Diabetes Mellitus, Type 2, Hyperlipidemia, Hypertension
Conditions
Keywords
health information technology, primary care, visit-independent, medication monitoring
Brief summary
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.
Detailed description
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.
Interventions
DEVICEMedication 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 will initiate the follow-up result monitoring, patient outreach, and PCP reminders that constitute the Medication Metronome system.
OTHERUsual Care
Sponsors
Agency for Healthcare Research and Quality (AHRQ)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All primary care physicians from participating practices will be eligible to participate in the study. * Patients Eligible for Analysis: The primary unit of analysis will be prescribed medicine, grouped with patient and within prescribing PCP. Three potentially overlapping medication-based cohorts will be defined: 1) Patients prescribed any hypoglycemic agents, 2) Patients prescribed thiazide diuretics, ACE-Is, or ARBs, and 3) Patients prescribed statins. Based on this design, individual patients may contribute to more than one medication analytic cohort.
Exclusion criteria
* Patients Excluded from Analysis: Patients who are subsequently identified as having died during the course of the study intervention using the Social Security Death Index, to have left the MGH system, or to have changed PCPs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness Outcome - LDL | 1 year | 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). |
| Primary Effectiveness Outcome - A1c | 1 year | 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%). |
| Medication Safety Monitoring - Statins | Within 4 weeks following prescription | 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. |
| Medication Safety Monitoring - Metformin | Within 4 weeks following prescription | 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. |
| Medication Safety Monitoring - ACE/ARB, Thiazide | Within 4 weeks following prescription | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 2,049 |
| 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. | 1,606 |
| Total | 3,655 |
Baseline characteristics
| Characteristic | Use of Medication Metronome | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 65.9 years STANDARD_DEVIATION 13.1 | 65.7 years STANDARD_DEVIATION 12.8 | 65.8 years STANDARD_DEVIATION 13 |
| Sex: Female, Male Female | 979 Participants | 850 Participants | 1829 Participants |
| Sex: Female, Male Male | 1070 Participants | 756 Participants | 1826 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 26 | 0 / 26 | 0 / 2,049 | 0 / 1,606 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 | 0 / 2,049 | 0 / 1,606 |
Outcome results
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.
Time frame: Within 4 weeks following prescription
Population: Patients prescribed ACE/ARB, thiazide
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Use of Medication Metronome | Medication Safety Monitoring - ACE/ARB, Thiazide | 26.9 percentage of tests within 4 weeks |
| Usual Care | Medication Safety Monitoring - ACE/ARB, Thiazide | 24.0 percentage of tests within 4 weeks |
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.
Time frame: Within 4 weeks following prescription
Population: Patients prescribed metformin
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Use of Medication Metronome | Medication Safety Monitoring - Metformin | 13.7 percentage of tests within 4 weeks |
| Usual Care | Medication Safety Monitoring - Metformin | 16.2 percentage of tests within 4 weeks |
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.
Time frame: Within 4 weeks following prescription
Population: Patients prescribed statins
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Use of Medication Metronome | Medication Safety Monitoring - Statins | 6.7 percentage of tests within 4 weeks |
| Usual Care | Medication Safety Monitoring - Statins | 8.6 percentage of tests within 4 weeks |
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%).
Time frame: 1 year
Population: Patients prescribed oral medications for diabetes control during the study period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Use of Medication Metronome | Primary Effectiveness Outcome - A1c | 32.5 percentage of time spent at goal | Standard Deviation 43.2 |
| Usual Care | Primary Effectiveness Outcome - A1c | 34.3 percentage of time spent at goal | Standard Deviation 42.5 |
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).
Time frame: 1 year
Population: Patients prescribed statins during the study period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Use of Medication Metronome | Primary Effectiveness Outcome - LDL | 57.9 percentage of time spent at goal | Standard Deviation 44.4 |
| Usual Care | Primary Effectiveness Outcome - LDL | 54.8 percentage of time spent at goal | Standard Deviation 46.2 |