Heart Failure Medication Adherence

• Meds to Beds (Behavioral): Medications will be delivered to patient bedside before discharge
• Electronic Prescription (Behavioral): Patient or surrogate can pick up medication from pharmacy

Primary outcomes

• 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.
• 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.

Secondary outcomes

• 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.
• 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.

Sex: All, ages: 18 Years to any

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

Participant flow

Outcome results

• Adherence to Medication (Primary), Count of participants, Participants: Meds to Beds 2; Standard Care 3
• Pharmacy Refill Adherence to Medication (Primary), Count of participants, Participants: Meds to Beds 7; Standard Care 6
• Physical Health as Assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) Questionnaire (Secondary), Mean, score on a scale: Meds to Beds 11.81 +/- 4.09; Standard Care 11.50 +/- 3.90
• Number of Participants That Received Their Medications Prior to Discharge. (Secondary), Count of participants, Participants: Meds to Beds 7; Standard Care 5
• Intervention Acceptance (Secondary), Count of participants, Participants: Meds to Beds 10; Standard Care 9

Adverse events

Time frame: 30 days

Serious adverse events by term

• Study Protocol (PDF, 2018-07-19)
• Statistical Analysis Plan (PDF, 2018-07-19)

• Brian E McCabe, PhD, Principal investigator, University of Miami