Back to resultsHeart Failure Medication Adherence
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meds to Beds
Electronic Prescription
Sponsored by
About this trial
This is an interventional supportive care trial for Heart Failure focused on measuring Adherence, Medication, Prescription
Eligibility Criteria
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
Sites / Locations
- Jackson Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Meds to Beds
Standard Care
Arm Description
Patients receive medication in-hand at discharge from the hospital
Electronic prescription with patient pickup at the pharmacy
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT03402750
First Posted
January 10, 2018
Last Updated
November 6, 2019
Sponsor
University of Miami
Collaborators
Beta Tau Chapter of Sigma Theta Tau International
1. Study Identification
Unique Protocol Identification Number
NCT03402750
Brief Title
Heart Failure Medication Adherence
Official Title
Heart Failure Medication Adherence Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
May 28, 2018 (Actual)
Primary Completion Date
April 8, 2019 (Actual)
Study Completion Date
April 8, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Beta Tau Chapter of Sigma Theta Tau International
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Adherence, Medication, Prescription
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Meds to Beds
Arm Type
Experimental
Arm Description
Patients receive medication in-hand at discharge from the hospital
Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
Electronic prescription with patient pickup at the pharmacy
Intervention Type
Behavioral
Intervention Name(s)
Meds to Beds
Intervention Description
Medications will be delivered to patient bedside before discharge
Intervention Type
Behavioral
Intervention Name(s)
Electronic Prescription
Intervention Description
Patient or surrogate can pick up medication from pharmacy
Primary Outcome Measure Information:
Title
Adherence to Medication
Description
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.
Time Frame
Day 30
Title
Pharmacy Refill Adherence to Medication
Description
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.
Time Frame
Day 30
Secondary Outcome Measure Information:
Title
Physical Health as Assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) Questionnaire
Description
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.
Time Frame
Baseline and Day 30
Title
Number of Participants That Received Their Medications Prior to Discharge.
Description
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.
Time Frame
Day 0
Title
Intervention Acceptance
Description
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.
Time Frame
Day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian E McCabe, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Heart Failure Medication Adherence
We'll reach out to this number within 24 hrs