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The Medication Metronome Project - Study to Facilitate Follow-up Testing Resulting From Prescribed Medications to Improve Patient Safety and Care

Primary Purpose

Diabetes Mellitus, Type 2, Hypertension, Hyperlipidemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medication Metronome
Usual Care
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring health information technology, primary care, visit-independent, medication monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Use of Medication Metronome

Usual Care

Arm Description

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.

PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.

Outcomes

Primary Outcome Measures

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).
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%).
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 25, 2012
Last Updated
December 8, 2015
Sponsor
Massachusetts General Hospital
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT01586897
Brief Title
The Medication Metronome Project - Study to Facilitate Follow-up Testing Resulting From Prescribed Medications to Improve Patient Safety and Care
Official Title
The Medication Metronome Project
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Hypertension, Hyperlipidemia
Keywords
health information technology, primary care, visit-independent, medication monitoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Use of Medication Metronome
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.
Intervention Type
Device
Intervention Name(s)
Medication Metronome
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Primary Outcome Measure Information:
Title
Primary Effectiveness Outcome - LDL
Description
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
Title
Primary Effectiveness Outcome - A1c
Description
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
Title
Medication Safety Monitoring - Statins
Description
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
Title
Medication Safety Monitoring - Metformin
Description
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
Title
Medication Safety Monitoring - ACE/ARB, Thiazide
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven J Atlas, MD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

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The Medication Metronome Project - Study to Facilitate Follow-up Testing Resulting From Prescribed Medications to Improve Patient Safety and Care

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