Adverse Drug EventNCT03857100
Improving Wisely - Polypharmacy
A study testing Audit and feedback - letter and report in people with Adverse Drug Event, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adverse Drug Event
- What is being tested?
- Audit and feedback - letter and report
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11,000 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2019to 30 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Primary care physician
- Must be the primary care physician for at least ten Medicare patients
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Audit and feedback - letter and report
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audit and feedback - letter and reportOther
letter describing project and report of participants' outlier status and how participants compare to peers
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Receives letter and report Receives: Other: Audit and feedback - letter and report |
| Control | No intervention | Does not receive letter and report |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean number of concurrent medications per older patient
Measured: 3 years
Secondary outcomes (4)
Proportion of patients who received at least one designated high risk medication by physician
Measured: 3 years
Proportion of older patients with concurrent use of multiple Central Nervous System (CNS)-active medications
Measured: 3 years
Proportion of older patients with chronic use of benzodiazepine sedative hypnotic medications
Measured: 3 years
Proportion of older patients with concurrent use of opioids and benzodiazepines
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start4 Jan 2019
- Primary completion30 Jan 2021
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Drug EventStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Gordon and Betty Moore Foundation
- Responsible party
- Sponsor
- Investigators
- Martin A Makary, MD, MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857100
- Sponsor's protocol ID
- IRB00171337
- Status last verified
- Feb 2021
- First submitted
- 26 Feb 2019
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Audit and Feedback Intervention to Improve High Risk Prescribing Primary Care Physicians - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03857100
- Acronym / sponsor ID
- IRB00171337
- Conditions
- Adverse Drug Event
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11,000 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Gordon and Betty Moore Foundation
- Study start
- 4 Jan 2019 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 27 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Other: Audit and feedback - letter and reportReceives letter and report |
| Control | No intervention | –Does not receive letter and report |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Primary care physician
- Must be the primary care physician for at least ten Medicare patients
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audit and feedback - letter and reportletter describing project and report of participants' outlier status and how participants compare to peers | Other | Intervention |
Primary outcome
Mean number of concurrent medications per older patient
Time frame: 3 years
4 secondary outcomes
Proportion of patients who received at least one designated high risk medication by physician
Time frame: 3 years
Proportion of older patients with concurrent use of multiple Central Nervous System (CNS)-active medications
Time frame: 3 years
Proportion of older patients with chronic use of benzodiazepine sedative hypnotic medications
Time frame: 3 years
Proportion of older patients with concurrent use of opioids and benzodiazepines
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin A Makary, MD, MPH principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audit and feedback - letter and report in people with Adverse Drug Event, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean number of concurrent medications per older patient (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.