NCT03857100

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2021

Completed
Last Updated

February 23, 2021

Status Verified

February 1, 2021

Enrollment Period

2.1 years

First QC Date

February 26, 2019

Last Update Submit

February 22, 2021

Conditions

Adverse Drug Event

Outcome Measures

Primary Outcomes (1)

  • Mean number of concurrent medications per older patient

    3 years

Secondary Outcomes (4)

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

    3 years

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

    3 years

  • Proportion of older patients with chronic use of benzodiazepine sedative hypnotic medications

    3 years

  • Proportion of older patients with concurrent use of opioids and benzodiazepines

    3 years

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Receives letter and report

Other: Audit and feedback - letter and report

Control

NO INTERVENTION

Does not receive letter and report

Interventions

Audit and feedback - letter and reportOTHER

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

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

  • Martin A Makary, MD, MPH

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2019

First Posted

February 27, 2019

Study Start

January 4, 2019

Primary Completion

January 30, 2021

Study Completion

January 30, 2021

Last Updated

February 23, 2021

Record last verified: 2021-02

Locations

US(1)