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NCT04441034 · ClinicalTrials.gov registry record · Phase 4
Stanford Pragmatic Effectiveness Comparison
A Phase 4 study of Chronic Pain, sponsored by Stanford University.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 450
- Enrollment target
- 1
- Study location
NCT04441034 is a Phase 4 study of Chronic Pain that is actively recruiting participants, run by Stanford University. The registered enrollment target is 450 participants, below the 771-participant average among 301 other Chronic Pain trials with a reported enrollment target (42% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04441034, a Phase 4 study of Chronic Pain, is actively recruiting participants, sponsored by Stanford University.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 450 participants
- Enrollment target
- 1
- Study location
Study Summary
Chronic pain is a major healthcare problem with an annual cost of above $600 billion. The quality of data available for treatments of chronic pain is not optimal. Generalizability of explanatory randomized controlled trial data is problematic as these trials exclude up to 90% of patients: leaving out real-world patients with serious medical and psychological comorbidities. Pragmatic trials embedded in patient care compare effectiveness of currently used treatments in real-world application leading to findings that generalize to broader range of patients. The changes in clinical practice and workflow necessary to integrate this type of research within patient care present pragmatic challenges. In this research, the overall objective is to overcome these challenges using an open-source learning health care system - CHOIR. CHOIR is currently used to track patients' clinical trajectory and treatment response across multiple academic sites resulting in over 25 publications characterizing chronic pain. Through the pilot studies, the investigators have already developed a point-of-care randomization for CHOIR that facilitates integration of research and patient care by allowing the physicians to randomize patients during clinic visits. The investigators have already demonstrated feasibility of the randomization and data collection platform in two ongoing pilot pragmatic clinical trials. The investigators are proposing to better integrate pragmatic research within clinical practice through conducting a randomized comparative effectiveness trial in 450 patients with chronic pain comparing effectiveness of anti-convulsants and anti-depressants (two most commonly used classes of medications for treatment of chronic pain). The investigators will also perform a qualitative interview with all physicians in our clinic to study the impact of integrating pragmatic research into clinical care. The investigators will use the data available in CHOIR as well as the real-world data gen
Conditions Studied
Interventions
- DRUG Anti-convulsant medications
- DRUG Anti-depressant medications
Study Locations (1)
California
- Stanford Pain Management Center - Redwood City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2022-04-12 |
| Est. Completion | 2026-04-30 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04441034
The ClinicalTrials.gov registry entry for NCT04441034 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 771-participant average among 301 other Chronic Pain trials with a reported enrollment target (42% lower). The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Chronic Pain appearing as the primary indexed condition, and to 2 interventions - of which Anti-convulsant medications is the first listed.
NCT04441034 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT04441034 about?
NCT04441034 is a clinical study titled "Stanford Pragmatic Effectiveness Comparison". Chronic pain is a major healthcare problem with an annual cost of above $600 billion. The quality of data available for treatments of chronic pain is not optimal. Generalizability of explanatory randomized controlled trial data is problematic as these trials exclude up to 90% of patients: leaving ou...
What is the current status of trial NCT04441034?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 450 participants. The study started on 2022-04-12. Estimated completion is 2026-04-30.
What conditions does trial NCT04441034 study?
This clinical trial studies the following conditions: Chronic Pain.
What interventions are being tested in trial NCT04441034?
The interventions under investigation include: Anti-convulsant medications (DRUG), Anti-depressant medications (DRUG).
Who is sponsoring clinical trial NCT04441034?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04441034 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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