<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/NCT03284359</url>
  </required_header>
  <id_info>
    <org_study_id>828046</org_study_id>
    <nct_id>NCT03284359</nct_id>
  </id_info>
  <brief_title>Use of Nudges To Enhance Enrollment in Critical Care Research</brief_title>
  <official_title>A Randomized Trial of Nudges To Enhance Enrollment in Critical Care Research</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pennsylvania</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>
      Difficulties enrolling patients in randomized clinical trials (RCTs) have long been&#xD;
      recognized as a major barrier to successful evaluation of medical interventions. This is&#xD;
      particularly problematic among intensive care unit (ICU) trials, of which more than one-third&#xD;
      do not reach target enrollment. Under-enrollment and selective enrollment reduce RCTs'&#xD;
      abilities to answer the research questions, thereby degrading the trials' scientific value&#xD;
      and ethics.&#xD;
&#xD;
      Current evidence suggests that financial incentives can ethically increase study enrollment,&#xD;
      but this approach can pose large up-front costs to researchers. However, several nonmonetary&#xD;
      behavioral interventions, or nudges, may offer novel and easily scalable approaches to&#xD;
      increase enrollment in RCTs.&#xD;
&#xD;
      The investigation team propose a 2-arm RCT in 10 ICUs at Penn to test the relative&#xD;
      effectiveness of nudges on enrollment rates. Investigators hypothesize that a bundle of&#xD;
      nudges during recruitment will increase enrollment rates compared to usual recruitment&#xD;
      procedures will increase enrollment.&#xD;
&#xD;
      Investigators will enroll 182 critically ill patients' surrogate decision&#xD;
      makers(participants) to engage in recruitment procedures for a simulated RCT comparing two&#xD;
      mechanical ventilation weaning protocols among mechanically ventilated patients.&#xD;
      Investigators will also measure participants' assessment of risk of the simulated trial after&#xD;
      the informed consent process. This work will provide the first empirical evidence regarding&#xD;
      the efficacy of inexpensive, scalable nudges to potentially augment enrollment and reduce&#xD;
      costs of future clinical trials.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 19, 2018</start_date>
  <completion_date type="Actual">August 8, 2019</completion_date>
  <primary_completion_date type="Actual">August 8, 2019</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>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Consent Rate</measure>
    <time_frame>Up to 96 hours</time_frame>
    <description>The primary outcome is consent rate for a simulated RCT. This is an easily measurable binary outcome that has the potential for significant impact on future trial recruitment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Risk Assessment</measure>
    <time_frame>Up to 96 hours</time_frame>
    <description>Secondarily we will quantitatively assess the participant's assessment of the risk of participating in the simulated RCT. The risk assessment tool has been previously used in the assessment of risk perception of RCT participation in the setting of behavioral economic nudges. The risk assessment will be used to evaluate participants' impressions of the risk of participating in the RCT using a Likert scale ranging from 1 (Not risky at all) to 7 (very risky), as well as 9 comparative questions, each of which asks whether a study procedure was riskier than another risky activity, such as talking on one's cell phone while driving.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">182</enrollment>
  <condition>Critical Illness</condition>
  <arm_group>
    <arm_group_label>Pre-Consent Nudge Bundle</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm 1 will be administered a novel pre-consent nudge bundle which incorporates several behavioral economic interventions within a brief survey. Participants will subsequently be asked by the same research personnel to participate in a simulated randomized control trial (RCT) comparing two mechanical ventilation weaning protocols among mechanically ventilated patients. Participants will receive the standard consent form followed by a risk assessment and demographic survey.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Consent</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Arm 2 will serve as the control arm. Participants will be approached by the research personnel to participate in a simulated RCT comparing two mechanical ventilation weaning protocols among mechanically ventilated patients. Participants will receive a standard consent form as detailed in the Study Instruments section. Following the consent process participants will conduct the same risk assessment survey and demographic survey.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pre-Consent Nudge Bundle</intervention_name>
    <description>The pre-consent nudge bundle survey was developed by the study team and incorporates several behavioral interventions into a bundle of 5 types of nudges: (i) injunctive norms; (ii) descriptive norms; (iii) duty of reciprocity; (iv) self-prophecy; and (v) foot-in-the-door. Injunctive norms involve the perception of what behavior is acceptable, while descriptive norms highlight what behaviors others are engaging in. The duty of reciprocity is the sense that one should repeat pro-social behavior for which they have benefited from. The foot-in-the-door nudge involves asking a participant to perform a small request which has a high consent rate followed by a larger request. The bundle consists of six questions and one statement.</description>
    <arm_group_label>Pre-Consent Nudge Bundle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Surrogate decision-makers of patients who are:&#xD;
&#xD;
          1. Patient and surrogate is 18 years of age or older&#xD;
&#xD;
          2. Surrogate is English-proficient&#xD;
&#xD;
          3. Patient is mechanically ventilated&#xD;
&#xD;
          4. Patient is admitted to participating ICU&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Surrogate decision-makers of patients who are:&#xD;
&#xD;
          1. Patient is receiving comfort care only&#xD;
&#xD;
          2. Patient has anticipated extubation in the next 24 hours.&#xD;
&#xD;
          3. Patient with tracheostomy.&#xD;
&#xD;
          4. Bedside clinician declines patient participation.&#xD;
&#xD;
          5. Surrogate decision maker not available to approach prior to patient being extubated.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katherine Courtright, M.D., M.S.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104-6006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <results_first_submitted>February 11, 2021</results_first_submitted>
  <results_first_submitted_qc>February 11, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 3, 2021</results_first_posted>
  <last_update_submitted>February 11, 2021</last_update_submitted>
  <last_update_submitted_qc>February 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Critical Illness</keyword>
  <keyword>Mechanical Ventilation</keyword>
  <keyword>Economics, Behavioral</keyword>
  <keyword>Surrogate decision maker</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 1, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/59/NCT03284359/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Pre-Consent Nudge Bundle</title>
          <description>Arm 1 will be administered a novel pre-consent nudge bundle which incorporates several behavioral economic interventions within a brief survey. Participants will subsequently be asked by the same research personnel to participate in a simulated randomized control trial (RCT) comparing two mechanical ventilation weaning protocols among mechanically ventilated patients. Participants will receive the standard consent form followed by a risk assessment and demographic survey.&#xD;
Pre-Consent Nudge Bundle: The pre-consent nudge bundle survey was developed by the study team and incorporates several behavioral interventions into a bundle of 5 types of nudges: (i) injunctive norms; (ii) descriptive norms; (iii) duty of reciprocity; (iv) self-prophecy; and (v) foot-in-the-door. Injunctive norms involve the perception of what behavior is acceptable, while descriptive norms highlight what behaviors others are engaging in. The duty of reciprocity is the sense that one should repeat pro-social behavior for which they have benefited from. The foot-in-the-door nudge involves asking a participant to perform a small request which has a high consent rate followed by a larger request. The bundle consists of six questions and one statement.</description>
        </group>
        <group group_id="P2">
          <title>Standard Consent</title>
          <description>Arm 2 will serve as the control arm. Participants will be approached by the research personnel to participate in a simulated RCT comparing two mechanical ventilation weaning protocols among mechanically ventilated patients. Participants will receive a standard consent form as detailed in the Study Instruments section. Following the consent process participants will conduct the same risk assessment survey and demographic survey.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="93"/>
                <participants group_id="P2" count="89"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="93"/>
                <participants group_id="P2" count="89"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intention to treat</population>
      <group_list>
        <group group_id="B1">
          <title>Pre-Consent Nudge Bundle</title>
          <description>Arm 1 will be administered a novel pre-consent nudge bundle which incorporates several behavioral economic interventions within a brief survey. Participants will subsequently be asked by the same research personnel to participate in a simulated randomized control trial (RCT) comparing two mechanical ventilation weaning protocols among mechanically ventilated patients. Participants will receive the standard consent form followed by a risk assessment and demographic survey.&#xD;
Pre-Consent Nudge Bundle: The pre-consent nudge bundle survey was developed by the study team and incorporates several behavioral interventions into a bundle of 5 types of nudges: (i) injunctive norms; (ii) descriptive norms; (iii) duty of reciprocity; (iv) self-prophecy; and (v) foot-in-the-door. Injunctive norms involve the perception of what behavior is acceptable, while descriptive norms highlight what behaviors others are engaging in. The duty of reciprocity is the sense that one should repeat pro-social behavior for which they have benefited from. The foot-in-the-door nudge involves asking a participant to perform a small request which has a high consent rate followed by a larger request. The bundle consists of six questions and one statement.</description>
        </group>
        <group group_id="B2">
          <title>Standard Consent</title>
          <description>Arm 2 will serve as the control arm. Participants will be approached by the research personnel to participate in a simulated RCT comparing two mechanical ventilation weaning protocols among mechanically ventilated patients. Participants will receive a standard consent form as detailed in the Study Instruments section. Following the consent process participants will conduct the same risk assessment survey and demographic survey.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="93"/>
            <count group_id="B2" value="89"/>
            <count group_id="B3" value="182"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.3" spread="13.6"/>
                    <measurement group_id="B2" value="58.6" spread="17.2"/>
                    <measurement group_id="B3" value="60" spread="15.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="71"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="111"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="74"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="133"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Length of ICU stay at enrollment</title>
          <units>Hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="97.8" spread="73.1"/>
                    <measurement group_id="B2" value="114.5" spread="90.6"/>
                    <measurement group_id="B3" value="106.2" spread="81.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Consent Rate</title>
        <description>The primary outcome is consent rate for a simulated RCT. This is an easily measurable binary outcome that has the potential for significant impact on future trial recruitment.</description>
        <time_frame>Up to 96 hours</time_frame>
        <population>Intention to treat</population>
        <group_list>
          <group group_id="O1">
            <title>Pre-Consent Nudge Bundle</title>
            <description>Arm 1 will be administered a novel pre-consent nudge bundle which incorporates several behavioral economic interventions within a brief survey. Participants will subsequently be asked by the same research personnel to participate in a simulated randomized control trial (RCT) comparing two mechanical ventilation weaning protocols among mechanically ventilated patients. Participants will receive the standard consent form followed by a risk assessment and demographic survey.&#xD;
Pre-Consent Nudge Bundle: The pre-consent nudge bundle survey was developed by the study team and incorporates several behavioral interventions into a bundle of 5 types of nudges: (i) injunctive norms; (ii) descriptive norms; (iii) duty of reciprocity; (iv) self-prophecy; and (v) foot-in-the-door. Injunctive norms involve the perception of what behavior is acceptable, while descriptive norms highlight what behaviors others are engaging in. The duty of reciprocity is the sense that one should repeat pro-social behavior for which they have benefited from. The foot-in-the-door nudge involves asking a participant to perform a small request which has a high consent rate followed by a larger request. The bundle consists of six questions and one statement.</description>
          </group>
          <group group_id="O2">
            <title>Standard Consent</title>
            <description>Arm 2 will serve as the control arm. Participants will be approached by the research personnel to participate in a simulated RCT comparing two mechanical ventilation weaning protocols among mechanically ventilated patients. Participants will receive a standard consent form as detailed in the Study Instruments section. Following the consent process participants will conduct the same risk assessment survey and demographic survey.</description>
          </group>
        </group_list>
        <measure>
          <title>Consent Rate</title>
          <description>The primary outcome is consent rate for a simulated RCT. This is an easily measurable binary outcome that has the potential for significant impact on future trial recruitment.</description>
          <population>Intention to treat</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="93"/>
                <count group_id="O2" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Risk Assessment</title>
        <description>Secondarily we will quantitatively assess the participant's assessment of the risk of participating in the simulated RCT. The risk assessment tool has been previously used in the assessment of risk perception of RCT participation in the setting of behavioral economic nudges. The risk assessment will be used to evaluate participants' impressions of the risk of participating in the RCT using a Likert scale ranging from 1 (Not risky at all) to 7 (very risky), as well as 9 comparative questions, each of which asks whether a study procedure was riskier than another risky activity, such as talking on one's cell phone while driving.</description>
        <time_frame>Up to 96 hours</time_frame>
        <population>Intention to treat</population>
        <group_list>
          <group group_id="O1">
            <title>Pre-Consent Nudge Bundle</title>
            <description>Arm 1 will be administered a novel pre-consent nudge bundle which incorporates several behavioral economic interventions within a brief survey. Participants will subsequently be asked by the same research personnel to participate in a simulated randomized control trial (RCT) comparing two mechanical ventilation weaning protocols among mechanically ventilated patients. Participants will receive the standard consent form followed by a risk assessment and demographic survey.&#xD;
Pre-Consent Nudge Bundle: The pre-consent nudge bundle survey was developed by the study team and incorporates several behavioral interventions into a bundle of 5 types of nudges: (i) injunctive norms; (ii) descriptive norms; (iii) duty of reciprocity; (iv) self-prophecy; and (v) foot-in-the-door. Injunctive norms involve the perception of what behavior is acceptable, while descriptive norms highlight what behaviors others are engaging in. The duty of reciprocity is the sense that one should repeat pro-social behavior for which they have benefited from. The foot-in-the-door nudge involves asking a participant to perform a small request which has a high consent rate followed by a larger request. The bundle consists of six questions and one statement.</description>
          </group>
          <group group_id="O2">
            <title>Standard Consent</title>
            <description>Arm 2 will serve as the control arm. Participants will be approached by the research personnel to participate in a simulated RCT comparing two mechanical ventilation weaning protocols among mechanically ventilated patients. Participants will receive a standard consent form as detailed in the Study Instruments section. Following the consent process participants will conduct the same risk assessment survey and demographic survey.</description>
          </group>
        </group_list>
        <measure>
          <title>Risk Assessment</title>
          <description>Secondarily we will quantitatively assess the participant's assessment of the risk of participating in the simulated RCT. The risk assessment tool has been previously used in the assessment of risk perception of RCT participation in the setting of behavioral economic nudges. The risk assessment will be used to evaluate participants' impressions of the risk of participating in the RCT using a Likert scale ranging from 1 (Not risky at all) to 7 (very risky), as well as 9 comparative questions, each of which asks whether a study procedure was riskier than another risky activity, such as talking on one's cell phone while driving.</description>
          <population>Intention to treat</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="93"/>
                <count group_id="O2" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="0" upper_limit="5"/>
                    <measurement group_id="O2" value="2" lower_limit="0" upper_limit="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were monitored during the interaction. Long term adverse events were not evaluated.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Pre-Consent Nudge Bundle</title>
          <description>Arm 1 will be administered a novel pre-consent nudge bundle which incorporates several behavioral economic interventions within a brief survey. Participants will subsequently be asked by the same research personnel to participate in a simulated randomized control trial (RCT) comparing two mechanical ventilation weaning protocols among mechanically ventilated patients. Participants will receive the standard consent form followed by a risk assessment and demographic survey.&#xD;
Pre-Consent Nudge Bundle: The pre-consent nudge bundle survey was developed by the study team and incorporates several behavioral interventions into a bundle of 5 types of nudges: (i) injunctive norms; (ii) descriptive norms; (iii) duty of reciprocity; (iv) self-prophecy; and (v) foot-in-the-door. Injunctive norms involve the perception of what behavior is acceptable, while descriptive norms highlight what behaviors others are engaging in. The duty of reciprocity is the sense that one should repeat pro-social behavior for which they have benefited from. The foot-in-the-door nudge involves asking a participant to perform a small request which has a high consent rate followed by a larger request. The bundle consists of six questions and one statement.</description>
        </group>
        <group group_id="E2">
          <title>Standard Consent</title>
          <description>Arm 2 will serve as the control arm. Participants will be approached by the research personnel to participate in a simulated RCT comparing two mechanical ventilation weaning protocols among mechanically ventilated patients. Participants will receive a standard consent form as detailed in the Study Instruments section. Following the consent process participants will conduct the same risk assessment survey and demographic survey.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Katherine Courtright</name_or_title>
      <organization>University of Pennsylvania</organization>
      <phone>267-978-5083</phone>
      <email>Katherine.Courtright@pennmedicine.upenn.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03284359
org study id: 828046
nct id: NCT03284359
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Difficulties enrolling patients in randomized clinical trials (RCTs) have long been
      recognized as a major barrier to successful evaluation of medical interventions. This is
      particularly problematic among intensive care unit (ICU) trials, of which more than one-third
      do not reach target enrollment. Under-enrollment and selective enrollment reduce RCTs'
      abilities to answer the research questions, thereby degrading the trials' scientific value
      and ethics.

      Current evidence suggests that financial incentives can ethically increase study enrollment,
      but this approach can pose large up-front costs to researchers. However, several nonmonetary
      behavioral interventions, or nudges, may offer novel and easily scalable approaches to
      increase enrollment in RCTs.

      The investigation team propose a 2-arm RCT in 10 ICUs at Penn to test the relative
      effectiveness of nudges on enrollment rates. Investigators hypothesize that a bundle of
      nudges during recruitment will increase enrollment rates compared to usual recruitment
      procedures will increase enrollment.

      Investigators will enroll 182 critically ill patients' surrogate decision
      makers(participants) to engage in recruitment procedures for a simulated RCT comparing two
      mechanical ventilation weaning protocols among mechanically ventilated patients.
      Investigators will also measure participants' assessment of risk of the simulated trial after
      the informed consent process. This work will provide the first empirical evidence regarding
      the efficacy of inexpensive, scalable nudges to potentially augment enrollment and reduce
      costs of future clinical trials.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: Consent Rate
time frame: Up to 96 hours
description: The primary outcome is consent rate for a simulated RCT. This is an easily measurable binary outcome that has the potential for significant impact on future trial recruitment.
measure: Risk Assessment
time frame: Up to 96 hours
description: Secondarily we will quantitatively assess the participant's assessment of the risk of participating in the simulated RCT. The risk assessment tool has been previously used in the assessment of risk perception of RCT participation in the setting of behavioral economic nudges. The risk assessment will be used to evaluate participants' impressions of the risk of participating in the RCT using a Likert scale ranging from 1 (Not risky at all) to 7 (very risky), as well as 9 comparative questions, each of which asks whether a study procedure was riskier than another risky activity, such as talking on one's cell phone while driving.
arm group label: Pre-Consent Nudge Bundle
arm group type: Experimental
description: Arm 1 will be administered a novel pre-consent nudge bundle which incorporates several behavioral economic interventions within a brief survey. Participants will subsequently be asked by the same research personnel to participate in a simulated randomized control trial (RCT) comparing two mechanical ventilation weaning protocols among mechanically ventilated patients. Participants will receive the standard consent form followed by a risk assessment and demographic survey.
arm group label: Standard Consent
arm group type: No Intervention
description: Arm 2 will serve as the control arm. Participants will be approached by the research personnel to participate in a simulated RCT comparing two mechanical ventilation weaning protocols among mechanically ventilated patients. Participants will receive a standard consent form as detailed in the Study Instruments section. Following the consent process participants will conduct the same risk assessment survey and demographic survey.
intervention type: Behavioral
intervention name: Pre-Consent Nudge Bundle
description: The pre-consent nudge bundle survey was developed by the study team and incorporates several behavioral interventions into a bundle of 5 types of nudges: (i) injunctive norms; (ii) descriptive norms; (iii) duty of reciprocity; (iv) self-prophecy; and (v) foot-in-the-door. Injunctive norms involve the perception of what behavior is acceptable, while descriptive norms highlight what behaviors others are engaging in. The duty of reciprocity is the sense that one should repeat pro-social behavior for which they have benefited from. The foot-in-the-door nudge involves asking a participant to perform a small request which has a high consent rate followed by a larger request. The bundle consists of six questions and one statement.
arm group label: Pre-Consent Nudge Bundle
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Katherine Courtright, M.D., M.S.
role: Principal Investigator
affiliation: University of Pennsylvania
facility: 
country: United States
responsible party type: Sponsor
mesh term: Critical Illness
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 