Case in point is this study that was just published in the New England Journal of Medicine. Authored by Sarwat Chaudhry et al, the "Telemonitoring to Improve Heart Failure Outcomes Trial" (Tele-HF) randomly assigned recently discharged heart failure patients to one of two treatment arms: 1) an intervention group, that was asked to make daily call into a computer controlled system that generated an automated series of questions about health status, such as the presence of shortness of breath or fluid gain; if there was a decline, the patient's physician's office was alerted, or 2) usual care without any patient calls.
826 patients were in the telemonitoring arm and 827 were in the usual care arm. Over the 180 days following entry into the study, the number of readmissions, days in the hospital and death rates were compared. Since not all patients used the system as prescribed (14% didn't use the phone even once and toward the end of the study, about 55% were calling in at least three times a week), the analysis was correctly performed on an "intention to treat" basis.
There was no difference in outcomes. About 49% and 47% of the patients in the intervention and treatment arms, respectively, ended up being admitted. 27% of both arms were admitted for treatment of their heart failure. 11% of the patients in both arms died.
The DMCB is not surprised at the shortcoming of heart failure telemonitoring. Years ago, it agreed to implement a similar stand-alone program and came away very unimpressed. The DMCB thought that much more was needed, sch as nurse-based patient coaching, promulgation of evidence-based guidelines, identification and triage of patients with different levels of risk and facilitated access to an array of specialist and community-based programs.
In fact, the authors of the study would seem to agree with the DMCB. In the Discussion section of the paper, the DMCB found this very telling quote that couldn't have said it better:
In a previous, small, single-site trial of remote monitoring of patients, our group found a 44-percentage-point reduction in the rate of readmission, which was associated with significant cost savings. However, we were concerned that, in that trial, reliance on a single, highly skilled and motivated nurse case-manager who deployed an intervention developed by the investigative team limited the generalizability and scalability of the findings (bolding DMCB).
The DMCB says that's the point. Interventions like telemonitoring only add value when they are mixed with other population-based interventions, such as motivated nurse care coaches and coordinators.
However, the authors - as is generally typical of the mainstream academic community - also got it wrong. There is a sector of the health care industry that has figured out how to overcome the limited "generalizable and scalability" that is mentioned above.
It's called disease management. The DMCB thinks the failure to recognize that by not including that principle in the study design took an otherwise very promising intervention and made it look unnecessarily bad.
Patients with heart failure deserve better.
2 comments:
Monitoring is nice but it also requires:
1) a patient-initiated, physician-approved sick day action plan
2) early access to phone follow up by office (not at the end of the day)
3) alternate venues of care besides the ER for when the patient-initiated sick day plan fails to lead to improvement.
To often monitoring leads to a message that your sick call your doctor and he/she either:
1) doesn't call back till the patient has already gone to the ER -OR-
20 he/she calls back and says "Go to the ER"
As I read I kept thinking, “Oh, the DMCB doesn’t think so,” and then you had him in your post before I could even comment. I’m not experienced enough in the matter to make a judgement call, but it sounds like we’re still talking about the same basic policy, just semantically changing focus. For those interested, Dr. Sidorov has promised a future blog post explaining why he thinks the term will rise again.
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