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.

Objectives

To examine the effect of the relationship between literacy and other individual-level factors on having an advance directive (AD).

Design

Face-to-face structured interview.

Setting

Participants were recruited from an academic general internal medicine clinic and one of four federally qualified health centers in Chicago.

Participants

Seven hundred eighty-four adults aged 55 to 74.

Measurements

Assessment of participant literacy, sociodemographic factors, and having an AD for medical care.

Results

One-eighth (12.4%) of participants with low literacy, 26.6% of those with marginal literacy, and 49.5% of those with adequate literacy reported having an AD (P < .001). In multivariable analyses, literacy and race were independently associated with less likelihood of having an AD. Specifically, participants with limited literacy (risk ratio (RR) = 0.45, 95% confidence interval (CI) = 0.22-0.95) and African Americans (RR = 0.64, 95% CI = 0.47-0.88) were less likely to have an AD. Exploratory analyses showed that there was not a significant interaction between the effect of literacy and race.

Conclusion

Limited literacy and African-American race were significant risk factors for not having an AD in this cohort of older adults. Literacy and race probably represent two separate but important causal pathways that need to be understood to improve how the healthcare system ascertains and protects individuals' advance care preferences.

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.

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.