Heart Failure Medication Adherence

• Sponsor: University of Miami (Other)
• Overall Status: Completed
• CT.gov ID: NCT03402750
• Collaborator: Beta Tau Chapter of Sigma Theta Tau International (Other)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.3
• Patients Per Site Per Month: 3.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Behavioral: Meds to Beds; Behavioral: Electronic Prescription	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Heart Failure Medication Adherence Study
• Actual Study Start Date: May 28, 2018
• Actual Primary Completion Date: Apr 8, 2019
• Actual Study Completion Date: Apr 8, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Adherence to Medication [Day 30]

   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.

2. Pharmacy Refill Adherence to Medication [Day 30]

   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

1. Physical Health as Assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) Questionnaire [Baseline and Day 30]

   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.

2. Number of Participants That Received Their Medications Prior to Discharge. [Day 0]

   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.

3. Intervention Acceptance [Day 30]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jackson Memorial Hospital	Miami	Florida	United States	33136

Sponsors and Collaborators

• University of Miami
• Beta Tau Chapter of Sigma Theta Tau International

Investigators

• Principal Investigator: Brian E McCabe, PhD, University of Miami

Study Documents (Full-Text)

• Study Protocol - Jul 19, 2018
• Statistical Analysis Plan - Jul 19, 2018

More Information

Publications

None provided.

• Responsible Party: Brian McCabe, Research Associate Professor, University of Miami
• ClinicalTrials.gov Identifier: NCT03402750
• Other Study ID Numbers: 20160741
• First Posted: Jan 18, 2018
• Last Update Posted: Nov 7, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Brian McCabe, Research Associate Professor, University of Miami: Adherence, Medication, Prescription
• Additional relevant MeSH terms: Heart Failure

Study Results

Participant Flow

Arm/Group Title	Meds to Beds	Standard Care
Arm/Group Description	Patients receive medication in-hand at discharge from the hospital Meds to Beds: Medications will be delivered to patient bedside before discharge	Electronic prescription with patient pickup at the pharmacy Electronic Prescription: Patient or surrogate can pick up medication from pharmacy
Period Title: Overall Study
STARTED	20	20
COMPLETED	18	19
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Meds to Beds	Standard Care	Total
Arm/Group Description	Patients receive medication in-hand at discharge from the hospital Meds to Beds: Medications will be delivered to patient bedside before discharge	Electronic prescription with patient pickup at the pharmacy Electronic Prescription: Patient or surrogate can pick up medication from pharmacy	Total of all reporting groups
Overall Participants	20	20	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.85 (6.54)	58.55 (11.18)	58.20 (8.86)
Sex: Female, Male (Count of Participants)
Female	2 10%	3 15%	5 12.5%
Male	18 90%	17 85%	35 87.5%
Race/Ethnicity, Customized (Count of Participants)
Hispanic	11 55%	12 60%	23 57.5%
African American	7 35%	8 40%	15 37.5%
White	2 10%	0 0%	2 5%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

4 participants in each condition did not complete this measure.

Arm/Group Title	Meds to Beds	Standard Care
Arm/Group Description	Patients receive medication in-hand at discharge from the hospital Meds to Beds: Medications will be delivered to patient bedside before discharge	Electronic prescription with patient pickup at the pharmacy Electronic Prescription: Patient or surrogate can pick up medication from pharmacy
Measure Participants	16	16
Count of Participants [Participants]	2 10%	3 15%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Data on electronic medical record for refills of heart failure medications were only available for 10 participants in Meds to Beds and 11 in Standard Care.

Arm/Group Title	Meds to Beds	Standard Care
Arm/Group Description	Patients receive medication in-hand at discharge from the hospital Meds to Beds: Medications will be delivered to patient bedside before discharge	Electronic prescription with patient pickup at the pharmacy Electronic Prescription: Patient or surrogate can pick up medication from pharmacy
Measure Participants	10	11
Count of Participants [Participants]	7 35%	6 30%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Interviews completed at follow-up and baseline. Not all participants completed the PROMIS questionnaire at the 30-day follow up visit.

Arm/Group Title	Meds to Beds	Standard Care
Arm/Group Description	Patients receive medication in-hand at discharge from the hospital Meds to Beds: Medications will be delivered to patient bedside before discharge	Electronic prescription with patient pickup at the pharmacy Electronic Prescription: Patient or surrogate can pick up medication from pharmacy
Measure Participants	20	20
30-Day follow-up	11.81 (4.09)	11.50 (3.90)
Baseline/Discharge	8.56 (3.16)	10.19 (3.51)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients in Standard Care arm could receive delivery of medications, contrary to intentions.

Arm/Group Title	Meds to Beds	Standard Care
Arm/Group Description	Patients receive medication in-hand at discharge from the hospital Meds to Beds: Medications will be delivered to patient bedside before discharge	Electronic prescription with patient pickup at the pharmacy Electronic Prescription: Patient or surrogate can pick up medication from pharmacy
Measure Participants	20	20
Count of Participants [Participants]	7 35%	5 25%

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants completing follow-up interview. Not all participants completed the questionnaire.

Arm/Group Title	Meds to Beds	Standard Care
Arm/Group Description	Patients receive medication in-hand at discharge from the hospital Meds to Beds: Medications will be delivered to patient bedside before discharge	Electronic prescription with patient pickup at the pharmacy Electronic Prescription: Patient or surrogate can pick up medication from pharmacy
Measure Participants	16	16
Count of Participants [Participants]	10 50%	9 45%

Adverse Events

Time Frame	30 days
Adverse Event Reporting Description	Event data collected from interview and medical records
Arm/Group Title	Meds to Beds		Standard Care
Arm/Group Description	Patients receive medication in-hand at discharge from the hospital Meds to Beds: Medications will be delivered to patient bedside before discharge		Electronic prescription with patient pickup at the pharmacy Electronic Prescription: Patient or surrogate can pick up medication from pharmacy
All Cause Mortality
	Meds to Beds		Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/20 (5%)		1/20 (5%)
Serious Adverse Events
	Meds to Beds		Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/20 (5%)		1/20 (5%)
Cardiac disorders
Death	1/20 (5%)	1	1/20 (5%)	1
Other (Not Including Serious) Adverse Events
	Meds to Beds		Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.