth interviews of 23 EMPs from 11 sites, and 20 APNs from 18 sites across the US. An interview guide was designed to elicit their current experience using rt-PA in AIS, approach to discussing rt-PA with patients and families, and cultural attitudes. Results: EMPs (male = 74%; 12 average years of experience) and APNs (male = 5%; 9.4 average years of experience) described two themes as shared perspectives: Timely Presentation and Neurology Presence were both thought to be important facilitators to receive rt-PA. However, differing perspectives emerged in four themes: Knowledge of Long-term Outcomes; Impression of Data; Communication of Risk and Benefit; and Use of Written/Educational Material (Table). The themes and representative quotes are presented by subject number and years in practice. Conclusions: While common perspectives were described, mainly contrasting beliefs emerged, most of which provide an opportunity to develop future strategies to improve guideline adherence for rt-PA use in AIS for each discipline.

Background: Explaining the risks and benefits of recombinant tissue plasminogen activator (rt-PA) occurs in a hurried conversation in the emergency department and may not be fully grasped by patients and their caregivers. Risk models describing the heterogeneity of benefits from rt-PA in acute ischemic stroke (AIS) have been created, but are not used in routine clinical practice. To develop a tool (RESOLVE) for modeling each patient’s benefits and risks for rt-PA, we conducted qualitative interviews with survivors, their caregivers and emergency physicians to inform the design and improve usability. Methods: A multidisciplinary research team conducted qualitative research through 10 focus groups of survivors and caregivers. We obtained feedback on their preferred role, desired information and their impressions of alternative formats for presenting risk and benefits. Three emergency physicians from 2 sites have been interviewed (with >15 additional physician interviews being currently conducted, the results of which will supplement these preliminary data at the time of presentation). Results: Survivors and caregivers (63 participants: 39 stroke survivors; 43% male) express a need for more information, including specific risks and benefits to treatment. In general, both groups desired an active role in the acute stroke treatment decision. In contrast, the initial physician interviews indicated a hesitancy to provide NINDS data to patients and caregivers, skepticism of the existing data and cultural barriers to the use of rt-PA in AIS, the latter acquired through residency training or the opinions of their clinical colleagues. The interviewed clinicians, however, felt more positive about using rt-PA when a neurologist was readily available to support the decision. Conclusions: Preliminary findings suggest reluctance by emergency physicians to share data about the benefits of rt-PA to stroke patients and their caregivers, despite the desire of the latter for such information. While the additional planned interviews will be needed to confirm these findings, preliminary insights suggest a compelling need to overcome the reticence of emergency physicians to use clinical data to better engage patients in making a shared decision about rt-PA in AIS.

Background: Explaining the benefits and risks of tissue plasminogen activator (tPA) is typically done through hurried verbal explanations in the emergency department, but it may not be understood by patients and caregivers. However, spending more time to explain the risks and benefits may delay the administration of tPA. We sought to develop a decision aid tool to facilitate this communication. Methods: A multidisciplinary research team searched available materials of stroke descriptions intended for a lay audience. The research team and medical illustrator also developed different formats of presenting results from the NINDS tPA trial. We conducted focus groups of stroke survivors and their caregivers at two medical centers to provide feedback on what information should be communicated and how it should be presented. Results: To date, we have convened three focus groups. We have enrolled 12 stroke survivors with a mean age of 54. Two had received tPA. We also enrolled three caregivers with a mean age of 68. Survivors typically did not recall being educated about acute stroke or its treatment during the hospitalization. Participants preferred broadening the definition of a “good” outcome to functional independence (i.e. modified Rankin score of 0-2) over a narrower one of being symptom-free. They also preferred viewing information about the increased chance of a good outcome rather than the decreased chance of a bad outcome such as death. Participants’ opinions sometimes differed from researchers’, such as the choice of colors to depict good outcome or death and the preference of simple bar graphs over pictographs. Conclusions: The different opinions between researchers and patients and caregivers highlight the need to obtain input from all stakeholders in designing effective decision aid tools. Further focus groups are planned to refine the decision-aid tool. We also plan to pilot-test the implementation of this tool in the workflow of managing patients with stroke in the emergency department.

Background: Intravenous tissue plasminogen activator (IVtPA) is the only approved treatment for acute ischemic stroke (AIS), but is used in only 4-6% of potentially eligible patients. The risk of hemorrhage is fairly easy to communicate, but the benefits of treatment in reducing disability are difficult to estimate for individual patients. During development of an evidence-based tool to encourage participation of stroke survivors and families in tPA treatment decisions, we conducted qualitative interviews to learn how best to present risk/benefit data. Methods: We conducted 3 focus groups to determine effective strategies for presenting the beneficial outcome (modified Rankin Scale; mRS) and the risk of bleeding. Twelve stroke survivors (mean age = 54; 4 female) and 3 family members (mean age = 68; 3 female) participated at 2 different sites. Results: The majority of survivors do not recall being educated about acute stroke or treatment, though families provide vivid recollection. Four themes emerged as they expressed a need for more information (subject identified by Patient/Caregiver, gender, study number, and site): A ‘good’ outcome is a mRS of 0,1, or 2 - “¼I think that 0-2 is REALLY a good outcome as [I’ve] seen severely disabled patients throughout recovery” (PM04LA). Preferred both overall and personalized outcomes estimates: “Tell me my individual risk and then show me how that compares to the general population. As far as the general population, maybe your risk is higher than others.” (PM07KC). Present risk as ‘positive’ outcomes (e.g. the likelihood of mRS 0-2, rather than 3-6): “’Bad outcome’, I don’t like those words. You’re talking about somebody I love, you know.” (CF10KC). Present both risks and benefits of tPA: “I would be open to take a risk if I thought there would be a good chance of a major improvement” (PM08KC). Conclusions: Stroke survivors and families desire more information at the time of acute stroke and agreed that mRS of 0-2 constitutes a good outcome. They articulated what information would be important for deciding about treatment with IVtPA and this will be used to create a decision aid to deliver individualized risk/benefit estimates in an understandable format that can support communication and shared medical decision-making.

ObjectivesThis study sought to assess whether incorporation of routine bleeding risk estimates affected the utilization of bivalirudin during percutaneous coronary intervention (PCI).BackgroundBivalirudin use during PCI has been shown to reduce bleeding complications. However, a risk–treatment paradox exists, in which patients at highest risk for bleeding are least likely to receive bivalirudin. Whether routine estimation of individualized bleeding risk can affect physicians' use of bivalirudin is unknown.MethodsPCI data from a single health system between 2007 and 2011 were analyzed. Beginning in July 2009, individualized bleeding risk estimates were provided immediately preceding PCI. Using a pre–post design, we compared bivalirudin use before and after this implementation, for patients across 3 strata of bleeding risk (3%).ResultsData from 6,491 PCI procedures were analyzed. Overall, bivalirudin use increased in the post-implementation period (26.9% vs. 34.2%, p < 0.001). Bivalirudin use increased in intermediate (27% to 35%, p < 0.001) and high bleeding risk patients (25% to 43%, p < 0.001), and decreased in low-risk patients (30% to 25%, p = 0.014). During the same period, bleeding complications decreased in intermediate-risk (3.4% to 1.8%, p = 0.009) and high-risk (6.9% to 3.7%, p = 0.005) patients and remained unchanged in low-risk patients (1.1% to 1.0%, p = 0.976).ConclusionsThere was an increase in bivalirudin use and a lower incidence of bleeding after the incorporation of individualized bleeding risk estimates into clinical practice. This implementation led to a reversal of the risk–treatment paradox, through a rational increase in bivalirudin use in patients at intermediate and high bleeding risk and decreased use in lower-risk patients.

Background In the setting of coronary angiography, generic consent forms permit highly variable communication between patients and physicians. Even with the existence of multiple risk models, clinicians have been unable to readily access them and thus provide patients with vague estimations regarding risks of the procedure. Methods We created a web-based vehicle, PREDICT, for embedding patient-specific estimates of risk from validated multivariable models into individualized consent documents at the point-of-care. Beginning August 2006, outpatients undergoing coronary angiography at the Mid America Heart Institute received individualized consent documents generated by PREDICT. In February 2007 this approach was expanded to all patients undergoing coronary angiography within the four Kansas City hospitals of the Saint Luke's Health System. Qualitative research methods were used to identify the implementation challenges and successes with incorporating PREDICT-enhanced consent documents into routine clinical care from multiple perspectives: administration, information systems, nurses, physicians, and patients. Results Most clinicians found usefulness in the tool (providing clarity and educational value for patients) and satisfaction with the altered processes of care, although a few cardiologists cited delayed patient flow and excessive patient questions. The responses from administration and patients were uniformly positive. The key barrier was related to informatics. Conclusion This preliminary experience suggests that successful change in clinical processes and organizational culture can be accomplished through multidisciplinary collaboration. A randomized trial of PREDICT consent, leveraging the accumulated knowledge from this first experience, is needed to further evaluate its impact on medical decision-making, patient compliance, and clinical outcomes.

Background While the process of informed consent is designed to transfer knowledge of the risks and benefits of treatment and to engage patients in shared medical decision-making, this is poorly done in routine clinical care. We assessed the impact of a novel informed consent form for percutaneous coronary intervention (PCI) that is more simply written, includes images of the procedure, and embeds individualized estimates of outcomes on multiple domains of successful informed consent and shared decision-making. Methods We interviewed 590 PCI patients receiving traditional consent documents and 527 patients receiving novel ePRISM consents at 9 US centers and compared patients’ perceptions, knowledge transfer, and engagement in medical decision-making. Heterogeneity across sites was assessed and adjusted for using hierarchical models. Results Site-adjusted analyses revealed more frequent review (72% for ePRISM vs 45% for original consents) and better understanding of the ePRISM consents (ORs = 1.8-3.0, depending upon the outcome) with marked heterogeneity across sites (median relative difference [MRD] in the ORs of ePRISM’s effect =2-3.2). Patients receiving ePRISM consents better understood the purposes and risks of the procedure (ORs = 1.9-3.9, MRDs = 1.1-6.2), engaged more in shared decision-making (proportional OR = 2.1 [95% CI = 1.02-4.4], MRD = 2.2) and discussed stent options with their physicians (58% vs. 31%; site-adjusted odds ratio = 2.7 [95% CI = 1.2, 6.3], MRD = 2.6) more often. Conclusions A personalized consent document improved the process of informed consent and shared decision-making. Marked heterogeneity across hospitals highlights that consent documents are but one aspect of engaging patients in understanding and participating in treatment.

Bivalirudin reduces post-PCI bleeding. However, there exists a risk-treatment paradox in which patients at lower risk for bleeding are preferentially treated and those at higher risk are not. Whether routine estimation of an individual's bleeding risk impacts physician use of bivalirudin is

Objectives The objective of this study was to compare the consistency in appropriate use criteria (AUC) ratings among a broad range of practicing cardiologists and the AUC Technical Panel. Background AUC for coronary revascularization have been developed by selected experts. Methods Before AUC publication, 85 cardiologists from 10 U.S. institutions assessed the appropriateness of coronary revascularization for 68 indications that had been evaluated by the AUC Technical Panel. Each indication was classified as appropriate, uncertain, or inappropriate, based on the physician group9s median rating. Rates of concordance between the physician group and the AUC Technical Panel (i.e., same appropriateness category assignment) and rates of nonagreement within the physician group (≥25% of panelists9 ratings outside the group9s appropriateness category assessment) were determined. Results Overall concordance between the 2 groups was 84%. Among indications classified as appropriate by the AUC Technical Panel, concordance between the 2 groups was excellent (94% [34 of 36]); however, nonagreement within the physician group was 44% (16 of 36). Among indications classified as uncertain, there was 73% (16 of 22) concordance between the 2 groups. Among inappropriate indications, concordance was moderate (70% [7 of 10]), but nonagreement occurred frequently (70% [7 of 10]). Moreover, there was substantial variation in appropriateness ratings between individual physicians and the AUC Technical Panel (weighted kappa range: 0.05 to 0.76). Conclusions Although there was good concordance in assessments of appropriateness for coronary revascularization between physicians and the AUC Technical Panel, nonagreement within the physician group was common and there was marked variation in ratings between individual physicians and the AUC Technical Panel.