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| Name | Class |
|---|---|
| Icahn School of Medicine at Mount Sinai | OTHER |
| Emory University | OTHER |
| Northwestern Memorial Hospital | OTHER |
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The investigators will leverage increasingly available technologies to impart a Universal Medication Schedule (UMS) in primary care to help patients living with diabetes safely use and adhere to complex drug regimens. The UMS standardizes the prescribing and dispensing of medicine by using health literacy principles and more explicit times to describe when to take medicine (morning, noon, evening, bedtime). This eliminates variability found in the way prescriptions are written by physicians and transcribed by pharmacists onto drug bottle labels. The proposed intervention will standardize prescribing within an electronic health record (EHR) so all medication orders include UMS prescription instructions ('sigs') and patients receive a medication information sheet with their after-visit summaries. Additionally, to help patients remember when to take prescribed medicines we will link unidirectional short message service (SMS) text reminders to the EHR, delivering medication reminders to patients around UMS intervals.
The investigators will leverage increasingly available technologies to impart a Universal Medication Schedule (UMS) in primary care to help patients living with diabetes safely use and adhere to complex drug regimens. The UMS standardizes the prescribing and dispensing of medicine by using health literacy principles and more explicit times to describe when to take medicine (morning, noon, evening, bedtime). This eliminates variability found in the way prescriptions are written by physicians and transcribed by pharmacists onto drug bottle labels. The proposed intervention will standardize prescribing within an electronic health record (EHR) so all medication orders include UMS prescription instructions ('sigs') and patients receive a medication information sheet with their after-visit summaries. Additionally, to help patients remember when to take prescribed medicines we will link unidirectional short message service (SMS) text reminders to the EHR, delivering medication reminders to patients around UMS intervals.
The investigators will conduct a 3-arm, multi-site trial to test the effectiveness of the UMS, and UMS + SMS text reminder strategies compared to usual care. The investigators will enroll a total of 900 English and Spanish-speaking patients with poorly controlled type 2 diabetes mellitus. Enrolled patients will complete follow-up interviews 3 and 6 months following their baseline interview.
The aims of the investigation are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UMS Strategy | Experimental | Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. These materials will be generated within the electronic health record.
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| UMS Strategy + SMS Text Messaging | Experimental | In addition to the components from the UMS strategy arm, patients will receive daily text message reminders for 6 months. |
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| Usual Care | No Intervention | Patients of providers randomized to the usual care arm will receive their standard care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UMS Strategy | Behavioral | Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. |
| Measure | Description | Time Frame |
|---|---|---|
| Medication Adherence: Pill Count | Adherence will be measured for each prescription medication using an objective pill count of the number of pills within each prescription bottle. The proportion of pills taken over pills prescribed (PT/PP) will be calculated for each medication at baseline and 6Month. Pills taken will be calculated by subtracting the number of pills from the total quantity prescribed. Pills prescribed will be calculated by multiplying the number of pills prescribed each day by the number of days since the medication was filled. A proportion of pills taken over pills prescribed (PT/PP) of 80% or more is considered adherent. | 6 months after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Medication Adherence: 24-hour Recall | Adherence will be measured for each prescription medication using self-report of how many pills and how often each medicine was taken over the last 24 hours. Patients are asked to specify the amount taken (i.e. dose) and when taken (to determine frequency and interval between doses). A patient is considered adherent on a specific medication if they answered all correctly: 1.dose, 2.frequency, 3.interval between doses |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Wolf, PhD MPH | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States | ||
| Mount Sinai School of Medicine |
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| ID | Title | Description |
|---|---|---|
| FG000 | UMS Strategy | Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. These materials will be generated within the electronic health record.
UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. |
| FG001 | UMS Strategy + SMS Text Messaging | In addition to the components from the UMS strategy arm, patients will receive daily text message reminders for 6 months. UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. SMS Text Messaging: Patients will receive daily text message reminders about when to take medicines based on UMS intervals. |
| FG002 | Usual Care | Patients of providers randomized to the usual care arm will receive their standard care |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
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| 3Month |
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| 6Month |
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Excluded participants with a protocol violation
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| ID | Title | Description |
|---|---|---|
| BG000 | UMS Strategy | Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. These materials will be generated within the electronic health record.
UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Medication Adherence: Pill Count | Adherence will be measured for each prescription medication using an objective pill count of the number of pills within each prescription bottle. The proportion of pills taken over pills prescribed (PT/PP) will be calculated for each medication at baseline and 6Month. Pills taken will be calculated by subtracting the number of pills from the total quantity prescribed. Pills prescribed will be calculated by multiplying the number of pills prescribed each day by the number of days since the medication was filled. A proportion of pills taken over pills prescribed (PT/PP) of 80% or more is considered adherent. | Observations were excluded if: 1.Medications were not in pill form; 2.Participants couldn't provide quantities on their bottles; 3.Missing Fill or Start Dates, 4.Participants started their medications on the same date as their pill count date; 5. Missing medications labels; 6. Participants combined medication bottles and discarded their old bottles; 7. Pills taken > Quantity on bottle; 8. PRN Medications 2 Participants from the UMS Strategy were also excluded due to a Protocol Violation. | Posted | Least Squares Mean | 95% Confidence Interval | Probability of adherence (PT/PP =>0.80) | 6 months after baseline | medications | medications |
6 months
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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 | UMS Strategy | Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. These materials will be generated within the electronic health record.
UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. |
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Due to COVID-19, our recruitment was reduced, approved by the sponsor, from a total sample size of 750 vs. 900 to address new hardships in accessing patients and changes to healthcare delivery. In addition, all interviews were switched to remote vs. in-person data collection. This translated to a remote video interview (Zoom) to capture pill count vs. use of an automated pill counter, and blood pressure could not be collected following the revised protocol.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Wolf | Northwestern University | (312) 503-5592 | mswolf@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 28, 2021 | Jan 20, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| SMS Text Messaging | Behavioral | Patients will receive daily text message reminders about when to take medicines based on UMS intervals. |
|
| 6 months after baseline |
| Medication Adherence: ASK-12 | Adherence will be measured by the ASK-12 Adherence Barrier Survey, a subjective assessment of general adherence behaviors and barriers to treatment adherence. The ASK-12 is scored by summing the selected responses (with scores ranging from 12 to 60) with higher scores indicating greater barriers to adherence. | 6 months after baseline |
| Treatment Knowledge | Identification of drug purpose | 6 months after baseline |
| New York |
| New York |
| 10029 |
| United States |
| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| BG001 | UMS Strategy + SMS Text Messaging | In addition to the components from the UMS strategy arm, patients will receive daily text message reminders for 6 months. UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. SMS Text Messaging: Patients will receive daily text message reminders about when to take medicines based on UMS intervals. |
| BG002 | Usual Care | Patients of providers randomized to the usual care arm will receive their standard care |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Recruitment Site | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | UMS Strategy | Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. These materials will be generated within the electronic health record.
UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. |
| OG001 | UMS Strategy + SMS Text Messaging | In addition to the components from the UMS strategy arm, patients will receive daily text message reminders for 6 months. UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. SMS Text Messaging: Patients will receive daily text message reminders about when to take medicines based on UMS intervals. |
| OG002 | Usual Care | Patients of providers randomized to the usual care arm will receive their standard care |
|
|
| Secondary | Medication Adherence: 24-hour Recall | Adherence will be measured for each prescription medication using self-report of how many pills and how often each medicine was taken over the last 24 hours. Patients are asked to specify the amount taken (i.e. dose) and when taken (to determine frequency and interval between doses). A patient is considered adherent on a specific medication if they answered all correctly: 1.dose, 2.frequency, 3.interval between doses | Observations were excluded if participants did not complete the 24-hour recall questions. 2 Participants from the UMS Strategy were also excluded due to a Protocol Violation. | Posted | Least Squares Mean | 95% Confidence Interval | Probability of Adherence (Yes) | 6 months after baseline | medications | medications |
|
|
|
| Secondary | Medication Adherence: ASK-12 | Adherence will be measured by the ASK-12 Adherence Barrier Survey, a subjective assessment of general adherence behaviors and barriers to treatment adherence. The ASK-12 is scored by summing the selected responses (with scores ranging from 12 to 60) with higher scores indicating greater barriers to adherence. | Observations were excluded if participants did not complete the ASK12 survey 2 Participants from the UMS Strategy were also excluded due to a Protocol Violation. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale (12-60) | 6 months after baseline |
|
|
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| Secondary | Treatment Knowledge | Identification of drug purpose | Observations were excluded if participants did not answer the question. 2 Participants from the UMS Strategy were also excluded due to a Protocol Violation. | Posted | Least Squares Mean | 95% Confidence Interval | Probability of Knowledge | 6 months after baseline | Medications | Medications |
|
|
|
| 1 |
| 244 |
| 0 |
| 244 |
| 0 |
| 244 |
| EG001 | UMS Strategy + SMS Text Messaging | In addition to the components from the UMS strategy arm, patients will receive daily text message reminders for 6 months. UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. SMS Text Messaging: Patients will receive daily text message reminders about when to take medicines based on UMS intervals. | 2 | 267 | 0 | 267 | 0 | 267 |
| EG002 | Usual Care | Patients of providers randomized to the usual care arm will receive their standard care | 4 | 244 | 0 | 244 | 0 | 244 |
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| D004700 | Endocrine System Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |