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

NCT01586897 | Completed Results

• 1 other identifier: R18HS018648
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Hypertension; Hyperlipidemia

Keywords

health information technology; primary care; visit-independent; medication monitoring

Outcome Measures

Primary Outcomes (5)

• 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).

  1 year

• 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%).

  1 year

• 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.

  Within 4 weeks following prescription

• 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.

  Within 4 weeks following prescription

• 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.

  Within 4 weeks following prescription

Study Arms (2)

Use of Medication Metronome

EXPERIMENTAL

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.

Device: Medication Metronome

Usual Care

ACTIVE COMPARATOR

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

Other: Usual Care

Interventions

Medication Metronome DEVICE

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.

Use of Medication Metronome

Usual Care OTHER

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension; Hyperlipidemias

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders

Limitations and Caveats

Study participants did not embrace this method of non-visit based care, with only 660 medication prescriptions using the Medication Metronome ordering option (21% of possible orders).

Results Point of Contact

• Title: Steven J. Atlas, Director of Massachusetts General Primary Care Practice Based Research Network
• Organization: Massachusetts General Hospital

satlas@partners.org

617-724-4736

Study Officials

• Steven J Atlas, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 25, 2012
• First Posted: April 27, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: January 11, 2016
• Results First Posted: December 9, 2015

Record last verified: 2015-12

Locations

US (1)