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3 Relationship of Health Literacy, Knowledge, and Patient Activation with Self-Management in Persons with Heart Failure
Heart & Lung 46 (2017) 215e219
Contents lists available at ScienceDirect
Heart & Lung journal homepage: www.heartandlung.org
RESEARCH PUB 1 A Multi-Sensor Algorithm Predicts Heart Failure Events in Patients with Implanted Devices: Results from the MultiSENSE Study JOHN BOEHMER, RAMESH HARIHARAN, FAUSTO DEVECCHI, ANDREW SMITH, QI AN, VIKTORIA AVERINA, CRAIG STOLEN, PRAMODSINGH THAKUR, JULIE THOMPSON, YI ZHANG, JAGMEET SINGH Purpose: To evaluate to performance of an algorithm developed using diagnostic sensor data from implanted cardiac resynchronization therapy defibrillators (CRT-D) to detect impending heart failure decompensation events. Background: Heart Failure (HF), a growing health-care challenge globally, involves costly hospitalizations with adverse impact on patient outcomes. Reliable monitoring for early signs of worsening HF is needed to enable proactive interventions for prevention of acute decompensations. We hypothesize that an algorithm combining information from a diverse set of implanted device based sensors judiciously chosen to target different aspects of HF pathophysiology can effectively detect worsening HF. Methods: MultiSENSE enrolled patients with HF and reduced EF (HFrEF) implanted with CRT-D, converted into an investigational device to enable chronic ambulatory data collection. HF events (HFEs) were defined as HF admissions or unscheduled visits with augmented intravenous HF treatment, and were independently adjudicated. Patients were assigned to Development or Test set cohorts in chronological order of enrollment. The development set was used to construct a composite index and alert algorithm (HeartLogic) combining Heart Sounds, Respiration, Thoracic Impedance, Heart Rate and Activity; whereas the test set was sequestered for its subsequent independent validation. Sensitivity was defined as the proportion of usable HFEs detected by HeartLogic alerts. Unexplained alert rate (UAR) was defined as the ratio of alerts not explained by HF to the total usable follow-up duration. The two co-primary endpoints: 1. Sensitivity performance goal (PG) of > 40%; 2. UAR PG of < 2 alerts per patient year were tested with a 2-sided 95% confidence interval (CI). Results: Overall, 900 (Development ¼ 500, Test ¼ 400) patients had sensor data collection enabled and followed for up to a year. Primary endpoints were evaluated using the 320 patient years of follow-up data and 50 adjudicated usable HFEs in the Test Set cohort (72% male; age 66.8 10.3 years; NYHA Class at enrollment I/II/III/IV/unknown: 5%/69%/25%/1%/1%; LVEF 30.0 11.4%). With an observed sensitivity of 70% (Lower 2-sided 95% CI: 55.4%) and UAR of 1.47 (Upper 2-sided 95% CI: 1.65), both endpoints were significantly exceeded. Conclusion: The HeartLogic multi-sensor HF diagnostic algorithm significantly exceeded its pre-specified endpoints demonstrating compelling performance for worsening HF detection.
0147-9563/$ e see front matter
2 Treatment with Patiromer Decreases Aldosterone in Patients with Heart Failure, Chronic Kidney Disease, and Hyperkalemia on RAAS Inhibitors DAHLIA GARZA, COLEMAN GROSS, MARTHA MAYO, JINWEI YUAN, DANIEL WILSON, MATTHEW WEIR, BERTRAM PITT Purpose: Patiromer, a nonabsorbed potassium (K+)-binding polymer that uses calcium rather than sodium as the cation for exchange with K+ was shown in the OPAL-HK study to decrease serum K+ and aldosterone levels independent of plasma renin activity in patients with chronic kidney disease (CKD) on reninangiotensin-aldosterone system (RAAS) inhibitors. In a post-hoc analysis of OPAL-HK, we examined changes in serum K+ and aldosterone during the 4-week treatment phase in the subgroup with CKD and heart failure (HF). Background: Aldosterone plays an important role in the progression of HF and may be increased in HF due to activation of the RAAS. Hyperkalemia may also increase aldosterone and limits the use of RAAS inhibitors. This limitation is a concern, especially in patients with HF, with or without renal dysfunction, in whom the effects of aldosterone reduction provide the greatest benefit. Methods: Mean change from baseline to week 4 in serum K+ and aldosterone were analyzed in 102 patients with NYHA classes I-III HF and in 141 patients without HF. Patiromer starting doses were 8.4 g/day for patients with mild hyperkalemia (serum K+ 5.1-<5.5 mEq/L) and 16.8 g/day for patients with moderate-severe hyperkalemia (serum K+ >5.5 mEq/L), given divided twice daily. Results: Baseline aldosterone was higher in patients with HF than without HF (Table). In patients with mild hyperkalemia, small or nonsignificant changes in aldosterone were observed with modest serum K+ reductions, regardless of HF status. In patients with moderate-severe hyperkalemia, significant decreases in aldosterone, which were greater in the HF subgroup, were observed with larger serum K+ reductions. Conclusion: HF patients with moderate-severe hyperkalemia experienced the most improvement in aldosterone level with patiromer treatment. Serum K+ may play an important role in modulating aldosterone in HF. 3 Relationship of Health Literacy, Knowledge, and Patient Activation with Self-Management in Persons with Heart Failure ANN JACOBSON, VERONICA SUMODI, DONNA WALKER, LORI DEJOHN, KELLY DION, HUA-LI LIN TAI, LINDA BLANKENSHIP, DONNA ROSS Purpose: The purpose of the study was to identify factors related to self-management behavior in persons with heart failure (HF). Specifically, we analyzed the relationship of health literacy, patient
216
Abstracts / Heart & Lung 46 (2017) 215e219
activation, and heart failure knowledge with self-management behavior. The hypothesis was that in persons with heart failure, self-care behaviors are associated with health literacy, heart failure knowledge, and patient activation. Background: Current investigations of self-management by persons with HF have focused primarily on examining the effects of clinical interventions by health care providers to improve patients’ self-management behaviors. While clinician support of self-management is important, more information is needed to understand intrinsic patient characteristics that influence selfmanagement behaviors. Knowledge of these characteristics can better inform providers in delivering care to promote self-management and remove barriers. More research regarding determinants of self-care behavior in HF patients can enhance the knowledge base for nurses and other providers to design evidencebased, effective interventions. Methods: The study used a prospective, cross-sectional, correlational design to test the hypothesis. A convenience sample of 151 persons meeting eligibility criteria (18 years or older; diagnosis of heart failure, ability to read and respond to questionnaires in English) completed questionnaires containing the European Heart Failure Self-Care Behavior Scale, the Test of Functional Health Literacy in Adults, Short form (S-TOFHLA), the 13-Item Patient Activation Measure, the Dutch Heart Failure Knowledge Scale, the Stanford Self-Rated Health Measure, and a demographic data form. A member of the research team approached potential participants, who were present for their regularly-scheduled appointments at one of six chronic care outpatient clinics of a regional health system, informed them of the nature of the study, and invited them to participate. Those willing to participate completed questionnaires at the site. Data were entered using the double entry technique to reduce error, and analyzed using SAS software. Sample size was based on a power analysis for 4 variables and an effect size of .20. Scale scores were computed according to published recommendations, and all scale scores were computed so that higher scores represented higher levels of the attribute being measured. Means and frequencies were computed to describe the sample. To test the hypothesis, correlations and multiple regression were used, with alpha set at .05. Results: The sample was 57% male with a mean age of 68 (SD 13.0). Fifty-one percent were white and 44% African American. Highest education completed was 18% below high school, 27% high school, 31% some college, and 25% college degree or higher. Self-management (measured with the European Heart Failure Self-Care Behavior Scale) was significantly correlated with patient activation level (r ¼ .266, p ¼ .001) and age (r ¼ .275, p ¼ .002). Relationships between self-management and functional health literacy (r ¼ -.096, p ¼ .25), and self-management and heart failure knowledge (r ¼ .019, p ¼ .81) were not statistically significant. However, health literacy was correlated with educational level (r ¼ .234, p < .05) and heart failure knowledge (r ¼ .292, p < .05). Heart failure knowledge and educational level were also positively correlated (r ¼ .339, p < .05). Conclusion: The findings of this study partially support the hypothesis, in that self-management behavior was positively associated with patient activation, but not with health literacy or heart failure knowledge, in persons with heart failure. Although further research is needed to confirm and further elucidate these findings, they suggest that persons with HF may better manage their condition if sufficiently activated, regardless of their level of health literacy or knowledge of their disease process. Caution in interpreting these results is warranted based on the potential for bias in self-report. Because of the significant correlations between heart failure knowledge, health literacy and educational level, this study’s findings suggest that interventions targeted at promoting knowledge in persons with heart failure should take into account patients’ educational level and health literacy.
4 Measures of Ventricular-Arterial Coupling and Incident Heart Failure Preserved Ejection Fraction (HFpEF): A Matched Case-Control Analysis CAROLYN LEKAVICH Purpose: This study was designed to detect differences in markers associated with incident heart failure preserved ejection fraction (HFpEF) when comparing matched case-control groups. Background: Evidence continues to demonstrate increasing prevalence, cost and mortality implications of HFpEF, but clearly defined parameters for early detection have not been established. Methods: A study cohort of case (incident HFpEF patients, n¼155) and matched control (patients with no prior HF, n¼155) groups was retrospectively identified. Matching criteria included race, sex, age and date of echocardiogram (within 1 year). Physiologic and echocardiographic markers were collected from previously acquired transthoracic echocardiograms. These echocardiogram images were re-analyzed and measures of ventricular-arterial coupling were calculated. Using conditional logistic regression and controlling for covariates, models were fit to detect differences in HFpEF markers between cases and controls. Results: Statistically significant differences in markers that reflect ventricular elastance (Ees) (p¼0.003) and left atrial diameter (LAdiam) (p¼0.0002) were detected when comparing the case and control groups. Conditional logistic regression analyses suggested a 32% higher odds of being in the case group with every 1 unit increase in Ees, OR 1.32 (1.10, 1.58) and a 4.57 times higher odds of being in the case group for every 1 cm increase in LAdiam, OR 4.57 (2.04, 10.22) Conclusion: Ees and LAdiam are easily measurable echocardiographic markers which may have a role in identifying and tracking the progression toward incident HFpEF without increasing cost or risk to the patient. Prospective studies are indicated to explore the use of Ees and LAdiam as predictors of impending HFpEF. 5 Development of a Symptom Tracker for Use by Patients with Heart Failure ELDRIN LEWIS, AMY BARRETT, SANDY LEWIS, THERESA COLES, CARLA DEMURO, DONALD STULL, STUART TURNER, ENGELS OBI, CHUN-LAN CHANG, KATHERINE WALTMAN JOHNSON Purpose: A novel patient-reported tool, the HF Symptom Tracker (HFaST), was developed to improve patient-health care provider (HCP) communication, which may positively impact heart failure patient outcomes, including hospitalization rates. Background: Heart failure (HF) is a progressive disease associated with a significant risk of hospitalization and death. Presently, there are no tools available to track changes in patient-reported symptoms over. Many hospitalizations occur due to failure to recognize symptom progression. Methods: The HFaST was developed through a comprehensive process that included review of the literature, expert clinician input, and qualitative interviews with patients, caregivers of patients with HF, and HCPs. Results: Individual interviews were conducted with stakeholders (8 HCPs, 6 patients, 6 caregivers). An initial 40-item symptom list was piloted with 5 HCPs, and a refined 20-item set was debriefed with patients, caregivers, and 3 HCPs. The resultant HFaST consists of 10 items selected based on combined importance rankings from stakeholders, with 8 response options comparing the respondent’s experience of each symptom during the past 24 hours to what he or she usually experiences (much better, somewhat better, slightly better, about the same, slightly worse, somewhat worse, or much worse than usual, did not experience). The response choices were
Contents lists available at ScienceDirect
Heart & Lung journal homepage: www.heartandlung.org
RESEARCH PUB 1 A Multi-Sensor Algorithm Predicts Heart Failure Events in Patients with Implanted Devices: Results from the MultiSENSE Study JOHN BOEHMER, RAMESH HARIHARAN, FAUSTO DEVECCHI, ANDREW SMITH, QI AN, VIKTORIA AVERINA, CRAIG STOLEN, PRAMODSINGH THAKUR, JULIE THOMPSON, YI ZHANG, JAGMEET SINGH Purpose: To evaluate to performance of an algorithm developed using diagnostic sensor data from implanted cardiac resynchronization therapy defibrillators (CRT-D) to detect impending heart failure decompensation events. Background: Heart Failure (HF), a growing health-care challenge globally, involves costly hospitalizations with adverse impact on patient outcomes. Reliable monitoring for early signs of worsening HF is needed to enable proactive interventions for prevention of acute decompensations. We hypothesize that an algorithm combining information from a diverse set of implanted device based sensors judiciously chosen to target different aspects of HF pathophysiology can effectively detect worsening HF. Methods: MultiSENSE enrolled patients with HF and reduced EF (HFrEF) implanted with CRT-D, converted into an investigational device to enable chronic ambulatory data collection. HF events (HFEs) were defined as HF admissions or unscheduled visits with augmented intravenous HF treatment, and were independently adjudicated. Patients were assigned to Development or Test set cohorts in chronological order of enrollment. The development set was used to construct a composite index and alert algorithm (HeartLogic) combining Heart Sounds, Respiration, Thoracic Impedance, Heart Rate and Activity; whereas the test set was sequestered for its subsequent independent validation. Sensitivity was defined as the proportion of usable HFEs detected by HeartLogic alerts. Unexplained alert rate (UAR) was defined as the ratio of alerts not explained by HF to the total usable follow-up duration. The two co-primary endpoints: 1. Sensitivity performance goal (PG) of > 40%; 2. UAR PG of < 2 alerts per patient year were tested with a 2-sided 95% confidence interval (CI). Results: Overall, 900 (Development ¼ 500, Test ¼ 400) patients had sensor data collection enabled and followed for up to a year. Primary endpoints were evaluated using the 320 patient years of follow-up data and 50 adjudicated usable HFEs in the Test Set cohort (72% male; age 66.8 10.3 years; NYHA Class at enrollment I/II/III/IV/unknown: 5%/69%/25%/1%/1%; LVEF 30.0 11.4%). With an observed sensitivity of 70% (Lower 2-sided 95% CI: 55.4%) and UAR of 1.47 (Upper 2-sided 95% CI: 1.65), both endpoints were significantly exceeded. Conclusion: The HeartLogic multi-sensor HF diagnostic algorithm significantly exceeded its pre-specified endpoints demonstrating compelling performance for worsening HF detection.
0147-9563/$ e see front matter
2 Treatment with Patiromer Decreases Aldosterone in Patients with Heart Failure, Chronic Kidney Disease, and Hyperkalemia on RAAS Inhibitors DAHLIA GARZA, COLEMAN GROSS, MARTHA MAYO, JINWEI YUAN, DANIEL WILSON, MATTHEW WEIR, BERTRAM PITT Purpose: Patiromer, a nonabsorbed potassium (K+)-binding polymer that uses calcium rather than sodium as the cation for exchange with K+ was shown in the OPAL-HK study to decrease serum K+ and aldosterone levels independent of plasma renin activity in patients with chronic kidney disease (CKD) on reninangiotensin-aldosterone system (RAAS) inhibitors. In a post-hoc analysis of OPAL-HK, we examined changes in serum K+ and aldosterone during the 4-week treatment phase in the subgroup with CKD and heart failure (HF). Background: Aldosterone plays an important role in the progression of HF and may be increased in HF due to activation of the RAAS. Hyperkalemia may also increase aldosterone and limits the use of RAAS inhibitors. This limitation is a concern, especially in patients with HF, with or without renal dysfunction, in whom the effects of aldosterone reduction provide the greatest benefit. Methods: Mean change from baseline to week 4 in serum K+ and aldosterone were analyzed in 102 patients with NYHA classes I-III HF and in 141 patients without HF. Patiromer starting doses were 8.4 g/day for patients with mild hyperkalemia (serum K+ 5.1-<5.5 mEq/L) and 16.8 g/day for patients with moderate-severe hyperkalemia (serum K+ >5.5 mEq/L), given divided twice daily. Results: Baseline aldosterone was higher in patients with HF than without HF (Table). In patients with mild hyperkalemia, small or nonsignificant changes in aldosterone were observed with modest serum K+ reductions, regardless of HF status. In patients with moderate-severe hyperkalemia, significant decreases in aldosterone, which were greater in the HF subgroup, were observed with larger serum K+ reductions. Conclusion: HF patients with moderate-severe hyperkalemia experienced the most improvement in aldosterone level with patiromer treatment. Serum K+ may play an important role in modulating aldosterone in HF. 3 Relationship of Health Literacy, Knowledge, and Patient Activation with Self-Management in Persons with Heart Failure ANN JACOBSON, VERONICA SUMODI, DONNA WALKER, LORI DEJOHN, KELLY DION, HUA-LI LIN TAI, LINDA BLANKENSHIP, DONNA ROSS Purpose: The purpose of the study was to identify factors related to self-management behavior in persons with heart failure (HF). Specifically, we analyzed the relationship of health literacy, patient
216
Abstracts / Heart & Lung 46 (2017) 215e219
activation, and heart failure knowledge with self-management behavior. The hypothesis was that in persons with heart failure, self-care behaviors are associated with health literacy, heart failure knowledge, and patient activation. Background: Current investigations of self-management by persons with HF have focused primarily on examining the effects of clinical interventions by health care providers to improve patients’ self-management behaviors. While clinician support of self-management is important, more information is needed to understand intrinsic patient characteristics that influence selfmanagement behaviors. Knowledge of these characteristics can better inform providers in delivering care to promote self-management and remove barriers. More research regarding determinants of self-care behavior in HF patients can enhance the knowledge base for nurses and other providers to design evidencebased, effective interventions. Methods: The study used a prospective, cross-sectional, correlational design to test the hypothesis. A convenience sample of 151 persons meeting eligibility criteria (18 years or older; diagnosis of heart failure, ability to read and respond to questionnaires in English) completed questionnaires containing the European Heart Failure Self-Care Behavior Scale, the Test of Functional Health Literacy in Adults, Short form (S-TOFHLA), the 13-Item Patient Activation Measure, the Dutch Heart Failure Knowledge Scale, the Stanford Self-Rated Health Measure, and a demographic data form. A member of the research team approached potential participants, who were present for their regularly-scheduled appointments at one of six chronic care outpatient clinics of a regional health system, informed them of the nature of the study, and invited them to participate. Those willing to participate completed questionnaires at the site. Data were entered using the double entry technique to reduce error, and analyzed using SAS software. Sample size was based on a power analysis for 4 variables and an effect size of .20. Scale scores were computed according to published recommendations, and all scale scores were computed so that higher scores represented higher levels of the attribute being measured. Means and frequencies were computed to describe the sample. To test the hypothesis, correlations and multiple regression were used, with alpha set at .05. Results: The sample was 57% male with a mean age of 68 (SD 13.0). Fifty-one percent were white and 44% African American. Highest education completed was 18% below high school, 27% high school, 31% some college, and 25% college degree or higher. Self-management (measured with the European Heart Failure Self-Care Behavior Scale) was significantly correlated with patient activation level (r ¼ .266, p ¼ .001) and age (r ¼ .275, p ¼ .002). Relationships between self-management and functional health literacy (r ¼ -.096, p ¼ .25), and self-management and heart failure knowledge (r ¼ .019, p ¼ .81) were not statistically significant. However, health literacy was correlated with educational level (r ¼ .234, p < .05) and heart failure knowledge (r ¼ .292, p < .05). Heart failure knowledge and educational level were also positively correlated (r ¼ .339, p < .05). Conclusion: The findings of this study partially support the hypothesis, in that self-management behavior was positively associated with patient activation, but not with health literacy or heart failure knowledge, in persons with heart failure. Although further research is needed to confirm and further elucidate these findings, they suggest that persons with HF may better manage their condition if sufficiently activated, regardless of their level of health literacy or knowledge of their disease process. Caution in interpreting these results is warranted based on the potential for bias in self-report. Because of the significant correlations between heart failure knowledge, health literacy and educational level, this study’s findings suggest that interventions targeted at promoting knowledge in persons with heart failure should take into account patients’ educational level and health literacy.
4 Measures of Ventricular-Arterial Coupling and Incident Heart Failure Preserved Ejection Fraction (HFpEF): A Matched Case-Control Analysis CAROLYN LEKAVICH Purpose: This study was designed to detect differences in markers associated with incident heart failure preserved ejection fraction (HFpEF) when comparing matched case-control groups. Background: Evidence continues to demonstrate increasing prevalence, cost and mortality implications of HFpEF, but clearly defined parameters for early detection have not been established. Methods: A study cohort of case (incident HFpEF patients, n¼155) and matched control (patients with no prior HF, n¼155) groups was retrospectively identified. Matching criteria included race, sex, age and date of echocardiogram (within 1 year). Physiologic and echocardiographic markers were collected from previously acquired transthoracic echocardiograms. These echocardiogram images were re-analyzed and measures of ventricular-arterial coupling were calculated. Using conditional logistic regression and controlling for covariates, models were fit to detect differences in HFpEF markers between cases and controls. Results: Statistically significant differences in markers that reflect ventricular elastance (Ees) (p¼0.003) and left atrial diameter (LAdiam) (p¼0.0002) were detected when comparing the case and control groups. Conditional logistic regression analyses suggested a 32% higher odds of being in the case group with every 1 unit increase in Ees, OR 1.32 (1.10, 1.58) and a 4.57 times higher odds of being in the case group for every 1 cm increase in LAdiam, OR 4.57 (2.04, 10.22) Conclusion: Ees and LAdiam are easily measurable echocardiographic markers which may have a role in identifying and tracking the progression toward incident HFpEF without increasing cost or risk to the patient. Prospective studies are indicated to explore the use of Ees and LAdiam as predictors of impending HFpEF. 5 Development of a Symptom Tracker for Use by Patients with Heart Failure ELDRIN LEWIS, AMY BARRETT, SANDY LEWIS, THERESA COLES, CARLA DEMURO, DONALD STULL, STUART TURNER, ENGELS OBI, CHUN-LAN CHANG, KATHERINE WALTMAN JOHNSON Purpose: A novel patient-reported tool, the HF Symptom Tracker (HFaST), was developed to improve patient-health care provider (HCP) communication, which may positively impact heart failure patient outcomes, including hospitalization rates. Background: Heart failure (HF) is a progressive disease associated with a significant risk of hospitalization and death. Presently, there are no tools available to track changes in patient-reported symptoms over. Many hospitalizations occur due to failure to recognize symptom progression. Methods: The HFaST was developed through a comprehensive process that included review of the literature, expert clinician input, and qualitative interviews with patients, caregivers of patients with HF, and HCPs. Results: Individual interviews were conducted with stakeholders (8 HCPs, 6 patients, 6 caregivers). An initial 40-item symptom list was piloted with 5 HCPs, and a refined 20-item set was debriefed with patients, caregivers, and 3 HCPs. The resultant HFaST consists of 10 items selected based on combined importance rankings from stakeholders, with 8 response options comparing the respondent’s experience of each symptom during the past 24 hours to what he or she usually experiences (much better, somewhat better, slightly better, about the same, slightly worse, somewhat worse, or much worse than usual, did not experience). The response choices were