Improving Metoclopramide Prescribing Practices at Penn Through a Physician-targeted Intervention

December 3, 2015 updated by: University of Pennsylvania

The investigators hypothesized that:

1) an intervention targeted at the prescribing physician would increase the rate of a metoclopramide discontinuation among patients prescribed the medication for questionable or unclear indications; and 2) the discontinuation would be durable.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Center for Clinical Epidemiology and Biostatistics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Physicians at University of Pennsylvania Health System who ordered an active metoclopramide prescription with a questionable indication.

Exclusion Criteria:

  • Physicians-in-training (e.g., residents, fellows)
  • Physicians how were investigators on this study
  • Physicians serving on the the University of Pennsylvania Drug Use and Effects Committee or Information Technology Oversight Board

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention

Physicians in the intervention group were mailed a written feedback letter regarding their patients who were prescribed questionable metoclopramide therapy. Non-intervention providers received no letter. The letter consisted of the following components:

  1. The name and medical record # of the patients involved
  2. Information regarding the metoclopramide prescription: dates, dosage, indication recorded, and the duration of therapy
  3. A reminder of the adverse effect of long-term metoclopramide therapy
  4. A recommendation to consider having the patient undergo a trial of metoclopramide discontinuation if appropriate, and documentation of a discussion of risk and benefits of metoclopramide therapy with patients
  5. A request that the physician document the discontinuation trial in the electronic medical record
Other: intervention letter

Physicians in the intervention group were mailed a written feedback letter regarding their patients who were prescribed questionable metoclopramide therapy. Non-intervention providers received no letter. The letter consisted of the following components:

  1. The name and medical record # of the patients involved
  2. Information regarding the metoclopramide prescription: dates, dosage, indication recorded, and the duration of therapy
  3. A reminder of the adverse effect of long-term metoclopramide therapy
  4. A recommendation to consider having the patient undergo a trial of metoclopramide discontinuation if appropriate, and documentation of a discussion of risk and benefits of metoclopramide therapy with patients
  5. A request that the physician document the discontinuation trial in the electronic medical record
No Intervention: non-intervention
No intervention letters were sent to subjects in this arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discontinuation of metoclopramide therapy
Time Frame: 12 weeks after intervention period
Twelve weeks after the intervention period, we searched the medical records of patients in the intervention and non-intervention groups to determine whether discontinuation of metoclopramide therapy had taken place.
12 weeks after intervention period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

  • Principal Investigator: Yu-Xiao Yang, MD, MSCE, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

May 17, 2010

First Submitted That Met QC Criteria

May 18, 2010

First Posted (Estimate)

May 19, 2010

Study Record Updates

Last Update Posted (Estimate)

December 4, 2015

Last Update Submitted That Met QC Criteria

December 3, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPenn - 802142

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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