Self-reported recall and daily diary-recorded measures of weight monitoring adherence: associations with heart failure-related hospitalization.

BACKGROUND: Weight monitoring is an important element of HF self-care, yet the most clinically meaningful way to evaluate weight monitoring adherence is uncertain. We conducted this study to evaluate the association of (1) self-reported recall and (2) daily diary-recorded weight monitoring adherence with heart failure-related (HF-related) hospitalization. METHODS: We conducted a prospective cohort study among 216 patients within a randomized trial of HF self-care training. All patients had an initial self-care training session followed by 15 calls (median) to reinforce educational material; patients were also given digital scales, instructed to weigh daily, record weights in a diary, and mail diaries back monthly. Weight monitoring adherence was assessed with a self-reported recall question administered at 12 months and dichotomized into at least daily versus less frequent weighing. Diary-recorded weight monitoring was evaluated over 12 months and dichotomized into ≥80% and <80% adherence. HF-related hospitalizations were ascertained through patient report and confirmed through record review. RESULTS: Over 12 months in 216 patients, we identified 50 HF-related hospitalizations. Patients self-reporting daily or more frequent weight monitoring had an incidence rate ratio of 1.34 (95% CI 0.24-7.32) for HF-related hospitalizations compared to those reporting less frequent weight monitoring. Patients who completed ≥80% of weight diaries had an IRR of 0.37 (95% CI 0.18-0.75) for HF-related hospitalizations compared to patients who completed <80% of weight diaries. CONCLUSIONS: Self-reported recall of weight monitoring adherence was not associated with fewer HF hospitalizations. In contrast, diary-recorded adherence ≥80% of days was associated with fewer HF-related hospitalizations. Incorporating diary-based measures of weight monitoring adherence into HF self-care training programs may help to identify patients at risk for HF-related hospitalizations.

A single-item self-report medication adherence question predicts hospitalisation and death in patients with heart failure.

AIMS AND OBJECTIVES: To determine whether a single-item self-report medication adherence question predicts hospitalisation and death in patients with heart failure. BACKGROUND: Poor medication adherence is associated with increased morbidity and mortality. Having a simple means of identifying suboptimal medication adherence could help identify at-risk patients for interventions. DESIGN: We performed a prospective cohort study in 592 participants with heart failure within a four-site randomised trial. METHODS: Self-report medication adherence was assessed at baseline using a single-item question: 'Over the past seven days, how many times did you miss a dose of any of your heart medication?' Participants who reported no missing doses were defined as fully adherent, and those missing more than one dose were considered less than fully adherent. The primary outcome was combined all-cause hospitalisation or death over one year and the secondary endpoint was heart failure hospitalisation. Outcomes were assessed with blinded chart reviews, and heart failure outcomes were determined by a blinded adjudication committee. We used negative binomial regression to examine the relationship between medication adherence and outcomes. RESULTS: Fifty-two percent of participants were 52% male, mean age was 61 years, and 31% were of New York Heart Association class III/IV at enrolment; 72% of participants reported full adherence to their heart medicine at baseline. Participants with full medication adherence had a lower rate of all-cause hospitalisation and death (0·71 events/year) compared with those with any nonadherence (0·86 events/year): adjusted-for-site incidence rate ratio was 0·83, fully adjusted incidence rate ratio 0·68. Incidence rate ratios were similar for heart failure hospitalisations. CONCLUSION: A single medication adherence question at baseline predicts hospitalisation and death over one year in heart failure patients. RELEVANCE TO CLINICAL PRACTICE: Medication adherence is associated with all-cause and heart failure-related hospitalisation and death in heart failure. It is important for clinicians to assess patients' medication adherence on a regular basis at their clinical follow-ups.

Multisite randomized trial of a single-session versus multisession literacy-sensitive self-care intervention for patients with heart failure.

BACKGROUND: Self-care training can reduce hospitalization for heart failure (HF), and more intensive intervention may benefit more vulnerable patients, including those with low literacy. METHODS AND RESULTS: A 1-year, multisite, randomized, controlled comparative effectiveness trial with 605 patients with HF was conducted. Those randomized to a single session received a 40-minute in-person, literacy-sensitive training; the multisession group received the same initial training and then ongoing telephone-based support. The primary outcome was combined incidence of all-cause hospitalization or death; secondary outcomes included HF-related hospitalization and HF-related quality of life, with prespecified stratification by literacy. Overall, the incidence of all-cause hospitalization and death did not differ between intervention groups (incidence rate ratio, 1.01; 95% confidence interval, 0.83-1.22). The effect of multisession training compared with single-session training differed by literacy group: Among those with low literacy, the multisession training yielded a lower incidence of all-cause hospitalization and death (incidence rate ratio, 0.75; 95% confidence interval, 0.45-1.25), and among those with higher literacy, the multisession intervention yielded a higher incidence (incidence rate ratio, 1.22; 95% confidence interval, 0.99-1.50; interaction P=0.048). For HF-related hospitalization, among those with low literacy, multisession training yielded a lower incidence (incidence rate ratio, 0.53; 95% confidence interval, 0.25-1.12), and among those with higher literacy, it yielded a higher incidence (incidence rate ratio, 1.32; 95% confidence interval, 0.92-1.88; interaction P=0.005). HF-related quality of life improved more for patients receiving multisession than for those receiving single-session interventions at 1 and 6 months, but the difference at 12 months was smaller. Effects on HF-related quality of life did not differ by literacy. CONCLUSIONS: Overall, an intensive multisession intervention did not change clinical outcomes compared with a single-session intervention. People with low literacy appear to benefit more from multisession interventions than people with higher literacy. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00378950.

Low literacy is associated with increased risk of hospitalization and death among individuals with heart failure.

BACKGROUND: Low literacy increases the risk for many adverse health outcomes, but the relationship between literacy and adverse outcomes in heart failure (HF) has not been well studied. METHODS: We studied a cohort of ambulatory patients with symptomatic HF (NYHA Class II-IV within the past 6 months) who were enrolled in a randomized controlled trial of self-care training recruited from internal medicine and cardiology clinics at four academic medical centers in the US. The primary outcome was combined all-cause hospitalization or death, with a secondary outcome of hospitalization for HF. Outcomes were assessed through blinded interviews and subsequent chart reviews, with adjudication of cause by a panel of masked assessors. Literacy was measured using the short Test of Functional Health Literacy in Adults. We used negative binomial regression to examine whether the incidence of the primary and secondary outcomes differed according to literacy. RESULTS: Of the 595 study participants, 37 % had low literacy. Mean age was 61, 31 % were NYHA class III/IV at baseline, 16 % were Latino, and 38 % were African-American. Those with low literacy were older, had a higher NYHA class, and were more likely to be Latino (all p < 0.001). Adjusting for site only, participants with low literacy had an incidence rate ratio (IRR) of 1.39 (95 % CI: 0.99, 1.94) for all-cause hospitalization or death and 1.36 (1.11, 1.66) for HF-related hospitalization. After adjusting for demographic, clinical, and self-management factors, the IRRs were 1.31 (1.06, 1.63) for all-cause hospitalization and death and 1.46 (1.20, 1.78) for HF-related hospitalization. CONCLUSIONS: Low literacy increased the risk of hospitalization for ambulatory patients with heart failure. Interventions designed to mitigate literacy-related disparities in outcomes are warranted.

Is adherence to weight monitoring or weight-based diuretic self-adjustment associated with fewer heart failure-related emergency department visits or hospitalizations?

BACKGROUND: Heart failure (HF) self-care interventions can improve outcomes, but less than optimal adherence may limit their effectiveness. We evaluated if adherence to weight monitoring and diuretic self-adjustment was associated with HF-related emergency department (ED) visits or hospitalizations. METHODS AND RESULTS: We performed a case-control analysis nested in a HF self-care randomized trial. Participants received HF self-care training, including weight monitoring and diuretic self-adjustment, which they were to record in a diary. We defined case time periods as HF-related ED visits or hospitalizations in the 7 preceding days; control time periods were defined as 7-day periods free of ED visits and hospitalizations. We used logistic regression to compare weight monitoring and diuretic self-adjustment adherence in case and control time periods, adjusted for demographic and clinical covariates. Among 303 participants, we identified 81 HF-related ED visits or hospitalizations (cases) in 54 patients over 1 year of follow-up. Weight monitoring adherence (odds ratio [OR] 0.42, 95% confidence interval [CI] 0.23-0.76) and diuretic self-adjustment adherence (OR 0.44, 95% CI 0.19-0.98) were both associated with lower adjusted odds of HF-related ED visits or hospitalizations. CONCLUSIONS: Adherence to weight monitoring and diuretic self-adjustment was associated with lower odds of HF-related ED visits or hospitalizations. Adherence to these activities may reduce HF-related morbidity.

The effect of progressive, reinforcing telephone education and counseling versus brief educational intervention on knowledge, self-care behaviors and heart failure symptoms.

BACKGROUND: The optimal strategy for promoting self-care for heart failure (HF) is unclear. METHODS AND RESULTS: We conducted a randomized trial to determine whether a "teach to goal" (TTG) educational and behavioral support program provided incremental benefits to a brief (1 hour) educational intervention (BEI) for knowledge, self-care behaviors, and HF-related quality of life (HFQOL). The TTG program taught use of adjusted-dose diuretics and then reinforced learning goals and behaviors with 5 to 8 telephone counseling sessions over 1 month. Participants' (n = 605) mean age was 61 years; 37% had marginal or inadequate literacy; 69% had ejection fraction <0.45; and 31% had Class III or IV symptoms. The TTG group had greater improvements in general and salt knowledge (P < .001) and greater increases in self-care behaviors (from mean 4.8 to 7.6 for TTG vs. 5.2 to 6.7 for BEI; P < .001). HFQOL improved from 58.5 to 64.6 for the TTG group but did not change for the BEI group (64.7 to 63.9; P < .001 for the difference in change scores). Improvements were similar regardless of participants' literacy level. CONCLUSIONS: Telephone reinforcement of learning goals and self-care behaviors improved knowledge, health behaviors, and HF-related QOL compared to a single education session.

Relationship between literacy, knowledge, self-care behaviors, and heart failure-related quality of life among patients with heart failure.

BACKGROUND: We sought to examine the relationship between literacy and heart failure-related quality of life (HFQOL), and to explore whether literacy-related differences in knowledge, self-efficacy and/or self-care behavior explained the relationship. METHODS: We recruited patients with symptomatic heart failure (HF) from four academic medical centers. Patients completed the short version of the Test of Functional Health Literacy in Adults (TOFHLA) and questions on HF-related knowledge, HF-related self-efficacy, and self-care behaviors. We assessed HFQOL with the Heart Failure Symptom Scale (HFSS) (range 0-100), with higher scores denoting better quality of life. We used bivariate (t-tests and chi-square) and multivariate linear regression analyses to estimate the associations between literacy and HF knowledge, self-efficacy, self-care behaviors, and HFQOL, controlling for demographic characteristics. Structural equation modeling was conducted to assess whether general HF knowledge, salt knowledge, self-care behaviors, and self-efficacy mediated the relationship between literacy and HFQOL. RESULTS: We enrolled 605 patients with mean age of 60.7 years; 52% were male; 38% were African-American and 16% Latino; 26% had less than a high school education; and 67% had annual incomes under $25,000. Overall, 37% had low literacy (marginal or inadequate on TOFHLA). Patients with adequate literacy had higher general HF knowledge than those with low literacy (mean 6.6 vs. 5.5, adjusted difference 0.63, p < 0.01), higher self-efficacy (5.0 vs. 4.1, adjusted difference 0.99, p < 0.01), and higher prevalence of key self-care behaviors (p < 0.001). Those with adequate literacy had better HFQOL scores compared to those with low literacy (63.9 vs. 55.4, adjusted difference 7.20, p < 0.01), but differences in knowledge, self-efficacy, and self-care did not mediate this difference in HFQOL. CONCLUSION: Low literacy was associated with worse HFQOL and lower HF-related knowledge, self-efficacy, and self-care behaviors, but differences in knowledge, self-efficacy and self-care did not explain the relationship between low literacy and worse HFQOL.

Developing and testing the health literacy universal precautions toolkit.

The health literacy demands of the healthcare system often exceed the health literacy skills of Americans. This article reviews the development of the Health Literacy Universal Precautions (HLUP) Toolkit, commissioned by the Agency for Healthcare Research and Quality and designed to help primary care practices structure the delivery of care as if every patient may have limited health literacy. The development of the toolkit spanned 2 years and consisted of 3 major tasks: (1) developing individual tools (modules explaining how to use or implement a strategy to minimize the effects of low health literacy), using existing health literacy resources when possible, (2) testing individual tools in clinical practice and assembling them into a prototype toolkit, and (3) testing the prototype toolkit in clinical practice. Testing revealed that practices will use tools that are concise and actionable and are not perceived as being resource intensive. Conducting practice self-assessments and generating enthusiasm among staff were key elements for successful implementation. Implementing practice changes required more time than anticipated and some knowledge of quality improvement techniques. In sum, the HLUP Toolkit holds promise as a means of improving primary care for people with limited health literacy, but further testing is needed.

Comparison of a one-time educational intervention to a teach-to-goal educational intervention for self-management of heart failure: design of a randomized controlled trial.

BACKGROUND: Heart failure (HF) is common, costly and associated with significant morbidity and poor quality of life, particularly for patients with low socioeconomic status. Self-management training has been shown to reduce HF related morbidity and hospitalization rates, but there is uncertainty about how best to deliver such training and what patients benefit. This study compares a single session self-management HF training program against a multiple session training intervention and examines whether their effects differ by literacy level. METHODS/DESIGN: In this randomized controlled multi-site trial, English and Spanish-speaking patients are recruited from university-affiliated General Internal Medicine and Cardiology clinics at 4 sites across the United States. Eligible patients have HF with New York Heart Association class II-IV symptoms and are prescribed a loop diuretic. Baseline data, including literacy level, are collected at enrollment and follow-up surveys are conducted at 1, 6 and 12 months. Upon enrollment, both the control and intervention groups receive the same 40 minute, literacy-sensitive, in-person, HF education session covering the 4 key self-management components of daily self assessment and having a plan, salt avoidance, exercise, and medication adherence. All participants also receive a literacy-sensitive workbook and a digital bathroom scale. After the baseline education was completed, patients are randomly allocated to return to usual care or to receive ongoing education and training. The intervention group receives an additional 20 minutes of education on weight and symptom-based diuretic self-adjustment, as well as periodic follow-up phone calls from the educator over the course of 1 year. These phone calls are designed to reinforce the education, assess participant knowledge of the education and address barriers to success.The primary outcome is the combined incidence of all cause hospitalization and death. Secondary outcomes include HF-related quality of life, HF-related hospitalizations, knowledge regarding HF, self-care behavior, and self-efficacy. The effects of each intervention will be stratified by patient literacy, in order to identify any differential effects. DISCUSSION: Enrollment of the proposed 660 subjects will continue through the end of 2009. Outcome assessments are projected to be completed by early 2011. TRIAL REGISTRATION: ClinicalTrials.gov (http://www.clinicaltrials.gov/) NCT00378950.