Gastroesophageal Reflux DiseaseNCT01126034
Improving Metoclopramide Prescribing Practices at Penn Through a Physician-targeted Intervention
A study testing intervention letter in people with Gastroesophageal Reflux Disease and Diabetic Gastroparesis, run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux Disease, Diabetic Gastroparesis
- What is being tested?
- intervention letter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Apr 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Physicians at University of Pennsylvania Health System who ordered an active metoclopramide prescription with a questionable indication.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Center for Clinical Epidemiology and Biostatistics
Philadelphia, Pennsylvania, 19104
About this study
The investigators hypothesized that:
- 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.
- Being tested
- intervention letter
- Keywords
- Metoclopramide, Randomized Controlled Trial
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intervention letterOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: intervention letter |
| non-intervention | No intervention | No intervention letters were sent to subjects in this arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks after intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2010 (estimated)
- Study startMar 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Xiao Yang, MD, MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01126034
- Sponsor's protocol ID
- UPenn - 802142
- Status last verified
- Dec 2015
- First submitted
- 17 May 2010
- Last updated
- 4 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Metoclopramide Prescribing Practices at Penn Through a Physician-targeted Intervention
- ClinicalTrials.gov ID
- NCT01126034
- Acronym / sponsor ID
- UPenn - 802142
- Keywords
- Metoclopramide, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 19 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesized that:
- 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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: intervention letterPhysicians 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 | –No intervention letters were sent to subjects in this arm |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Physicians at University of Pennsylvania Health System who ordered an active metoclopramide prescription with a questionable indication.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intervention letterPhysicians 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 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Xiao Yang, MD, MSCE principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intervention letter in people with Gastroesophageal Reflux Disease and Diabetic Gastroparesis, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discontinuation of metoclopramide therapy (time frame: 12 weeks after intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2015.