Heart Failure
Conditions
Keywords
Adherence, Medication, Prescription
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.
Interventions
BEHAVIORALMeds to Beds
Medications will be delivered to patient bedside before discharge
BEHAVIORALElectronic Prescription
Patient or surrogate can pick up medication from pharmacy
Sponsors
Beta Tau Chapter of Sigma Theta Tau International
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| Standard Care Electronic prescription with patient pickup at the pharmacy
Electronic Prescription: Patient or surrogate can pick up medication from pharmacy | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
Baseline characteristics
| Characteristic | Meds to Beds | Standard Care | Total |
|---|---|---|---|
| Age, Continuous | 57.85 years STANDARD_DEVIATION 6.54 | 58.55 years STANDARD_DEVIATION 11.18 | 58.20 years STANDARD_DEVIATION 8.86 |
| Race/Ethnicity, Customized Ethnicity African American | 7 Participants | 8 Participants | 15 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic | 11 Participants | 12 Participants | 23 Participants |
| Race/Ethnicity, Customized Ethnicity White | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 18 Participants | 17 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 20 | 1 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 1 / 20 | 1 / 20 |
Outcome results
Primary
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
Population: 4 participants in each condition did not complete this measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Meds to Beds | Adherence to Medication | 2 Participants |
| Standard Care | Adherence to Medication | 3 Participants |
Primary
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
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Meds to Beds | Pharmacy Refill Adherence to Medication | 7 Participants |
| Standard Care | Pharmacy Refill Adherence to Medication | 6 Participants |
Secondary
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
Population: All participants completing follow-up interview. Not all participants completed the questionnaire.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Meds to Beds | Intervention Acceptance | 10 Participants |
| Standard Care | Intervention Acceptance | 9 Participants |
Secondary
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
Population: Patients in Standard Care arm could receive delivery of medications, contrary to intentions.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Meds to Beds | Number of Participants That Received Their Medications Prior to Discharge. | 7 Participants |
| Standard Care | Number of Participants That Received Their Medications Prior to Discharge. | 5 Participants |
Secondary
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
Population: Interviews completed at follow-up and baseline. Not all participants completed the PROMIS questionnaire at the 30-day follow up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Meds to Beds | 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 |
| Meds to Beds | 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 |
| Standard Care | Physical Health as Assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) Questionnaire | 30-Day follow-up | 11.50 score on a scale | Standard Deviation 3.9 |
| Standard Care | Physical Health as Assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) Questionnaire | Baseline/Discharge | 10.19 score on a scale | Standard Deviation 3.51 |