<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/NCT03764839</url>
  </required_header>
  <id_info>
    <org_study_id>42569</org_study_id>
    <nct_id>NCT03764839</nct_id>
  </id_info>
  <brief_title>Digital Behavioral Pain Medicine for Orthopedic Trauma Surgery Patients</brief_title>
  <official_title>&quot;My Surgical Success&quot;: A Randomized Controlled Trial of a Perioperative Digital Behavioral Pain Medicine Treatment Tested in Orthopedic Trauma Patients</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>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this study is to determine the feasibility and preliminary efficacy of&#xD;
      a perioperative digital behavioral pain medicine intervention delivered to orthopedic trauma&#xD;
      surgery patients (compared to an active control group that receives digital health&#xD;
      education).&#xD;
&#xD;
      Aim 1: Determine feasibility of and satisfaction, and perceived utility of &quot;My Surgical&#xD;
      Success&quot;&#xD;
&#xD;
      Hypothesis 1: For My Surgical Success, the investigators anticipate 50% engagement in the&#xD;
      study (feasibility). Of those who complete My Surgical Success, the investigators expect 80%&#xD;
      satisfaction ratings, and 80% perceived utility of the information learned.&#xD;
&#xD;
      Aim 2: Determine group differences in time to post-surgical pain and opioid cessation.&#xD;
&#xD;
      Hypothesis 2: &quot;My Surgical Success&quot; participants will evidence quicker time to post-surgical&#xD;
      pain and opioid cessation compared to the HE Control Group.&#xD;
&#xD;
      Aim 3: Determine group differences in within-subject pain catastrophizing scores (baseline to&#xD;
      post-surgery).&#xD;
&#xD;
      Hypothesis 3: &quot;My Surgical Success&quot; participants evidence greater reduction in pain&#xD;
      catastrophizing (measured with the Pain Catastrophizing Scale; PCS) compared to the HE&#xD;
      Control group.&#xD;
&#xD;
      Aim 4: Determine group differences in post-surgical psychological correlates (PROMIS&#xD;
      Depression, Anxiety, Function, Pain Interference, Sleep Disturbance, Social Isolation,&#xD;
      Fatigue, and Pain Intensity).&#xD;
&#xD;
      Hypothesis 4: &quot;My Surgical Success&quot; participants will evidence greater post-surgical function&#xD;
      and lower pain related interference compared to the HE Control Group.&#xD;
&#xD;
      The goal of this research is to advance our understanding regarding the feasibility and&#xD;
      effectiveness of &quot;My Surgical Success&quot; (a digital, perioperative behavioral pain medicine&#xD;
      treatment) and its impact on post-surgical outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients are identified by their orthopedic surgeon or study personnel immediately prior to&#xD;
      surgery or during their stay on the inpatient post-surgical recovery unit. Beyond&#xD;
      recruitment, the entire study is conducted remotely with no in-person contact with study&#xD;
      staff. After enrollment, study staff follow-up with patients by phone, text or email&#xD;
      (depending on patient preference); informed consent is obtained online.&#xD;
&#xD;
      All participants are asked to provide baseline demographic information, as well as&#xD;
      self-reported measures assessing mood, pain, cognitive and emotional responses to pain,&#xD;
      catastrophizing, and medications. All measures are administered via a secure, HIPAA&#xD;
      compliant, online system (REDCap).&#xD;
&#xD;
      Participants are then randomized to receive one of two digital treatments: a behavioral pain&#xD;
      medicine intervention (&quot;My Surgical Success&quot;) or to a health education (HE Control).&#xD;
      Participants who have been randomized to the HE control group receive online text information&#xD;
      about health and nutrition, and are oriented that the information is relevant for improving&#xD;
      recovery from surgery. The digital behavioral pain medicine intervention emphasizes treatment&#xD;
      content that targets cognitive and emotional regulation in the context of pain. &quot;My Surgical&#xD;
      Success&quot; includes three brief psychoeducational video learning modules, a downloadable app&#xD;
      with an audio file, and a downloadable PDF Personalized Plan for Success. After participants&#xD;
      in the &quot;My Surgical Success&quot; group view the online treatment videos, they complete questions&#xD;
      regarding their satisfaction with the video content, perceived usefulness of information, and&#xD;
      likelihood to use the skills learned. All participants are tracked twice per week&#xD;
      post-surgically to assess pain and opioid use. Data are captured for the duration of the&#xD;
      study (12 weeks) or until patients reach opioid cessation (four consecutive surveys&#xD;
      indicating zero opioid use). Psychosocial data are collected post-surgically at weeks 4, 8,&#xD;
      and 12.&#xD;
&#xD;
      Post-treatment questions:&#xD;
&#xD;
      Participants in the &quot;My Surgical Success&quot; group are asked to rate questions about the about&#xD;
      the video content in regards to its understandability, relevance, usefulness, their overall&#xD;
      satisfaction, how likely they are to use the information learned.&#xD;
&#xD;
      Following surgery, all participants fill out online brief pain check-ins (2 times per week)&#xD;
      to assess pain and medication use. Daily measures continue until the participant reports 4&#xD;
      consecutive reports of zero opiate use. Until reaching this endpoint, pain check-ins are&#xD;
      collected for 12 weeks (the duration of the study).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 5, 2018</start_date>
  <completion_date type="Actual">April 5, 2020</completion_date>
  <primary_completion_date type="Actual">February 5, 2020</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Participant ratings (0-6) for acceptability, satisfaction, usefulness of the information presented, ease of understanding, and likelihood to use skills learning (for the My Surgical Success group only)</measure>
    <time_frame>Immediately post-treatment</time_frame>
    <description>Participants complete a single time point rating for 5 items listed above. Ratings occur on a 0-6 point scale (e.g., 0=completely useless and 6=Very useful). Percentages will be reported for each item. A higher score indicates better acceptability, satisfaction, usefulness of the information.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Group difference in time to pain and opioid cessation</measure>
    <time_frame>This is a survival curve with time being a variable of interest. The examination will occur within the 3-month window after surgery.</time_frame>
    <description>This will be measured in days until patients achieve opioid cessation. Fewer days indicate better treatment effects</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Group difference in within-subject Pain Catastrophizing Scale (PCS)</measure>
    <time_frame>Baseline to 1 month</time_frame>
    <description>PCS measures pain catastrophizing</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Group differences in post-surgical Patient Reported Outcomes Measurement Information System (PROMIS) function and PROMIS average pain intensity</measure>
    <time_frame>Post-surgical month 1</time_frame>
    <description>PROMIS function measures patients' level of physical functioning, and PROMIS pain intensity measures patients' average level of pain intensity. PROMIS scores for function and pain interference will be reported at month 1. The investigators will conduct within subject analyses and will report pre-post treatment changes. Also, the investigators will aggregate scores by group and conduct between group analyses to report differences between group means and SD. Higher value on PROMIS function indicates better levels of physical functioning and higher levels of PROMIS pain intensity indicate worse pain levels.</description>
  </other_outcome>
  <other_outcome>
    <measure>Characterize responders to &quot;My Surgical Success&quot; (demographics and psychological correlates)</measure>
    <time_frame>Baseline</time_frame>
    <description>The investigators with report the baseline demographic and psychosocial scores for patients who report high satisfaction with the &quot;My Surgical Success&quot; treatment.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">141</enrollment>
  <condition>Orthopedic Trauma Surgery Patients</condition>
  <arm_group>
    <arm_group_label>Active Control Group (Digital Health Education)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Demographics survey&#xD;
Baseline surveys&#xD;
Participants receive a digital information sheet on nutrition and exercise that are relevant for people recovering from surgery. Participants are encouraged to incorporate healthy lifestyle choices into their daily routines as they recover from surgery&#xD;
Post-surgery:&#xD;
Pain check-ins (2 times per week) (detailed above)&#xD;
Patients receive 30 second booster videos at 7, 14, and 21 days after surgery&#xD;
Follow-up surveys (4, 8, and 12 weeks after surgery)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>&quot;My Surgical Success&quot; Treatment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Demographics survey&#xD;
Baseline surveys&#xD;
Intervention:&#xD;
45-minute digital behavioral pain medicine intervention &quot;My Surgical Success&quot; that emphasized cognitive and emotional regulation of pain and downregulation of physiologic arousal.&#xD;
downloadable app with an audio file&#xD;
personalized plan that allows learners to incorporate the treatment information&#xD;
Post-video survey (detailed above)&#xD;
Post-surgery:&#xD;
Pain check-ins (2 times per week) (detailed above)&#xD;
Follow-up surveys (4, 8, and 12 weeks after surgery) Intervention: Behavioral: Perioperative Digital Behavioral Pain Medicine &quot;My Surgical Success&quot;</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Perioperative Digital Behavioral Pian Medicine &quot;My Surgical Success&quot;</intervention_name>
    <description>The &quot;My Surgical Success&quot; website include 45 minutes of psychoeducation material developed and delivered by Beth Darnall, PhD. Viewers learn basic skills to improve regulation of pain-related distress. Treatment includes an app and a personalized plan for surgical success.</description>
    <arm_group_label>&quot;My Surgical Success&quot; Treatment Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-80 years&#xD;
&#xD;
          -  Undergoing a scheduled surgery for orthopedic trauma&#xD;
&#xD;
          -  Post-surgery up to 7 days&#xD;
&#xD;
          -  English fluency&#xD;
&#xD;
          -  Ability and willingness to complete electronic study procedures including&#xD;
             questionnaires, assessments, and receipt of treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any conditions causing inability to complete study procedures (e.g. cognitive ability,&#xD;
             mental status, medical status) or lack of access to internet and phone that would&#xD;
             prevent participation in study procedures - at the discretion of the staff member.&#xD;
&#xD;
          -  long-term opioid use prior to surgery&#xD;
&#xD;
          -  Known pregnancy&#xD;
&#xD;
          -  Ongoing legal action related to pain or disability claim&#xD;
&#xD;
          -  Multiple surgeries and/or infections&#xD;
&#xD;
          -  Injury is not fracture related or non-trauma surgery&#xD;
&#xD;
          -  Documented history of alcohol abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Beth Darnall, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford Hospital</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>October 23, 2020</last_update_submitted>
  <last_update_submitted_qc>October 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Beth Darnall</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>pain</keyword>
  <keyword>treatment</keyword>
  <keyword>opioid cessation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_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/NCT03764839
org study id: 42569
nct id: NCT03764839
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary purpose of this study is to determine the feasibility and preliminary efficacy of
      a perioperative digital behavioral pain medicine intervention delivered to orthopedic trauma
      surgery patients (compared to an active control group that receives digital health
      education).

      Aim 1: Determine feasibility of and satisfaction, and perceived utility of "My Surgical
      Success"

      Hypothesis 1: For My Surgical Success, the investigators anticipate 50% engagement in the
      study (feasibility). Of those who complete My Surgical Success, the investigators expect 80%
      satisfaction ratings, and 80% perceived utility of the information learned.

      Aim 2: Determine group differences in time to post-surgical pain and opioid cessation.

      Hypothesis 2: "My Surgical Success" participants will evidence quicker time to post-surgical
      pain and opioid cessation compared to the HE Control Group.

      Aim 3: Determine group differences in within-subject pain catastrophizing scores (baseline to
      post-surgery).

      Hypothesis 3: "My Surgical Success" participants evidence greater reduction in pain
      catastrophizing (measured with the Pain Catastrophizing Scale; PCS) compared to the HE
      Control group.

      Aim 4: Determine group differences in post-surgical psychological correlates (PROMIS
      Depression, Anxiety, Function, Pain Interference, Sleep Disturbance, Social Isolation,
      Fatigue, and Pain Intensity).

      Hypothesis 4: "My Surgical Success" participants will evidence greater post-surgical function
      and lower pain related interference compared to the HE Control Group.

      The goal of this research is to advance our understanding regarding the feasibility and
      effectiveness of "My Surgical Success" (a digital, perioperative behavioral pain medicine
      treatment) and its impact on post-surgical outcomes.
Patients are identified by their orthopedic surgeon or study personnel immediately prior to
      surgery or during their stay on the inpatient post-surgical recovery unit. Beyond
      recruitment, the entire study is conducted remotely with no in-person contact with study
      staff. After enrollment, study staff follow-up with patients by phone, text or email
      (depending on patient preference); informed consent is obtained online.

      All participants are asked to provide baseline demographic information, as well as
      self-reported measures assessing mood, pain, cognitive and emotional responses to pain,
      catastrophizing, and medications. All measures are administered via a secure, HIPAA
      compliant, online system (REDCap).

      Participants are then randomized to receive one of two digital treatments: a behavioral pain
      medicine intervention ("My Surgical Success") or to a health education (HE Control).
      Participants who have been randomized to the HE control group receive online text information
      about health and nutrition, and are oriented that the information is relevant for improving
      recovery from surgery. The digital behavioral pain medicine intervention emphasizes treatment
      content that targets cognitive and emotional regulation in the context of pain. "My Surgical
      Success" includes three brief psychoeducational video learning modules, a downloadable app
      with an audio file, and a downloadable PDF Personalized Plan for Success. After participants
      in the "My Surgical Success" group view the online treatment videos, they complete questions
      regarding their satisfaction with the video content, perceived usefulness of information, and
      likelihood to use the skills learned. All participants are tracked twice per week
      post-surgically to assess pain and opioid use. Data are captured for the duration of the
      study (12 weeks) or until patients reach opioid cessation (four consecutive surveys
      indicating zero opioid use). Psychosocial data are collected post-surgically at weeks 4, 8,
      and 12.

      Post-treatment questions:

      Participants in the "My Surgical Success" group are asked to rate questions about the about
      the video content in regards to its understandability, relevance, usefulness, their overall
      satisfaction, how likely they are to use the information learned.

      Following surgery, all participants fill out online brief pain check-ins (2 times per week)
      to assess pain and medication use. Daily measures continue until the participant reports 4
      consecutive reports of zero opiate use. Until reaching this endpoint, pain check-ins are
      collected for 12 weeks (the duration of the study).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Participant ratings (0-6) for acceptability, satisfaction, usefulness of the information presented, ease of understanding, and likelihood to use skills learning (for the My Surgical Success group only)
time frame: Immediately post-treatment
description: Participants complete a single time point rating for 5 items listed above. Ratings occur on a 0-6 point scale (e.g., 0=completely useless and 6=Very useful). Percentages will be reported for each item. A higher score indicates better acceptability, satisfaction, usefulness of the information.
measure: Group difference in time to pain and opioid cessation
time frame: This is a survival curve with time being a variable of interest. The examination will occur within the 3-month window after surgery.
description: This will be measured in days until patients achieve opioid cessation. Fewer days indicate better treatment effects
measure: Group difference in within-subject Pain Catastrophizing Scale (PCS)
time frame: Baseline to 1 month
description: PCS measures pain catastrophizing
measure: Group differences in post-surgical Patient Reported Outcomes Measurement Information System (PROMIS) function and PROMIS average pain intensity
time frame: Post-surgical month 1
description: PROMIS function measures patients' level of physical functioning, and PROMIS pain intensity measures patients' average level of pain intensity. PROMIS scores for function and pain interference will be reported at month 1. The investigators will conduct within subject analyses and will report pre-post treatment changes. Also, the investigators will aggregate scores by group and conduct between group analyses to report differences between group means and SD. Higher value on PROMIS function indicates better levels of physical functioning and higher levels of PROMIS pain intensity indicate worse pain levels.
measure: Characterize responders to "My Surgical Success" (demographics and psychological correlates)
time frame: Baseline
description: The investigators with report the baseline demographic and psychosocial scores for patients who report high satisfaction with the "My Surgical Success" treatment.
arm group label: Active Control Group (Digital Health Education)
arm group type: No Intervention
description: Demographics survey
Baseline surveys
Participants receive a digital information sheet on nutrition and exercise that are relevant for people recovering from surgery. Participants are encouraged to incorporate healthy lifestyle choices into their daily routines as they recover from surgery
Post-surgery:
Pain check-ins (2 times per week) (detailed above)
Patients receive 30 second booster videos at 7, 14, and 21 days after surgery
Follow-up surveys (4, 8, and 12 weeks after surgery)
arm group label: "My Surgical Success" Treatment Group
arm group type: Experimental
description: Demographics survey
Baseline surveys
Intervention:
45-minute digital behavioral pain medicine intervention "My Surgical Success" that emphasized cognitive and emotional regulation of pain and downregulation of physiologic arousal.
downloadable app with an audio file
personalized plan that allows learners to incorporate the treatment information
Post-video survey (detailed above)
Post-surgery:
Pain check-ins (2 times per week) (detailed above)
Follow-up surveys (4, 8, and 12 weeks after surgery) Intervention: Behavioral: Perioperative Digital Behavioral Pain Medicine "My Surgical Success"
intervention type: Behavioral
intervention name: Perioperative Digital Behavioral Pian Medicine "My Surgical Success"
description: The "My Surgical Success" website include 45 minutes of psychoeducation material developed and delivered by Beth Darnall, PhD. Viewers learn basic skills to improve regulation of pain-related distress. Treatment includes an app and a personalized plan for surgical success.
arm group label: "My Surgical Success" Treatment Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Beth Darnall, PhD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Beth Darnall
investigator title: Clinical Professor
mesh term: Wounds and Injuries
sharing ipd: No