Heart Failure Medication Adherence
- Conditions
- Heart Failure
- Interventions
- Behavioral: Meds to BedsBehavioral: Electronic Prescription
- Registration Number
- NCT03402750
- Lead Sponsor
- University of Miami
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Meds to Beds Meds to Beds Patients receive medication in-hand at discharge from the hospital Standard Care Electronic Prescription Electronic prescription with patient pickup at the pharmacy
- Primary Outcome Measures
Name Time Method Pharmacy Refill Adherence to Medication 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 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 Outcome Measures
Name Time Method Number of Participants That Received Their Medications Prior to Discharge. Day 0 The program's feasibility will be evaluated by tracking whether medications can be successfully delivered (i.e., before discharge) to patients in the Meds to Beds condition. This measure will be evaluated as a proportion within the intervention condition.
Intervention Acceptance Day 30 All participants will be asked one question about the acceptability of the intervention program. Responses for acceptability items will be recorded on a 10-point scale (1, very unsatisfactory - 10, very satisfactory). Dichotomized due to extreme skew. Intervention acceptance will be reported as the number of participants that provides a score of 1 and higher.
Physical Health as Assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) Questionnaire Baseline and Day 30 Physical health is measured using the 10 item PROMIS questionnaire. Responses are recorded along a 5-point Likert scale with a total score ranging from 10-50. A higher score indicates better physical health.
Trial Locations
- Locations (1)
Jackson Memorial Hospital
🇺🇸Miami, Florida, United States