Examining Whether a Self-Care Program Reduces Healthcare Use and Improves Health among Patients with Acute Heart Failure—The Guided HF Study [Internet]

Excerpt

Background: Despite a relative reduction in the hospitalization rate for heart failure (HF), the actual number of HF hospitalizations remains >1 million annually. More than 80% of patients who are hospitalized are initially seen in the emergency department (ED). Importantly, the ED is the safety net for acute HF (AHF) care. Thus, it is the primary provider for vulnerable patients, including those with low socioeconomic status, minority populations, and those with poor health literacy. Hospitalized patients with HF are among those most frequently readmitted within 30 days; they have up to a 25% risk of readmission within a month and a 50% risk within 6 months of discharge. Events in patients with AHF discharged from the ED are reportedly much higher, and an even greater disparity exists between vulnerable and nonvulnerable patients. Self-care education and other strategies could improve this disparity gap. We proposed studying the impact of a self-care intervention on patients with AHF discharged from the ED.

Objectives: We determined the impact of our self-care intervention on our primary outcome, a composite global rank prioritizing outcomes in the following order: cardiovascular (CV) death, HF event (first ED/clinic revisit or hospital admission), and Kansas City Cardiomyopathy Questionnaire (KCCQ) score at 90 days. We (1) determined the overall impact of our strategy regardless of vulnerable characteristics, (2) explored individual characteristics of vulnerability associated with the highest (and lowest) improvements from our intervention, and (3) assessed the reduction in disparities in our primary outcome between those with and without characteristics of vulnerability. Secondary end points included our primary composite outcome at 30 days, patient satisfaction, HF knowledge, and HF health status based on the KCCQ at 30 and 90 days.

Methods: Patients with AHF who were discharged after a brief ED stay at 15 sites were screened to ensure that they fulfilled our broad inclusion and exclusion criteria: history of HF, not on an outpatient inotrope infusion, systolic blood pressure (BP) >100 mm Hg, and no evidence of an acute coronary syndrome. They were randomly assigned 1:1 to structured usual ED discharge care vs a tailored intervention strategy that focused on self-care strategies over the subsequent 90 days. This intervention was conducted by study team coordinators, nurses, and paramedics trained under an identical protocol. We stratified by site and randomized at the patient level using random permuted blocks. Research staff who were blinded to intervention arm called all patients at 30 and 90 days after discharge to determine the primary and secondary outcomes. For our primary outcome, we analyzed the impact of our intervention on our global rank end point at 90 days. This outcome was also evaluated in our subset of vulnerable patients. Key secondary outcomes included the impact of our intervention on our global rank end point at 30 days and changes in the KCCQ and Dutch Heart Failure Knowledge Scale (DHFKS) scores at 30 and 90 days. We used means and medians for simple descriptive statistics, and the proportional hazards model for the global ranking outcome. Our models adjusted for traditional covariates of HF severity, including age, sex, systolic BP, prior ejection fraction (EF) (moderate/severe vs normal), and estimated glomerular filtration rate.

Results: From October 28, 2015, to September 5, 2019, we randomly assigned 491 patients at 15 sites. Of these 491 patients, 245 were allocated to structured usual care, and 246 were allocated to our intervention arm. The overall median age was 63 years, 63% were African American, 36% were female, and 40% had a normal prior EF. Comorbidities such as diabetes, hypertension, and chronic kidney disease were prevalent and well balanced between the 2 arms. Our adjusted analysis for the global rank primary outcome showed that patients in the intervention arm were 10% less likely (hazard ratio [HR], 0.89; 95% CI, 0.73-1.10; P = .28) to have a worse global ranking over 90 days compared with patients in the usual care arm. Compared with patients in the structured usual care arm, patients in the intervention arm had a 4% (95% CI, ‒0.04 to 0.13; P = .29) overall lower rate of CV death and HF-related events over 90 days. The adjusted model for 90-day CV death and HF events found a 22% reduction in events in the intervention arm compared with the usual care arm (HR, 0.78; 95% CI, 0.57-1.06; P = .11). Similar differences were seen between the intervention arm and usual care arm among our vulnerable population. For our key secondary end point, compared with patients in the usual care arm, patients in the intervention arm were significantly less likely to have a worse global ranking over 30 days (HR, 0.80; 95% CI, 0.64-0.99; P = .04).

Median 30-day changes from baseline to 30 days in KCCQ score were 9.5 points in the intervention arm and 5.7 in the usual care arm (P = .05). Median 90-day change in KCCQ score was 10.9 points in the intervention arm and 9.4 points in the structured usual care arm (P = .75). Based on our adjusted model, 30-day changes in KCCQ score for patients in the intervention arm were 5.49 points higher (95% CI, 1.25-9.72; P = .01) than for patients in the structured usual care arm. There were no significant differences in KCCQ score at 90 days (β = 2.7; P = .25). We used a linear regression model, with changes in the DHFKS score as the outcome while adjusting for the baseline DHFKS score. The adjusted difference in DHFKS score between the intervention arm and the structured usual care arm was 1.22 points (95% CI, 0.34-2.09; P = .007) at 30 days and 1.94 points (95% CI, 1.02-2.87; P < .001) at 90 days.

Conclusions: We successfully completed the first randomized study of patients with AHF discharged from the ED and collected 30-day and 90-day event rates. There were no significant differences between arms in our primary 90-day outcome. At 30 days, our intervention resulted in a significant improvement in our primary global rank outcome. Importantly, as a result of our intervention, significant differences in patient-centered outcomes, such as KCCQ score and HF knowledge, were seen at 30 and 90 days. A variety of health care providers successfully delivered our intervention strategy, suggesting that this strategy would be readily amenable to rapid dissemination and implementation.

Limitations: There are several limitations of this work. First, we had projected CV death, hospital admission, and ED revisit event rates of 62% in the usual care arm but experienced only a 36% rate, drastically limiting our power to detect differences between usual care and the intervention. Second, participant withdrawal in the intervention arm was greater than in the usual care arm, which suggests that certain patients may be more amenable to self-care coaching and that our results may be most applicable to this group. Third, our overall accrual rate was slower than expected, resulting in an extension of study duration; a discussion with PCORI resulted in a target sample size adjustment and a change in our primary outcome. Temporal changes in admission patterns at certain sites were largely responsible for this occurrence. Finally, the consent rate was only 56%, suggesting that patients may still be hesitant to allow virtual or in-person home visits. The receptivity to telehealth may change as a result of the COVID-19 virus pandemic.