xml: <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/NCT06013176</url>
    </required_header>
    <id_info>
      <org_study_id>852748</org_study_id>
      <secondary_id>P50CA244690</secondary_id>
      <nct_id>NCT06013176</nct_id>
    </id_info>
    <brief_title>Behavioral Economic Strategies to Improve PRO Adherence</brief_title>
    <acronym>BEST-PRO</acronym>
    <official_title>Behavioral Economic Strategies to Improve PRO Adherence</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Abramson Cancer Center at Penn Medicine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Cancer Institute (NCI)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Abramson Cancer Center at Penn Medicine</source>
    <oversight_info>
      <has_dmc>Yes</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 main purpose of this research study is to evaluate the implementation and effectiveness&#xD;
        of patient- and nurse-directed strategies across in-clinic and remote patient reported&#xD;
        outcome (PRO) monitoring settings, using a three-arm pragmatic cluster randomized controlled&#xD;
        trial. Additionally, the goal is to evaluate moderators of implementation effects on PRO&#xD;
        monitoring.&#xD;
  &#xD;
        Eligible patients will be randomized independently to: (1) usual practice (i.e.,&#xD;
        encounter-based PRO administration via patient portal or tablet); (2) encounter-based PRO&#xD;
        monitoring with patient reminders and nurse alerts; or (3) remote PRO monitoring with patient&#xD;
        reminders and nurse alerts. The investigators hypothesize that nudges to patients and alerts&#xD;
        to nurses will improve patient-level PRO completion and clinician-level PRO engagement.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Routine PRO monitoring is an evidence-based practice that improves patient outcomes. Patients&#xD;
        with cancer commonly experience symptoms which go unrecognized by clinical teams up to half&#xD;
        of the time. PROs are a powerful tool to bridge this gap, amplifying the patient experience&#xD;
        and improving communication between patients and clinicians. A seminal clinical trial was&#xD;
        conducted in which weekly PRO symptom assessments with care team alerts led to reduced care&#xD;
        utilization, improved quality of life, and lengthened overall survival among patients&#xD;
        receiving active treatment for advanced solid tumors. Subsequent randomized trials have&#xD;
        corroborated the quality of life and survival advantages of PRO monitoring in other cancer&#xD;
        populations and practice settings.&#xD;
  &#xD;
        Real-world adherence to PRO monitoring is lower than in seminal clinical trials, with&#xD;
        potential racial/ethnic disparities. Multilevel barriers to PRO implementation exist at the&#xD;
        patient, clinician, practice, and system levels. While patient adherence to PRO monitoring in&#xD;
        seminal trials ranged from 70 to 90 percent, real-world adherence is much lower and more&#xD;
        variable. Our preliminary research demonstrates that in a large, multi-site rollout of PRO&#xD;
        monitoring, mean patient-level adherence was less than 50 percent. Moreover, compared to&#xD;
        non-Hispanic White patients, Black and Hispanic patients were 9% and 4% less likely to&#xD;
        complete PRO questionnaires, respectively, but more likely to report more severe symptoms.&#xD;
        These results highlight that historically marginalized subgroups may benefit less from&#xD;
        current methods of PRO administration, potentially reinforcing existing disparities in&#xD;
        symptom management if not remediated.&#xD;
  &#xD;
        This will be the first study to apply behavioral economic strategies to align clinicians and&#xD;
        patients in achieving sustained patient-level PRO adherence, and addresses limitations of&#xD;
        current PRO approaches. Current approaches to PRO collection are limited by: (1) suboptimal&#xD;
        clinician engagement, (2) encounter-based assessments which preclude longitudinal monitoring&#xD;
        of PROs outside of the clinic, and (3) insufficient automated effectors actively linking&#xD;
        reported symptoms with clinical response. This proposal addresses these limitations by&#xD;
        employing behavioral strategies directly targeting clinician engagement, utilizing novel&#xD;
        electronic remote monitoring methods to maximize real-time PRO capture, and linking these&#xD;
        with pathway-driven automated effectors.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 1, 2024</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>
      <intervention_model_description>Eligible patients will be identified pragmatically and will be independently randomized to study arms using a three-arm design.</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>Single (Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>PRO adherence</measure>
      <time_frame>3 months</time_frame>
      <description>The primary outcome will be PRO adherence, measured at the patient level as the proportion of expected PRO questionnaires completed per patient.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Percent of patients with at least one note documenting PROs during study period</measure>
      <time_frame>3 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percent of patients with at least one note documenting PROs per month during study period</measure>
      <time_frame>3 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to alert response (for arms 2 and 3 only)</measure>
      <time_frame>3 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percent of patients who trigger an alert for triage nurses (for arms 2 and 3 only)</measure>
      <time_frame>3 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acute care utilization</measure>
      <time_frame>6 months</time_frame>
      <description>Percent of patients with an emergency department visit or hospitalization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment delays/modifications</measure>
      <time_frame>6 months</time_frame>
      <description>Percent of patients with a treatment delay/modification</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of therapy</measure>
      <time_frame>6 months</time_frame>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Cancer</condition>
    <arm_group>
      <arm_group_label>Usual practice</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>This arm will consist of encounter-based PRO monitoring, in which patients have an opportunity to complete PRO questionnaires via patient portal in advance of clinical encounters or via tablet during clinical encounters. While clinicians will be encouraged to view and discuss PROs with patients during clinical encounters, they will not be prompted to do so in real-time, nor will there be alerts for escalating symptoms.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Encounter-based PRO monitoring</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Encounter-based PRO monitoring (usual practice) plus patient reminders and triage nurse alerts</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Remote PRO monitoring</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Remote PRO monitoring plus patient reminders and triage nurse alerts</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Encounter-based PRO monitoring</intervention_name>
      <description>This arm consists of usual practice plus the addition of patient reminders to complete PRO questionnaires and triage nurse alerts for severe symptoms. Patient reminders will be operationalized through the Epic patient portal. Triage nurse alerts will be routed to Epic symptom management pools in response to a patient reporting moderate or severe symptoms. Patients will have the opportunity to decline or opt-out of triage nurse support. Clinical interventions stemming from triage nurse alerts will be up to the discretion of clinical teams - i.e., clinical responses will be neither prescriptive nor mandatory. Notably, the entry point for triage nurse alerts (i.e., Epic symptom management pools), as well as resultant clinical responses, are existing standard operating procedures/practices for patients reporting symptoms by phone.</description>
      <arm_group_label>Encounter-based PRO monitoring</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Remote PRO monitoring</intervention_name>
      <description>This arm will consist of weekly PRO questionnaires administered via the patient portal, de-linked from clinical encounters. Patient reminders will be operationalized through the Epic patient portal. Triage nurse alerts will be routed to Epic symptom management pools in response to a patient reporting moderate or severe symptoms. Patients will have the opportunity to decline or opt-out of triage nurse support. Clinical interventions stemming from triage nurse alerts will be up to the discretion of clinical teams - i.e., clinical responses will be neither prescriptive nor mandatory. Notably, the entry point for triage nurse alerts (i.e., Epic symptom management pools), as well as resultant clinical responses, are existing standard operating procedures/practices for patients reporting symptoms by phone.</description>
      <arm_group_label>Remote PRO monitoring</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients must initiate a new line of systemic cancer therapy (i.e., intravenous&#xD;
               chemotherapy or immunotherapy) at a participating Implementation Lab site&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Actively enrolled in a therapeutic clinical trial&#xD;
  &#xD;
            -  Patient opts out of pragmatic research&#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>Ravi Parikh, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Pennsylvania</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Samuel Takvorian, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Pennsylvania</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Abramson Cancer Center</name>
        <address>
          <city>Philadelphia</city>
          <state>Pennsylvania</state>
          <zip>19104</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Ravi Parikh, MD</last_name>
        <email>Ravi.Parikh@pennmedicine.upenn.edu</email>
      </contact>
      <contact_backup>
        <last_name>Samuel Takvorian, MD</last_name>
        <email>Samuel.Takvorian@pennmedicine.upenn.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Basch E, Deal AM, Kris MG, Scher HI, Hudis CA, Sabbatini P, Rogak L, Bennett AV, Dueck AC, Atkinson TM, Chou JF, Dulko D, Sit L, Barz A, Novotny P, Fruscione M, Sloan JA, Schrag D. Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. J Clin Oncol. 2016 Feb 20;34(6):557-65. doi: 10.1200/JCO.2015.63.0830. Epub 2015 Dec 7. Erratum In: J Clin Oncol. 2016 Jun 20;34(18):2198. J Clin Oncol. 2019 Feb 20;37(6):528.</citation>
      <PMID>26644527</PMID>
    </reference>
    <reference>
      <citation>Basch E, Deal AM, Dueck AC, Scher HI, Kris MG, Hudis C, Schrag D. Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment. JAMA. 2017 Jul 11;318(2):197-198. doi: 10.1001/jama.2017.7156.</citation>
      <PMID>28586821</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06013176
  org study id: 852748
  secondary id: P50CA244690
  nct id: NCT06013176
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The main purpose of this research study is to evaluate the implementation and effectiveness
        of patient- and nurse-directed strategies across in-clinic and remote patient reported
        outcome (PRO) monitoring settings, using a three-arm pragmatic cluster randomized controlled
        trial. Additionally, the goal is to evaluate moderators of implementation effects on PRO
        monitoring.
  
        Eligible patients will be randomized independently to: (1) usual practice (i.e.,
        encounter-based PRO administration via patient portal or tablet); (2) encounter-based PRO
        monitoring with patient reminders and nurse alerts; or (3) remote PRO monitoring with patient
        reminders and nurse alerts. The investigators hypothesize that nudges to patients and alerts
        to nurses will improve patient-level PRO completion and clinician-level PRO engagement.
  Routine PRO monitoring is an evidence-based practice that improves patient outcomes. Patients
        with cancer commonly experience symptoms which go unrecognized by clinical teams up to half
        of the time. PROs are a powerful tool to bridge this gap, amplifying the patient experience
        and improving communication between patients and clinicians. A seminal clinical trial was
        conducted in which weekly PRO symptom assessments with care team alerts led to reduced care
        utilization, improved quality of life, and lengthened overall survival among patients
        receiving active treatment for advanced solid tumors. Subsequent randomized trials have
        corroborated the quality of life and survival advantages of PRO monitoring in other cancer
        populations and practice settings.
  
        Real-world adherence to PRO monitoring is lower than in seminal clinical trials, with
        potential racial/ethnic disparities. Multilevel barriers to PRO implementation exist at the
        patient, clinician, practice, and system levels. While patient adherence to PRO monitoring in
        seminal trials ranged from 70 to 90 percent, real-world adherence is much lower and more
        variable. Our preliminary research demonstrates that in a large, multi-site rollout of PRO
        monitoring, mean patient-level adherence was less than 50 percent. Moreover, compared to
        non-Hispanic White patients, Black and Hispanic patients were 9% and 4% less likely to
        complete PRO questionnaires, respectively, but more likely to report more severe symptoms.
        These results highlight that historically marginalized subgroups may benefit less from
        current methods of PRO administration, potentially reinforcing existing disparities in
        symptom management if not remediated.
  
        This will be the first study to apply behavioral economic strategies to align clinicians and
        patients in achieving sustained patient-level PRO adherence, and addresses limitations of
        current PRO approaches. Current approaches to PRO collection are limited by: (1) suboptimal
        clinician engagement, (2) encounter-based assessments which preclude longitudinal monitoring
        of PROs outside of the clinic, and (3) insufficient automated effectors actively linking
        reported symptoms with clinical response. This proposal addresses these limitations by
        employing behavioral strategies directly targeting clinician engagement, utilizing novel
        electronic remote monitoring methods to maximize real-time PRO capture, and linking these
        with pathway-driven automated effectors.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Eligible patients will be identified pragmatically and will be independently randomized to study arms using a three-arm design.
  primary purpose: Health Services Research
  masking: Single (Investigator)
  measure: PRO adherence
  time frame: 3 months
  description: The primary outcome will be PRO adherence, measured at the patient level as the proportion of expected PRO questionnaires completed per patient.
  measure: Percent of patients with at least one note documenting PROs during study period
  time frame: 3 months
  measure: Percent of patients with at least one note documenting PROs per month during study period
  time frame: 3 months
  measure: Time to alert response (for arms 2 and 3 only)
  time frame: 3 months
  measure: Percent of patients who trigger an alert for triage nurses (for arms 2 and 3 only)
  time frame: 3 months
  measure: Acute care utilization
  time frame: 6 months
  description: Percent of patients with an emergency department visit or hospitalization
  measure: Treatment delays/modifications
  time frame: 6 months
  description: Percent of patients with a treatment delay/modification
  measure: Duration of therapy
  time frame: 6 months
  arm group label: Usual practice
  arm group type: No Intervention
  description: This arm will consist of encounter-based PRO monitoring, in which patients have an opportunity to complete PRO questionnaires via patient portal in advance of clinical encounters or via tablet during clinical encounters. While clinicians will be encouraged to view and discuss PROs with patients during clinical encounters, they will not be prompted to do so in real-time, nor will there be alerts for escalating symptoms.
  arm group label: Encounter-based PRO monitoring
  arm group type: Experimental
  description: Encounter-based PRO monitoring (usual practice) plus patient reminders and triage nurse alerts
  arm group label: Remote PRO monitoring
  arm group type: Experimental
  description: Remote PRO monitoring plus patient reminders and triage nurse alerts
  intervention type: Other
  intervention name: Encounter-based PRO monitoring
  description: This arm consists of usual practice plus the addition of patient reminders to complete PRO questionnaires and triage nurse alerts for severe symptoms. Patient reminders will be operationalized through the Epic patient portal. Triage nurse alerts will be routed to Epic symptom management pools in response to a patient reporting moderate or severe symptoms. Patients will have the opportunity to decline or opt-out of triage nurse support. Clinical interventions stemming from triage nurse alerts will be up to the discretion of clinical teams - i.e., clinical responses will be neither prescriptive nor mandatory. Notably, the entry point for triage nurse alerts (i.e., Epic symptom management pools), as well as resultant clinical responses, are existing standard operating procedures/practices for patients reporting symptoms by phone.
  arm group label: Encounter-based PRO monitoring
  intervention type: Other
  intervention name: Remote PRO monitoring
  description: This arm will consist of weekly PRO questionnaires administered via the patient portal, de-linked from clinical encounters. Patient reminders will be operationalized through the Epic patient portal. Triage nurse alerts will be routed to Epic symptom management pools in response to a patient reporting moderate or severe symptoms. Patients will have the opportunity to decline or opt-out of triage nurse support. Clinical interventions stemming from triage nurse alerts will be up to the discretion of clinical teams - i.e., clinical responses will be neither prescriptive nor mandatory. Notably, the entry point for triage nurse alerts (i.e., Epic symptom management pools), as well as resultant clinical responses, are existing standard operating procedures/practices for patients reporting symptoms by phone.
  arm group label: Remote PRO monitoring
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ravi Parikh, MD
  role: Principal Investigator
  affiliation: University of Pennsylvania
  last name: Samuel Takvorian, MD
  role: Principal Investigator
  affiliation: University of Pennsylvania
  facility: 
  contact: 
  contact backup: 
  country: United States
  citation: Basch E, Deal AM, Kris MG, Scher HI, Hudis CA, Sabbatini P, Rogak L, Bennett AV, Dueck AC, Atkinson TM, Chou JF, Dulko D, Sit L, Barz A, Novotny P, Fruscione M, Sloan JA, Schrag D. Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. J Clin Oncol. 2016 Feb 20;34(6):557-65. doi: 10.1200/JCO.2015.63.0830. Epub 2015 Dec 7. Erratum In: J Clin Oncol. 2016 Jun 20;34(18):2198. J Clin Oncol. 2019 Feb 20;37(6):528.
  PMID: 26644527
  citation: Basch E, Deal AM, Dueck AC, Scher HI, Kris MG, Hudis C, Schrag D. Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment. JAMA. 2017 Jul 11;318(2):197-198. doi: 10.1001/jama.2017.7156.
  PMID: 28586821
  responsible party type: Sponsor
  sharing ipd: No