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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK103684 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Boston Medical Center | OTHER |
| University of North Carolina, Chapel Hill | OTHER |
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This study evaluates the effectiveness of an electronic health record based educational intervention (the EMC2 strategy) to improve patient understanding and use of higher-risk medications. Half of the participants will receive the intervention, while the other half will receive the usual amount of information (usual care).
Research has repeatedly demonstrated that individuals lack essential information on how to safely take prescribed (Rx) medications. A risk communication and surveillance strategy is needed in primary care to ensure that patients are adequately informed about medication risks and are taking prescribed regimens safely.
The investigators devised an Electronic health record-based Medication Complete Communication (EMC2) Strategy that leverages electronic health record (EHR) and interactive voice response (IVR) technologies to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Subjects will receive the current standard of care. | |
| EMC2 Strategy | Experimental | Subjects will receive the EMC2 Strategy. See description of strategy below. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMC2 Strategy | Behavioral | The intervention includes 1) distribution of simplified one-page medication guide summaries, 2) an automated follow-up call to assess medication safety and problematic side effects and 3) summary reports of call to providers with any concerns flagged for clinic follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Medication Knowledge (0-100) | Adjusted Least-square means of Medication Knowledge are calculated based on patient's ability to identify each medication's purpose and side effects, risks, warnings and benefits using general linear mixed models, specifying the identity link (PROC GLIMMIX). Treatment assignment by time is the independent variable of interest and modeled as a fixed effect, and clinic as a random effect, with additional subject statement to model correlations with patient. Confounding variables, such as age, preferred language, race, education, health status, number of chronic diseases, drug class, and health literacy (Newest Vital Sign) are included as fixed effects in the model. Patients are asked 10 questions (a scale developed by our team), and each questions is scored as correct/incorrect, and percentage of correctly answered questions is calculated (0-100 with 100 as best). Results are presented as adjusted least square means with 95% Confidence Intervals | Baseline to 3 Months post baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Probability of Prescription Medication Proper Use | Subjects will be asked to demonstrate proper use of the medication by indicating the correct dose (amount of medication taken each time), frequency (times per day), and total pills/units per day. For non-PRN medications, all must be answered correctly to be considered proper use (yes/no) , whereas for PRN medications, proper use is determined if the patient indicated the correct dose or less, the correct frequency or less, and the correct total pills/units or less. Proper use is modelled as a binary outcome, and General linear mixed models are used, specifying the logit link (PROC GLIMMIX). Treatment assignment by time is the independent variable of interest and modeled as a fixed effect, and clinic as a random effect, with additional subject statement to model correlations with patient. Confounding factors, such as drug class and health literacy (Newest Vital Sign) are also included in the model as fixed effects. Results are presented as adjusted least square means with 95% CI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael S Wolf, PhD | Northwestern University | Principal Investigator |
| Stacy C Bailey, PhD | Northwestern University | Principal Investigator |
| Michael K Paasche-Orlow, MD | Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Near North Health Services Corporation | Chicago | Illinois | 60610 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Subjects will receive the current standard of care. |
| FG001 | EMC2 Strategy | Subjects will receive the EMC2 Strategy. See description of strategy below. EMC2 Strategy: The intervention includes 1) distribution of simplified one-page medication guide summaries, 2) an automated follow-up call to assess medication safety and problematic side effects and 3) summary reports of call to providers with any concerns flagged for clinic follow-up. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
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| 1 Month |
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| 3 Months |
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Subjects will receive the current standard of care. |
| BG001 | EMC2 Strategy | Subjects will receive the EMC2 Strategy. See description of strategy below. EMC2 Strategy: The intervention includes 1) distribution of simplified one-page medication guide summaries, 2) an automated follow-up call to assess medication safety and problematic side effects and 3) summary reports of call to providers with any concerns flagged for clinic follow-up. |
| 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 Knowledge (0-100) | Adjusted Least-square means of Medication Knowledge are calculated based on patient's ability to identify each medication's purpose and side effects, risks, warnings and benefits using general linear mixed models, specifying the identity link (PROC GLIMMIX). Treatment assignment by time is the independent variable of interest and modeled as a fixed effect, and clinic as a random effect, with additional subject statement to model correlations with patient. Confounding variables, such as age, preferred language, race, education, health status, number of chronic diseases, drug class, and health literacy (Newest Vital Sign) are included as fixed effects in the model. Patients are asked 10 questions (a scale developed by our team), and each questions is scored as correct/incorrect, and percentage of correctly answered questions is calculated (0-100 with 100 as best). Results are presented as adjusted least square means with 95% Confidence Intervals | 127 individuals were excluded from analysis, because their study med was either a short term medication or an antibiotics | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline to 3 Months post baseline |
3 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 | Usual Care | Subjects will receive the current standard of care. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael S. Wolf, PhD MPH | 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 |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 14, 2018 | Jul 10, 2019 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 3, 2019 | Sep 30, 2020 | Prot_SAP_001.pdf |
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| University of Illinois at Chicago |
| OTHER |
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|
| 1 Month post baseline to 3 Months post baseline |
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| NOT COMPLETED |
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| BG002 | 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 | 23 Individuals refused to identify their race, 4 individuals did not know how to identify their race | Count of Participants | Participants |
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| Education | 5 participants refused to answer the question, 1 did not know their highest education level | Count of Participants | Participants |
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| Self-reported Health Status | 4 individuals refused to answer the question | Count of Participants | Participants |
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| Drug Class | Count of Participants | Participants |
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| Preferred Language | Count of Participants | Participants |
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| Health Literacy (NVS) | Health Literacy (NVS):Newest Vital Sign | 174 individuals did not complete the health literacy assessment | Count of Participants | Participants |
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| ID | Title | Description |
|---|
| OG000 | Usual Care | Subjects will receive the current standard of care. |
| OG001 | EMC2 Strategy | Subjects will receive the EMC2 Strategy. See description of strategy below. EMC2 Strategy: The intervention includes 1) distribution of simplified one-page medication guide summaries, 2) an automated follow-up call to assess medication safety and problematic side effects and 3) summary reports of call to providers with any concerns flagged for clinic follow-up. |
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| Secondary | Probability of Prescription Medication Proper Use | Subjects will be asked to demonstrate proper use of the medication by indicating the correct dose (amount of medication taken each time), frequency (times per day), and total pills/units per day. For non-PRN medications, all must be answered correctly to be considered proper use (yes/no) , whereas for PRN medications, proper use is determined if the patient indicated the correct dose or less, the correct frequency or less, and the correct total pills/units or less. Proper use is modelled as a binary outcome, and General linear mixed models are used, specifying the logit link (PROC GLIMMIX). Treatment assignment by time is the independent variable of interest and modeled as a fixed effect, and clinic as a random effect, with additional subject statement to model correlations with patient. Confounding factors, such as drug class and health literacy (Newest Vital Sign) are also included in the model as fixed effects. Results are presented as adjusted least square means with 95% CI | 248 participants were excluded, due to either completing their evaluation early, or not filling their medication | Posted | Least Squares Mean | 95% Confidence Interval | Probability | 1 Month post baseline to 3 Months post baseline |
|
|
|
| 526 |
| 0 |
| 526 |
| 0 |
| 526 |
| EG001 | EMC2 Strategy | Subjects will receive the EMC2 Strategy. See description of strategy below. EMC2 Strategy: The intervention includes 1) distribution of simplified one-page medication guide summaries, 2) an automated follow-up call to assess medication safety and problematic side effects and 3) summary reports of call to providers with any concerns flagged for clinic follow-up. | 0 | 479 | 0 | 479 | 0 | 479 |
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| Hispanic or Latino |
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| Others |
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| College Graduate |
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| Fair/Poor |
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| Diabetes |
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| LABA |
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| NSAID |
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| PPI |
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| Others |
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| Adequate |
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