Heart Failure Medication Adherence

Heart Failure Clinical Trial

Official title:

Heart Failure Medication Adherence Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03402750
• Other study ID #: 20160741
• Status: Completed
• Phase: N/A
• Start date: May 28, 2018
• Est. completion date: April 8, 2019

Study information

• Verified date: November 2019
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 8, 2019
• Est. primary completion date: April 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
United States	Jackson Memorial Hospital	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Beta Tau Chapter of Sigma Theta Tau International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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