Self-Care Education for Rural HF Patients: Could 'Less' Be 'More'?

September 13, 2012

September 13, 2012 (Seattle, Washington) — Disease management programs for heart failure often aren't readily accessible to patients who live in rural regions of the US, so as an alternative, what sort of educational program for self-care skills will help prevent HF hospitalizations and prolong survival? The results of a randomized trial comparing two versions of such a program with usual care in rural HF patients suggested they didn't necessarily improve those outcomes, but a less intensive version of the program may have worked better than the one that allowed more patient contact with caregivers [1].

Dr Kathleen A Dracup

The programs, dubbed Fluid Watchers--the basic program was called Fluid Watchers LITE and the more intensive one Fluid Watchers PLUS--focused on skills patients would need to control their own symptoms and especially to reduce the risk of volume overload, according to the study's principal investigator Dr Kathleen A Dracup (University of California, San Francisco).

Over a two-year follow-up in the 602-patient trial, called Rural Education to Improve Outcomes in Heart Failure (REMOTE-HF), the rate of HF hospitalization or cardiac death was about 29% for patients in the LITE group compared with 40% for those in the PLUS group (p=0.058); it was about 39% in the usual-care control group, reported Dracup here at the Heart Failure Society of America 2012 Scientific Meeting.

Although the end point for the LITE group bested the control group with a p value of 0.047, it reached only 0.167 after adjustment for the number of follow-up days, Dracup reported.

"Maybe Some of Our Assumptions Are Incorrect"

"This is not the first time we've seen this in really large and high-quality clinical trials," said Dr Barbara J Riegel (University of Pennsylvania, Philadelphia), invited to comment on REMOTE-HF after Dracup's presentation. Other studies of heart-failure self-help strategies found they had little impact on outcomes, she said, specifically pointing out the HART and COACH trials, while others have suggested they can work.

"When we are faced with not seeing an intervention effect, the literature is just fascinating to look at. Over and over again," she said, negative results tend to be explained as coming from some fault or bias in the trial design or execution--for example, from poor patient compliance, a low patient follow-up rate, or a control group that received more guidance or better care than typically occurs in practice.

"But I would like to take it in a different direction and say that maybe some of our assumptions are incorrect. We're assuming that all heart-failure self-care interventions work, but of course they're all different," she said. "We're also assuming that a particular type of program is going to work everywhere and that we're going to have a yes or no answer. I actually would question these assumptions and say that variations in outcomes should be expected, because the programs are in different settings with different populations."

"We Took a Page From the Cancer Literature"

So why didn't the educational programs improve outcomes compared with usual care, and why did the LITE program show at least a trend of advantage over the more intensive program?

In a pilot study [2], Dracup explained, patients tracked and documented their weight and symptoms but less readily called their physicians on signs of volume overload. So in REMOTE-HF, they explored ways to lower barriers to contacting caregivers.

"There was a real focus on calling their physician or nurse practitioner to report an increase in symptoms that suggested hypervolemia," she said. For example, "we took a page from the cancer literature, which shows that patients in pain often needed a scrip in order to call their physician and have a focused conversation." So patients in the LITE and PLUS programs were given a prescription to call their providers, she said, with the goal of lowering their threshold for seeking help if they experienced signs of volume overload.

In addition, LITE patients received a follow-up phone call at two and four weeks after attending the self-care educational session. Those in the PLUS group, however, could receive as many such calls as the providers deemed necessary and received additional counseling and took home more educational aids, including an audiotape of the educational session. The number of follow-up calls to PLUS patients ranged from one to 19.

"Opening the Black Box"

The 614 patients randomized at three sites across the US had to have been hospitalized for heart failure within the past six months, be without serious comorbidities, and not be in a disease management program. With a 98% follow-up at two years, the rate of cardiac death/rehospitalization was 35% overall. The rate for cardiac death was 12.5% and for noncardiac death 8.3%.

Effect of self-care education on outcomes for HF patients in rural areas not in a disease management program

End point Usual care, n=209 LITE, n=200 PLUS, n=193 p
HF admission/cardiac death (%) 37.8 28.5 38.9 0.058
Physician office visits (n) 15.9 11.5 23.8 0.001

"Increasing the number of telephone contacts between the patient and nurse after an educational session did not significantly improve clinical outcomes," Dracup observed. "In fact, the higher number of phone calls to the PLUS group may have led to the increased number of doctor visits [that were] documented in the PLUS group, which [apparently] in turn led to increased hospital readmissions."

Trials that show self-help education that improves outcomes as well as those that are negative can be instructive, according to Riegel. "I think it's really our responsibility to be collecting the data that will allow us to get into the explanation of what's really going on, really focusing on the mechanisms," she said. "This is being called in the literature as opening the black box."

For example, the number of physician contacts seems to have influenced clinical outcomes, she affirmed. Other potential "moderators" to look at might include the specific effects of the education on self-care, whether the patient lived alone, comorbidities, and NYHA functional class.

She recommended that analyses "focus on what works for whom, when, and why. It's this understanding of mechanisms that I think will really teach us a lot about trials like this."

REMOTE-HF was funded by the National Institutes of Health. Dracup and Riegel said they have no disclosures.