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Stanford Pragmatic Effectiveness Comparison
Recruiting
I'm InterestedTrial ID: NCT04441034
Purpose
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 generated from this clinical trial to
build, validate and test a model to predict what clinical characteristics can predict
response to either of these classes of medications.
The proposed study is the first step to use flexible point-of-care randomization to compare
effectiveness of different treatments in different subgroups of patients whenever equipoise
exists. The prediction model will guide decision making process of clinicians choosing
between these medications based on clinical characteristics of individual patients.
Official Title
Integrating Pragmatic Comparative Effectiveness Research Into a Tertiary Pain Management Center
Stanford Investigator(s)
Vafi Salmasi
Assistant Professor of Anesthesiology, Perioperative and Pain Medicine (Adult Pain)
Eligibility
Inclusion Criteria:
- Age of 18 years old or above
- Persistent pain for more than 3 months
- Candidate for treatment by anti-convulsants or anti-depressants based on treating pain
provider
- Equipoise between anti-convulsants and anti-depressants according to the treating pain
provider
Exclusion Criteria:
- Contraindication to taking anti-convulsants or anti-depressants: this exclusion is
based on the judgement of the treating pain provider; e.g. if the patient is on a
large dose of serotonin specific reuptake inhibitor (SSRI) anti-depressant, it will
stop the physician from considering any other anti-depressants; thus, excluding the
patient
- Patient refusal
Intervention(s):
drug: Anti-convulsant medications
drug: Anti-depressant medications
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Vafi Salmasi, MD
6507250246