Trial Outcomes & Findings for Heart Failure Medication Adherence (NCT NCT03402750)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

Day 30

Results posted on

2019-11-07

Participant Flow

Participant milestones

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

Reasons for withdrawal

Reasons for withdrawal
Measure	Meds to Beds Patients receive medication in-hand at discharge from the hospital Meds to Beds: Medications will be delivered to patient bedside before discharge	Standard Care Electronic prescription with patient pickup at the pharmacy Electronic Prescription: Patient or surrogate can pick up medication from pharmacy
Overall Study Lost to Follow-up	2	1

Baseline Characteristics

Heart Failure Medication Adherence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Meds to Beds n=20 Participants Patients receive medication in-hand at discharge from the hospital Meds to Beds: Medications will be delivered to patient bedside before discharge	Standard Care n=20 Participants Electronic prescription with patient pickup at the pharmacy Electronic Prescription: Patient or surrogate can pick up medication from pharmacy	Total n=40 Participants Total of all reporting groups
Age, Continuous	57.85 years STANDARD_DEVIATION 6.54 • n=5 Participants	58.55 years STANDARD_DEVIATION 11.18 • n=7 Participants	58.20 years STANDARD_DEVIATION 8.86 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · African American	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · White	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 30

Population: 4 participants in each condition did not complete this measure.

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.

Outcome measures

Outcome measures
Measure	Meds to Beds n=16 Participants Patients receive medication in-hand at discharge from the hospital Meds to Beds: Medications will be delivered to patient bedside before discharge	Standard Care n=16 Participants Electronic prescription with patient pickup at the pharmacy Electronic Prescription: Patient or surrogate can pick up medication from pharmacy
Adherence to Medication	2 Participants	3 Participants

PRIMARY outcome

Timeframe: Day 30

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Meds to Beds n=10 Participants Patients receive medication in-hand at discharge from the hospital Meds to Beds: Medications will be delivered to patient bedside before discharge	Standard Care n=11 Participants Electronic prescription with patient pickup at the pharmacy Electronic Prescription: Patient or surrogate can pick up medication from pharmacy
Pharmacy Refill Adherence to Medication	7 Participants	6 Participants

SECONDARY outcome

Timeframe: Baseline and Day 30

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

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.

Outcome measures

Outcome measures
Measure	Meds to Beds n=20 Participants Patients receive medication in-hand at discharge from the hospital Meds to Beds: Medications will be delivered to patient bedside before discharge	Standard Care n=20 Participants Electronic prescription with patient pickup at the pharmacy Electronic Prescription: Patient or surrogate can pick up medication from pharmacy
Physical Health as Assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) Questionnaire 30-Day follow-up	11.81 score on a scale Standard Deviation 4.09	11.50 score on a scale Standard Deviation 3.90
Physical Health as Assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) Questionnaire Baseline/Discharge	8.56 score on a scale Standard Deviation 3.16	10.19 score on a scale Standard Deviation 3.51

SECONDARY outcome

Timeframe: Day 0

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

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.

Outcome measures

Outcome measures
Measure	Meds to Beds n=20 Participants Patients receive medication in-hand at discharge from the hospital Meds to Beds: Medications will be delivered to patient bedside before discharge	Standard Care n=20 Participants Electronic prescription with patient pickup at the pharmacy Electronic Prescription: Patient or surrogate can pick up medication from pharmacy
Number of Participants That Received Their Medications Prior to Discharge.	7 Participants	5 Participants

SECONDARY outcome

Timeframe: Day 30

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

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.

Outcome measures

Outcome measures
Measure	Meds to Beds n=16 Participants Patients receive medication in-hand at discharge from the hospital Meds to Beds: Medications will be delivered to patient bedside before discharge	Standard Care n=16 Participants Electronic prescription with patient pickup at the pharmacy Electronic Prescription: Patient or surrogate can pick up medication from pharmacy
Intervention Acceptance	10 Participants	9 Participants

Adverse Events

Meds to Beds

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Standard Care

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Meds to Beds n=20 participants at risk Patients receive medication in-hand at discharge from the hospital Meds to Beds: Medications will be delivered to patient bedside before discharge	Standard Care n=20 participants at risk Electronic prescription with patient pickup at the pharmacy Electronic Prescription: Patient or surrogate can pick up medication from pharmacy
Cardiac disorders Death	5.0% 1/20 • Number of events 1 • 30 days Event data collected from interview and medical records	5.0% 1/20 • Number of events 1 • 30 days Event data collected from interview and medical records

Other adverse events

Adverse event data not reported

Additional Information

Brian McCabe

University of Miami

Phone: 305-248-1530

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place