Jocelyn S. Thompson

Educational Resources for Patients Considering a Left Ventricular Assist Device

Background—Left ventricular assist devices (LVADs) are being used with increasing frequency to treat severe heart failure. Patients seek out informational resources when considering implantation. The primary study objective was to characterize the scope and quality of available LVAD educational materials. Methods and Results—In July 2013, we performed a cross-sectional search of Internet, print, and multimedia resources available to patients considering LVAD. Written materials <10 sentences, videos <2 minutes, and materials clearly directed to healthcare professionals were excluded. Seventy-seven materials met inclusion criteria. Potential benefits of LVAD therapy were discussed in all (n=77), whereas less often mentioned were risks (n=43), lifestyle considerations (n=29), surgical details (n=26), caregiver information (n=9), and hospice or palliative care (n=2). Of the 14 materials that recognized a decision or alternate treatment option, 7 used outdated statistics, 12 scored above an eighth grade reading comprehension level, and 12 met <50% of International Patient Decision Aid Standards criteria. In the survey participants rated all but one as biased toward accepting LVAD therapy. Conclusions—Although many resources exist for patients considering an LVAD, the content is suboptimal. Benefits of LVADs are often presented in the absence of risks, alternative options, and caregiver considerations. Most materials use outdated statistics, are above the reading level of average Americans, and are biased toward accepting LVAD therapy. There is no tool that would qualify as a formal decision aid.

A Multicenter Trial of a Shared Decision Support Intervention for Patients and Their Caregivers Offered Destination Therapy for Advanced Heart Failure: Decide-lvad

Background:Shared decision making is important to ensure that patients receive therapies aligned with their goals and values. Based upon a detailed needs assessment with diverse stakeholders, pamphlet and video decision aids for destination therapy left ventricular assist devices (DT LVAD) were developed to help patients and their caregivers think through, forecast, and deliberate their options. These decision aids are the foundation of the Multicenter Trial of a Shared Decision Support Intervention for Patients and their Caregivers Offered Destination Therapy for End-Stage Heart Failure (DECIDE-LVAD) study, a multicenter, randomized trial aimed at understanding the effectiveness and implementation of a shared decision support intervention for patients considering DT LVAD. Methods/Design:A stepped-wedge randomized controlled trial was designed, guided by the RE-AIM framework and modeled after an effectiveness-implementation hybrid type II design. Six DT LVAD programs from across the United States will participate. Primary outcomes include knowledge and values-treatment concordance. Patients with advanced heart failure who are being considered for DT LVAD and their caregivers are eligible with a target enrollment of 168 dyads. From August 2014 to January 2015, an acceptability and feasibility pilot study was performed, which clarified opportunities and challenges around decision support for DT LVAD and resulted in significant modifications to the DECIDE-LVAD study. Discussion:Study findings will provide a foundation for implementing decision support interventions, including decision aids, with patients who have chronic progressive illness facing end-of-life decisions involving invasive, preference-sensitive therapy options.

The Perceptions of Important Elements of Caregiving for a Left Ventricular Assist Device Patient: A Qualitative Meta-Synthesis.

Background:The use of a left ventricular assist device (LVAD) is becoming increasingly common in patients with end-stage heart failure. Many LVAD programs require patients to have a caregiver before receiving a device. There are few studies exploring the experience, burden, and impacts on caregivers of patients with LVADs. Objectives:The aim of this study was to synthesize the qualitative literature regarding caregiver’s perceptions about caring for an adult LVAD patient. Methods:We searched MEDLINE, CINAHL, PsychInfo, and Web of Science to find English articles on the topic of LVAD caregiver’s perceptions. The articles were then synthesized using a formal process of qualitative meta-synthesis. Results:Eight articles met criteria for inclusion. The meta-synthesis across the articles resulted in 8 themes categorized under 3 domains. Many of the articles suggested a longitudinal process of caregiving with perceptions largely dependent upon the time of interview in relation to the LVAD. The first domain of caregiving is the “early” stage, covering the life before the LVAD through the procedure. This phase is characterized by the pre-LVAD “emotional rollercoaster,” the decision seen as “no option,” and the thought of “leave it [the LVAD] at the hospital.” The second domain is the “middle” stage, covering the time frame after discharge from the hospital. This phase is characterized by fragility of the patient, recognition of a need to adapt, and a transformed life. The final domain is “late LVAD” and describes how late in the LVAD process the LVAD indication (bridge to transplant or destination therapy) brings in to focus what is important to caregivers. Conclusions:Existing literature indicates that the LVAD caregiver experience is intense as well as burdensome and entails the need to adapt to a new life. Given the burdens caregivers experience, clinicians and future research should explore strategies to support these important individuals.

Effectiveness of an Intervention Supporting Shared Decision Making for Destination Therapy Left Ventricular Assist Device: The DECIDE-LVAD Randomized Clinical Trial

Importance Shared decision making helps patients and clinicians elect therapies aligned with patients’ values and preferences. This is particularly important for invasive therapies with considerable trade-offs. Objective To assess the effectiveness of a shared decision support intervention for patients considering destination therapy left ventricular assist device (DT LVAD) placement. Design, Setting, and Participants From 2015 to 2017, a randomized, stepped-wedge trial was conducted in 6 US LVAD implanting centers including 248 patients being considered for DT LVAD. After randomly varying time in usual care, sites were transitioned to an intervention consisting of clinician education and use of DT LVAD pamphlet and video patient decision aids. Follow up occurred at 1 and 6 months. Main Outcomes and Measures Decision quality as measured by knowledge and values-choice concordance. Results In total, 135 patients were enrolled during control and 113 during intervention periods. At enrollment, 59 (23.8%) participants were in intensive care, 60 (24.1%) were older than 70 years, 39 (15.7%) were women, 45 (18.1%) were racial/ethnic minorities, and 62 (25.0%) were college graduates. Patient knowledge (mean test performance) during the decision-making period improved from 59.5% to 64.9% in the control group vs 59.1% to 70.0% in the intervention group (adjusted difference of difference, 5.5%; P = .03). Stated values at 1 month (scale 1 = “do everything I can to live longer…” to 10 = “live with whatever time I have left…”) were a mean of 2.37 in control and 3.33 in intervention (P = .03). Patient-reported treatment choice at 1 month favored LVAD more in the control group (than in the intervention group (47 [59.5%] vs 95 [91.3%], P < .001). Correlation between stated values and patient-reported treatment choice at 1 month was stronger in the intervention group than in the control group (difference in Kendall’s &tgr;, 0.28; 95% CI, 0.05-0.45); however, there was no improved correlation between stated values and actual treatment received by 6 months for the intervention compared with the control group (difference in Kendall’s &tgr;, 0.01; 95% CI, −0.24 to 0.25). The adjusted rate of LVAD implantation by 6 months was higher for those in the control group (79.9%) than those in the intervention group (53.9%, P = .008), with significant variation by site. There were no differences in decision conflict, decision regret, or preferred control. Conclusions and Relevance A shared decision-making intervention for DT LVAD modestly improved patient decision quality as measured by patient knowledge and concordance between stated values and patient-reported treatment choice, but did not improve concordance between stated values and actual treatment received. The rate of implantation of LVADs was substantially lower in the intervention compared with the control group. Trial Registration clinicaltrials.gov Identifier: NCT02344576

The influence of expected risks on decision making for destination therapy left ventricular assist device: An MTurk survey.

The influence of expected risks on decision making for destination therapy left ventricular assist device: An MTurk survey Kate H. Magid, Daniel D. Matlock, MD, MPH, Jocelyn S. Thompson, MA, Colleen K. McIlvennan, DNP, ANP, and Larry A. Allen, MD, MHS From the School of Public Health, Brown University, Providence, Rhode Island; Adult and Child Center for Health Outcomes Research and Delivery Science, University of Colorado School of Medicine, Aurora, Colorado; Division of General Internal Medicine, University of Colorado School of Medicine, Aurora, Colorado; Colorado Cardiovascular Outcomes Research Consortium, Aurora, Colorado; and the Division of Cardiology, University of Colorado School of Medicine, Aurora, Colorado.

Clinical Outcomes After Continuous-Flow Left Ventricular Assist Device

Background—Conveying the complex trade-offs of continuous-flow left ventricular assist devices is challenging and made more difficult by absence of an evidence summary for the full range of possible outcomes. We aimed to summarize the current evidence on outcomes of continuous-flow left ventricular assist devices. Methods and Results—PubMed and Cochrane Library were searched from January 2007 to December 2013, supplemented with manual review. Three reviewers independently assessed each study for saliency on patient-centered outcomes. Data were summarized in tabular form. Overall study characteristics encouraged inclusion of all indications (destination therapy and bridge to transplant) and prevented meta-analysis. The electronic search identified 465 abstracts, of which 50 met inclusion criteria; manual review added 2 articles in press. The articles included 10 industry-funded trials and registries, 10 multicenter reports, and the remainder single-center observational experiences. Estimated actuarial survival after continuous-flow left ventricular assist devices ranged from 56% to 87% at 1 year, 43% to 84% at 2 years, and 47% at 4 years. Improvements in functional class and quality of life were reported, but missing data complicated interpretation. Adverse events were experienced by the majority of patients, but estimates for bleeding, stroke, infection, right heart failure, arrhythmias, and rehospitalizations varied greatly. Conclusions—The totality of data for continuous-flow left ventricular assist devices show consistent improvements in survival and quality of life counterbalanced by a range of common complications. Although this summary should provide a practical resource for healthcare provider-led discussions with patients, it highlights the critical need for high-quality patient-centered data collected with standard definitions.

Exploring cognitive bias in destination therapy left ventricular assist device decision making: A retrospective qualitative framework analysis

BACKGROUND Cognitive biases are psychological influences, which cause humans to make decisions, which do not seemingly maximize utility. For people with heart failure, the left ventricular assist device (LVAD) is a surgically implantable device with complex tradeoffs. As such, it represents an excellent model within which to explore cognitive bias in a real-world decision. We conducted a framework analysis to examine for evidence of cognitive bias among people deciding whether or not to get an LVAD. OBJECTIVES The aim of this study was to explore the influence of cognitive bias on the LVAD decision-making process. METHODS We analyzed previously conducted interviews of patients who had either accepted or declined an LVAD using a deductive, predetermined framework of cognitive biases. We coded and analyzed the interviews using an inductive-deductive framework approach, which also allowed for other themes to emerge. RESULTS We interviewed a total of 22 heart failure patients who had gone through destination therapy LVAD decision making (15 who had accepted the LVAD and 7 who had declined). All patients appeared influenced by state dependence, where both groups described high current state of suffering, but the groups differed in whether they believed LVAD would relieve suffering or not. We found evidence of cognitive bias that appeared to influence decision making in both patient groups, but groups differed in terms of which cognitive biases were present. Among accepters, we found evidence of anchoring bias, availability bias, optimism bias, and affective forecasting. Among decliners, we found evidence of errors in affective forecasting. CONCLUSIONS Medical decision making is often a complicated and multifaceted process that includes cognitive bias as well as other influences. It is important for clinicians to recognize that patients can be affected by cognitive bias, so they can better understand and improve the decision-making process to ensure that patients are fully informed.

Organic Dissemination and Real-World Implementation of Patient Decision Aids for Left Ventricular Assist Device

Background. Although patient decision aids (PtDAs) have been shown to improve patient knowledge and satisfaction, they are infrequently used in the real world. We aimed to understand how our publicly available PtDAs developed for destination therapy left ventricular assist device (DT LVAD) were implemented in clinical practice and characterize factors influencing adoption. Methods. We contacted 39 people, 31 who had independently emailed inquiring about our DT LVAD PtDAs and 8 identified through snowball sampling. Thirty people from 23 programs participated in semistructured interviews, which were analyzed using normalization process theory. Results. Eleven programs currently use the PtDAs, 5 plan to use them but have not yet, and 7 do not currently use them nor have active plans to use them. Due to major tradeoffs and preference sensitivity of the DT LVAD decision, participants recognized a role for shared decision making and a need for significant information transfer. Due to a relative lack of resources, participants saw the PtDAs as a way to help facilitate a higher quality decision-making process. Limited time, lack of personnel, and perceived burden to implementing system-level change were cited as barriers to use. Initial implementation was accomplished by a champion of the PtDAs. Actual use of the PtDAs most commonly occurred through LVAD coordinators at the start of formal patient teaching sessions, where the PtDAs could be integrated into the existing LVAD consent and education structure. Conclusion. Interest in and implementation of PtDAs occurred independently at several LVAD programs due to a favorable decisional context, including a perceived role for shared decision making in the high-stakes decision around DT LVAD, unmet informational needs, preexisting education sessions, and invested clinical champions.

Qualitative evaluation of a narrative reflection program to help medical trainees recognize and avoid overuse: “Am I doing what’s right for the patient?”

OBJECTIVE The Do No Harm Project is a novel reflective writing program that encourages medical trainees to reflect on and write up clinical narratives about instances of avoidable medical overuse. Our goal is to describe this program and to explore the effect of the program on those participating. METHODS Semi-structured interviews were conducted to explore how participating in the project influenced the thinking, attitudes, and behaviors of participating internal medicine residents. Interviews were conducted with 20 out of the 24 participants from the first 15 months of the program. RESULTS The following themes emerged from our analysis: 1) learning through reflection (with three sub-themes: empathy for the patient perspective, a critical approach to ones own clinical practice, and awareness of the problem of overuse); 2) empowerment to discuss instances of overuse and act before it occurs; and 3) perceptions of enhanced evidence-based practice and shared decision-making. CONCLUSION Trainees volunteering to complete a reflective writing exercise perceived improved ability to avoid overuse and improved self-efficacy to change clinical behaviors that do not align with optimal patient care. PRACTICE IMPLICATIONS Reflective writing may help trainees recognize and avoid medical overuse.

Clinical Outcomes After Continuous-Flow Left Ventricular Assist DeviceCLINICAL PERSPECTIVE

Background—Conveying the complex trade-offs of continuous-flow left ventricular assist devices is challenging and made more difficult by absence of an evidence summary for the full range of possible outcomes. We aimed to summarize the current evidence on outcomes of continuous-flow left ventricular assist devices. Methods and Results—PubMed and Cochrane Library were searched from January 2007 to December 2013, supplemented with manual review. Three reviewers independently assessed each study for saliency on patient-centered outcomes. Data were summarized in tabular form. Overall study characteristics encouraged inclusion of all indications (destination therapy and bridge to transplant) and prevented meta-analysis. The electronic search identified 465 abstracts, of which 50 met inclusion criteria; manual review added 2 articles in press. The articles included 10 industry-funded trials and registries, 10 multicenter reports, and the remainder single-center observational experiences. Estimated actuarial survival after continuous-flow left ventricular assist devices ranged from 56% to 87% at 1 year, 43% to 84% at 2 years, and 47% at 4 years. Improvements in functional class and quality of life were reported, but missing data complicated interpretation. Adverse events were experienced by the majority of patients, but estimates for bleeding, stroke, infection, right heart failure, arrhythmias, and rehospitalizations varied greatly. Conclusions—The totality of data for continuous-flow left ventricular assist devices show consistent improvements in survival and quality of life counterbalanced by a range of common complications. Although this summary should provide a practical resource for healthcare provider-led discussions with patients, it highlights the critical need for high-quality patient-centered data collected with standard definitions.