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 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.

This study aims to increase generalizability of clinical data for current treatments of chronic pain by integrating pragmatic comparative effectiveness research within patient care. Chronic pain is a major healthcare problem with 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. Thus, national institutions and societies (including National Institute of Health) have called for pragmatic trials embedded in patient care to compare effectiveness of currently used treatments leading to findings that generalize to broader range of patients. The long-term goal is to integrate pragmatic research within clinical pain practice; the investigators will then collect high-quality longitudinal data in the form of randomized comparative effectiveness research. This research will be a platform for development of precision health in the field of pain medicine. Personalized treatment options for each patient will not be possible without understanding how effective these treatments are in real-world application. 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 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. To move this forward, the investigators are proposing to integrate pragmatic research within clinical practice through conducting a randomized comparative effectiveness trial in 450 patients with chronic pain pursuing the following aims: Aim 1: To compare effectiveness of anti-convulsants and anti-depressants in patients with chronic pain using point-of-care randomization. Anti-convulsants and anti-depressants are two most-commonly used classes of medications for treating chronic pain. Clinicians usually choose between them based on clinical judgement; these decisions often lack clinical evidence. The investigators need to understand how effective these medications are in real-world applications, and which patients respond better to each class of medication. The investigators will thus randomize the patients in our clinic to either anti-convulsants or anti-depress trial.show_full_description

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