Heart Failure Medication Adherence

Study Overview
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Brief Summary
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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.

Official Title
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Heart Failure Medication Adherence Study

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: Meds to Beds
* Behavioral: Electronic Prescription


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meds to Beds<br>Patients receive medication in-hand at discharge from the hospital | Behavioral: Meds to Beds<br>* Medications will be delivered to patient bedside before discharge<br>|
| Active Comparator: Standard Care<br>Electronic prescription with patient pickup at the pharmacy | Behavioral: Electronic Prescription<br>* Patient or surrogate can pick up medication from pharmacy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to Medication | 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. | Day 30 | 
| Pharmacy Refill Adherence to Medication | 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. | Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Health as Assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) Questionnaire | 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. | Baseline and Day 30 | 
| Number of Participants That Received Their Medications Prior to Discharge. | 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. | Day 0 | 
| Intervention Acceptance | 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. | Day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adherence, Medication, Prescription