Daniel D. Matlock

Health Literacy and Outcomes Among Patients With Heart Failure

CONTEXT Little is known about the effects of low health literacy among patients with heart failure, a condition that requires self-management and frequent interactions with the health care system. OBJECTIVE To evaluate the association between low health literacy and all-cause mortality and hospitalization among outpatients with heart failure. DESIGN, SETTING, AND PATIENTS Retrospective cohort study conducted at Kaiser Permanente Colorado, an integrated managed care organization. Outpatients with heart failure were identified between January 2001 and May 2008, were surveyed by mail, and underwent follow-up for a median of 1.2 years. Health literacy was assessed using 3 established screening questions and categorized as adequate or low. Responders were excluded if they did not complete at least 1 health literacy question or if they did not have at least 1 year of enrollment prior to the survey date. MAIN OUTCOME MEASURES All-cause mortality and all-cause hospitalization. RESULTS Of the 2156 patients surveyed, 1547 responded (72% response rate). Of 1494 included responders, 262 (17.5%) had low health literacy. Patients with low health literacy were older, of lower socioeconomic status, less likely to have at least a high school education, and had higher rates of coexisting illnesses. In multivariable Cox regression, low health literacy was independently associated with higher mortality (unadjusted rate, 17.6% vs 6.3%; adjusted hazard ratio, 1.97 [95% confidence interval, 1.3-2.97]; P = .001) but not hospitalization (unadjusted rate, 30.5% vs 23.2%; adjusted hazard ratio, 1.05 [95% confidence interval, 0.8-1.37]; P = .73). CONCLUSION Among patients with heart failure in an integrated managed care organization, low health literacy was significantly associated with higher all-cause mortality.

Establishing the effectiveness of patient decision aids: key constructs and measurement instruments

BackgroundEstablishing the effectiveness of patient decision aids (PtDA) requires evidence that PtDAs improve the quality of the decision-making process and the quality of the choice made, or decision quality. The aim of this paper is to review the theoretical and empirical evidence for PtDA effectiveness and discuss emerging practical and research issues in the measurement of effectiveness.MethodsThis updated overview incorporates: a) an examination of the instruments used to measure five key decision-making process constructs (i.e., recognize decision, feel informed about options and outcomes, feel clear about goals and preferences, discuss goals and preferences with health care provider, and be involved in decisions) and decision quality constructs (i.e., knowledge, realistic expectations, values-choice agreement) within the 86 trials in the Cochrane review; and b) a summary of the 2011 Cochrane Collaboration’s review of PtDAs for these key constructs. Data on the constructs and instruments used were extracted independently by two authors from the 86 trials and any disagreements were resolved by discussion, with adjudication by a third party where required.ResultsThe 86 studies provide considerable evidence that PtDAs improve the decision-making process and decision quality. A majority of the studies (76/86; 88%) measured at least one of the key decision-making process or decision quality constructs. Seventeen different measurement instruments were used to measure decision-making process constructs, but no single instrument covered all five constructs. The Decisional Conflict Scale was most commonly used (n = 47), followed by the Control Preference Scale (n = 9). Many studies reported one or more constructs of decision quality, including knowledge (n = 59), realistic expectation of risks and benefits (n = 21), and values-choice agreement (n = 13). There was considerable variability in how values-choice agreement was defined and determined. No study reported on all key decision-making process and decision quality constructs.ConclusionsEvidence of PtDA effectiveness in improving the quality of the decision-making process and decision quality is strong and growing. There is not, however, consensus or standardization of measurement for either the decision-making process or decision quality. Additional work is needed to develop and evaluate measurement instruments and further explore theoretical issues to advance future research on PtDA effectiveness.

Frailty and the Selection of Patients for Destination Therapy Left Ventricular Assist Device

Frailty is the aggregation of subclinical physiological insults across many organ systems resulting in a syndrome of heightened vulnerability in the face of stress. Measures of frailty are highly predictive of adverse outcomes in many medical and surgical populations but have never been formally applied to patient selection for destination therapy left ventricular assist device (LVAD). Patients with severe heart failure being considered for destination therapy LVAD often have advanced age or noncardiac morbidity that renders them ineligible for transplantation. At the same time, these patients should have reasonable life expectancy to adequately realize the benefits of LVAD. As such, destination therapy LVAD-eligible patients are in a precariously narrow state of health often marked by a high degree of frailty. However, distinguishing frailty that will reverse with LVAD therapy (LVAD-responsive frailty) from frailty that will not (LVAD-independent frailty) is challenging. In this review, we summarize existing tools for destination therapy LVAD patient selection, define the syndrome of frailty, propose a conceptual distinction between LVAD-responsive frailty and LVAD-independent frailty, extrapolate the existing frailty literature to destination therapy LVAD-eligible patients, and identify directions for future research, including systematic collection of preoperative gait speed in this patient population.

Geographic variation in cardiovascular procedure use among medicare fee-for-service vs medicare advantage beneficiaries

IMPORTANCE Little is known about how different financial incentives between Medicare Advantage and Medicare fee-for-service (FFS) reimbursement structures influence use of cardiovascular procedures. OBJECTIVE To compare regional cardiovascular procedure rates between Medicare Advantage and Medicare FFS beneficiaries. DESIGN, SETTING, AND PARTICIPANTS Cross-sectional study of Medicare beneficiaries older than 65 years between 2003-2007 comparing rates of coronary angiography, percutaneous coronary intervention (PCI), and coronary artery bypass graft (CABG) surgery across 32 hospital referral regions in 12 states. MAIN OUTCOMES AND MEASURES Rates of coronary angiography, PCI, and CABG surgery. RESULTS We evaluated a total of 878,339 Medicare Advantage patients and 5,013,650 Medicare FFS patients. Compared with Medicare FFS patients, Medicare Advantage patients had lower age-, sex-, race-, and income-adjusted procedure rates per 1000 person-years for angiography (16.5 [95% CI, 14.8-18.2] vs 25.9 [95% CI, 24.0-27.9]; P < .001) and PCI (6.8 [95% CI, 6.0-7.6] vs 9.8 [95% CI, 9.0-10.6]; P < .001) but similar rates for CABG surgery (3.1 [95% CI, 2.8-3.5] vs 3.4 [95% CI, 3.1-3.7]; P = .33). There were no significant differences between Medicare Advantage and Medicare FFS patients in the rates per 1000 person-years of urgent angiography (3.9 [95% CI, 3.6-4.2] vs 4.3 [95% CI, 4.0-4.6]; P = .24) or PCI (2.4 [95% CI, 2.2-2.7] vs 2.7 [95% CI, 2.5-2.9]; P = .16). Procedure rates varied widely across hospital referral regions among Medicare Advantage and Medicare FFS patients. For angiography, the rates per 1000 person-years ranged from 9.8 to 40.6 for Medicare Advantage beneficiaries and from 15.7 to 44.3 for Medicare FFS beneficiaries. For PCI, the rates ranged from 3.5 to 16.8 for Medicare Advantage and from 4.7 to 16.1 for Medicare FFS. The rates for CABG surgery ranged from 1.5 to 6.1 for Medicare Advantage and from 2.5 to 6.0 for Medicare FFS. Across regions, we found no statistically significant correlation between Medicare Advantage and Medicare FFS beneficiary utilization for angiography (Spearman r = 0.19, P = .29) and modest correlations for PCI (Spearman r = 0.33, P = .06) and CABG surgery (Spearman r = 0.35, P = .05). Among Medicare Advantage beneficiaries, adjustment for additional cardiac risk factors had little influence on procedure rates. CONCLUSIONS AND RELEVANCE Although Medicare beneficiaries enrolled in capitated Medicare Advantage programs had lower angiography and PCI procedure rates than those enrolled in Medicare FFS, the degree of geographic variation in procedure rates was substantial among Medicare Advantage beneficiaries and was similar in magnitude to that observed among Medicare FFS beneficiaries.

Decision Making for Destination Therapy Left Ventricular Assist Devices “There Was No Choice” Versus “I Thought About It an Awful Lot”

Background—Destination therapy left ventricular assist devices (DT LVADs) are one of the most invasive medical interventions for end-stage illness. How patients decide whether or not to proceed with device implantation is unknown. We aimed to understand the decision-making processes of patients who either accept or decline DT LVADs. Methods and Results—Between October 2012 and September 2013, we conducted semistructured, in-depth interviews to understand patients’ decision-making experiences. Data were analyzed using a mixed inductive and deductive approach. Twenty-two eligible patients were interviewed, 15 with DT LVADs and 7 who declined. We found a strong dichotomy between decision processes with some patients (11 accepters) being automatic and others (3 accepters, 7 decliners) being reflective in their approach to decision making. The automatic group was characterized by a fear of dying and an over-riding desire to live as long as possible: “[LVAD] was the only option I had…that or push up daisies…so I automatically took this.” By contrast, the reflective group went through a reasoned process of weighing risks, benefits, and burdens: “There are worse things than death.” Irrespective of approach, most patients experienced the DT LVAD decision as a highly emotional process and many sought support from their families or spiritually. Conclusions—Some patients offered a DT LVAD face the decision by reflecting on a process and reasoning through risks and benefits. For others, the desire to live supersedes such reflective processing. Acknowledging this difference is important when considering how to support patients who are faced with this complex decision.

Patient and Cardiologist Perceptions on Decision Making for Implantable Cardioverter‐Defibrillators: A Qualitative Study

Background:  Although implantable cardioverter‐defibrillators (ICDs) reduce mortality in selected patients, they are also associated with potential risks. Periprocedural decision making requires understanding both benefits and risks.

2017 AHA/ACC/HRS Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society.

Sana M. Al-Khatib, MD, MHS, FACC, FAHA, FHRS, Chair, Writing Committee, William G. Stevenson, MD, FACC, FAHA, FHRS, Vice Chair, Writing Committee, Michael J. Ackerman, MD, PhD, Writing Committee Member, William J. Bryant, JD, LLM, Writing Committee Member, David J. Callans, MD, FACC, FHRS, Writing Committee Member, Anne B. Curtis, MD, FACC, FAHA, FHRS, Writing Committee Member, Barbara J. Deal, MD, FACC, FAHA, Writing Committee Member, Timm Dickfeld, MD, PhD, FHRS, Writing Committee Member, Michael E. Field, MD, FACC, FAHA, FHRS, Writing Committee Member, Gregg C. Fonarow, MD, FACC, FAHA, FHFSA, Writing Committee Member, Anne M. Gillis, MD, FHRS, Writing Committee Member, Mark A. Hlatky, MD, FACC, FAHA, Writing Committee Member, Christopher B. Granger, MD, FACC, FAHA, Writing Committee Member, Stephen C. Hammill, MD, FACC, FHRS, Writing Committee Member, José A. Joglar, MD, FACC, FAHA, FHRS, Writing Committee Member, G. Neal Kay, MD, Writing Committee Member, Daniel D. Matlock, MD, MPH, Writing Committee Member, Robert J. Myerburg, MD, FACC, Writing Committee Member, Richard L. Page, MD, FACC, FAHA, FHRS, Writing Committee Member

Big Brother Is Watching You What Do Patients Think About ICD Home Monitoring

Patients with implantable cardioverter-defibrillators (ICDs) are burdened with frequent visits to their doctors. Current guidelines suggest that patients should be seen every three to six months to have their devices interrogated and to make adjustments.1 The majority of these visits do not result in programming or device changes.2 Given the growth in the number of patients receiving ICDs, the burden on clinics to meet these interrogation guidelines is increasing. The Lumos-T Safely RedUceS RouTine Office Device Follow-up (TRUST) trial, published in this issue of Circulation , reports the results of an intervention that could improve the quality of care for patients with ICDs by decreasing the number of ICD follow-up visits while simultaneously providing closer monitoring of the ICD.3 The Institute of Medicine has stated that quality health care is care that is safe, effective, patient-centered, timely, equitable, and efficient4; the TRUST trial should be both praised and criticized based on these quality domains. Article see p 325 The TRUST trial was a large, multi-center, randomized trial of 1339 patients designed to test a new home monitoring (HM) system against routine medical care for the ongoing surveillance of ICDs. The HM system evaluates a patients ICD daily through a remote monitoring device that allows clinicians to intervene earlier if and when abnormalities are detected. As such, patients would then only have to have their ICDs interrogated in person once a year. The authors specified two a priori primary end points for their HM trial, one for efficacy and one for safety.5 The efficacy end point was to show that HM decreased the number of office-based ICD follow-up visits; the safety end point (appropriately powered to test noninferiority) was to show that the HM system did not increase death, stroke, or surgical interventions when compared …

Regional Variation in the Use of Implantable Cardioverter-Defibrillators for Primary Prevention Results From the National Cardiovascular Data Registry

Background— Although the use of implantable cardioverter-defibrillators (ICDs) for the primary prevention of sudden cardiac death varies by sex, race, and hospital, geographic variation in ICD use remains unexplored. Our objective was to quantify regional variations in the utilization of primary prevention ICDs in the United States, and to evaluate if an association exists between utilization and physician supply or the proportion of patients meeting the trial inclusion criteria. Methods and Results— This is a cross-sectional analysis among the Medicare, fee-for-service population from the National Cardiovascular Data Registry. Using hospital referral regions, we calculated the age-, sex-, and race-adjusted rates of ICD placement for each region and assessed the correlation between these rates and (1) physician supply and (2) the proportion of patients meeting trial inclusion criteria. Substantial variation was found across quintiles of rate ratios of ICD implantation, ranging from 0.39 to 1.77 (compared with a national mean rate of 1.0). This ratio was not correlated with the supply of cardiologists (R 2=0.01), electrophysiologists (R 2=0.01), or with the proportion of patients meeting trial inclusion criteria (R 2<0.01). Over all, 13% of all patients receiving ICDs did not meet trial criteria. Conclusions— Marked geographic variation in the use of primary prevention ICDs exists across the United States that is not correlated with physician supply. Although >1 in 10 patients received ICDs outside of trial criteria, this potential overuse did not explain the variation. Future studies should consider underuse or misuse of primary prevention ICDs as causes of geographic variation.

Variation in use of dual-chamber implantable cardioverter-defibrillators: results from the national cardiovascular data registry.

BACKGROUND Among patients without an indication for a pacemaker, current evidence is inconclusive whether a dual-chamber implantable cardioverter-defibrillator (ICD) is superior to a single-chamber ICD. The current use of dual-chamber ICDs is not well characterized. METHODS We conducted a cross-sectional study exploring hospital-level variation in the use of dual-chamber ICDs across the United States. Patients receiving a primary prevention ICD from 2006 through 2009 without a documented indication for a pacemaker were included. Multivariate hierarchical logistic regression was used to explore patient, health care provider, and physician factors related to the use of a dual-chamber device. RESULTS Dual-chamber devices were implanted in 58% of the 87,115 patients without a pacing indication among 1293 hospitals, with hospital rates ranging from 0% in 33 centers to 100% in 109 centers. In multivariate analysis, geographic region was a strong independent predictor of dual-chamber device use, ranging from 36.4% in New England (reference region) to 66.4% in the Pacific region (odds ratio [OR], 5.25; 95% CI, 3.35-8.21). Hospital clustering was assessed using a median OR which was 3.96, meaning that 2 identical patients at different hospitals would have nearly a 4-fold difference in their chance of receiving a dual-chamber ICD. CONCLUSIONS Use of dual-chamber ICDs for the primary prevention of sudden cardiac death among patients without an indication for permanent pacing varies markedly at the hospital level in the United States. This is a clear example of how practice can vary independent of patient factors.