The article is open access but, knowing readers are a busy lot, the DMCB is happy to provide this quick summary.
The authors were interested in testing whether patient "self management" education would be successful in reducing death and hospitalization among patients with chronic heart failure. Their rationale was that self management was different compared to disease management which "keep[s] patients in a passive role and, as such, raise questions about optimum duration and cost effectiveness."
Despite being very misinformed about disease management, the authors devised a rigorous self management intervention that consisted of eighteen 2-hour, 10 patients-per-group sessions that were spread over one year. Health education professionals conducted the sessions using content from American Heart Association-based "tip sheets." In addition to the education, the educators relied on problem-solving formats and barrier management for topics that included medication adherence, addressing weight gain, diet, exercise and stress management.
3152 patients were screened and 902 were eventually enrolled in the trial. Enrollment was limited to patients with NYHA Class 2 or 3 heart failure (1 means generally no symptoms while 4 patients are so ill that different self-management skills are necessary). Half of the enrollees were assigned to the intervention described above, while the patients assigned to the control group were simply mailed the tip sheets. Patients were followed for up to two years after the one year intervention (making it a 3 year study).
The baseline status of the study cohorts was instructive to the DMCB and may serve as a useful benchmark in making assumptions about similar populations with heart failure. 23% had "preserved systolic function" (yes, it is possible ), 37% failed to take their life-saving ACE or beta blocker medications at least 80% of the time, most exceeded recommendations for salt intake, 29% had evidence of major depression and 7 was the mean number of medications that were being used.
When the authors finally compared the end-point of hospitalization or death for the two groups, there was no statistically difference (you can see the disappointing graph here ). Over three years, the death rate was 21% (control) to 24% (intervention), while the hospitalization rate was 30% (both groups). Other measures in change in the NYHA class, exercise endurance, tobacco use, blood pressure, body mass index, quality of life did not differ over time between the two groups. Except for individuals with low income (defined as less than $30,000 per year) there was also lack of any impact for any of the subgroups within the study..
The DMCB can't say it's surprised at the negative outcome because, as the authors readily admit, this wasn't disease management. In other words, it wasn't personalized patient engagement by a trusted nurse that not only sought behavior change but also interacted with the patient's physician and coordinated other care and community resources. These were group education sessions. It's enough to give the DMCB a Gomer Pyle moment .
While the intervention has been described in greater detail here , the DMCB was also stymied by the apparent lack of any mention about two other study features that could have made a difference 1. The participation of the intervention group's principal or primary care physicians. It may be that the group sessions occurred without the active support of the doctor. As the disease management industry learned, the lack of that key ingredient can lead to zero improvement in outcomes.
2. How the depression was managed. In fact, the DMCB didn't see this specifically measured in the course of follow-up. If this was ignored, then it's little wonder that some of patients were unable to adopt behavior change, which could have led to the negative study.