Trialing an automated medication dispensing device (AMDD) to improve medication adherence in patients with heart failure.

Background:

Medication adherence [MA] is a complex issue depending on both patient and healthcare factors. Non-adherence due to patient-dependent factors is common; analyses of large broad-based clinical trials in the general population demonstrate that 20-30% of study medication doses may be missed. In community-dwelling HF patients with polypharmacy this percentage is likely even higher. One of the factors in poor adherence in elderly non-HF patients has been shown to be cognitive impairment [CI]. Non-adherence to medical regimen is one factor that is associated with worse outcomes in patients with HF, including readmissions. Measures that improve MA are also likely to improve outcomes.

Objectives:

We evaluated a novel intervention incorporating new technology with the goal of improving adherence in patients with HF and CI. Specific objectives of the study were (1) to assess the feasibility of using the Automated Medication Dispensing Device (AMDD) in veterans with HF and CI by measuring patient qualifying rate, consent rate, user rate, patient-level response rate, medication-level response rate, and success rate, (2) to calculate the improvement of MA based on pill counts before and after the introduction of the AMDD, and (3) qualitatively describe patient satisfaction with the AMDD and the reasons for not using the AMDD.

Methods:

This pilot was designed as a feasibility study testing an intervention using a commercially available, off the shelf Automated Medication Dispensing Device (AMDD) with subjects serving as their own controls. The study was conducted at the VALLHS, Loma Linda, CA which serves a population of 246,000 veterans. The study planned to enroll 50 patients with HF and CI (defined as SLUMS score of <27 in a person with high school education or <25 in a person with less than high school education) from the outpatient HF clinic. Baseline adherence to prescribed medications was measured by an initial 30-day pill count (month 1). Subjects with baseline adherence <88% were given the AMDD to use for 90 days (one month to familiarize the study subjects with the device, two months to collect outcome data). This dispenser was pre-filled by home health nurses once a month; the dispenser is equipped with an alarm mechanism that alerts the patient to take the medications; when the patient pushes the button on the device, it will dispense the medications. 30-day pill counts were performed while patients were using the AMDD on months 3 and 4. The study was powered to detect the success rate of the AMDD, defined as both patient acceptance and a clinical response to the AMDD.

Status:

Complete. This project was opened for recruitment as of July 1, 2012. The study is now closed for recruitment and all enrolled patients have completed the intervention. Manuscript outlining the findings of this study and discussing the available interventions to improve medication adherence is in progress.

Inclusion Criteria:

• Patients with established diagnosis of clinical heart failure
• English-speaking
• Able to provide informed consent
• Able to participate in cognitive function testing
• Age over 18

Exclusion Criteria:

• Life expectancy < 6 months
• Documented dementia requiring a caregiver
• inability to set up the AMDD at the patient's home due to technical limitations

Adverse event data was collected throughout the intervention part of the study (4 month-period for each patient).

We did not collect data on patient outcomes or hospitalizations because the study did not use investigational medications or devices, and only tested feasibility of a patient self-care assist device. We did collect data on the technical support for the medication dispensing device, as well as technical issues with the device.

Low enrollment in the study reflects the fact that many patients with HF do not admit the need for assistance with their medications. Patients should first be tested for the presence of cognitive impairment and baseline medication adherence problems.