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| Name | Class |
|---|---|
| Beta Tau Chapter of Sigma Theta Tau International | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meds to Beds | Experimental | Patients receive medication in-hand at discharge from the hospital |
|
| Standard Care | Active Comparator | Electronic prescription with patient pickup at the pharmacy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meds to Beds | Behavioral | Medications will be delivered to patient bedside before discharge |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian E McCabe, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jackson Memorial Hospital | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Standard Care | Electronic prescription with patient pickup at the pharmacy Electronic Prescription: Patient or surrogate can pick up medication from pharmacy |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Standard Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 4 participants in each condition did not complete this measure. | Posted | Count of Participants | Participants | Day 30 |
|
30 days
Event data collected from interview and medical records
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian McCabe | University of Miami | 305-248-1530 | bmccabe@miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 19, 2018 | Oct 3, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 19, 2018 | Oct 3, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D055695 | Electronic Prescribing |
| ID | Term |
|---|---|
| D055656 | Prescriptions |
| D010593 | Pharmaceutical Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Electronic Prescription | Behavioral | Patient or surrogate can pick up medication from pharmacy |
|
| 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. | 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. | Day 30 |
Electronic prescription with patient pickup at the pharmacy
Electronic Prescription: Patient or surrogate can pick up medication from pharmacy
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Electronic prescription with patient pickup at the pharmacy Electronic Prescription: Patient or surrogate can pick up medication from pharmacy |
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Day 30 |
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|
|
| 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. | Interviews completed at follow-up and baseline. Not all participants completed the PROMIS questionnaire at the 30-day follow up visit. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Day 30 |
|
|
|
| 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. | Patients in Standard Care arm could receive delivery of medications, contrary to intentions. | Posted | Count of Participants | Participants | Day 0 |
|
|
|
| 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. | All participants completing follow-up interview. Not all participants completed the questionnaire. | Posted | Count of Participants | Participants | Day 30 |
|
|
|
| 1 |
| 20 |
| 1 |
| 20 |
| 0 |
| 20 |
| EG001 | Standard Care | Electronic prescription with patient pickup at the pharmacy Electronic Prescription: Patient or surrogate can pick up medication from pharmacy | 1 | 20 | 1 | 20 | 0 | 20 |
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| Baseline/Discharge |
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