Trial Outcomes & Findings for The Medication Metronome Project - Study to Facilitate Follow-up Testing Resulting From Prescribed Medications to Improve Patient Safety and Care (NCT NCT01586897)
NCT ID: NCT01586897
Last Updated: 2016-01-11
Results Overview
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).
COMPLETED
NA
52 participants
1 year
2016-01-11
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
|
Overall Study
COMPLETED
|
26
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Medication Metronome Project - Study to Facilitate Follow-up Testing Resulting From Prescribed Medications to Improve Patient Safety and Care
Baseline characteristics by cohort
| Measure |
Use of Medication Metronome
n=2049 Participants
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.
|
Usual Care
n=1606 Participants
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.
|
Total
n=3655 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.9 years
STANDARD_DEVIATION 13.1 • n=99 Participants
|
65.7 years
STANDARD_DEVIATION 12.8 • n=107 Participants
|
65.8 years
STANDARD_DEVIATION 13.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
979 Participants
n=99 Participants
|
850 Participants
n=107 Participants
|
1829 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1070 Participants
n=99 Participants
|
756 Participants
n=107 Participants
|
1826 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Patients prescribed statins during the study period
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).
Outcome measures
| Measure |
Use of Medication Metronome
n=953 Participants
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
|
Usual Care
n=703 Participants
PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.
Usual Care
|
|---|---|---|
|
Primary Effectiveness Outcome - LDL
|
57.9 percentage of time spent at goal
Standard Deviation 44.4
|
54.8 percentage of time spent at goal
Standard Deviation 46.2
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Patients prescribed oral medications for diabetes control during the study period
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%).
Outcome measures
| Measure |
Use of Medication Metronome
n=318 Participants
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
|
Usual Care
n=300 Participants
PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.
Usual Care
|
|---|---|---|
|
Primary Effectiveness Outcome - A1c
|
32.5 percentage of time spent at goal
Standard Deviation 43.2
|
34.3 percentage of time spent at goal
Standard Deviation 42.5
|
PRIMARY outcome
Timeframe: Within 4 weeks following prescriptionPopulation: Patients prescribed 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.
Outcome measures
| Measure |
Use of Medication Metronome
n=1134 Participants
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
|
Usual Care
n=699 Participants
PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.
Usual Care
|
|---|---|---|
|
Medication Safety Monitoring - Statins
|
6.7 percentage of tests within 4 weeks
|
8.6 percentage of tests within 4 weeks
|
PRIMARY outcome
Timeframe: Within 4 weeks following prescriptionPopulation: Patients prescribed 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.
Outcome measures
| Measure |
Use of Medication Metronome
n=445 Participants
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
|
Usual Care
n=425 Participants
PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.
Usual Care
|
|---|---|---|
|
Medication Safety Monitoring - Metformin
|
13.7 percentage of tests within 4 weeks
|
16.2 percentage of tests within 4 weeks
|
PRIMARY outcome
Timeframe: Within 4 weeks following prescriptionPopulation: Patients prescribed 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.
Outcome measures
| Measure |
Use of Medication Metronome
n=1411 Participants
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
|
Usual Care
n=1296 Participants
PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.
Usual Care
|
|---|---|---|
|
Medication Safety Monitoring - ACE/ARB, Thiazide
|
26.9 percentage of tests within 4 weeks
|
24.0 percentage of tests within 4 weeks
|
Adverse Events
Use of Medication Metronome - PCPs
Usual Care - PCPs
Use of Medication Metronome - Patients
Usual Care - Patients
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Steven J. Atlas, Director of Massachusetts General Primary Care Practice Based Research Network
Massachusetts General Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place