Proton Pump Inhibitors for Acid Reflux

Overseen By Katelyn Clinical Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Less than 25% clinical FTE

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

372 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different methods for prescribing proton pump inhibitors (PPIs), a common treatment for acid reflux, to determine if altering prescription lengths can enhance prescribing habits. The goal is to ensure PPIs are prescribed according to best practices, avoiding unnecessary long-term use. The trial includes several approaches: maintaining the current method, using an automated system to suggest prescription lengths based on patient needs, and requiring doctors to actively choose the duration. This study targets UCLA Health primary care doctors who work at least 25% of the time. As an unphased trial, it offers a unique opportunity to improve prescription practices and patient care.

Do I need to stop my current medications for this trial?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that these PPI order panel variations are safe for patients?

Studies have shown that proton pump inhibitors (PPIs) are generally safe and well-tolerated, especially for short-term use. These medications commonly treat issues like acid reflux and GERD (gastroesophageal reflux disease) by reducing stomach acid.

Research indicates that short-term PPI use usually doesn't cause serious side effects. However, some studies on long-term use have noted potential risks, such as a higher chance of bone fractures, heart problems, and certain infections. These risks often appear in people who use PPIs for extended periods.

One large study found that using a specific PPI, pantoprazole, for up to three years did not lead to major side effects, except for a possible increase in some infections. This suggests that while PPIs are mostly safe, it's important to use them as directed by a doctor, especially for long-term use.

In summary, PPIs are safe for most people when used as prescribed, but it's wise to be aware of potential risks if taken over a long time. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to enhance how Proton Pump Inhibitors (PPIs) are prescribed for acid reflux and related conditions. Unlike the usual approach where physicians follow a fixed prescribing pattern, the trial is testing two new methods. The first method uses an algorithm to automatically determine whether short-term or long-term PPI use is appropriate based on a patient's condition, potentially optimizing treatment duration. The second method requires doctors to actively choose the duration based on guidelines, encouraging more personalized patient care. These strategies aim to improve treatment effectiveness and safety by tailoring prescriptions more closely to individual patient needs.

What evidence suggests that this trial's treatments could be effective for optimizing PPI prescribing workflows?

Research has shown that proton pump inhibitors (PPIs) effectively treat acid reflux and conditions like gastroesophageal reflux disease (GERD). Studies have found that PPIs relieve GERD symptoms in about 95% of cases. They reduce stomach acid, preventing heartburn and other symptoms. In this trial, participants will follow different approaches for prescribing PPIs: the Control group will adhere to the standard prescribing workflow, the Algorithmic Defaulting group will use an automated system to suggest prescription durations, and the Active Physician Choice group will require providers to actively select prescription durations. PPIs are the main recommended treatment for GERD, and many patients experience significant relief. However, some may not feel completely better, and symptoms can return if they stop taking PPIs. Overall, PPIs are a proven and effective way to manage acid reflux. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for healthcare providers at UCLA Health who prescribe proton pump inhibitors (PPIs) for conditions like acid reflux. The study aims to optimize PPI prescribing practices within the Electronic Health Record system.

Inclusion Criteria

UCLA Health primary care physicians who have a clinical full-time equivalency of at least 25%

Exclusion Criteria

Physicians with a clinical full-time equivalency of less than 25%

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Evaluation of new variations of PPI order panels within the EHR system to optimize prescribing workflows

12 months

Follow-up

Participants are monitored for safety and effectiveness after intervention, focusing on prescription discontinuations and GI bleeding hospitalizations

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Proton Pump Inhibitors

Trial Overview The study tests new variations of PPI order panels in the EHR, specifically changing default prescription lengths from a standard of 90 days with three refills to shorter periods that align with clinical guidelines.

How Is the Trial Designed?

Group I: Algorithmic Defaulting (Indication-Based Default) Experimental Treatment 1 Intervention

The Electronic Health Record (EHR) automatically evaluates whether the patient at hand meets guideline criteria for long-term vs. short-term Proton Pump Inhibitors (PPI) use and it selects a default PPI prescription duration. (Providers can override the defaulted duration if they disagree with the automated assessment.) The order panel displays each PPI option below one of the following duration choices: For short-term PPI, this includes patients with conditions like Gastroesophageal reflux disease (GERD). For long-term PPI, this includes patients with conditions requiring extended therapy (e.g. Barrett's esophagus, chronic NSAID use)

Group II: Active Physician Choice Experimental Treatment 1 Intervention

•The order panel displays each PPI option below one of the following duration choices: For short-term PPI, this includes patients with conditions like GERD. For long-term PPI, this includes patients with conditions requiring extended therapy (e.g. Barrett's esophagus, chronic NSAID use). The order panel removes the default selection, thus requiring providers to actively select a prescription duration for each patient, given the guideline education presented in the panel.

Group III: Control Active Control 1 Intervention

•Physicians use an unchanged prescribing workflow for Proton Pump Inhibitors (PPI) medications, with no changes to default dosage or duration.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10112961/

Current management of gastro-oesophageal reflux disease ... PPIs are very effective (95%), but only when proton pumps are actively secreting acid. PPIs have a short plasma half-life (90 min) but a ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2590257124000257

GERD: Latest update on acid-suppressant drugs Although proton pump inhibitors are very effective at treating GERD and relieving its symptoms (Klok et al., 2003), advancements have yet to stop after the FDA ...

3. nature.com nature.com/articles/s43856-024-00632-6

Improving treatment of people with gastro-esophageal ... Proton pump inhibitors (PPIs) are the main treatment recommended and used for gastro-esophageal reflux disease (GERD). However, they fail to control symptoms.

4. gastrojournal.org gastrojournal.org/article/S0016-5085(21)04083-X/fulltext

AGA Clinical Practice Update on De-Prescribing of Proton ... The purpose of this clinical update was to provide Best Practice Advice (BPA) statements about how to approach PPI de-prescribing in ambulatory patients.

5. gutnliver.org gutnliver.org/journal/view.html?doi=10.5009/gnl15502

25 Years of Proton Pump Inhibitors: A Comprehensive ... Pooled data from 384 randomized controlled trials (RCTs) which included a total of 44,870 patients concluded that omeprazole was significantly more effective (p ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11474548/

Potential Risks Associated With Long-term Use of Proton ... Studies have reported diverse side effects of PPIs, such as increased fracture risk, cardiovascular concerns, enteric infections, neurological diseases,

7. dig.pharmacy.uic.edu dig.pharmacy.uic.edu/faqs/2023-2/june-2023-faqs/what-is-the-update-on-long-term-safety-evidence-with-proton-pump-inhibitor-use/

What is the update on long-term safety evidence with proton ... Although long-term PPI use carries more inherent benefits than risks, the possibility of adverse events identified in observational studies cannot be ...

8. gastrojournal.org gastrojournal.org/article/S0016-5085%2819%2940974-8/fulltext

Safety of Proton Pump Inhibitors Based on a Large, Multi ... Proton pump inhibitors (PPIs) are effective at treating acid-related disorders. These drugs are well tolerated in the short term, but long-term treatment ...

9. gastro.org gastro.org/press-releases/large-placebo-controlled-trial-confirms-safety-of-proton-pump-inhibitors-ppis/

Large placebo-controlled trial confirms safety of proton ... The results show that pantoprazole is not associated with any adverse event when used for 3 years, with the possible exception of an increased ...