Heart Failure Medication Adherence

University of Miami

Status: Completed

Conditions: Heart Failure

Treatments: Behavioral: Meds to Beds; Behavioral: Electronic Prescription

Study type: Interventional

Funder types: Other

Identifiers

NCT03402750

20160741

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Meds to Beds

Experimental group

Description:

Patients receive medication in-hand at discharge from the hospital

Treatment:

Behavioral: Meds to Beds

Standard Care

Active Comparator group

Description:

Electronic prescription with patient pickup at the pharmacy

Treatment:

Behavioral: Electronic Prescription