Targeted Intervention to Improve Medication Adherence in Cognitively Impaired Patients With HF (TARGET)

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