<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/NCT03828669</url>
  </required_header>
  <id_info>
    <org_study_id>IDCP18RT</org_study_id>
    <nct_id>NCT03828669</nct_id>
  </id_info>
  <brief_title>Recovery Toolkits: Assessment of Pragmatic Behavioral Pain Medicine Delivered In Hospital After Surgery</brief_title>
  <official_title>Recovery Toolkits: An Observational Assessment of Nurse-Delivered, Pragmatic, Behavioral Pain Medicine for Post-Surgical 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>
      Behavioral pain medicine is largely absent from perioperative pathways, and on post-surgical&#xD;
      recovery units. The goal of this project was to develop and implement &quot;Recovery Toolkits&quot;,&#xD;
      physical branded bags presented to patients after surgery. The &quot;Recovery Toolkits&quot; include a&#xD;
      descriptive brochure and orientation to the contents of the bag. &quot;Recovery Toolkits&quot; include&#xD;
      a behavioral pain medicine self-help book, an app with a downloadable pain management&#xD;
      audiofile, earbuds, and a pen. Patients on each unit have access to iPads where they may view&#xD;
      a digital behavioral pain medicine program (&quot;My Surgical Success&quot;), consisting of three&#xD;
      15-minute video learning modules. The &quot;Recovery Toolkits&quot; are psychologist-developed and&#xD;
      nurse-delivered to every patient on the surgical recovery units. This pragmatic project seeks&#xD;
      to understand:&#xD;
&#xD;
        1. Nurse perceived value of the intervention&#xD;
&#xD;
        2. Burden to nurses to deliver the intervention to all patients&#xD;
&#xD;
        3. Patient engagement with the Recovery Toolkits&#xD;
&#xD;
        4. Patient perceived value of the Recovery Toolkits&#xD;
&#xD;
        5. Patient satisfaction with pain care&#xD;
&#xD;
        6. Impact of Recovery Toolkits on pain and opioid use in hospital and at one-month&#xD;
           discharge relative to a pre-Recovery Toolkit program cohort of patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Stanford &quot;Recovery Toolkit&quot; program is delivered by nurses across multiple surgical&#xD;
      recovery units and surgery types, including neurosurgery, spine, and orthopedic surgeries.&#xD;
      All patients who enter the units are offered a &quot;Recovery Toolkit&quot;, which is a physical and&#xD;
      branded bag. The program includes the following elements: a descriptive brochure and&#xD;
      orientation to the contents of the bag. &quot;Recovery Toolkits&quot; include a behavioral pain&#xD;
      medicine self-help book, an app with a downloadable pain management audiofile, earbuds, and a&#xD;
      pen. Patients on all participating units have access to iPads where they may view a digital&#xD;
      behavioral pain medicine program (&quot;My Surgical Success&quot;), consisting of three 15-minute video&#xD;
      learning modules.&#xD;
&#xD;
      At discharge, patients are asked to evaluate their pain care and perception about the&#xD;
      &quot;Recovery Toolkit&quot; in a 10-item survey that includes items as to whether the patient received&#xD;
      a &quot;Recovery Toolkit&quot; (yes/no), did they use the &quot;Recovery Toolkit&quot; (yes/no), their&#xD;
      satisfaction with the &quot;Recovery Toolkit&quot; (6-point likert scale), and recommendation for&#xD;
      continuing the program (5-point likert scale). Chart review will extract data for&#xD;
      demographics, surgery type, existing pain conditions and comorbidities, pain intensity scores&#xD;
      averaged over the duration of their inpatient stay, as well as total opioid use during&#xD;
      hospital stay and a daily average for inpatient opioid use. At one month after surgery,&#xD;
      patients who agreed to be contacted will be asked their average pain intensity (0-10),&#xD;
      whether they are taking opioid medication (yes/no) and how much (morphine equivalent daily&#xD;
      dose), whether they have used the Recovery Toolkit information (yes/no), and, if yes, to&#xD;
      please rate the helpfulness of the Recovery Toolkit information (0-10).&#xD;
&#xD;
      Nurses will be surveyed to determine the level of burden to deliver the intervention (0-6),&#xD;
      their perceived value of the intervention to their patients (0-6), and their assessment on&#xD;
      whether the program should be continued/expanded (0-6).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 25, 2019</start_date>
  <completion_date type="Actual">February 16, 2021</completion_date>
  <primary_completion_date type="Actual">February 16, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Satisfaction with Recovery Toolkits</measure>
    <time_frame>10 minute survey administered at hospital discharge</time_frame>
    <description>6-point scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Likelihood to recommend</measure>
    <time_frame>10 minute survey administered at hospital discharge</time_frame>
    <description>5-point scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Binary Opioid Use</measure>
    <time_frame>Duration of inpatient hospital stay</time_frame>
    <description>Average Morphine Equivalent Daily Dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Pain</measure>
    <time_frame>Duration of inpatient hospital stay</time_frame>
    <description>Average of all pain ratings (0-10 numeric rating scale)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid Daily Dose</measure>
    <time_frame>5 minuute survey administered 1 month after surgery</time_frame>
    <description>Morphine Equivalent Daily Dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid use</measure>
    <time_frame>5 minute survey administered 1 month after surgery</time_frame>
    <description>Binary question about continued opioid use (yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Pain Intensity</measure>
    <time_frame>5 minute survey administered 1 month after surgery</time_frame>
    <description>Rating on 0-10 numeric rating scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid use</measure>
    <time_frame>5 minute survey administered 1 month after surgery</time_frame>
    <description>Morphine Equivalent Daily Dose</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">649</enrollment>
  <condition>Post Surgical Pain</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <description>Prior to the roll-out of the Recovery Toolkit program, all post-surgical patients receiving current standard of care are given pain care surveys at hospital discharge. Survey questions ask about pain, and satisfaction with pain care. The investigators will conduct chart review for pain and opioid use.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Recovery Toolkit</arm_group_label>
    <description>After launch of the Recovery Toolkit program on Jan 25, all post-surgical patients will be offered a Recovery Toolkit by a unit nurse. A pain survey will be administered at hospital discharge to assess about pain in the hospital, satisfaction with pain care, whether they received a Toolkit, use of the Toolkit, and likelihood to recommend the Toolkit. The investigators will conduct chart review for pain and opioid use.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Recovery Toolkits</intervention_name>
    <description>Recovery Toolkits are presented to patients in a branded bag and include a brochure, a self-help behavioral pain medicine book, a downloadable app, earbuds, and access to digital behavioral medicine (the &quot;My Surgical Success&quot; program including online educational videos)</description>
    <arm_group_label>Recovery Toolkit</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Post-surgical inpatients (spine, neurosurgery, and other specialties)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Everyone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None, though Recovery Toolkits are English language&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </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>94034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>July 7, 2021</last_update_submitted>
  <last_update_submitted_qc>July 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2021</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>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>behavioral medicine</keyword>
  <keyword>pain</keyword>
  <keyword>perioperative</keyword>
  <keyword>enhanced recovery after surgery</keyword>
  <keyword>surgery</keyword>
  <keyword>intervention</keyword>
  <keyword>post-operative pain</keyword>
  <keyword>opioid</keyword>
  <keyword>digital</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</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/NCT03828669
org study id: IDCP18RT
nct id: NCT03828669
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Behavioral pain medicine is largely absent from perioperative pathways, and on post-surgical
      recovery units. The goal of this project was to develop and implement "Recovery Toolkits",
      physical branded bags presented to patients after surgery. The "Recovery Toolkits" include a
      descriptive brochure and orientation to the contents of the bag. "Recovery Toolkits" include
      a behavioral pain medicine self-help book, an app with a downloadable pain management
      audiofile, earbuds, and a pen. Patients on each unit have access to iPads where they may view
      a digital behavioral pain medicine program ("My Surgical Success"), consisting of three
      15-minute video learning modules. The "Recovery Toolkits" are psychologist-developed and
      nurse-delivered to every patient on the surgical recovery units. This pragmatic project seeks
      to understand:

        1. Nurse perceived value of the intervention

        2. Burden to nurses to deliver the intervention to all patients

        3. Patient engagement with the Recovery Toolkits

        4. Patient perceived value of the Recovery Toolkits

        5. Patient satisfaction with pain care

        6. Impact of Recovery Toolkits on pain and opioid use in hospital and at one-month
           discharge relative to a pre-Recovery Toolkit program cohort of patients.
The Stanford "Recovery Toolkit" program is delivered by nurses across multiple surgical
      recovery units and surgery types, including neurosurgery, spine, and orthopedic surgeries.
      All patients who enter the units are offered a "Recovery Toolkit", which is a physical and
      branded bag. The program includes the following elements: a descriptive brochure and
      orientation to the contents of the bag. "Recovery Toolkits" include a behavioral pain
      medicine self-help book, an app with a downloadable pain management audiofile, earbuds, and a
      pen. Patients on all participating units have access to iPads where they may view a digital
      behavioral pain medicine program ("My Surgical Success"), consisting of three 15-minute video
      learning modules.

      At discharge, patients are asked to evaluate their pain care and perception about the
      "Recovery Toolkit" in a 10-item survey that includes items as to whether the patient received
      a "Recovery Toolkit" (yes/no), did they use the "Recovery Toolkit" (yes/no), their
      satisfaction with the "Recovery Toolkit" (6-point likert scale), and recommendation for
      continuing the program (5-point likert scale). Chart review will extract data for
      demographics, surgery type, existing pain conditions and comorbidities, pain intensity scores
      averaged over the duration of their inpatient stay, as well as total opioid use during
      hospital stay and a daily average for inpatient opioid use. At one month after surgery,
      patients who agreed to be contacted will be asked their average pain intensity (0-10),
      whether they are taking opioid medication (yes/no) and how much (morphine equivalent daily
      dose), whether they have used the Recovery Toolkit information (yes/no), and, if yes, to
      please rate the helpfulness of the Recovery Toolkit information (0-10).

      Nurses will be surveyed to determine the level of burden to deliver the intervention (0-6),
      their perceived value of the intervention to their patients (0-6), and their assessment on
      whether the program should be continued/expanded (0-6).
observational model: Cohort
time perspective: Prospective
measure: Satisfaction with Recovery Toolkits
time frame: 10 minute survey administered at hospital discharge
description: 6-point scale
measure: Likelihood to recommend
time frame: 10 minute survey administered at hospital discharge
description: 5-point scale
measure: Binary Opioid Use
time frame: Duration of inpatient hospital stay
description: Average Morphine Equivalent Daily Dose
measure: Average Pain
time frame: Duration of inpatient hospital stay
description: Average of all pain ratings (0-10 numeric rating scale)
measure: Opioid Daily Dose
time frame: 5 minuute survey administered 1 month after surgery
description: Morphine Equivalent Daily Dose
measure: Opioid use
time frame: 5 minute survey administered 1 month after surgery
description: Binary question about continued opioid use (yes/no)
measure: Average Pain Intensity
time frame: 5 minute survey administered 1 month after surgery
description: Rating on 0-10 numeric rating scale
measure: Opioid use
time frame: 5 minute survey administered 1 month after surgery
description: Morphine Equivalent Daily Dose
arm group label: Usual Care
description: Prior to the roll-out of the Recovery Toolkit program, all post-surgical patients receiving current standard of care are given pain care surveys at hospital discharge. Survey questions ask about pain, and satisfaction with pain care. The investigators will conduct chart review for pain and opioid use.
arm group label: Recovery Toolkit
description: After launch of the Recovery Toolkit program on Jan 25, all post-surgical patients will be offered a Recovery Toolkit by a unit nurse. A pain survey will be administered at hospital discharge to assess about pain in the hospital, satisfaction with pain care, whether they received a Toolkit, use of the Toolkit, and likelihood to recommend the Toolkit. The investigators will conduct chart review for pain and opioid use.
intervention type: Behavioral
intervention name: Recovery Toolkits
description: Recovery Toolkits are presented to patients in a branded bag and include a brochure, a self-help behavioral pain medicine book, a downloadable app, earbuds, and access to digital behavioral medicine (the "My Surgical Success" program including online educational videos)
arm group label: Recovery Toolkit
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
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: Principal Investigator
mesh term: Pain, Postoperative
sharing ipd: No