Heart Failure Medication Adherence Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- University of Miami
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Pharmacy Refill Adherence to Medication
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The objective of this investigation is to pilot test a medication in-hand intervention (Meds to Beds) compared to standard care for patients with heart failure (ICD-50[all numbers]). The study will evaluate if the intervention improves adherence and physical health, and reduces hospital re-admissions. The study will provide evidence for the feasibility and acceptability of the medication-in-hand intervention.
Investigators
Brian McCabe
Research Associate Professor
University of Miami
Eligibility Criteria
Inclusion Criteria
- •Admission diagnosis of heart failure ICD-50, including I50.1, I50.2, I50.20, I50.21, I50.22, I50.23, I50.3, I50.30, I50.31, I50.32, I50.33, I50.4, I50.40, I50.41, I50.42, I50.43, I50.8, I50.81, I50.810, I50.811, I50.812, I50.813, I50.814, I50.82, I50.83, I50.84, I50.89, I50.9, or any combination thereof
- •Age 18 or older
- •New York Heart Association Heart Failure Class II or Class III, with ejection fraction below 45%
- •Cognitively intact, without significant psychological impairment affecting medication adherence such as dementia noted in patient record.
Exclusion Criteria
- •Medical conditions, such as active cancer or pregnancy, expected to alter heart failure medication management
- •Discharged to nursing homes or hospice care, where patient may not responsible for their own adherence
- •High risk of loss to follow-up, e.g., leaving the hospital against medical advice, prisoners, living in a homeless shelter, or unable to provide a phone number
- •No plan to fill medications at the Jackson Memorial Hospital pharmacy
Outcomes
Primary Outcomes
Pharmacy Refill Adherence to Medication
Time Frame: Day 30
Medication adherence will be reported as the number of participants that completed their expected pharmacy refill. Standard Care participants are expected to complete one initial fill and one refill. Meds to Beds participants are expected to complete one pharmacy refill as the initial fill is handed upon discharge.
Adherence to Medication
Time Frame: Day 30
Adherence to medication will be reported as the number of participants that scores 12 and lower in a self-reported Adherence to Refills and Medications Scale (ARMS) Questionnaire. The questionnaire has 12 items with each item being recorded on a four-point Likert scale. The total score ranges from 12-48 with the lower score indicating better adherence.
Secondary Outcomes
- Number of Participants That Received Their Medications Prior to Discharge.(Day 0)
- Intervention Acceptance(Day 30)
- Physical Health as Assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) Questionnaire(Baseline and Day 30)