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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The purpose of this study test the effectiveness of the Universal Medication Schedule (UMS), which was designed as a strategy to standardize and simplify medication instructions to support safe and effective prescription drug use among diabetic.
Research has shown the UMS (1) improves patients' understanding of how much to take of a medicine and when, and (2) reduces the number of times per day patients would take a multi-drug regimen. In this study, UMS tools will be exported into a second electronic health record platform to demonstrate ease of dissemination. Also, as patients may require assistance outside of clinic visits to adapt their prescription regimen to the UMS, this study will test the potential benefit of daily short message service (SMS) text reminders via cell phone.
We will conduct a three-arm, provider-randomized controlled trial among English and Spanish-speaking adults taking three or more prescription drugs to evaluate the effectiveness of the UMS strategy, with and without SMS text reminders, to improve patient understanding, consolidation, and adherence compared to usual care.We will conduct a three-arm, provider-randomized trial at two community health centers in Chicago, IL to evaluate the UMS and UMS+SMS text reminder strategies compared to usual care. English and Spanish-speaking patients who are prescribed three or more medications will be recruited and assessed by phone at baseline, three months, and six months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Employ the current standard of care. No intervention. | |
| 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.
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| UMS strategy + SMS texting reminders | Experimental | In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UMS Strategy | Other | 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 |
|---|---|---|
| Prescription Understanding | Predictive probabilities of prescription understanding will be calculated based on patients' ability to correctly dose their prescription medications using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. Correct dosing per medication will be scored as yes or no, reflecting having demonstrated all of the following: proper dose (# of pills), spacing (hours between doses), frequency (# of times per day), and total pills per day. Results are presented as predicted probabilities with 95% Confidence Intervals. | 6 months after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Medication Knowledge | Predictive probabilities of medication knowledge will be calculated based on patients' ability to identify each medication's purpose and side effects, risks, warnings, and benefits using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. Patients will be asked through a structured questionnaire about each of the above via structured, open-ended items. Each medication will be scored as correct/incorrect if the participant knew the purpose and could name at least 1 side effect, risk, or warning of the medication. Results are presented as predicted probabilities with 95% Confidence Intervals. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Blood Pressure | An exploratory analysis will be conducted to investigate the impact of receiving the UMS in either intervention arm on biologic outcomes for these prevalent conditions. Systolic blood pressure will be obtained from patients' electronic health records. Differences will be measured between the last clinical measurement prior to baseline assessment and the last measured value during the study period (closest to 6 month assessment). |
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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Employ the current standard of care. No intervention. |
| FG001 | 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.
|
| FG002 | UMS Strategy + SMS Texting Reminders | In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription. 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 Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
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| 3 Month |
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| 6 Month |
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Employ the current standard of care. No intervention. |
| BG001 | 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, Categorical | Count of Participants |
| 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 | Prescription Understanding | Predictive probabilities of prescription understanding will be calculated based on patients' ability to correctly dose their prescription medications using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. Correct dosing per medication will be scored as yes or no, reflecting having demonstrated all of the following: proper dose (# of pills), spacing (hours between doses), frequency (# of times per day), and total pills per day. Results are presented as predicted probabilities with 95% Confidence Intervals. | All participants who completed the 6 month assessment and had complete data for the outcome for at least 1 medication. | Posted | Least Squares Mean | 95% Confidence Interval | Probability | 6 months after baseline | Medications | Medications |
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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 | Usual Care | Employ the current standard of care. No intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Wolf | Northwestern University | (312) 503-5592 | mswolf@northwestern.edu |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| SMS Texting Reminders | Other | In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription. |
|
| 6 months after baseline |
| Medication Adherence: Pill Count | Predictive probabilities of medication adherence will be calculated based on telephone pill counts using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. Pills taken/pills prescribed will be calculated for each medication and scored as adherent for that medication if that score is between 80% and 120%. Results are presented as predicted probabilities with 95% Confidence Intervals. | 6 months after baseline |
| Medication Adherence: PMAQ | Predictive probabilities of medication adherence will be calculated based on a 4-item validated Patient Medication Adherence Questionnaire (PMAQ) using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. The PMAQ assesses adherence behaviors by asking patients to self-report missed/wrong doses in past 4 days, scoring each medication as adherent for that medication if no missed doses were reported. Results are presented as predicted probabilities with 95% Confidence Intervals. | 6 months after baseline |
| Medication Adherence: Pharmacy Records | Predictive probabilities of primary medication adherence will be calculated based on the proportion of days covered (PDC) with medication obtained from pharmacy records using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. PDC is calculated by summing the number of days' supply obtained by a patient during a given time period and dividing by the number of days for which the patient was prescribed the medication. Each medication is scored as adherent if the patient was covered for that medication more than 80% of the time. Results are presented as predicted probabilities with 95% Confidence Intervals. | 6 months after baseline |
| 6 months before baseline to 1 year after baseline |
| Changes in Hemoglobin A1c (hbA1c) | An exploratory analysis will be conducted to investigate the impact of receiving the UMS in either intervention arm on biologic outcomes for these prevalent conditions. Hemoglobin A1c (hbA1c) will be obtained from patients' electronic health records. Differences will be measured between the last clinical measurement prior to baseline assessment and the last measured value during the study period (closest to 6 month assessment). | 6 months before baseline to 1 year after baseline |
| Changes in Low-density Lipoprotein Cholesterol (LDL) | An exploratory analysis will be conducted to investigate the impact of receiving the UMS in either intervention arm on biologic outcomes for these prevalent conditions. Low-density lipoprotein cholesterol (LDL) will be obtained from patients' electronic health records. Differences will be measured between the last clinical measurement prior to baseline assessment and the last measured value during the study period (closest to 6 month assessment). | 6 months before baseline to 1 year after baseline |
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| BG002 | UMS Strategy + SMS Texting Reminders | In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription. 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 Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription. |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Employ the current standard of care. No intervention.
| OG001 | 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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| OG002 | UMS Strategy + SMS Texting Reminders | In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription. 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 Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription. |
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| Secondary | Medication Knowledge | Predictive probabilities of medication knowledge will be calculated based on patients' ability to identify each medication's purpose and side effects, risks, warnings, and benefits using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. Patients will be asked through a structured questionnaire about each of the above via structured, open-ended items. Each medication will be scored as correct/incorrect if the participant knew the purpose and could name at least 1 side effect, risk, or warning of the medication. Results are presented as predicted probabilities with 95% Confidence Intervals. | All participants who completed the 6 month assessment and had complete outcome data for at least 1 medication | Posted | Least Squares Mean | 95% Confidence Interval | Probability of medication knowledge | 6 months after baseline | Medications | Medications |
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| Secondary | Medication Adherence: Pill Count | Predictive probabilities of medication adherence will be calculated based on telephone pill counts using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. Pills taken/pills prescribed will be calculated for each medication and scored as adherent for that medication if that score is between 80% and 120%. Results are presented as predicted probabilities with 95% Confidence Intervals. | All participants who completed the 6 month assessment and had complete outcome data for at least 1 medication | Posted | Least Squares Mean | 95% Confidence Interval | Probability of adherence | 6 months after baseline | Medications | Medications |
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| Secondary | Medication Adherence: PMAQ | Predictive probabilities of medication adherence will be calculated based on a 4-item validated Patient Medication Adherence Questionnaire (PMAQ) using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. The PMAQ assesses adherence behaviors by asking patients to self-report missed/wrong doses in past 4 days, scoring each medication as adherent for that medication if no missed doses were reported. Results are presented as predicted probabilities with 95% Confidence Intervals. | All participants who completed the 6 month assessment and had complete outcome data for at least 1 medication | Posted | Least Squares Mean | 95% Confidence Interval | Probability of adherence | 6 months after baseline | Medications | Medications |
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| Secondary | Medication Adherence: Pharmacy Records | Predictive probabilities of primary medication adherence will be calculated based on the proportion of days covered (PDC) with medication obtained from pharmacy records using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. PDC is calculated by summing the number of days' supply obtained by a patient during a given time period and dividing by the number of days for which the patient was prescribed the medication. Each medication is scored as adherent if the patient was covered for that medication more than 80% of the time. Results are presented as predicted probabilities with 95% Confidence Intervals. | Participants who filled medications at Walgreens during the study period. | Posted | Least Squares Mean | 95% Confidence Interval | Probability of adherence | 6 months after baseline | Medications | Medications |
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| Other Pre-specified | Changes in Blood Pressure | An exploratory analysis will be conducted to investigate the impact of receiving the UMS in either intervention arm on biologic outcomes for these prevalent conditions. Systolic blood pressure will be obtained from patients' electronic health records. Differences will be measured between the last clinical measurement prior to baseline assessment and the last measured value during the study period (closest to 6 month assessment). | All participants with both a baseline and 6 month systolic blood pressure measurement | Posted | Mean | Standard Deviation | mmHG | 6 months before baseline to 1 year after baseline |
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| Other Pre-specified | Changes in Hemoglobin A1c (hbA1c) | An exploratory analysis will be conducted to investigate the impact of receiving the UMS in either intervention arm on biologic outcomes for these prevalent conditions. Hemoglobin A1c (hbA1c) will be obtained from patients' electronic health records. Differences will be measured between the last clinical measurement prior to baseline assessment and the last measured value during the study period (closest to 6 month assessment). | All participants with both a baseline and 6 month hbA1c measurement | Posted | Mean | Standard Deviation | percent of glycated hemoglobin | 6 months before baseline to 1 year after baseline |
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| Other Pre-specified | Changes in Low-density Lipoprotein Cholesterol (LDL) | An exploratory analysis will be conducted to investigate the impact of receiving the UMS in either intervention arm on biologic outcomes for these prevalent conditions. Low-density lipoprotein cholesterol (LDL) will be obtained from patients' electronic health records. Differences will be measured between the last clinical measurement prior to baseline assessment and the last measured value during the study period (closest to 6 month assessment). | All participants with both a baseline and 6 month LDL measurement | Posted | Mean | Standard Deviation | mg/dL | 6 months before baseline to 1 year after baseline |
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| 0 |
| 157 |
| 0 |
| 157 |
| EG001 | 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.
| 0 | 168 | 0 | 168 |
| EG002 | UMS Strategy + SMS Texting Reminders | In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription. 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 Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription. | 0 | 127 | 0 | 127 |
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