Self-Care Intervention May Only Temporize HF Patients Discharged From ED

Extra self-care education and outpatient check-ins weren't enough to prevent events for long among heart failure (HF) patients who visited the emergency department (ED) without hospitalization, a randomized trial found.

In a cohort with many vulnerable patients using the ED as their main source of healthcare, people assigned to the self-care intervention at ED discharge experienced no reduction in the primary endpoint, a 90-day composite outcome of cardiovascular death, HF-related events (unscheduled clinic visit due to HF, ED revisit, or hospitalization), and adverse change in the KCCQ-12 quality of life summary score compared with usual care (HR 0.89, 95% CI 0.73-1.10).

At 30 days, however, the incidence of these events did favor the intervention arm (HR 0.80, 95% CI 0.64-0.99), reported the GUIDED-HF group led by Sean Collins, MD, MSc, of Vanderbilt University Medical Center, Nashville. A full manuscript was published online in JAMA Cardiology.

A major caveat was that investigators had not been able to enroll enough patients to have a trial that was powered to show a difference in outcomes; they could only randomize 479 out of a planned 700 people due to slow enrollment.

In the trial, the usual care group underwent a structured discharge process including HF medication reconciliation, HF medication prescriptions, and an appointment with an HF clinician at 7 days.

The self-care intervention comprised usual care plus a home or telehealth visit within 7 days of discharge aimed at helping patients identify self-care barriers in eating habits, recording daily weight, using a weekly medication organizer, and recognition of early signs of worsening HF. Recipients also got twice-monthly telephone coaching over 3 months (by nurses, study coordinators, and paramedics).

"This is a really interesting and really important trial, looking at a high-risk group of patients for whom we sorely need evidence-based clinical innovations," commented Karen Joynt Maddox, MD, MPH, of Washington University School of Medicine in St. Louis.

"I think there is a lot to learn here. First, reducing 30-day events is a huge accomplishment! I think this suggests that home visits and close follow-up can help ease a difficult transition," she told MedPage Today in an email.

Past 30 days, patients may need ongoing support from a stable, trusted care team, she noted. "We need to ease care transitions, but also be respectful of and help build long-term care relationships that can make sustained change over time."

"What will make a difference in the long run, and hopefully make these gains sustainable, is if this care becomes the norm [that] all patients who go to the ER have their PCP alerted, are seen by a trusted care provider (or visited at home by a trusted care provider), and continue to see that trusted care provider," Joynt Maddox suggested.

Long-term care is ideally personalized to each patient, according to Larry Allen, MD, MHS, and Colleen McIlvennan, PhD, DNP, ANP, both of University of Colorado School of Medicine, Aurora, writing in an accompanying editorial.

"Long-term care management is not a simple daily pill or single procedure; interventions of this nature are contextualized, personalized, time-intensive, multidisciplinary, and multicomponent. They must be pragmatic by nature. Each community, hospital, and patient face different barriers when it comes to care of HF," Allen and McIlvennan said.

"We need trials such as GUIDED-HF to explore what can and cannot be standardized, as well as what core components do and do not work," the pair continued.

The unblinded GUIDED-HF trial was conducted at 15 EDs across the U.S. The 479 participants were randomized 1:1 to usual care or the self-care intervention. Median age was 63 years, and 64% of the cohort were men. Nearly two in three were African American.

The intervention was associated with 5.5-point higher KCCQ-12 summary scores at 30 days (P=0.01) before this benefit dissipated at 90 days (2.7 points higher, P=0.25).

There was no significant difference in cardiovascular death and HF events between intervention and control groups at either 30 days (14% vs 18%) or 90 days (32% vs 36%). This finding was unchanged on per-protocol analysis including intervention patients who completed a home visit, had an outpatient visit scheduled, and received at least one coaching call.

Limited statistical power aside, the GUIDED-HF trial saw more patients withdraw from the intervention arm than the control arm.

However, the option of a telehealth visit at the start of the intervention did present an opportunity to improve access and support for remote, disadvantaged, or vulnerable populations, Allen and McIlvennan noted.

"We anticipate seeing an increased number of telehealth or app-based interventions being offered, and we need to continue to test and refine these interventions to make them accessible, practical, effective, and equitable," the editorialists wrote.

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