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

NCT ID: NCT01126034

Last Updated: 2015-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastroesophageal Reflux Disease Diabetic Gastroparesis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

intervention letter

Intervention Type OTHER

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

non-intervention

No intervention letters were sent to subjects in this arm

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yu-Xiao Yang, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Pennsylvania Center for Clinical Epidemiology and Biostatistics

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UPenn - 802142

Identifier Type: -

Identifier Source: org_study_id