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Improving Wisely - Polypharmacy

Primary Purpose

Adverse Drug Event

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Audit and feedback - letter and report
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Adverse Drug Event

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Sites / Locations

  • Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention

Control

Arm Description

Receives letter and report

Does not receive letter and report

Outcomes

Primary Outcome Measures

Mean number of concurrent medications per older patient

Secondary Outcome Measures

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

Full Information

First Posted
February 26, 2019
Last Updated
February 22, 2021
Sponsor
Johns Hopkins University
Collaborators
Gordon and Betty Moore Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03857100
Brief Title
Improving Wisely - Polypharmacy
Official Title
An Audit and Feedback Intervention to Improve High Risk Prescribing Primary Care Physicians - A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 4, 2019 (Actual)
Primary Completion Date
January 30, 2021 (Actual)
Study Completion Date
January 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Gordon and Betty Moore Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adverse Drug Event

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Receives letter and report
Arm Title
Control
Arm Type
No Intervention
Arm Description
Does not receive letter and report
Intervention Type
Other
Intervention Name(s)
Audit and feedback - letter and report
Intervention Description
letter describing project and report of participants' outlier status and how participants compare to peers
Primary Outcome Measure Information:
Title
Mean number of concurrent medications per older patient
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Proportion of patients who received at least one designated high risk medication by physician
Time Frame
3 years
Title
Proportion of older patients with concurrent use of multiple Central Nervous System (CNS)-active medications
Time Frame
3 years
Title
Proportion of older patients with chronic use of benzodiazepine sedative hypnotic medications
Time Frame
3 years
Title
Proportion of older patients with concurrent use of opioids and benzodiazepines
Time Frame
3 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary care physician Must be the primary care physician for at least ten Medicare patients Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin A Makary, MD, MPH
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

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Improving Wisely - Polypharmacy

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