Heart Failure Optimal Outcomes From Pharmacy Study - HOOPS

Description:

There appears to be a large gap between known data on efficacy of medications such as angiotensin-converting enzyme inhibitors (ACEIs)/beta-blockers in patients with congestive heart failure (CHF), and translation into clinical practice. The current trial sought to study if pharmacist intervention to optimize medical treatment in patients with left ventricular (LV) systolic CHF would improve clinical outcomes.

Hypothesis:

Pharmacist intervention would result in improved compliance with evidence-based medications in CHF and result in improved clinical outcomes.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • LV systolic dimension, with or without signs of CHF

    Number screened: 6,716
    Number of enrollees: 2,164
    Duration of follow-up: 4.7 years
    Mean patient age: 71 years
    Percentage female: 30%

Exclusions:

  • Registration with CHF-nurse service
  • Concurrent disease other than CHF likely to reduce life-expectancy
  • Severe cognitive impairment or psychiatric illness
  • Dialysis
  • Resident in a long-term care facility

Primary Endpoints:

  • Death from any cause or CHF hospitalization

Secondary Endpoints:

  • All-cause mortality/any hospitalization
  • All-cause mortality/CV hospitalization
  • Total number of admissions for CHF, CV cause, and any cause
  • Emergency room visits, hospital outpatient clinics, primary care visits
  • Prescribing of evidence-based medications

Drug/Procedures Used:

Patients randomized to pharmacist intervention received 30-minute face-to-face consultations. If changes were made, 3-4 additional consultations were arranged. Patients in the other arm received usual medical therapy.

Concomitant Medications:

Beta-blocker (62%), ACEI/angiotensin-receptor blocker (ARB) (86%), aldosterone antagonist (5%), diuretic (61%), antithrombotic (91%), statin (79%), antithrombotic/antiplatelet (91%)

Principal Findings:

A total of 2,164 patients were enrolled, 1,092 to pharmacist intervention and 1,074 to usual care. Baseline characteristics were similar between the different arms. The mean blood pressure was 127/72 mm Hg. The majority of patients had either mild (40%) or moderate (42%) LV dysfunction, and about 78% had ischemic cardiomyopathy. The mean duration of LV systolic dimension was about 3.4 years. Only about 2% had been admitted for CHF in the past year. The mean number of medicines was about 8.5.

At the end of the first year of follow-up, patients in the pharmacist intervention arm were more likely to have started on increased dose of ACEI/ARB (33.1% vs. 18.5%, p < 0.001) or beta-blockers (17.9% vs. 11.1%, p < 0.001). The primary endpoint of death or hospitalization for CHF was similar between the two arms at the end of 5 years (35.8% vs. 35.4, hazard ratio 0.97, 95% confidence interval 0.83-1.14, p = 0.72). Similarly, CHF hospitalization (10% vs. 11%, p = 0.36), all-cause mortality (31% vs. 31%, p = 0.68), and all-cause mortality/cardiovascular (CV) hospitalization (45% vs. 44%, p = 0.70) were similar.

Interpretation:

The results of this trial indicate that a low-intensity pharmacist-led collaborative intervention in preventive care resulted in improved compliance with evidence-based measures, but did not improve outcomes up to 5 years of follow-up. One reason for the lack of a difference between the groups is the high proportion of patients on ACEI/ARB at baseline (86%). Another reason is the exclusion of high-risk CHF patients (only 2% had been admitted with CHF in the past year), in whom improved adherence is most likely to impact clinical outcomes. Finally, although unlikely, it is possible that a difference may be noted with longer-term follow-up.

References:

Lowrie R, Mair FS, Greenlaw N, et al. Pharmacist intervention in primary care to improve outcomes in patients with left ventricular systolic dysfunction. Eur Heart J 2012;33:314-24.

Presented by Dr. Richard Lowrie at the American Heart Association Scientific Sessions, Orlando, FL, November 14, 2011.

Clinical Topics: Heart Failure and Cardiomyopathies, Acute Heart Failure

Keywords: Pharmacists, Follow-Up Studies, Cardiomyopathies, Referral and Consultation, Heart Failure, Blood Pressure, Confidence Intervals


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