<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04441034</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-57237</org_study_id>
    <nct_id>NCT04441034</nct_id>
  </id_info>
  <brief_title>Stanford Pragmatic Effectiveness Comparison</brief_title>
  <acronym>SPEC-AA</acronym>
  <official_title>Integrating Pragmatic Comparative Effectiveness Research Into a Tertiary Pain Management Center</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic pain is a major healthcare problem with an annual cost of above $600 billion. The&#xD;
      quality of data available for treatments of chronic pain is not optimal. Generalizability of&#xD;
      explanatory randomized controlled trial data is problematic as these trials exclude up to 90%&#xD;
      of patients: leaving out real-world patients with serious medical and psychological&#xD;
      comorbidities. Pragmatic trials embedded in patient care compare effectiveness of currently&#xD;
      used treatments in real-world application leading to findings that generalize to broader&#xD;
      range of patients.&#xD;
&#xD;
      The changes in clinical practice and workflow necessary to integrate this type of research&#xD;
      within patient care present pragmatic challenges. In this research, the overall objective is&#xD;
      to overcome these challenges using an open-source learning health care system - CHOIR. CHOIR&#xD;
      is currently used to track patients' clinical trajectory and treatment response across&#xD;
      multiple academic sites resulting in over 25 publications characterizing chronic pain.&#xD;
      Through the pilot studies, the investigators have already developed a point-of-care&#xD;
      randomization for CHOIR that facilitates integration of research and patient care by allowing&#xD;
      the physicians to randomize patients during clinic visits. The investigators have already&#xD;
      demonstrated feasibility of the randomization and data collection platform in two ongoing&#xD;
      pilot pragmatic clinical trials.&#xD;
&#xD;
      The investigators are proposing to better integrate pragmatic research within clinical&#xD;
      practice through conducting a randomized comparative effectiveness trial in 450 patients with&#xD;
      chronic pain comparing effectiveness of anti-convulsants and anti-depressants (two most&#xD;
      commonly used classes of medications for treatment of chronic pain). The investigators will&#xD;
      also perform a qualitative interview with all physicians in our clinic to study the impact of&#xD;
      integrating pragmatic research into clinical care. The investigators will use the data&#xD;
      available in CHOIR as well as the real-world data generated from this clinical trial to&#xD;
      build, validate and test a model to predict what clinical characteristics can predict&#xD;
      response to either of these classes of medications.&#xD;
&#xD;
      The proposed study is the first step to use flexible point-of-care randomization to compare&#xD;
      effectiveness of different treatments in different subgroups of patients whenever equipoise&#xD;
      exists. The prediction model will guide decision making process of clinicians choosing&#xD;
      between these medications based on clinical characteristics of individual patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to increase generalizability of clinical data for current treatments of&#xD;
      chronic pain by integrating pragmatic comparative effectiveness research within patient care.&#xD;
&#xD;
      Chronic pain is a major healthcare problem with annual cost of above $600 billion. The&#xD;
      quality of data available for treatments of chronic pain is not optimal. Generalizability of&#xD;
      explanatory randomized controlled trial data is problematic as these trials exclude up to 90%&#xD;
      of patients: leaving out real-world patients with serious medical and psychological&#xD;
      comorbidities. Thus, national institutions and societies (including National Institute of&#xD;
      Health) have called for pragmatic trials embedded in patient care to compare effectiveness of&#xD;
      currently used treatments leading to findings that generalize to broader range of patients.&#xD;
&#xD;
      The long-term goal is to integrate pragmatic research within clinical pain practice; the&#xD;
      investigators will then collect high-quality longitudinal data in the form of randomized&#xD;
      comparative effectiveness research. This research will be a platform for development of&#xD;
      precision health in the field of pain medicine. Personalized treatment options for each&#xD;
      patient will not be possible without understanding how effective these treatments are in&#xD;
      real-world application. The changes in clinical practice and workflow necessary to integrate&#xD;
      this type of research within patient care present pragmatic challenges. In this research, the&#xD;
      overall objective is to overcome these challenges using an open-source learning health care&#xD;
      system - CHOIR. CHOIR is currently used to track patients' clinical trajectory and treatment&#xD;
      response across multiple academic sites resulting in over 25 publications characterizing&#xD;
      chronic pain. Through pilot studies, the investigators have already developed a point-of-care&#xD;
      randomization for CHOIR that facilitates integration of research and patient care by allowing&#xD;
      the physicians to randomize patients during clinic visits. The investigators have already&#xD;
      demonstrated feasibility of the randomization and data collection platform in two ongoing&#xD;
      pilot pragmatic clinical trials. To move this forward, the investigators are proposing to&#xD;
      integrate pragmatic research within clinical practice through conducting a randomized&#xD;
      comparative effectiveness trial in 450 patients with chronic pain pursuing the following&#xD;
      aims:&#xD;
&#xD;
      Aim 1: To compare effectiveness of anti-convulsants and anti-depressants in patients with&#xD;
      chronic pain using point-of-care randomization. Anti-convulsants and anti-depressants are two&#xD;
      most-commonly used classes of medications for treating chronic pain. Clinicians usually&#xD;
      choose between them based on clinical judgement; these decisions often lack clinical&#xD;
      evidence. The investigators need to understand how effective these medications are in&#xD;
      real-world applications, and which patients respond better to each class of medication. The&#xD;
      investigators will thus randomize the patients in our clinic to either anti-convulsants or&#xD;
      anti-depressants.&#xD;
&#xD;
      Randomization: The participants are going to be randomized by the treating pain provider&#xD;
      using point-of-care randomization during the clinic visit. Point-of-care randomization will&#xD;
      be done through CHOIR using computer generated random numbers. The randomization algorithm&#xD;
      will disregard the patients who are randomized but decline to participate in the study to&#xD;
      maintain a balanced number of patients in each arm.&#xD;
&#xD;
      Intervention: The participants will be randomized to receiving either classes of medications.&#xD;
      Then using a patient centered approach, the participant and their treating pain provider will&#xD;
      choose one medication within the class the patient are randomized to. The decision will be&#xD;
      based on participants' comorbidities, goals of care, preferences and best interest. For&#xD;
      example, if a participant is randomized to receive an anti-convulsant and wants to avoid any&#xD;
      weight gain, topiramate would be an appropriate choice; or if a participant is randomized to&#xD;
      receive an anti-depressant and has poor sleep, a tricyclic anti-depressant would be an&#xD;
      appropriate choice.&#xD;
&#xD;
      Participants will continue the medications for at least 6 months provided that they can&#xD;
      tolerate the side effects, consider the treatment effective, and are willing to continue the&#xD;
      treatment. Titration of doses based on participants' tolerance and response is allowed based&#xD;
      on clinical decision of the treating pain provider. Concomitant use of other analgesics or&#xD;
      pain medications as well as pain interventions is also allowed. The investigators allow the&#xD;
      participants to stop medications in consultation with their primary pain provider if they&#xD;
      cannot tolerate side effects or experience no benefit. In these circumstances, we encourage&#xD;
      the patients and their physicians to choose another medication within the class of&#xD;
      randomization; however, the investigators will not limit the choices of participants.&#xD;
&#xD;
      Data collection: The participants will receive electronic surveys similar to their routine&#xD;
      clinical care. The investigators will send out the surveys at one, three, and six months&#xD;
      after randomization. These surveys are going to be abbreviated to include average and worst&#xD;
      Numerical Rating Scale (11-point NRS) of pain; pain catastrophizing scale; National Institute&#xD;
      of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) measures&#xD;
      for pain interference, depression, anxiety, and sleep disturbance; and questions about&#xD;
      medication compliance, dose and adverse events.24-30 Data about use of other analgesics and&#xD;
      medications, and pain interventions will also be recorded at these intervals from&#xD;
      participants' electronic health records. If the participants do not complete the surveys&#xD;
      within five days of receipt of the survey link, they will be contacted to be reminded of the&#xD;
      survey. The investigators will also record participants' baseline characteristics including&#xD;
      age, sex, main pain diagnosis, other pain diagnoses, psychological comorbidities, medical&#xD;
      comorbidities, medication use, and education.&#xD;
&#xD;
      Observation Arm: The patients who do not enter the randomization arms (patient refusal or&#xD;
      contraindication to receive one class of medications) will be included in an observation arm&#xD;
      after obtaining informed consent. The investigators will collect data from these patients&#xD;
      identical to what explained above for randomized patients.&#xD;
&#xD;
      Aim 2: To characterize the level of satisfaction of physicians with pragmatic comparative&#xD;
      effectiveness trials. The investigators will perform a qualitative interview with all&#xD;
      physicians in our clinic before recruitment phase and then every six months until the end of&#xD;
      recruitment phase. Hypothesis. Integrating pragmatic randomized comparative effectiveness&#xD;
      research will not affect the satisfaction of physicians in our clinic with the flow of&#xD;
      clinical care.&#xD;
&#xD;
      Aim 3: To characterize factors impacting responsiveness to anti-convulsants and&#xD;
      anti-depressants in treating chronic pain. The investigators will use reduction in patients'&#xD;
      reported pain as response to a treatment. The investigators will use multivariate logistic&#xD;
      regression and machine learning algorithms to identify predictive factors for response to&#xD;
      these two treatment arms. The investigators predict that lower socioeconomic status; longer&#xD;
      duration of pain; widespread pain; and worse scores in pain catastrophizing, physical&#xD;
      function, pain interference, depression, anxiety, and social function will predict lower&#xD;
      responses to anti-convulsants and anti-depressants.&#xD;
&#xD;
      Summary: Successful completion of these aims will advance the ability to: (1) use flexible&#xD;
      point-of-care randomization to compare the effectiveness of different treatments in different&#xD;
      subgroups of patients whenever equipoise exists; (2) apply the identified predictive factors&#xD;
      to develop decision support systems to determine best choice of medication for individual&#xD;
      patients; inching closer to precision health; and (3) use the feedback from our physicians to&#xD;
      better integrate research and clinical care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 12, 2022</start_date>
  <completion_date type="Anticipated">June 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2025</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Two-arm parallel randomized clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Pain Intensity</measure>
    <time_frame>6 months</time_frame>
    <description>Change in pain intensity on numerical rating scale (0-10; worse is higher) of pain at 6 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Pain Interference</measure>
    <time_frame>6 months</time_frame>
    <description>Change in NIH Patient Reported Outcomes Measure Information System (PROMIS) Pain Interference Measure (standardized t-score; higher is worse) in 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Depression</measure>
    <time_frame>6 months</time_frame>
    <description>Change in NIH Patient Reported Outcomes Measure Information System (PROMIS) Depression Measure (standardized t-score; higher is worse) in 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Anxiety</measure>
    <time_frame>6 months</time_frame>
    <description>Change in NIH Patient Reported Outcomes Measure Information System (PROMIS) Anxiety Measure (standardized t-score; higher is worse) in 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sleep Disturbance</measure>
    <time_frame>6 months</time_frame>
    <description>Change in NIH Patient Reported Outcomes Measure Information System (PROMIS) Sleep Disturbance Measure (standardized t-score; higher is worse) in 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pain Catastrophizing</measure>
    <time_frame>6 months</time_frame>
    <description>Change in Pain Catastrophizing Scale (0-52; higher is worse) in 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication Compliance</measure>
    <time_frame>6 months</time_frame>
    <description>Measuring how long (from date of randomization to date stopping the medication) the participants continue study medication class</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">450</enrollment>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>Anti-convulsant medication</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants will be randomized to receiving an anti-convulsant medication. Then using a patient centered approach, the participant and their treating pain provider will choose one medication within the class. Participants will continue the medications for at least 6 months provided that they can tolerate the side effects, consider the treatment effective, and are willing to continue the treatment. We are studying two classes of medications and specific names of medications do not apply.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Anti-depressant medication</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants will be randomized to receiving an anti-depressant medication. Then using a patient centered approach, the participant and their treating pain provider will choose one medication within the class. Participants will continue the medications for at least 6 months provided that they can tolerate the side effects, consider the treatment effective, and are willing to continue the treatment. We are studying two classes of medications and specific names of medications do not apply.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anti-convulsant medications</intervention_name>
    <description>Anti-convulsants are very commonly used to treat patients with chronic pain.</description>
    <arm_group_label>Anti-convulsant medication</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anti-depressant medications</intervention_name>
    <description>Anti-depressants are very commonly used to treat patients with chronic pain.</description>
    <arm_group_label>Anti-depressant medication</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age of 18 years old or above&#xD;
&#xD;
          -  Persistent pain for more than 3 months&#xD;
&#xD;
          -  Candidate for treatment by anti-convulsants or anti-depressants based on treating pain&#xD;
             provider&#xD;
&#xD;
          -  Equipoise between anti-convulsants and anti-depressants according to the treating pain&#xD;
             provider&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication to taking anti-convulsants or anti-depressants: this exclusion is&#xD;
             based on the judgement of the treating pain provider; e.g. if the patient is on a&#xD;
             large dose of serotonin specific reuptake inhibitor (SSRI) anti-depressant, it will&#xD;
             stop the physician from considering any other anti-depressants; thus, excluding the&#xD;
             patient&#xD;
&#xD;
          -  Patient refusal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Vafi Salmasi, MD</last_name>
    <phone>6507250246</phone>
    <email>vsalmasi@stanford.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Corinne E Jung, PhD</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Stanford Pain Management Center</name>
      <address>
        <city>Redwood City</city>
        <state>California</state>
        <zip>94063</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vafi Salmasi, MD.</last_name>
      <phone>650-725-0246</phone>
      <email>vsalmasi@stanford.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>April 26, 2023</last_update_submitted>
  <last_update_submitted_qc>April 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Vafi Salmasi</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anticonvulsants</mesh_term>
    <mesh_term>Convulsants</mesh_term>
    <mesh_term>Antidepressive Agents</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04441034
org study id: IRB-57237
nct id: NCT04441034
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
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-depressants.

      Randomization: The participants are going to be randomized by the treating pain provider
      using point-of-care randomization during the clinic visit. Point-of-care randomization will
      be done through CHOIR using computer generated random numbers. The randomization algorithm
      will disregard the patients who are randomized but decline to participate in the study to
      maintain a balanced number of patients in each arm.

      Intervention: The participants will be randomized to receiving either classes of medications.
      Then using a patient centered approach, the participant and their treating pain provider will
      choose one medication within the class the patient are randomized to. The decision will be
      based on participants' comorbidities, goals of care, preferences and best interest. For
      example, if a participant is randomized to receive an anti-convulsant and wants to avoid any
      weight gain, topiramate would be an appropriate choice; or if a participant is randomized to
      receive an anti-depressant and has poor sleep, a tricyclic anti-depressant would be an
      appropriate choice.

      Participants will continue the medications for at least 6 months provided that they can
      tolerate the side effects, consider the treatment effective, and are willing to continue the
      treatment. Titration of doses based on participants' tolerance and response is allowed based
      on clinical decision of the treating pain provider. Concomitant use of other analgesics or
      pain medications as well as pain interventions is also allowed. The investigators allow the
      participants to stop medications in consultation with their primary pain provider if they
      cannot tolerate side effects or experience no benefit. In these circumstances, we encourage
      the patients and their physicians to choose another medication within the class of
      randomization; however, the investigators will not limit the choices of participants.

      Data collection: The participants will receive electronic surveys similar to their routine
      clinical care. The investigators will send out the surveys at one, three, and six months
      after randomization. These surveys are going to be abbreviated to include average and worst
      Numerical Rating Scale (11-point NRS) of pain; pain catastrophizing scale; National Institute
      of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) measures
      for pain interference, depression, anxiety, and sleep disturbance; and questions about
      medication compliance, dose and adverse events.24-30 Data about use of other analgesics and
      medications, and pain interventions will also be recorded at these intervals from
      participants' electronic health records. If the participants do not complete the surveys
      within five days of receipt of the survey link, they will be contacted to be reminded of the
      survey. The investigators will also record participants' baseline characteristics including
      age, sex, main pain diagnosis, other pain diagnoses, psychological comorbidities, medical
      comorbidities, medication use, and education.

      Observation Arm: The patients who do not enter the randomization arms (patient refusal or
      contraindication to receive one class of medications) will be included in an observation arm
      after obtaining informed consent. The investigators will collect data from these patients
      identical to what explained above for randomized patients.

      Aim 2: To characterize the level of satisfaction of physicians with pragmatic comparative
      effectiveness trials. The investigators will perform a qualitative interview with all
      physicians in our clinic before recruitment phase and then every six months until the end of
      recruitment phase. Hypothesis. Integrating pragmatic randomized comparative effectiveness
      research will not affect the satisfaction of physicians in our clinic with the flow of
      clinical care.

      Aim 3: To characterize factors impacting responsiveness to anti-convulsants and
      anti-depressants in treating chronic pain. The investigators will use reduction in patients'
      reported pain as response to a treatment. The investigators will use multivariate logistic
      regression and machine learning algorithms to identify predictive factors for response to
      these two treatment arms. The investigators predict that lower socioeconomic status; longer
      duration of pain; widespread pain; and worse scores in pain catastrophizing, physical
      function, pain interference, depression, anxiety, and social function will predict lower
      responses to anti-convulsants and anti-depressants.

      Summary: Successful completion of these aims will advance the ability to: (1) use flexible
      point-of-care randomization to compare the effectiveness of different treatments in different
      subgroups of patients whenever equipoise exists; (2) apply the identified predictive factors
      to develop decision support systems to determine best choice of medication for individual
      patients; inching closer to precision health; and (3) use the feedback from our physicians to
      better integrate research and clinical care.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Two-arm parallel randomized clinical trial
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Pain Intensity
time frame: 6 months
description: Change in pain intensity on numerical rating scale (0-10; worse is higher) of pain at 6 months
measure: Change in Pain Interference
time frame: 6 months
description: Change in NIH Patient Reported Outcomes Measure Information System (PROMIS) Pain Interference Measure (standardized t-score; higher is worse) in 6 months
measure: Change in Depression
time frame: 6 months
description: Change in NIH Patient Reported Outcomes Measure Information System (PROMIS) Depression Measure (standardized t-score; higher is worse) in 6 months
measure: Change in Anxiety
time frame: 6 months
description: Change in NIH Patient Reported Outcomes Measure Information System (PROMIS) Anxiety Measure (standardized t-score; higher is worse) in 6 months
measure: Change in Sleep Disturbance
time frame: 6 months
description: Change in NIH Patient Reported Outcomes Measure Information System (PROMIS) Sleep Disturbance Measure (standardized t-score; higher is worse) in 6 months
measure: Change in Pain Catastrophizing
time frame: 6 months
description: Change in Pain Catastrophizing Scale (0-52; higher is worse) in 6 months
measure: Medication Compliance
time frame: 6 months
description: Measuring how long (from date of randomization to date stopping the medication) the participants continue study medication class
arm group label: Anti-convulsant medication
arm group type: Experimental
description: The participants will be randomized to receiving an anti-convulsant medication. Then using a patient centered approach, the participant and their treating pain provider will choose one medication within the class. Participants will continue the medications for at least 6 months provided that they can tolerate the side effects, consider the treatment effective, and are willing to continue the treatment. We are studying two classes of medications and specific names of medications do not apply.
arm group label: Anti-depressant medication
arm group type: Experimental
description: The participants will be randomized to receiving an anti-depressant medication. Then using a patient centered approach, the participant and their treating pain provider will choose one medication within the class. Participants will continue the medications for at least 6 months provided that they can tolerate the side effects, consider the treatment effective, and are willing to continue the treatment. We are studying two classes of medications and specific names of medications do not apply.
intervention type: Drug
intervention name: Anti-convulsant medications
description: Anti-convulsants are very commonly used to treat patients with chronic pain.
arm group label: Anti-convulsant medication
intervention type: Drug
intervention name: Anti-depressant medications
description: Anti-depressants are very commonly used to treat patients with chronic pain.
arm group label: Anti-depressant medication
criteria: 
gender: All
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vafi Salmasi, MD
phone: 6507250246
email: vsalmasi@stanford.edu
last name: Corinne E Jung, PhD
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Vafi Salmasi
investigator title: Assistant Professor
mesh term: Chronic Pain
mesh term: Anticonvulsants
mesh term: Convulsants
mesh term: Antidepressive Agents
sharing ipd: No