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

Gastroesophageal Reflux Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01126034
• Other study ID #: UPenn - 802142
• Status: Completed
• Phase: N/A
• First received: May 17, 2010
• Last updated: December 3, 2015
• Start date: March 2007
• Est. completion date: April 2008

Study information

• Verified date: December 2015
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetic Gastroparesis
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease
• Gastroparesis

Intervention

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: The name and medical record # of the patients involved Information regarding the metoclopramide prescription: dates, dosage, indication recorded, and the duration of therapy A reminder of the adverse effect of long-term metoclopramide therapy 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 A request that the physician document the discontinuation trial in the electronic medical record

Locations

Country	Name	City	State
United States	University of Pennsylvania Center for Clinical Epidemiology and Biostatistics	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discontinuation of metoclopramide therapy	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	Yes