Eric Bushlow, Cardiovascular Roundtable
Medication management remains challenging for providers as patients continue to be readmitted for non-compliance with medication. With readmission penalties looming and the gradual shift to value-based models of care, programs must rethink how they can help modify patient behavior outside the hospital setting.
New technologies offer some promise in resolving adherence issues, leveraging reminders and behavioral modification to boost compliance. However many of these solutions have seen limited provider adoption aiming to address the growing readmissions problem.
Three technologies to improve medication adherence
As the accountable care era looms, cardiovascular leaders are ever-more focused on improving the long term care of chronically ill patients, including those with heart failure. While the Roundtable has demonstrated that aggressive care management programs have proved successful in bolstering outcomes for these patients, many rural providers find the frequent office visits necessary for such programs to be difficult if not impossible for their patients. Consequently, progressive programs have moved to telemedicine solutions in an attempt to provide effective care management despite limited encounters within the health system. One such facility, Flagstaff Medical Center, recently shared the details of their program with the Roundtable in an interview.
Limiting readmissions using only a smartphone
Last year, the Roundtable reported on the results of CardioMEMS Inc.’s CHAMPION trial, but despite seemingly favorable data, the FDA’s Circulatory System Devices panel this week recommended the FDA not approve the device based upon issues noticed with the trial design that may have impacted results. In particular, the FDA’s panel took issue with an apparent violation of approved pre-market approval (PMA) protocols. Following the FDA clinical-site inspections, it was discovered that vendor-provided emails on suggested treatments occurred in as much as 10 percent of study subjects within the treatment group. With many FDA panelists explaining there was no way to determine whether the device or the care protocols were responsible for results, the decision fell 3-7 against device effectiveness.
Pre-market approval (PMA) protocols outlined specific actions to be taken by physicians when readings suggested the need for intervention. However, CardioMEMS nurses apparently sent emails directly to physicians, influencing treatment decisions and ultimately confounding results.
Remote-monitoring technology receives FDA scrutiny over confounded clinical trial