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
About this trial
This is an interventional health services research trial for Adverse Drug Event
Eligibility Criteria
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
NCT ID
NCT03857100
First Posted
February 26, 2019
Last Updated
February 22, 2021
Sponsor
Johns Hopkins University
Collaborators
Gordon and Betty Moore Foundation
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
Learn more about this trial
Improving Wisely - Polypharmacy
We'll reach out to this number within 24 hrs