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OpenTrials
Completed

NCT Number: NCT03857100

Improving Wisely - Polypharmacy

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Audit and feedback - letter and report

Other

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

Primary outcomes

  1. Mean number of concurrent medications per older patient

    Time frame: 3 years

Secondary outcomes

  1. Proportion of patients who received at least one designated high risk medication by physician

    Time frame: 3 years

  2. Proportion of older patients with concurrent use of multiple Central Nervous System (CNS)-active medications

    Time frame: 3 years

  3. Proportion of older patients with chronic use of benzodiazepine sedative hypnotic medications

    Time frame: 3 years

  4. Proportion of older patients with concurrent use of opioids and benzodiazepines

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Gordon and Betty Moore Foundation

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 27, 2019
Registry last updated
Feb 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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