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| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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This project tests a model of chronic disease medication management in which the decision to initiate or adjust medical therapy is directly linked to a sequence of subsequent clinical actions (e.g. monitoring for adverse drug events, assessing response to therapy, changing medication dose) performed independently of the office visit. The investigators hypothesize that establishing a visit-independent, health information technology (IT) supported cycle of laboratory monitoring and iterative medication dose adjustment will result in more effective chronic disease care.
To implement a new model of chronic disease management, we will build on our existing electronic health record and integrated data systems to develop an advanced health IT application called the "Medication Metronome" to enable providers to schedule future laboratory tests related to a specific set of medications (for glycemic, cholesterol, and blood pressure management). As these lab test dates become due, the Medication Metronome system will remind patients via letter and inform providers when the tests remain "missing." The goal of this intervention is to implement an efficient, visit-independent system to ensure that patients are rapidly and safely brought to evidence-based treatment goals and to prevent delays in planned laboratory monitoring. This study has the following aims:
Aim 1: To develop the Medication Metronome system. This work involves health IT development and evaluation of design prototypes to create a system that supports timely medication intensification, improves safety, and meets both patient and provider needs.
Aim 2: To conduct a randomized controlled trial of the Medication Metronome system. We will use three target chronic conditions to test different elements of the system. We hypothesize that use of the Medication Metronome system will lead to:
H2a. More effective HbA1c control among patients with type 2 diabetes prescribed hypoglycemic medicines; H2b. Safer medication management among patients with hypertension prescribed thiazide diuretics, angiotensin converting enzyme inhibitors, or angiotensin II receptor blockers; H2c. Both more effective LDL-cholesterol control and safer monitoring for hepatitis among patients with hyperlipidemia prescribed HMG-CoA reductase inhibitors.
Aim 3: To evaluate the impact of the Medication Metronome visit-independent care model on the content of office-based visits. Time spent addressing different clinical care domains will be assessed using audiotape-based content analysis in a subset of selected office visits.
Summary: We will implement, and rigorously evaluate a health IT-supported model of visit-independent medication management designed to enable safer and more effective chronic disease care. We will also carefully investigate the impact of this system on primary care visits. The broader goal of this work is to support health delivery redesign that fosters patient-centered primary care by combining visit-independent medication management with more productive visit-based patient-provider interactions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Use of Medication Metronome | Experimental | Providers allocated to intervention will automatically see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipidemia will initiate the follow-up result monitoring, patient outreach, and PCP reminders that constitute the Medication Metronome system. |
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| Usual Care | Active Comparator | PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medication Metronome | Device | Providers allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipidemia will initiate the follow-up result monitoring, patient outreach, and PCP reminders that constitute the Medication Metronome system. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Effectiveness Outcome - LDL | Percentage of follow-up time (from initial prescription to final laboratory result available during the 18-month study period) that a patient is at or below risk factor goal for LDL(LDL-cholesterol ≤ 130 mg/dL for patients without cardiovascular risk and ≤ 100 mg/dl for patients with cardiovascular risk). | 1 year |
| Primary Effectiveness Outcome - A1c | Percentage of follow-up time (from initial prescription to final laboratory result available during the 18-month study period) that a patient is at or below risk factor goal for HbA1c(HbA1c ≤ 7.0%). | 1 year |
| Medication Safety Monitoring - Statins | Percentage of laboratory tests (liver function tests after a new statin prescription or a change in statin dose) that have been measured within 4 weeks following prescription. Treatment guidelines for prescription of statins recommend follow-up liver function testing. We chose 4-weeks following the prescription to represent successful safety monitoring. | Within 4 weeks following prescription |
| Medication Safety Monitoring - Metformin | Percentage of renal function laboratory tests that have been measured within 4-weeks following prescription. Treatment guidelines for prescription of metformin recommend renal function testing. We chose 4- weeks following the prescription to represent successful safety monitoring. | Within 4 weeks following prescription |
| Medication Safety Monitoring - ACE/ARB, Thiazide | Percentage of laboratory tests (potassium for thiazides, renal/potassium for ACE/ARBs that have been measured within 4-weeks following prescription. Treatment guidelines for prescription of ACE/ARBs recommend renal/potassium testing and potassium testing for prescription of thiazides. We chose 4-weeks following the prescription to represent successful safety monitoring. |
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Inclusion Criteria:
All primary care physicians from participating practices will be eligible to participate in the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven J Atlas, MD, MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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Primary Care Physicians were recruited and randomized to intervention or control arms, but data were collected and analyzed for the patients of the Primary Care Physicians.
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| ID | Title | Description |
|---|---|---|
| FG000 | Use of Medication Metronome | Medication Metronome: Providers allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipid. 26 Primary Care Physicians were randomized to "Use of Medication Metronome" with 2049 patients analyzed. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Usual Care | Other |
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| Within 4 weeks following prescription |
| FG001 | Usual Care | PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring. Usual Care 26 Primary Care Physicians randomized to Usual Care, with 1606 patients analyzed. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Use of Medication Metronome | Medication Metronome: PCPs allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipid. While PCPs were randomized, analyses were at the patient level. Characteristics presented represent eligible patients of randomized PCPs. |
| BG001 | Usual Care | PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring. Usual Care While PCPs were randomized, analyses were at the patient level. Characteristics presented represent eligible patients of randomized PCPs. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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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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| 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 | Primary Effectiveness Outcome - LDL | Percentage of follow-up time (from initial prescription to final laboratory result available during the 18-month study period) that a patient is at or below risk factor goal for LDL(LDL-cholesterol ≤ 130 mg/dL for patients without cardiovascular risk and ≤ 100 mg/dl for patients with cardiovascular risk). | Patients prescribed statins during the study period | Posted | Mean | Standard Deviation | percentage of time spent at goal | 1 year |
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| Primary | Primary Effectiveness Outcome - A1c | Percentage of follow-up time (from initial prescription to final laboratory result available during the 18-month study period) that a patient is at or below risk factor goal for HbA1c(HbA1c ≤ 7.0%). | Patients prescribed oral medications for diabetes control during the study period | Posted | Mean | Standard Deviation | percentage of time spent at goal | 1 year |
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| Primary | Medication Safety Monitoring - Statins | Percentage of laboratory tests (liver function tests after a new statin prescription or a change in statin dose) that have been measured within 4 weeks following prescription. Treatment guidelines for prescription of statins recommend follow-up liver function testing. We chose 4-weeks following the prescription to represent successful safety monitoring. | Patients prescribed statins | Posted | Number | percentage of tests within 4 weeks | Within 4 weeks following prescription |
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| Primary | Medication Safety Monitoring - Metformin | Percentage of renal function laboratory tests that have been measured within 4-weeks following prescription. Treatment guidelines for prescription of metformin recommend renal function testing. We chose 4- weeks following the prescription to represent successful safety monitoring. | Patients prescribed metformin | Posted | Number | percentage of tests within 4 weeks | Within 4 weeks following prescription |
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| Primary | Medication Safety Monitoring - ACE/ARB, Thiazide | Percentage of laboratory tests (potassium for thiazides, renal/potassium for ACE/ARBs that have been measured within 4-weeks following prescription. Treatment guidelines for prescription of ACE/ARBs recommend renal/potassium testing and potassium testing for prescription of thiazides. We chose 4-weeks following the prescription to represent successful safety monitoring. | Patients prescribed ACE/ARB, thiazide | Posted | Number | percentage of tests within 4 weeks | Within 4 weeks following prescription |
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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 | Use of Medication Metronome - PCPs | Medication Metronome: Providers allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipidemia. | 0 | 26 | 0 | 26 | ||
| EG001 | Usual Care - PCPs | PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring. Usual Care | 0 | 26 | 0 | 26 | ||
| EG002 | Use of Medication Metronome - Patients | Patients of PCPs allocated to the "Use of Medication Metronome" were eligible for our outcomes if prescribed a new study medication or if they experienced a dose change of a study medication. | 0 | 2,049 | 0 | 2,049 | ||
| EG003 | Usual Care - Patients | Patients of PCPs allocated to "Usual Care" were eligible for our outcomes if prescribed a new study medication or if they experienced a dose change of a study medication. | 0 | 1,606 | 0 | 1,606 |
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Study participants did not embrace this method of non-visit based care, with only 660 medication prescriptions using the Medication Metronome ordering option (21% of possible orders).
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven J. Atlas, Director of Massachusetts General Primary Care Practice Based Research Network | Massachusetts General Hospital | 617-724-4736 | satlas@partners.org |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006973 | Hypertension |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
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