Heart Failure Medication Adherence

Heart Failure Medication Adherence Study

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Behavioral: Meds to Beds; Behavioral: Electronic Prescription

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Jackson Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Beta Tau Chapter of Sigma Theta Tau International
• Investigators: Principal Investigator: Brian E McCabe, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2018
• Primary Completion (Actual): April 8, 2019
• Study Completion (Actual): April 8, 2019

Study Registration Dates

• First Submitted: January 10, 2018
• First Submitted That Met QC Criteria: January 10, 2018
• First Posted (Actual): January 18, 2018

Study Record Updates

• Last Update Posted (Actual): November 7, 2019
• Last Update Submitted That Met QC Criteria: November 6, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Adherence, Medication, Prescription
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 20160741

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No