Heart Failure
Conditions
Keywords
medication adherence
Brief summary
Trialing an automated medication dispensing device (AMDD) to improve medication adherence in patients with heart failure.
Detailed description
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.
Interventions
All patients had a pre-filled medication dispensing machine set up at their homes, filled by home health nurses once a month. Safety phone call was made by the AMDD company if doses were missed.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of AMDD to Improve Medication Adherence Via Completion Rate | 4 months | Rate that patient population completed set-up of AMDD was evaluated quantitatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of AMDD to Improve Medication Adherence | 30-day pill count before the use of AMDD and with AMDD | Change in medication adherence (proportion of pills taken of prescribed, as measured by pillcount) after the implementation of the AMDD |
Countries
United States
Participant flow
Recruitment details
This project was opened for recruitment as of July 1, 2012. Enrollment for the study originally took place in the heart failure (HF) clinic and Investigator's circle of confidentiality, but after poorer than anticipated enrollment, screening was expanded to all outpatients at the VALLHS with a diagnosis of HF.
Participants by arm
| Arm | Count |
|---|---|
| AMDD Subjects with \<88% medication adherence, determined by 30-day pillcount, will proceed to AMDD portion of study
Automated Medication Dispensing Device: A pre-filled medication dispensing machine with a safety phone call if doses are missed | 45 |
| Total | 45 |
Baseline characteristics
| Characteristic | AMDD |
|---|---|
| Age, Continuous | 67.3 years STANDARD_DEVIATION 8.5 |
| Education level college degree | 7 participants |
| Education level high school or equivalent | 10 participants |
| Education level no high school | 2 participants |
| Education level postgraduate degree | 3 participants |
| Education level some college | 23 participants |
| Full Range of Saint Louis University Mental Status Scores | 20.9 units on a scale |
| Living arrangements live alone | 11 participants |
| Living arrangements live with others | 34 participants |
| Medication adherence | 69.9 Percentage STANDARD_DEVIATION 12 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 25 Participants |
| Saint Louis University Mental Status score | 20.9 units on a scale STANDARD_DEVIATION 5.8 |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 45 |
| serious Total, serious adverse events | 0 / 45 |
Outcome results
Feasibility of AMDD to Improve Medication Adherence Via Completion Rate
Rate that patient population completed set-up of AMDD was evaluated quantitatively.
Time frame: 4 months
Population: Of 45 patients who started the study, 24 patients met the predetermined criteria for AMDD. Though all of the patients had agreed to set up the AMDD in their home, only 15 out of 24 ended up completing the setup in their home.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Before AMDD | Feasibility of AMDD to Improve Medication Adherence Via Completion Rate | 15 participants |
Efficacy of AMDD to Improve Medication Adherence
Change in medication adherence (proportion of pills taken of prescribed, as measured by pillcount) after the implementation of the AMDD
Time frame: 30-day pill count before the use of AMDD and with AMDD
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Before AMDD | Efficacy of AMDD to Improve Medication Adherence | 65 percentage of adherence |
| After AMDD | Efficacy of AMDD to Improve Medication Adherence | 97 percentage of adherence |