Heart Failure Medication Adherence

NCT03402750 | Completed Results

• 1 other identifier: 20160741
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure

Keywords

Adherence, Medication, Prescription

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Physical Health as Assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) Questionnaire

  Baseline and Day 30

• Number of Participants That Received Their Medications Prior to Discharge.

  Day 0

• Intervention Acceptance

  Day 30

Study Arms (2)

Meds to Beds

EXPERIMENTAL

Patients receive medication in-hand at discharge from the hospital

Behavioral: Meds to Beds

Standard Care

ACTIVE COMPARATOR

Electronic prescription with patient pickup at the pharmacy

Behavioral: Electronic Prescription

Interventions

Meds to Beds BEHAVIORAL

Medications will be delivered to patient bedside before discharge

Meds to Beds

Electronic Prescription BEHAVIORAL

Patient or surrogate can pick up medication from pharmacy

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead
• Beta Tau Chapter of Sigma Theta Tau International: collaborator

Study Sites (1)

Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Electronic Prescribing

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Prescriptions; Pharmaceutical Services; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Brian McCabe
• Organization: University of Miami

bmccabe@miami.edu

305-248-1530

Study Officials

• Brian E McCabe, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: January 18, 2018
• Study Start: May 28, 2018
• Primary Completion: April 8, 2019
• Study Completion: April 8, 2019
• Last Updated: November 7, 2019
• Results First Posted: November 7, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)