Improving Wisely - Polypharmacy

NCT ID: NCT03857100

Last Updated: 2021-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-04
• Study Completion Date: 2021-01-30

Brief Summary

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.

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

Conditions

Adverse Drug Event

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention

Receives letter and report

Group Type: ACTIVE_COMPARATOR

Audit and feedback - letter and report

Intervention Type: OTHER

letter describing project and report of participants' outlier status and how participants compare to peers

Control

Does not receive letter and report

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Audit and feedback - letter and report

letter describing project and report of participants' outlier status and how participants compare to peers

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gordon and Betty Moore Foundation

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin A Makary, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00171337

Identifier Type: -

Identifier Source: org_study_id