NCT01126034

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2007

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

March 1, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2010

Completed
Last Updated

December 4, 2015

Status Verified

December 1, 2015

Enrollment Period

1.1 years

First QC Date

May 17, 2010

Last Update Submit

December 3, 2015

Conditions

Keywords

MetoclopramideRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

intervention

EXPERIMENTAL

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

non-intervention

NO INTERVENTION

No intervention letters were sent to subjects in this arm

Interventions

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

intervention

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania Center for Clinical Epidemiology and Biostatistics

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Yu-Xiao Yang, MD, MSCE

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 17, 2010

First Posted

May 19, 2010

Study Start

March 1, 2007

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

December 4, 2015

Record last verified: 2015-12

Locations