N/A
N=52
The Medication Metronome Project - Study to Facilitate Follow-up Testing Resulting From Prescribed Medications to Improve Patient Safety and Care
Diabetes Mellitus, Type 2 · Hypertension · Hyperlipidemia
Bottom Line
View on ClinicalTrials.gov: NCT01586897 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcome: Primary: Primary Effectiveness Outcome - LDL — 57.9; 54.8 percentage of time spent at goal
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Medication Metronome (Device); Usual Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Effectiveness Outcome - LDL |
57.9; 54.8 | — |
| PRIMARY Primary Effectiveness Outcome - A1c |
32.5; 34.3 | — |
| PRIMARY Medication Safety Monitoring - Statins |
6.7; 8.6 | — |
| PRIMARY Medication Safety Monitoring - Metformin |
13.7; 16.2 | — |
| PRIMARY Medication Safety Monitoring - ACE/ARB, Thiazide |
26.9; 24.0 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01586897). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.