An interventional study of Meds to Beds and Electronic Prescription in Heart Failure, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-07.
Sponsored by University of Miami · Not applicable, Interventional, and Supportive care
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.
Exclusion Criteria:
Patients receive medication in-hand at discharge from the hospital
Behavioral: Meds to Beds
Electronic prescription with patient pickup at the pharmacy
Behavioral: Electronic Prescription
Medications will be delivered to patient bedside before discharge
Patient or surrogate can pick up medication from pharmacy
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.
Time frame: 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.
Time frame: Day 30
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.
Time frame: Baseline and Day 30
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.
Time frame: Day 0
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.
Time frame: Day 30
| Milestone | Meds to Beds | Standard Care |
|---|---|---|
| Started | 20 | 20 |
| Completed | 18 | 19 |
| Not completed | 2 | 1 |
| Withdrew: Lost to follow-up | 2 | 1 |
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.
| Participants | Meds to Beds | Standard Care |
|---|---|---|
| Adherence to Medication | 2 | 3 |
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.
| Participants | Meds to Beds | Standard Care |
|---|---|---|
| Pharmacy Refill Adherence to Medication | 7 | 6 |
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.
| score on a scale | Meds to Beds | Standard Care |
|---|---|---|
| 30-Day follow-up | 11.81 ± 4.09 | 11.50 ± 3.90 |
| Baseline/Discharge | 8.56 ± 3.16 | 10.19 ± 3.51 |
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.
| Participants | Meds to Beds | Standard Care |
|---|---|---|
| Number of Participants That Received Their Medications Prior to Discharge. | 7 | 5 |
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.
| Participants | Meds to Beds | Standard Care |
|---|---|---|
| Intervention Acceptance | 10 | 9 |
Collected over 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Meds to Beds | 1/20 (5%) | 1/20 (5%) | 0/20 (0%) |
| Standard Care | 1/20 (5%) | 1/20 (5%) | 0/20 (0%) |
| Event | Meds to Beds | Standard Care |
|---|---|---|
| DeathCardiac disorders | 1/20 | 1/20 |
| Age, Continuous(years) | Meds to Beds | Standard Care | Total |
|---|---|---|---|
| Mean | 57.85 ± 6.54 | 58.55 ± 11.18 | 58.20 ± 8.86 |
| Sex: Female, Male(Participants) | Meds to Beds | Standard Care | Total |
|---|---|---|---|
| Female | 2 | 3 | 5 |
| Male | 18 | 17 | 35 |
| Race/Ethnicity, Customized(Participants) | Meds to Beds | Standard Care | Total |
|---|---|---|---|
| Ethnicity — Hispanic | 11 | 12 | 23 |
| Ethnicity — African American | 7 | 8 | 15 |
| Ethnicity — White | 2 | 0 | 2 |
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University of Miami