GERDNCT00691171
Electronic Health Record (EHR)-Based Intervention for Gastroesophageal Reflux Disease (GERD) and Chronic Non-steroidal Anti-inflammatory Drug (NSAID) Use
An observational study of GERD, run by AstraZeneca.
Trial summary
The purpose of the study is to examine the impact of augmented, high-quality physician-coordinated care executed via an electronic health record (EHR)-based intervention on quality of care for gastroesophageal reflux disease (GERD) and for gastroprotection for patients on chronic non-steroidal anti-inflammatory drugs… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GERD
- How many people
- 5,234 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Jun 2008
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primarily primary care practices of physicians participating in the Medical Quality Improvement Consortium (MQIC)
Who may be able to join
- Eligibility as determined by criteria for participation in studies as part of the MQIC
- Agreement of participating clinical practices to undergo training in the electronic health record (EHR) intervention designed for this study
Who cannot join
- Based on voluntary participation by MQIC practices, so practices were excluded if they decided to opt out
About this study
Official title: Using an Electronic Health Record-based Intervention and Broad Education Reach Strategies to Improve Quality of Care for GERD and Gastroprotection for Patients on NSAIDs: a Randomized Controlled Trial
The purpose of the study is to examine the impact of augmented, high-quality physician-coordinated care executed via an electronic health record (EHR)-based intervention on quality of care for gastroesophageal reflux disease (GERD) and for gastroprotection for patients on chronic non-steroidal anti-inflammatory drugs (NSAIDs) at increased risk for upper GI tract ulcers and ulcer related complications.
- Conditions
- GERD
- Keywords
- gastroesophageal reflux disease, GERD, nonsteroidal anti-inflammatory drugs, peptic ulcer, Diagnosed GERD, Atypical GERD symptoms, chronic NSAID therapy, Risk for ulcer
- Medical subject headings
- Gastroesophageal Reflux, Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | GERD: Patients with established diagnoses of GERD based on ICD-9 codes | |
| 2 | Atypical GERD: Patients without an established diagnosis of GERD with atypical symptoms that could be due to GERD (e.g., asthma) | |
| 3 | Chronic NSAID users: Patients using chronic NSAIDs who are at increased risk of GI complications (defined as previous diagnosis of peptic ulcer disease; age 75 or older; or concomitant use of corticosteroids, anticoagulants, or aspirin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnoses of GERD
Measured: After 12 months of intervention
Prescriptions for gastroprotective medicines in at-risk, chronic NSAID users
Measured: After 12 months of intervention
Secondary outcomes (3)
Prescriptions for GERD medications
Measured: After 12 months of intervention
Change in GERD symptoms score
Measured: After 12 months of intervention
NSAID-related GI complications
Measured: After 12 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startJan 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GERDStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 5,234 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James M Gill, MD, PhD, Principal investigator, Delaware Valley Outcomes Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00691171
- Sponsor's protocol ID
- NIS-GUS-DUM-2007/1
- Status last verified
- Apr 2015
- First submitted
- 30 May 2008
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Gill JM, Mainous AG 3rd, Koopman RJ, Player MS, Everett CJ, Chen YX, Diamond JJ, Lieberman MI. Impact of EHR-based clinical decision support on adherence to guidelines for patients on NSAIDs: a randomized controlled trial. Ann Fam Med. 2011 Jan-Feb;9(1):22-30. doi: 10.1370/afm.1172.
PubMed 21242557
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using an Electronic Health Record-based Intervention and Broad Education Reach Strategies to Improve Quality of Care for GERD and Gastroprotection for Patients on NSAIDs: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00691171
- Acronym / sponsor ID
- NIS-GUS-DUM-2007/1
- Conditions
- GERD
- Keywords
- gastroesophageal reflux disease, GERD, nonsteroidal anti-inflammatory drugs, peptic ulcer, Diagnosed GERD, Atypical GERD symptoms, chronic NSAID therapy, Risk for ulcer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,234 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 5 Jun 2008 (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 purpose of the study is to examine the impact of augmented, high-quality physician-coordinated care executed via an electronic health record (EHR)-based intervention on quality of care for gastroesophageal reflux disease (GERD) and for gastroprotection for patients on chronic non-steroidal anti-inflammatory drugs (NSAIDs) at increased risk for upper GI tract ulcers and ulcer related complications.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –GERD: Patients with established diagnoses of GERD based on ICD-9 codes |
| 2 | – | –Atypical GERD: Patients without an established diagnosis of GERD with atypical symptoms that could be due to GERD (e.g., asthma) |
| 3 | – | –Chronic NSAID users: Patients using chronic NSAIDs who are at increased risk of GI complications (defined as previous diagnosis of peptic ulcer disease; age 75 or older; or concomitant use of corticosteroids, anticoagulants, or aspirin) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primarily primary care practices of physicians participating in the Medical Quality Improvement Consortium (MQIC)
Key inclusion criteria (2 listed)
- Eligibility as determined by criteria for participation in studies as part of the MQIC
- Agreement of participating clinical practices to undergo training in the electronic health record (EHR) intervention designed for this study
Key exclusion criteria (1 listed)
- Based on voluntary participation by MQIC practices, so practices were excluded if they decided to opt out
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnoses of GERD
Time frame: After 12 months of intervention
Prescriptions for gastroprotective medicines in at-risk, chronic NSAID users
Time frame: After 12 months of intervention
3 secondary outcomes
Prescriptions for GERD medications
Time frame: After 12 months of intervention
Change in GERD symptoms score
Time frame: After 12 months of intervention
NSAID-related GI complications
Time frame: After 12 months of intervention
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 15 Apr 2015.
- Results publication: PubMed 21242557Gill JM, Mainous AG 3rd, Koopman RJ, Player MS, Everett CJ, Chen YX, Diamond JJ, Lieberman MI. Impact of EHR-based clinical decision support on adherence to guidelines for patients on NSAIDs: a randomized controlled trial. Ann Fam Med. 2011 Jan-Feb;9(1):22-30. doi: 10.1370/afm.1172.
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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.
James M Gill, MD, PhD principal investigator
Delaware Valley Outcomes Research
Questions about this trial
What is this clinical trial studying?
An observational study of GERD, run by AstraZeneca.
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 2 inclusion and 1 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 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Diagnoses of GERD (time frame: After 12 months of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00691171, which also lists 1 linked publication.
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 15 Apr 2015.