- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01586897
The Medication Metronome Project - Study to Facilitate Follow-up Testing Resulting From Prescribed Medications to Improve Patient Safety and Care
The Medication Metronome Project
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Use of Medication Metronome
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.
|
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.
|
ACTIVE_COMPARATOR: Usual Care
PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Effectiveness Outcome - LDL
Time Frame: 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).
|
1 year
|
Primary Effectiveness Outcome - A1c
Time Frame: 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%).
|
1 year
|
Medication Safety Monitoring - Statins
Time Frame: 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.
|
Within 4 weeks following prescription
|
Medication Safety Monitoring - Metformin
Time Frame: 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.
|
Within 4 weeks following prescription
|
Medication Safety Monitoring - ACE/ARB, Thiazide
Time Frame: 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.
|
Within 4 weeks following prescription
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R18HS018648 (AHRQ)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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