Heart Failure Medication Adherence Study
Phase: NA
Conditions: Heart Failure
Sponsor: University of Miami

 
 
 
 
 Heart Failure Medication Study 
Version: 6 
Date: July 19, 2018 
NCT Number: NCT03402750 
 

IRB Study Number: HRP-503 20160741 
Version #6 July 19, 2018 
Page 1 of 5 
Revised: July 19, 2018 
 
 
1) 
Protocol Title 
 
Heart Failure Medication Study 
 
2) 
Objectives* 
 
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]). 
We expect the intervention to improve adherence and physical health, and reduce hospital 
re-admissions. We also expect the study to provide evidence for the feasibility and 
acceptability of the medication-in-hand intervention. 
 
3) 
Background* 
 
Heart failure is a chronic disease that increases mortality, reduces quality of life, and 
increases health care system costs. About 6.5 million people in the United States and 26 
million worldwide have heart failure. Heart failure patients face many barriers to 
adherence to their medication regimen, including being prescribed an average of 6.4 
medications daily. Promoting continuity of care in regard to prescription medication from 
the bedside with a medication in-hand intervention (Meds to Beds) may therefore help 
patients with heart failure improve adherence to medications, and thus improve health. 
 
4) 
Inclusion and Exclusion Criteria* 
 
Primary inclusion criterion is an 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. 
 
To be included patients must also be: 
1. age 18 or older; 
2. in New York Heart Association Heart Failure Class II or Class III, with ejection 
fraction below 45%; 
3. Cognitively intact, without significant psychological impairment affecting 
medication adherence such as dementia noted in patient record. 
 
Exclusion criteria are: 
1. Patients with medical conditions, such as active cancer or pregnancy, expected to 
alter heart failure medication management; 
2. Patients discharged to nursing homes or hospice care, as they may not 
responsible for their own adherence; 
3. Prisoners and those unable to provide a point of contact for follow-up 
assessment; 
4. Patients who do not plan to fill discharge medications at the Jackson Memorial 
Hospital pharmacy. 

IRB Study Number: HRP-503 20160741 
Version #6 July 19, 2018 
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Revised: July 19, 2018 
 
 
5) 
Procedures Involved* 
 
Participants will be identified and recruited from inpatient units at Jackson Memorial 
Hospital using the electronic health record. At consent, participants will be asked to sign 
a HIPAA waiver to allow access to their medical record for 60 days after discharge. 60 
participants will be randomly assigned to one of two intervention conditions: 1) Meds to 
Beds, patients receive medication in-hand at discharge from the hospital, and 2) standard 
care (patient pickup at the pharmacy) comparison group. Adherence to medication will be 
measured with 1) self-report Adherence to Refills and Medications Scale (ARMS), and 2) 
pharmacy refill data. Health will be assessed with the self-report PROMIS 10, a measure 
developed by researchers for patient-reported evaluation of global health. Information on 
hospital readmission, other hospital visits, and deaths will be obtained from the electronic 
health record. Feasibility will be determined by tracking the number of patients who 
receive medications before discharge in the Meds to Beds intervention and by asking 
patients at follow-up how they received their discharge medications and about their 
experiences with healthcare. Acceptability will be assessed with 2 questions created for 
this study. A self-report questionnaire with 7 items created for this study will assess 
theoretical mechanisms of change for the Meds to Beds intervention. Self-report 
measures will be administered in-person before randomization, and/or about 30 days 
post-discharge by telephone or in-person. Prescription refill and other information from 
the electronic health record will be monitored for up to 60 days post-baseline in order to 
collect data about the period 30 days post-discharge. Measures are either available in 
English and Spanish from the authors, or will be translated using a translation back- 
translation approach. 
 
6) 
Data and Specimen Banking* 
 
There will be no specimen banking. 
 
7) 
Data Management* 
 
Protection of patient privacy and confidentiality will be maintained in highest priority at 
all times. All files will be kept in a locked office and data stored on a secured drive. All 
personally identifying patient information will be kept separate from patient data at all 
times. 
 
8) 
Risks to Subjects* 
 
This study is expected to be of minimal risk to participants. Special care will be taken to 
ensure patients do not confuse participation in this study with their treatment plan, and 
continue to contact their regular providers for any issues or questions regarding their 
medication or health. 
 
9) 
Potential Benefits to Subjects* 
 
This study provides no direct benefit to participants. 

IRB Study Number: HRP-503 20160741 
Version #6 July 19, 2018 
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Revised: July 19, 2018 
 
 
 
10) Vulnerable Populations* 
 
This study will not include pregnant women, prisoners, children or cognitively impaired 
adults. 
 
11) Setting 
 
Some study data will be collected at inpatient units at Jackson Memorial Hospital, with 
follow-up via telephone or in-person with these participants. 
 
12) Resources Available 
 
Lila de Tantillo, BSN, RN, PhDc is a fourth-year doctoral student in Nursing at the 
University of Miami School of Nursing and Health Studies. She has spent the past three 
years researching cardiovascular disease and medication adherence, including a 
participating in graduate-level nursing clinical at Jackson Memorial Hospital. She is fully 
bilingual in English and Spanish, and will be responsible for all data collection. 
 
13) Prior Approvals 
 
Approval of Jackson Memorial Hospital will be obtained before commencing this study. 
 
14) Recruitment Methods 
 
A partial HIPAA waiver will be requested to identify patients admitted to Jackson 
Memorial Hospital with a heart failure diagnosis who may qualify for the investigation. 
These patients will be approached at bedside by a known person such as a nurse or 
physician and invited to participate in the study. If interested in participating patients will 
be screened by researcher with a preliminary questionnaire regarding medical history and 
contact information. Qualifying patients will be asked to sign a consent form. At the time 
of inclusion in the study, participants will receive a gift card worth $20 as compensation. 
In addition, participants will receive $50 as compensation for completing the telephone 
follow-up portion of the study. 
 
15) Local Number of Subjects 
 
There will be up to 60 participants (30 Meds to Beds, 30 standard care). 
 
16) Confidentiality 
 
Patient confidentiality will be maintained at all times; they will only be contacted by one 
researcher. Data and responses will be linked using a numerical ID; a linking list with 
names matched to ID will be stored separately from data by the principal investigator in 
secure location. 

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No specimen samples will be taken, used or stored in this investigation. 
 
17) Provisions to Protect the Privacy Interests of Subjects 
 
One researcher will be responsible for the screening, consent process and interviews of 
participants to limit intrusion of privacy. 
 
18) Consent Process 
 
Potential participants will be approached at Jackson Memorial Hospital after 
identification in the medical record. 
 
Only patients with qualifying diagnoses identified by physicians as stable for 
participation in the research study will be approached after an introduction by a “known 
individual” (such as a nurse or doctor). 
 
The study PI is fluent in English and Spanish, and will recruit English- and Spanish- 
speaking participants for the study. All informational and consent material will be 
available in English and Spanish. 
 
There will be no individuals under age 18 included in the study. 

IRB Study Number: HRP-503 20160741 
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Revised: July 19, 2018 
 
 
 
19) Process to Document Consent in Writing 
 
Potential participants will be approached and informed of potential eligibility to enroll in 
the study. If the participants agree, they will be explained the risks and benefits of being 
involved in the study. They will be asked several screening questions to confirm 
eligibility. Participants who are eligible and wish to enroll in the study will be provided 
the consent form and any questions or concerns will be answered and addressed. A copy 
of the signed and dated consent form will be provided to the participant.