Improving Wisely - Polypharmacy

An Audit and Feedback Intervention to Improve High Risk Prescribing Primary Care Physicians - A Randomized Controlled Trial

This is a randomized controlled trial that uses an audit and feedback intervention to alert primary care physicians who are outliers in one or more metrics related to high risk prescribing of participants' outlier status. Primary care physicians will be randomized to the intervention or control arm, except in California, where all outliers will be notified. The investigators will evaluate the impact of the intervention on prescribing patterns.

Study Overview

• Status: Completed
• Conditions: Adverse Drug Event
• Intervention / Treatment: Other: Audit and feedback - letter and report

Detailed Description

The investigators have developed five different metrics related to low-value (and/or high risk) prescribing habits based on guidelines. The five metrics are listed below. The investigators are using 100% capture Medicare claims data to evaluate the prescribing habits of all US primary care physicians who prescribed to ten or more Medicare patients. A patient is attributed to the primary care physician who prescribed the patient the most medications that year.

The investigators have calculated the mean, median, and standard deviation for each of the five metrics based on data from 2016. All primary care physicians who are two or more standard deviation above the mean of a given metric are considered outliers. In each state (excluding California), half of the outliers while be randomly assigned to the intervention group and half will be assigned to the control group, using a random number generator. Those outliers who are assigned to the intervention group will receive a cover letter signed by a members from the Physician Engagement Council (PEC), which is composed of physicians from the Society of General Internal Medicine (SGIM) which explains the study. Participants will also receive a report of participants' status as an outlier which shows in both text and graphic representation, how participants compare to participants' peers. These communications will be sent by mail. The control group will not receive any communication. All outliers in California will receive the intervention.

Brief summary of metrics:

• Metric 1: Average number of concurrent medications per older patient, by physician
• Metric 2: Proportion of older patients who received at least one medication that is a designated high-risk medication in older patients, by physician
• Metric 3: Proportion of older patients with concurrent use of multiple central nervous system-active medications, by physician
• Metric 4: Proportion of older patients with chronic use of benzodiazepine sedative hypnotic medications, by physician
• Metric 5: Proportion of older patients with concurrent use of opioids and benzodiazepines, by physician

• Study Type: Interventional
• Enrollment (Actual): 11000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Primary care physician
• Must be the primary care physician for at least ten Medicare patients

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Intervention; Receives letter and report	Other: Audit and feedback - letter and report; letter describing project and report of participants' outlier status and how participants compare to peers
NO_INTERVENTION: Control; Does not receive letter and report

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean number of concurrent medications per older patient	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients who received at least one designated high risk medication by physician	3 years
Proportion of older patients with concurrent use of multiple Central Nervous System (CNS)-active medications	3 years
Proportion of older patients with chronic use of benzodiazepine sedative hypnotic medications	3 years
Proportion of older patients with concurrent use of opioids and benzodiazepines	3 years

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Gordon and Betty Moore Foundation
• Investigators: Principal Investigator: Martin A Makary, MD, MPH, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 4, 2019
• Primary Completion (ACTUAL): January 30, 2021
• Study Completion (ACTUAL): January 30, 2021

Study Registration Dates

• First Submitted: February 26, 2019
• First Submitted That Met QC Criteria: February 26, 2019
• First Posted (ACTUAL): February 27, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: IRB00171337

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No