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/NCT06014892</url>
    </required_header>
    <id_info>
      <org_study_id>2022P001157</org_study_id>
      <nct_id>NCT06014892</nct_id>
    </id_info>
    <brief_title>The 4th Trimester Initiative: The Impact of Parental Support on Pregnant Trainee Wellbeing</brief_title>
    <official_title>The 4th Trimester Initiative: The Impact of Parental Support on Pregnant Trainee Wellbeing</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Massachusetts General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Brigham and Women's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Boston Children's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Beth Israel Deaconess Medical Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Massachusetts General Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to determine the impact of a parental support package for&#xD;
        new trainee mothers which focuses on mentorship, lactation, and sleep, and access to&#xD;
        perinatal care. The main questions it aims to answer are whether this set of interventions&#xD;
        will improve trainee wellbeing and decrease medical error.&#xD;
  &#xD;
        Participants will be randomized to intervention and control groups. The intervention group&#xD;
        will receive:&#xD;
  &#xD;
          1. A Snoo smart sleep bassinet&#xD;
  &#xD;
          2. A Willow wearable breast pump&#xD;
  &#xD;
          3. Access to Maven Clinic for 24/7 on-demand perinatal care&#xD;
  &#xD;
          4. A faculty mentor in their own department&#xD;
  &#xD;
        The control group will receive the standard support currently offered by training programs.&#xD;
  &#xD;
        All participants will wear a Fitbit to track sleep and will take a series of surveys querying&#xD;
        pregnancy, birth, and postpartum experiences; wellbeing; and professional satisfaction.&#xD;
  &#xD;
        Researchers will compare intervention and control groups to see if the intervention group&#xD;
        has:&#xD;
  &#xD;
          1. decreased rates of burnout&#xD;
  &#xD;
          2. increased professional fulfillment&#xD;
  &#xD;
          3. decreased thoughts of leaving the profession&#xD;
  &#xD;
          4. increased perception of organizational and personal value alignment&#xD;
  &#xD;
          5. increased sleep&#xD;
  &#xD;
          6. decreased risk of medical errors&#xD;
  &#xD;
          7. increased personal fulfillment of breastfeeding goals&#xD;
  &#xD;
          8. decreased risk of postpartum depression&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The birth of a child during training is a significant life event that has been associated&#xD;
        with a high risk of attrition and career dissatisfaction. Post-graduate training lasts&#xD;
        between 3 and 9 years after medical school and overlaps with peak child-bearing years. The&#xD;
        difficulties facing new trainee parents have been characterized with stigma, health concerns&#xD;
        due to unmitigated work schedules during pregnancy, short parental leaves, and challenges&#xD;
        with lactation and childcare contributing to stress and fatigue. Program directors describe&#xD;
        marked variability in how childbearing affected residents' quality of work, with many&#xD;
        describing returning residents as conflicted and distracted. The increase in family&#xD;
        commitments in the setting of existing training demands can lead trainees to develop a&#xD;
        perception of work-life incompatibility, fatigue, to change their career trajectory, and to&#xD;
        have increased risk of burnout and postpartum depression. The investigators hypothesize that&#xD;
        a set of interventions for new trainee mothers, focusing on mentorship, lactation, and sleep&#xD;
        can improve trainee wellbeing and decrease the risk of medical errors.&#xD;
  &#xD;
        STUDY PROCEDURES:&#xD;
  &#xD;
        This study is designed as a prospective randomized clinical trial of pregnant trainees at&#xD;
        Massachusetts General Hospital (MGH), Brigham and Women's Hospital (BWH), Boston Children's&#xD;
        Hospital (BCH), and Beth Israel Deaconess Medical Center (BIDMC).&#xD;
  &#xD;
        Participants will be screened over the phone and consent to participate obtained in person.&#xD;
        All participants will take the electronic pre-intervention assessment survey after consent.&#xD;
        After completion of the pre-intervention assessment survey, participants will be randomized&#xD;
        into either the control arm or the intervention arm and provided a wearable device to monitor&#xD;
        sleep (for one week during pregnancy to establish a baseline and for 6 months after&#xD;
        delivery).&#xD;
  &#xD;
        After delivery, all participants will take a set of surveys at 4,12,16,20,24, and 52 weeks&#xD;
        postpartum querying obstetric and postpartum experiences; self-reported medical error;&#xD;
        fatigue; wellbeing; and professional satisfaction.&#xD;
  &#xD;
        The intervention group will receive:&#xD;
  &#xD;
          1. A Snoo smart sleep bassinet&#xD;
  &#xD;
          2. A Willow wearable breast pump&#xD;
  &#xD;
          3. Access to Maven Clinic for 24/7 on-demand perinatal care&#xD;
  &#xD;
          4. A faculty mentor in their own department&#xD;
  &#xD;
        The control group will receive standard parental support currently offered by training&#xD;
        programs.&#xD;
  &#xD;
        Researchers will compare the following between intervention and control groups:&#xD;
  &#xD;
          1. burnout&#xD;
  &#xD;
          2. professional fulfillment&#xD;
  &#xD;
          3. thoughts of leaving the profession&#xD;
  &#xD;
          4. perception of organizational and personal value alignment&#xD;
  &#xD;
          5. sleep and fatigue&#xD;
  &#xD;
          6. self-reported medical errors&#xD;
  &#xD;
          7. personal fulfillment of breastfeeding goals&#xD;
  &#xD;
          8. risk of postpartum depression&#xD;
  &#xD;
        The investigators plan to measure mean scores in burnout as our primary outcome. An effect&#xD;
        size of 0.5 standard deviation change in burnout between the control and intervention arm is&#xD;
        estimated to be a clinically relevant change. Trainees have mean burnout scores of 3.35&#xD;
        (SD=2.05). 76 subjects in each arm are estimated to be needed, 152 participants total, to&#xD;
        detect a statistically significant change in burnout score (by at least 1.025 using the&#xD;
        SPFI), with 80% power with a two tailed alpha of 10%, and allowing for 20% attrition of study&#xD;
        subjects.&#xD;
  &#xD;
        STATISTICAL ANALYSIS The investigators plan to report descriptive data including frequency,&#xD;
        mean (SD) and median (inter-quartile range) for all outcome measures, using chi-squared&#xD;
        analyses for categorical variables and t-test for continuous variables.&#xD;
  &#xD;
        Mass General Brigham (MGB) has more than 200 training programs across its training sites. Of&#xD;
        the 27/200+ programs that responded to a brief survey through the Wellbeing Council, 76&#xD;
        trainees (43 men and 33 women) became new parents this past academic year (2020-2021). Human&#xD;
        Resources at MGB estimates more than 70 trainees apply for formal parental leave yearly which&#xD;
        likely significantly underestimates the true number of new parents as most nonchildbearing&#xD;
        parent trainees do not take formal parental leave. Based on this information, the&#xD;
        investigators anticipate that the MGB training programs alone will have a sufficient number&#xD;
        of trainees to conduct this study.&#xD;
  &#xD;
        STUDY TERMINATION CRITERIA:&#xD;
  &#xD;
        The study will be terminated at the request of the participant for any reason. Otherwise, the&#xD;
        study will be terminated at 6 months. Subjects in the control arm who purchase a SNOO&#xD;
        bassinet or a wearable breast pump will be requested to notify the study PI and will be&#xD;
        categorized as a subgroup and analyzed in a planned sub-group analysis.&#xD;
  &#xD;
        MONITORING AND QUALITY ASSURANCE:&#xD;
  &#xD;
        To minimize the risk of loss of anonymity, participants will be assigned a unique study&#xD;
        identifier. Access to files linking identifiers with identifying coded data will be limited&#xD;
        only to need-to-know study personnel and stored in a Partners Password Protected online&#xD;
        storage drive, while survey data will be obtained using Partners REDCap. Data will be&#xD;
        accessible only to the PI and CITI-certified research staff. The Research staff will review&#xD;
        the database each time new patient data is collected using a Partners password-protected&#xD;
        computer and the PI will review the database once a month with details discussed at a monthly&#xD;
        research meeting.&#xD;
  &#xD;
        Identifying information (name, email address, phone number, shipping address, and due date)&#xD;
        will need to be released to the sponsoring companies to facilitate delivery of the automated&#xD;
        bassinet (Happiest Baby Inc), wearable breast pump (Willow Innovations) and access to&#xD;
        perinatal on-demand consultation (Maven Clinic). Data transfer will be performed via MGB&#xD;
        approved password protected and encrypted mechanisms. Both companies have designated&#xD;
        representatives that are HIPAA certified with no association to the study execution or&#xD;
        analysis. Data access by the company representatives will require multi-factor identification&#xD;
        for the single user who will be allowed access. The transferred information will be used to&#xD;
        order study related equipment for participants. The data will be deleted from the secure&#xD;
        electronic location at the conclusion of the study.&#xD;
  &#xD;
        Sleep tracking data is housed in secure Azure (Microsoft) servers. Fitabase uses Secure&#xD;
        Sockets Layer (SSL) for all authentication (logins), billing, and administration of the site.&#xD;
        The user's browser establishes the authenticity by requesting an SSL certificate that&#xD;
        verifies the identity of Fitabase. Once that SSL certificate is recognized, a Secure Sockets&#xD;
        Layer (SSL) connection is established for security, encrypting data transmitted between&#xD;
        browser and web server.&#xD;
  &#xD;
        Participants will be asked in person or online to authorize use of Fitabase to access their&#xD;
        wearable device data and make it available for download for analysis. Participants will be&#xD;
        informed that research staff will be able to access, view, and download deidentified data&#xD;
        through the Fitabase platform. Data collected will relate to sleep length, movement, and&#xD;
        quality. There are two instances when the PI will revoke access to data associated with&#xD;
        participants in this study. First, if a participant chooses to withdraw from the study, the&#xD;
        PI will remove the participant from the study platform (Fitabase) and data will be removed&#xD;
        from the study. Second, 90 days after the completion of data collection Fitabase will remove&#xD;
        the project from their data management system, disassociate the data from the project, and&#xD;
        begin remove access to the data by deleting it from its servers and backup systems.&#xD;
  &#xD;
        The PI will be responsible for determining whether the research should be altered or stopped.&#xD;
        Throughout the duration of the study, the PI will perform ongoing evaluation of subject&#xD;
        safety data to identify adverse events and trends as soon as possible. Any unanticipated&#xD;
        adverse events involving risk to human subjects will be reviewed by the Principal&#xD;
        Investigator and will be quickly reported to the Human Research Committee within the required&#xD;
        time frame and to all participating investigators by The PI according to the Partners Human&#xD;
        Research Committee guidelines.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 25, 2023</start_date>
    <completion_date type="Anticipated">June 2026</completion_date>
    <primary_completion_date type="Anticipated">December 2025</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>This study is designed as a prospective randomized open-labeled study. We plan to enroll 152 trainees who are pregnant or immediately post-partum. Participants will undergo stratified randomization to an intervention or no intervention arm in a 1 to 1 ratio based on training specialty (either procedural or non-procedural) and training site (MGH, BWH, BCH, or BIDMC). Procedural specialties are defined as specialties that spend a significant portion of their training performing procedures: this includes all surgical specialties, anesthesiologists, gastroenterologists, obstetricians-gynecologists, interventional-radiologist, interventional-pulmonologists, interventional-cardiologists, emergency physicians. All other training programs are considered non-procedural specialties.</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Burnout measured by emotional exhaustion and Interpersonal Disengagement components of the Stanford Professional Fulfillment Index</measure>
      <time_frame>At Enrollment; 16 weeks postpartum; 24 weeks postpartum</time_frame>
      <description>Emotional exhaustion and Interpersonal Disengagement are EACH scored on a scale of 0-10; The Emotional Exhaustion and Interpersonal Disengagement Scores are then averaged for score 0-10. Higher scores indicate higher likelihood of emotional exhaustion, interpersonal disengagement, and burnout (higher score is worse outcome)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Professional Fulfillment measured by the Stanford Professional Fulfillment Index</measure>
      <time_frame>At Enrollment; 16 weeks postpartum; 24 weeks postpartum; 1 year postpartum</time_frame>
      <description>Professional Fulfillment is score on a scale of 0-10 with higher scores indicating a higher likelihood of professional fulfillment (higher score is better outcome)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self reported medical error resulting in patient harm</measure>
      <time_frame>4 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks postpartum</time_frame>
      <description>Participants will be asked &quot;Over the past 4 weeks, how many times did you make a medical error that did result in patient harm?&quot;. Participants will be given options of &quot;0&quot;, &quot;1&quot;, &quot;2&quot;, &quot;3&quot;, or &quot;3 or more&quot;.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self reported medical error resulting in near miss for patient harm</measure>
      <time_frame>4 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks postpartum</time_frame>
      <description>Participants will be asked &quot;Over the past 4 weeks, how many times did you make a medical error that could have resulted in patient harm?&quot;. Participants will be given options of &quot;0&quot;, &quot;1&quot;, &quot;2&quot;, &quot;3&quot;, or &quot;3 or more&quot;.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Organizational and Personal Values Alignment</measure>
      <time_frame>At Enrollment; 16 weeks postpartum; 24 weeks postpartum</time_frame>
      <description>3-item Stanford Values Alignment Scale. This validated instrument contains 3 statements with which participants are asked to indicate their agreement on a 5-point Likert Scale (0=not at all true; 4=completely true). Aggregate scores are determined by summing the 0-4 score of the individual items to yield a total score ranging from 0-12. Higher values are positive (indicate better alignment between organizational and personal values).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Negative Impact of Work on Personal Relationships</measure>
      <time_frame>At Enrollment; 16 weeks postpartum; 24 weeks postpartum</time_frame>
      <description>4-item Impact of Work on Personal Relationships scale. This validated scale contains 4 items to which responders are asked to indicate their level of agreement over the previous year on a 5-point Likert scale (0=not at all true;4=completely true). The scale score is calculated by determining the mean 0-4 score across the 4 items and normalizing the score to 0-10 scale with higher scores indicating worse outcomes (more adverse impact of work on personal relationships)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postpartum Depression Screening</measure>
      <time_frame>At enrollment and at 16 weeks postpartum</time_frame>
      <description>Edinburgh Postnatal Depression Scale. This validated scale includes 10 short statements to which respondents indicate their level of agreement in the past week. Each question is scored from 0-3 and the total score is found by adding the scores from each of the 10 items. The range of the scale is 0-30 with higher scores indicating worse outcome (higher likelihood of postpartum depression)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ability to Meet Breastfeeding Goals</measure>
      <time_frame>24 weeks postpartum</time_frame>
      <description>Participants will be asked to answer the survey question, &quot;Did you feel that you achieved your breastfeeding goal?&quot;. Participants will be able to respond &quot;yes&quot;, &quot;no&quot;, and &quot;I am still breastfeeding and not sure if I will achieve my goal yet&quot;. Respondents who reply &quot;no&quot; indicate a worse outcome as they were unable to reach their personal goals for duration of breastfeeding.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Breastfeeding</measure>
      <time_frame>24 weeks postpartum</time_frame>
      <description>measured in months</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serious thoughts of quitting training program</measure>
      <time_frame>At enrollment, 16 weeks postpartum, and 24 weeks postpartum</time_frame>
      <description>Participants will be asked to indicate their level of agreement (1: strongly agree; 5: strongly disagree) to the following statement: &quot;I have considered leaving my program in the last year (due to the experience of pregnancy/parenthood in my current training specialty&quot;. Lower score indicates a worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Regret for a Medical Career</measure>
      <time_frame>At enrollment, 16 weeks postpartum and 24 weeks postpartum</time_frame>
      <description>Participants will be asked to indicate their level of agreement (1: strongly agree; 5: strongly disagree) with the following statement: &quot;If I could choose again, I would choose a non-medical career more accommodating of parenthood&quot;. Lower score indicates a worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Regret for a Chosen Specialty</measure>
      <time_frame>At enrollment, 16 weeks postpartum, and 24 weeks postpartum</time_frame>
      <description>Participants will be asked to indicate their level of agreement (1: strongly agree; 5: strongly disagree) with the following statement: &quot;If I could choose again, I would stay in medicine but choose a specialty more accommodating of parenthood than my current specialty&quot;. Lower score indicates a worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Nightly wakenings</measure>
      <time_frame>Daily for one week after enrollment, then daily from delivery date until 24 weeks postpartum</time_frame>
      <description>The total number of minutes spent awake per sleep episode will be measured by a wearable Fitbit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Nightly sleep duration</measure>
      <time_frame>Daily for one week after enrollment, then daily from delivery date until 24 weeks postpartum</time_frame>
      <description>The total number of minutes spent asleep per 24 hours will be measured by a wearable Fitbit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fatigue</measure>
      <time_frame>4 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks postpartum</time_frame>
      <description>Adult 8-item Patient Reported Outcomes Measurement Information System (PROMIS) Sleep -Related Impairment Scale.The sleep-related impairment items assess sleepiness during the day and perceived effects on performance in the past 7 days. The scale items are scored on a 5-point Likert scale indicating intensity from &quot;not at all&quot; to &quot;very much,&quot; and the raw scores range from 8 to 40 with high scores indicating worse outcomes (more fatigue).</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Burnout measured by emotional exhaustion and Interpersonal Disengagement components of the Stanford Professional Fulfillment Index</measure>
      <time_frame>12 months postpartum</time_frame>
      <description>Burnout measured by emotional exhaustion and depersonalization components of the Emotional exhaustion and Interpersonal Disengagement are EACH scored on a scale of 0-10; The Emotional Exhaustion and Interpersonal Disengagement Scores are then averaged for score 0-10. Higher scores indicate higher likelihood of emotional exhaustion, interpersonal disengagement, and burnout (higher score is worse outcome)</description>
    </other_outcome>
    <other_outcome>
      <measure>Professional Fulfillment measured by the Stanford Professional Fulfillment Index</measure>
      <time_frame>12 months postpartum</time_frame>
      <description>Professional Fulfillment is score on a scale of 0-10 with higher scores indicating a higher likelihood of professional fulfillment (higher score is better outcome)</description>
    </other_outcome>
    <other_outcome>
      <measure>Organization and personal values alignment</measure>
      <time_frame>12 months postpartum</time_frame>
      <description>3-item Stanford Values Alignment Scale. This validated instrument contains 3 statements with which participants are asked to indicate their agreement on a 5-point Likert Scale (0=not at all true; 4=completely true). Aggregate scores are determined by summing the 0-4 score of the individual items to yield a total score ranging from 0-12. Higher values are positive (indicate better alignment between organizational and personal values).</description>
    </other_outcome>
    <other_outcome>
      <measure>Negative Impact of Work on Personal Relationships</measure>
      <time_frame>12 months postpartum</time_frame>
      <description>4-item Impact of Work on Personal Relationships scale. This validated scale contains 4 items to which responders are asked to indicate their level of agreement over the previous year on a 5-point Likert scale (0=not at all true;4=completely true). The scale score is calculated by determining the mean 0-4 score across the 4 items and normalizing the score to 0-10 scale with higher scores indicating worse outcomes (more adverse impact of work on personal relationships)</description>
    </other_outcome>
    <other_outcome>
      <measure>Ability to meet breastfeeding goals</measure>
      <time_frame>12 months postpartum</time_frame>
      <description>Participants will be asked to answer the survey question, &quot;Did you feel that you achieved your breastfeeding goal?&quot;. Participants will be able to respond &quot;yes&quot;, &quot;no&quot;, and &quot;I am still breastfeeding and not sure if I will achieve my goal yet&quot;. Respondents who reply &quot;no&quot; indicate a worse outcome as they were unable to reach their personal goals for duration of breastfeeding.</description>
    </other_outcome>
    <other_outcome>
      <measure>Duration of breastfeeding</measure>
      <time_frame>12 months postpartum</time_frame>
      <description>measured in months</description>
    </other_outcome>
    <other_outcome>
      <measure>Serious thoughts of quitting training program</measure>
      <time_frame>12 months postpartum</time_frame>
      <description>articipants will be asked to indicate their level of agreement (1: strongly agree; 5: strongly disagree) to the following statement: &quot;I have considered leaving my program in the last year (due to the experience of pregnancy/parenthood in my current training specialty&quot;. Lower score indicates a worse outcome</description>
    </other_outcome>
    <other_outcome>
      <measure>Regret for a Medical Career</measure>
      <time_frame>12 months postpartum</time_frame>
      <description>Participants will be asked to indicate their level of agreement (1: strongly agree; 5: strongly disagree) with the following statement: &quot;If I could choose again, I would choose a non-medical career more accommodating of parenthood&quot;. Lower score indicates a worse outcome</description>
    </other_outcome>
    <other_outcome>
      <measure>Regret for a Chosen Specialty</measure>
      <time_frame>12 months postpartum</time_frame>
      <description>Participants will be asked to indicate their level of agreement (1: strongly agree; 5: strongly disagree) with the following statement: &quot;If I could choose again, I would stay in medicine but choose a specialty more accommodating of parenthood than my current specialty&quot;. Lower score indicates a worse outcome</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">152</enrollment>
    <condition>Pregnancy Related</condition>
    <condition>Burnout, Professional</condition>
    <condition>Wellness, Psychological</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The intervention group will receive:&#xD;
  A Snoo smart sleep bassinet&#xD;
  A Willow wearable breast pump&#xD;
  Access to Maven Clinic for 24/7 on-demand perinatal care&#xD;
  A faculty mentor in their own department</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The control arm will receive:&#xD;
  Current standard in the residency training program.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Snoo smart bassinet</intervention_name>
      <description>Participants in the intervention arm will be shipped a Snoo bassinet during their third trimester. The bassinet must be returned to the company at 6 months</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Willow wearable breast pump</intervention_name>
      <description>Participants in the intervention arm will be shipped a Willow wearable breast pump and milk storage bags during the third trimester, which participants may keep</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Maven Clinic on-demand perinatal consultation</intervention_name>
      <description>Participants in the intervention arm will receive immediate access to Maven Clinic for 24/7 on-demand consultation with perinatal specialists.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Faculty mentor</intervention_name>
      <description>After enrollment, participants in the intervention arm will be paired with a faculty mentor who is also a mother to discuss issues related to work-family integration during pregnancy and early infancy.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Currently pregnant&#xD;
  &#xD;
            -  Part of a residency or fellowship training program at MGH, BWH, BCH, or BIDMC during&#xD;
               pregnancy and for 6 months postpartum&#xD;
  &#xD;
            -  Clinically active and will remain clinically active until 6 months postpartum&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  significant cardiopulmonary, gastrointestinal, or neurologic comorbidities in&#xD;
               participant or her fetus&#xD;
  &#xD;
            -  on research elective or dedicated research time from time of enrollment until 6 months&#xD;
               postpartum.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Massachusetts General Hospital</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02114</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>The 4th Trimester Initiative Study Team</last_name>
        <phone>617-831-7824</phone>
        <email>the4thtrimesterinitiative@mgb.org</email>
      </contact>
      <contact_backup>
        <last_name>Erika Rangel, MD</last_name>
        <phone>617-831-7824</phone>
        <email>erangel@mgh.harvard.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Erika Rangel, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Beth Israel Deaconess Medical Center</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02115</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Huma Farid, MD</last_name>
        <phone>781-453-7240</phone>
        <email>hfarid@bidmc.harvard.edu</email>
      </contact>
      <investigator>
        <last_name>Huma Farid, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Boston Children's Hospital</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02115</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ariel Winn, MD</last_name>
        <phone>617-355-7584</phone>
        <email>Ariel.Winn@childrens.harvard.edu</email>
      </contact>
      <investigator>
        <last_name>Ariel Winn, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Christopher Landrigan, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Brigham and Women's Hospital</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02115</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Douglas S Smink, MD</last_name>
        <phone>617-983-7862</phone>
        <email>dsmink@bwh.harvard.edu</email>
      </contact>
      <investigator>
        <last_name>Douglas S Smink, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Rangel EL, Castillo-Angeles M, Easter SR, Atkinson RB, Gosain A, Hu YY, Cooper Z, Dey T, Kim E. Incidence of Infertility and Pregnancy Complications in US Female Surgeons. JAMA Surg. 2021 Oct 1;156(10):905-915. doi: 10.1001/jamasurg.2021.3301. Erratum In: JAMA Surg. 2021 Oct 1;156(10):991.</citation>
      <PMID>34319353</PMID>
    </reference>
    <reference>
      <citation>Rangel EL, Smink DS, Castillo-Angeles M, Kwakye G, Changala M, Haider AH, Doherty GM. Pregnancy and Motherhood During Surgical Training. JAMA Surg. 2018 Jul 1;153(7):644-652. doi: 10.1001/jamasurg.2018.0153.</citation>
      <PMID>29562068</PMID>
    </reference>
    <reference>
      <citation>Rangel EL, Lyu H, Haider AH, Castillo-Angeles M, Doherty GM, Smink DS. Factors Associated With Residency and Career Dissatisfaction in Childbearing Surgical Residents. JAMA Surg. 2018 Nov 1;153(11):1004-1011. doi: 10.1001/jamasurg.2018.2571.</citation>
      <PMID>30073246</PMID>
    </reference>
    <reference>
      <citation>Castillo-Angeles M, Smink DS, Rangel EL. Perspectives of US General Surgery Program Directors on Cultural and Fiscal Barriers to Maternity Leave and Postpartum Support During Surgical Training. JAMA Surg. 2021 Jul 1;156(7):647-653. doi: 10.1001/jamasurg.2021.1807.</citation>
      <PMID>34009280</PMID>
    </reference>
    <reference>
      <citation>West CP, Dyrbye LN, Shanafelt TD. Physician burnout: contributors, consequences and solutions. J Intern Med. 2018 Jun;283(6):516-529. doi: 10.1111/joim.12752. Epub 2018 Mar 24.</citation>
      <PMID>29505159</PMID>
    </reference>
    <reference>
      <citation>Dyrbye LN, West CP, Satele D, Boone S, Tan L, Sloan J, Shanafelt TD. Burnout among U.S. medical students, residents, and early career physicians relative to the general U.S. population. Acad Med. 2014 Mar;89(3):443-51. doi: 10.1097/ACM.0000000000000134.</citation>
      <PMID>24448053</PMID>
    </reference>
    <reference>
      <citation>Dyrbye LN, Freischlag J, Kaups KL, Oreskovich MR, Satele DV, Hanks JB, Sloan JA, Balch CM, Shanafelt TD. Work-home conflicts have a substantial impact on career decisions that affect the adequacy of the surgical workforce. Arch Surg. 2012 Oct;147(10):933-9. doi: 10.1001/archsurg.2012.835.</citation>
      <PMID>23117833</PMID>
    </reference>
    <reference>
      <citation>Stack SW, McKinney CM, Spiekerman C, Best JA. Childbearing and maternity leave in residency: determinants and well-being outcomes. Postgrad Med J. 2018 Dec;94(1118):694-699. doi: 10.1136/postgradmedj-2018-135960. Epub 2018 Dec 15.</citation>
      <PMID>30554173</PMID>
    </reference>
    <reference>
      <citation>Dyrbye LN, Burke SE, Hardeman RR, Herrin J, Wittlin NM, Yeazel M, Dovidio JF, Cunningham B, White RO, Phelan SM, Satele DV, Shanafelt TD, van Ryn M. Association of Clinical Specialty With Symptoms of Burnout and Career Choice Regret Among US Resident Physicians. JAMA. 2018 Sep 18;320(11):1114-1130. doi: 10.1001/jama.2018.12615.</citation>
      <PMID>30422299</PMID>
    </reference>
    <reference>
      <citation>Sandler BJ, Tackett JJ, Longo WE, Yoo PS. Pregnancy and Parenthood among Surgery Residents: Results of the First Nationwide Survey of General Surgery Residency Program Directors. J Am Coll Surg. 2016 Jun;222(6):1090-6. doi: 10.1016/j.jamcollsurg.2015.12.004. Epub 2015 Dec 18.</citation>
      <PMID>26776357</PMID>
    </reference>
    <reference>
      <citation>Melnitchouk N, Scully RE, Davids JS. Barriers to Breastfeeding for US Physicians Who Are Mothers. JAMA Intern Med. 2018 Aug 1;178(8):1130-1132. doi: 10.1001/jamainternmed.2018.0320.</citation>
      <PMID>29554184</PMID>
    </reference>
    <reference>
      <citation>Peters GW, Kuczmarska-Haas A, Holliday EB, Puckett L. Lactation challenges of resident physicians- results of a national survey. BMC Pregnancy Childbirth. 2020 Dec 9;20(1):762. doi: 10.1186/s12884-020-03436-3.</citation>
      <PMID>33297993</PMID>
    </reference>
    <reference>
      <citation>Kancherla BS, Upender R, Collen JF, Rishi MA, Sullivan SS, Ahmed O, Berneking M, Flynn-Evans EE, Peters BR, Gurubhagavatula I. What is the role of sleep in physician burnout? J Clin Sleep Med. 2020 May 15;16(5):807-810. doi: 10.5664/jcsm.8412. Epub 2020 Feb 28.</citation>
      <PMID>32108567</PMID>
    </reference>
    <reference>
      <citation>Ekstedt M, Soderstrom M, Akerstedt T. Sleep physiology in recovery from burnout. Biol Psychol. 2009 Dec;82(3):267-73. doi: 10.1016/j.biopsycho.2009.08.006. Epub 2009 Aug 21.</citation>
      <PMID>19699775</PMID>
    </reference>
    <reference>
      <citation>Lyu HG, Davids JS, Scully RE, Melnitchouk N. Association of Domestic Responsibilities With Career Satisfaction for Physician Mothers in Procedural vs Nonprocedural Fields. JAMA Surg. 2019 Aug 1;154(8):689-695. doi: 10.1001/jamasurg.2019.0529.</citation>
      <PMID>30969336</PMID>
    </reference>
    <reference>
      <citation>Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.</citation>
      <PMID>3651732</PMID>
    </reference>
    <reference>
      <citation>Livingston-Rosanoff D, Shubeck SP, Kanters AE, Dossett LA, Minter RM, Wilke LG. Got Milk? Design and Implementation of a Lactation Support Program for Surgeons. Ann Surg. 2019 Jul;270(1):31-32. doi: 10.1097/SLA.0000000000003269. No abstract available.</citation>
      <PMID>30921050</PMID>
    </reference>
    <reference>
      <citation>Trockel MT, Menon NK, Rowe SG, Stewart MT, Smith R, Lu M, Kim PK, Quinn MA, Lawrence E, Marchalik D, Farley H, Normand P, Felder M, Dudley JC, Shanafelt TD. Assessment of Physician Sleep and Wellness, Burnout, and Clinically Significant Medical Errors. JAMA Netw Open. 2020 Dec 1;3(12):e2028111. doi: 10.1001/jamanetworkopen.2020.28111.</citation>
      <PMID>33284339</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
      <investigator_full_name>Erika Rangel, MD</investigator_full_name>
      <investigator_title>Associate Surgeon, Assistant Professor of Surgery</investigator_title>
    </responsible_party>
    <keyword>burnout</keyword>
    <keyword>postpartum depression</keyword>
    <keyword>lactation</keyword>
    <keyword>resident attrition</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Burnout, Professional</mesh_term>
      <mesh_term>Burnout, Psychological</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Individual participant data will not be shared as this it contains sensitive information that is best presented in aggregate to ensure anonymity of participants</ipd_description>
    </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/NCT06014892
  org study id: 2022P001157
  nct id: NCT06014892
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  The goal of this clinical trial is to determine the impact of a parental support package for
        new trainee mothers which focuses on mentorship, lactation, and sleep, and access to
        perinatal care. The main questions it aims to answer are whether this set of interventions
        will improve trainee wellbeing and decrease medical error.
  
        Participants will be randomized to intervention and control groups. The intervention group
        will receive:
  
          1. A Snoo smart sleep bassinet
  
          2. A Willow wearable breast pump
  
          3. Access to Maven Clinic for 24/7 on-demand perinatal care
  
          4. A faculty mentor in their own department
  
        The control group will receive the standard support currently offered by training programs.
  
        All participants will wear a Fitbit to track sleep and will take a series of surveys querying
        pregnancy, birth, and postpartum experiences; wellbeing; and professional satisfaction.
  
        Researchers will compare intervention and control groups to see if the intervention group
        has:
  
          1. decreased rates of burnout
  
          2. increased professional fulfillment
  
          3. decreased thoughts of leaving the profession
  
          4. increased perception of organizational and personal value alignment
  
          5. increased sleep
  
          6. decreased risk of medical errors
  
          7. increased personal fulfillment of breastfeeding goals
  
          8. decreased risk of postpartum depression
  The birth of a child during training is a significant life event that has been associated
        with a high risk of attrition and career dissatisfaction. Post-graduate training lasts
        between 3 and 9 years after medical school and overlaps with peak child-bearing years. The
        difficulties facing new trainee parents have been characterized with stigma, health concerns
        due to unmitigated work schedules during pregnancy, short parental leaves, and challenges
        with lactation and childcare contributing to stress and fatigue. Program directors describe
        marked variability in how childbearing affected residents' quality of work, with many
        describing returning residents as conflicted and distracted. The increase in family
        commitments in the setting of existing training demands can lead trainees to develop a
        perception of work-life incompatibility, fatigue, to change their career trajectory, and to
        have increased risk of burnout and postpartum depression. The investigators hypothesize that
        a set of interventions for new trainee mothers, focusing on mentorship, lactation, and sleep
        can improve trainee wellbeing and decrease the risk of medical errors.
  
        STUDY PROCEDURES:
  
        This study is designed as a prospective randomized clinical trial of pregnant trainees at
        Massachusetts General Hospital (MGH), Brigham and Women's Hospital (BWH), Boston Children's
        Hospital (BCH), and Beth Israel Deaconess Medical Center (BIDMC).
  
        Participants will be screened over the phone and consent to participate obtained in person.
        All participants will take the electronic pre-intervention assessment survey after consent.
        After completion of the pre-intervention assessment survey, participants will be randomized
        into either the control arm or the intervention arm and provided a wearable device to monitor
        sleep (for one week during pregnancy to establish a baseline and for 6 months after
        delivery).
  
        After delivery, all participants will take a set of surveys at 4,12,16,20,24, and 52 weeks
        postpartum querying obstetric and postpartum experiences; self-reported medical error;
        fatigue; wellbeing; and professional satisfaction.
  
        The intervention group will receive:
  
          1. A Snoo smart sleep bassinet
  
          2. A Willow wearable breast pump
  
          3. Access to Maven Clinic for 24/7 on-demand perinatal care
  
          4. A faculty mentor in their own department
  
        The control group will receive standard parental support currently offered by training
        programs.
  
        Researchers will compare the following between intervention and control groups:
  
          1. burnout
  
          2. professional fulfillment
  
          3. thoughts of leaving the profession
  
          4. perception of organizational and personal value alignment
  
          5. sleep and fatigue
  
          6. self-reported medical errors
  
          7. personal fulfillment of breastfeeding goals
  
          8. risk of postpartum depression
  
        The investigators plan to measure mean scores in burnout as our primary outcome. An effect
        size of 0.5 standard deviation change in burnout between the control and intervention arm is
        estimated to be a clinically relevant change. Trainees have mean burnout scores of 3.35
        (SD=2.05). 76 subjects in each arm are estimated to be needed, 152 participants total, to
        detect a statistically significant change in burnout score (by at least 1.025 using the
        SPFI), with 80% power with a two tailed alpha of 10%, and allowing for 20% attrition of study
        subjects.
  
        STATISTICAL ANALYSIS The investigators plan to report descriptive data including frequency,
        mean (SD) and median (inter-quartile range) for all outcome measures, using chi-squared
        analyses for categorical variables and t-test for continuous variables.
  
        Mass General Brigham (MGB) has more than 200 training programs across its training sites. Of
        the 27/200+ programs that responded to a brief survey through the Wellbeing Council, 76
        trainees (43 men and 33 women) became new parents this past academic year (2020-2021). Human
        Resources at MGB estimates more than 70 trainees apply for formal parental leave yearly which
        likely significantly underestimates the true number of new parents as most nonchildbearing
        parent trainees do not take formal parental leave. Based on this information, the
        investigators anticipate that the MGB training programs alone will have a sufficient number
        of trainees to conduct this study.
  
        STUDY TERMINATION CRITERIA:
  
        The study will be terminated at the request of the participant for any reason. Otherwise, the
        study will be terminated at 6 months. Subjects in the control arm who purchase a SNOO
        bassinet or a wearable breast pump will be requested to notify the study PI and will be
        categorized as a subgroup and analyzed in a planned sub-group analysis.
  
        MONITORING AND QUALITY ASSURANCE:
  
        To minimize the risk of loss of anonymity, participants will be assigned a unique study
        identifier. Access to files linking identifiers with identifying coded data will be limited
        only to need-to-know study personnel and stored in a Partners Password Protected online
        storage drive, while survey data will be obtained using Partners REDCap. Data will be
        accessible only to the PI and CITI-certified research staff. The Research staff will review
        the database each time new patient data is collected using a Partners password-protected
        computer and the PI will review the database once a month with details discussed at a monthly
        research meeting.
  
        Identifying information (name, email address, phone number, shipping address, and due date)
        will need to be released to the sponsoring companies to facilitate delivery of the automated
        bassinet (Happiest Baby Inc), wearable breast pump (Willow Innovations) and access to
        perinatal on-demand consultation (Maven Clinic). Data transfer will be performed via MGB
        approved password protected and encrypted mechanisms. Both companies have designated
        representatives that are HIPAA certified with no association to the study execution or
        analysis. Data access by the company representatives will require multi-factor identification
        for the single user who will be allowed access. The transferred information will be used to
        order study related equipment for participants. The data will be deleted from the secure
        electronic location at the conclusion of the study.
  
        Sleep tracking data is housed in secure Azure (Microsoft) servers. Fitabase uses Secure
        Sockets Layer (SSL) for all authentication (logins), billing, and administration of the site.
        The user's browser establishes the authenticity by requesting an SSL certificate that
        verifies the identity of Fitabase. Once that SSL certificate is recognized, a Secure Sockets
        Layer (SSL) connection is established for security, encrypting data transmitted between
        browser and web server.
  
        Participants will be asked in person or online to authorize use of Fitabase to access their
        wearable device data and make it available for download for analysis. Participants will be
        informed that research staff will be able to access, view, and download deidentified data
        through the Fitabase platform. Data collected will relate to sleep length, movement, and
        quality. There are two instances when the PI will revoke access to data associated with
        participants in this study. First, if a participant chooses to withdraw from the study, the
        PI will remove the participant from the study platform (Fitabase) and data will be removed
        from the study. Second, 90 days after the completion of data collection Fitabase will remove
        the project from their data management system, disassociate the data from the project, and
        begin remove access to the data by deleting it from its servers and backup systems.
  
        The PI will be responsible for determining whether the research should be altered or stopped.
        Throughout the duration of the study, the PI will perform ongoing evaluation of subject
        safety data to identify adverse events and trends as soon as possible. Any unanticipated
        adverse events involving risk to human subjects will be reviewed by the Principal
        Investigator and will be quickly reported to the Human Research Committee within the required
        time frame and to all participating investigators by The PI according to the Partners Human
        Research Committee guidelines.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This study is designed as a prospective randomized open-labeled study. We plan to enroll 152 trainees who are pregnant or immediately post-partum. Participants will undergo stratified randomization to an intervention or no intervention arm in a 1 to 1 ratio based on training specialty (either procedural or non-procedural) and training site (MGH, BWH, BCH, or BIDMC). Procedural specialties are defined as specialties that spend a significant portion of their training performing procedures: this includes all surgical specialties, anesthesiologists, gastroenterologists, obstetricians-gynecologists, interventional-radiologist, interventional-pulmonologists, interventional-cardiologists, emergency physicians. All other training programs are considered non-procedural specialties.
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Burnout measured by emotional exhaustion and Interpersonal Disengagement components of the Stanford Professional Fulfillment Index
  time frame: At Enrollment; 16 weeks postpartum; 24 weeks postpartum
  description: Emotional exhaustion and Interpersonal Disengagement are EACH scored on a scale of 0-10; The Emotional Exhaustion and Interpersonal Disengagement Scores are then averaged for score 0-10. Higher scores indicate higher likelihood of emotional exhaustion, interpersonal disengagement, and burnout (higher score is worse outcome)
  measure: Professional Fulfillment measured by the Stanford Professional Fulfillment Index
  time frame: At Enrollment; 16 weeks postpartum; 24 weeks postpartum; 1 year postpartum
  description: Professional Fulfillment is score on a scale of 0-10 with higher scores indicating a higher likelihood of professional fulfillment (higher score is better outcome)
  measure: Self reported medical error resulting in patient harm
  time frame: 4 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks postpartum
  description: Participants will be asked "Over the past 4 weeks, how many times did you make a medical error that did result in patient harm?". Participants will be given options of "0", "1", "2", "3", or "3 or more".
  measure: Self reported medical error resulting in near miss for patient harm
  time frame: 4 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks postpartum
  description: Participants will be asked "Over the past 4 weeks, how many times did you make a medical error that could have resulted in patient harm?". Participants will be given options of "0", "1", "2", "3", or "3 or more".
  measure: Organizational and Personal Values Alignment
  time frame: At Enrollment; 16 weeks postpartum; 24 weeks postpartum
  description: 3-item Stanford Values Alignment Scale. This validated instrument contains 3 statements with which participants are asked to indicate their agreement on a 5-point Likert Scale (0=not at all true; 4=completely true). Aggregate scores are determined by summing the 0-4 score of the individual items to yield a total score ranging from 0-12. Higher values are positive (indicate better alignment between organizational and personal values).
  measure: Negative Impact of Work on Personal Relationships
  time frame: At Enrollment; 16 weeks postpartum; 24 weeks postpartum
  description: 4-item Impact of Work on Personal Relationships scale. This validated scale contains 4 items to which responders are asked to indicate their level of agreement over the previous year on a 5-point Likert scale (0=not at all true;4=completely true). The scale score is calculated by determining the mean 0-4 score across the 4 items and normalizing the score to 0-10 scale with higher scores indicating worse outcomes (more adverse impact of work on personal relationships)
  measure: Postpartum Depression Screening
  time frame: At enrollment and at 16 weeks postpartum
  description: Edinburgh Postnatal Depression Scale. This validated scale includes 10 short statements to which respondents indicate their level of agreement in the past week. Each question is scored from 0-3 and the total score is found by adding the scores from each of the 10 items. The range of the scale is 0-30 with higher scores indicating worse outcome (higher likelihood of postpartum depression)
  measure: Ability to Meet Breastfeeding Goals
  time frame: 24 weeks postpartum
  description: Participants will be asked to answer the survey question, "Did you feel that you achieved your breastfeeding goal?". Participants will be able to respond "yes", "no", and "I am still breastfeeding and not sure if I will achieve my goal yet". Respondents who reply "no" indicate a worse outcome as they were unable to reach their personal goals for duration of breastfeeding.
  measure: Duration of Breastfeeding
  time frame: 24 weeks postpartum
  description: measured in months
  measure: Serious thoughts of quitting training program
  time frame: At enrollment, 16 weeks postpartum, and 24 weeks postpartum
  description: Participants will be asked to indicate their level of agreement (1: strongly agree; 5: strongly disagree) to the following statement: "I have considered leaving my program in the last year (due to the experience of pregnancy/parenthood in my current training specialty". Lower score indicates a worse outcome
  measure: Regret for a Medical Career
  time frame: At enrollment, 16 weeks postpartum and 24 weeks postpartum
  description: Participants will be asked to indicate their level of agreement (1: strongly agree; 5: strongly disagree) with the following statement: "If I could choose again, I would choose a non-medical career more accommodating of parenthood". Lower score indicates a worse outcome
  measure: Regret for a Chosen Specialty
  time frame: At enrollment, 16 weeks postpartum, and 24 weeks postpartum
  description: Participants will be asked to indicate their level of agreement (1: strongly agree; 5: strongly disagree) with the following statement: "If I could choose again, I would stay in medicine but choose a specialty more accommodating of parenthood than my current specialty". Lower score indicates a worse outcome
  measure: Nightly wakenings
  time frame: Daily for one week after enrollment, then daily from delivery date until 24 weeks postpartum
  description: The total number of minutes spent awake per sleep episode will be measured by a wearable Fitbit
  measure: Nightly sleep duration
  time frame: Daily for one week after enrollment, then daily from delivery date until 24 weeks postpartum
  description: The total number of minutes spent asleep per 24 hours will be measured by a wearable Fitbit
  measure: Fatigue
  time frame: 4 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks postpartum
  description: Adult 8-item Patient Reported Outcomes Measurement Information System (PROMIS) Sleep -Related Impairment Scale.The sleep-related impairment items assess sleepiness during the day and perceived effects on performance in the past 7 days. The scale items are scored on a 5-point Likert scale indicating intensity from "not at all" to "very much," and the raw scores range from 8 to 40 with high scores indicating worse outcomes (more fatigue).
  measure: Burnout measured by emotional exhaustion and Interpersonal Disengagement components of the Stanford Professional Fulfillment Index
  time frame: 12 months postpartum
  description: Burnout measured by emotional exhaustion and depersonalization components of the Emotional exhaustion and Interpersonal Disengagement are EACH scored on a scale of 0-10; The Emotional Exhaustion and Interpersonal Disengagement Scores are then averaged for score 0-10. Higher scores indicate higher likelihood of emotional exhaustion, interpersonal disengagement, and burnout (higher score is worse outcome)
  measure: Professional Fulfillment measured by the Stanford Professional Fulfillment Index
  time frame: 12 months postpartum
  description: Professional Fulfillment is score on a scale of 0-10 with higher scores indicating a higher likelihood of professional fulfillment (higher score is better outcome)
  measure: Organization and personal values alignment
  time frame: 12 months postpartum
  description: 3-item Stanford Values Alignment Scale. This validated instrument contains 3 statements with which participants are asked to indicate their agreement on a 5-point Likert Scale (0=not at all true; 4=completely true). Aggregate scores are determined by summing the 0-4 score of the individual items to yield a total score ranging from 0-12. Higher values are positive (indicate better alignment between organizational and personal values).
  measure: Negative Impact of Work on Personal Relationships
  time frame: 12 months postpartum
  description: 4-item Impact of Work on Personal Relationships scale. This validated scale contains 4 items to which responders are asked to indicate their level of agreement over the previous year on a 5-point Likert scale (0=not at all true;4=completely true). The scale score is calculated by determining the mean 0-4 score across the 4 items and normalizing the score to 0-10 scale with higher scores indicating worse outcomes (more adverse impact of work on personal relationships)
  measure: Ability to meet breastfeeding goals
  time frame: 12 months postpartum
  description: Participants will be asked to answer the survey question, "Did you feel that you achieved your breastfeeding goal?". Participants will be able to respond "yes", "no", and "I am still breastfeeding and not sure if I will achieve my goal yet". Respondents who reply "no" indicate a worse outcome as they were unable to reach their personal goals for duration of breastfeeding.
  measure: Duration of breastfeeding
  time frame: 12 months postpartum
  description: measured in months
  measure: Serious thoughts of quitting training program
  time frame: 12 months postpartum
  description: articipants will be asked to indicate their level of agreement (1: strongly agree; 5: strongly disagree) to the following statement: "I have considered leaving my program in the last year (due to the experience of pregnancy/parenthood in my current training specialty". Lower score indicates a worse outcome
  measure: Regret for a Medical Career
  time frame: 12 months postpartum
  description: Participants will be asked to indicate their level of agreement (1: strongly agree; 5: strongly disagree) with the following statement: "If I could choose again, I would choose a non-medical career more accommodating of parenthood". Lower score indicates a worse outcome
  measure: Regret for a Chosen Specialty
  time frame: 12 months postpartum
  description: Participants will be asked to indicate their level of agreement (1: strongly agree; 5: strongly disagree) with the following statement: "If I could choose again, I would stay in medicine but choose a specialty more accommodating of parenthood than my current specialty". Lower score indicates a worse outcome
  arm group label: Intervention
  arm group type: Experimental
  description: The intervention group will receive:
  A Snoo smart sleep bassinet
  A Willow wearable breast pump
  Access to Maven Clinic for 24/7 on-demand perinatal care
  A faculty mentor in their own department
  arm group label: Control
  arm group type: No Intervention
  description: The control arm will receive:
  Current standard in the residency training program.
  intervention type: Device
  intervention name: Snoo smart bassinet
  description: Participants in the intervention arm will be shipped a Snoo bassinet during their third trimester. The bassinet must be returned to the company at 6 months
  arm group label: Intervention
  intervention type: Device
  intervention name: Willow wearable breast pump
  description: Participants in the intervention arm will be shipped a Willow wearable breast pump and milk storage bags during the third trimester, which participants may keep
  arm group label: Intervention
  intervention type: Behavioral
  intervention name: Maven Clinic on-demand perinatal consultation
  description: Participants in the intervention arm will receive immediate access to Maven Clinic for 24/7 on-demand consultation with perinatal specialists.
  arm group label: Intervention
  intervention type: Behavioral
  intervention name: Faculty mentor
  description: After enrollment, participants in the intervention arm will be paired with a faculty mentor who is also a mother to discuss issues related to work-family integration during pregnancy and early infancy.
  arm group label: Intervention
  criteria: 
  gender: Female
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  citation: Rangel EL, Castillo-Angeles M, Easter SR, Atkinson RB, Gosain A, Hu YY, Cooper Z, Dey T, Kim E. Incidence of Infertility and Pregnancy Complications in US Female Surgeons. JAMA Surg. 2021 Oct 1;156(10):905-915. doi: 10.1001/jamasurg.2021.3301. Erratum In: JAMA Surg. 2021 Oct 1;156(10):991.
  PMID: 34319353
  citation: Rangel EL, Smink DS, Castillo-Angeles M, Kwakye G, Changala M, Haider AH, Doherty GM. Pregnancy and Motherhood During Surgical Training. JAMA Surg. 2018 Jul 1;153(7):644-652. doi: 10.1001/jamasurg.2018.0153.
  PMID: 29562068
  citation: Rangel EL, Lyu H, Haider AH, Castillo-Angeles M, Doherty GM, Smink DS. Factors Associated With Residency and Career Dissatisfaction in Childbearing Surgical Residents. JAMA Surg. 2018 Nov 1;153(11):1004-1011. doi: 10.1001/jamasurg.2018.2571.
  PMID: 30073246
  citation: Castillo-Angeles M, Smink DS, Rangel EL. Perspectives of US General Surgery Program Directors on Cultural and Fiscal Barriers to Maternity Leave and Postpartum Support During Surgical Training. JAMA Surg. 2021 Jul 1;156(7):647-653. doi: 10.1001/jamasurg.2021.1807.
  PMID: 34009280
  citation: West CP, Dyrbye LN, Shanafelt TD. Physician burnout: contributors, consequences and solutions. J Intern Med. 2018 Jun;283(6):516-529. doi: 10.1111/joim.12752. Epub 2018 Mar 24.
  PMID: 29505159
  citation: Dyrbye LN, West CP, Satele D, Boone S, Tan L, Sloan J, Shanafelt TD. Burnout among U.S. medical students, residents, and early career physicians relative to the general U.S. population. Acad Med. 2014 Mar;89(3):443-51. doi: 10.1097/ACM.0000000000000134.
  PMID: 24448053
  citation: Dyrbye LN, Freischlag J, Kaups KL, Oreskovich MR, Satele DV, Hanks JB, Sloan JA, Balch CM, Shanafelt TD. Work-home conflicts have a substantial impact on career decisions that affect the adequacy of the surgical workforce. Arch Surg. 2012 Oct;147(10):933-9. doi: 10.1001/archsurg.2012.835.
  PMID: 23117833
  citation: Stack SW, McKinney CM, Spiekerman C, Best JA. Childbearing and maternity leave in residency: determinants and well-being outcomes. Postgrad Med J. 2018 Dec;94(1118):694-699. doi: 10.1136/postgradmedj-2018-135960. Epub 2018 Dec 15.
  PMID: 30554173
  citation: Dyrbye LN, Burke SE, Hardeman RR, Herrin J, Wittlin NM, Yeazel M, Dovidio JF, Cunningham B, White RO, Phelan SM, Satele DV, Shanafelt TD, van Ryn M. Association of Clinical Specialty With Symptoms of Burnout and Career Choice Regret Among US Resident Physicians. JAMA. 2018 Sep 18;320(11):1114-1130. doi: 10.1001/jama.2018.12615.
  PMID: 30422299
  citation: Sandler BJ, Tackett JJ, Longo WE, Yoo PS. Pregnancy and Parenthood among Surgery Residents: Results of the First Nationwide Survey of General Surgery Residency Program Directors. J Am Coll Surg. 2016 Jun;222(6):1090-6. doi: 10.1016/j.jamcollsurg.2015.12.004. Epub 2015 Dec 18.
  PMID: 26776357
  citation: Melnitchouk N, Scully RE, Davids JS. Barriers to Breastfeeding for US Physicians Who Are Mothers. JAMA Intern Med. 2018 Aug 1;178(8):1130-1132. doi: 10.1001/jamainternmed.2018.0320.
  PMID: 29554184
  citation: Peters GW, Kuczmarska-Haas A, Holliday EB, Puckett L. Lactation challenges of resident physicians- results of a national survey. BMC Pregnancy Childbirth. 2020 Dec 9;20(1):762. doi: 10.1186/s12884-020-03436-3.
  PMID: 33297993
  citation: Kancherla BS, Upender R, Collen JF, Rishi MA, Sullivan SS, Ahmed O, Berneking M, Flynn-Evans EE, Peters BR, Gurubhagavatula I. What is the role of sleep in physician burnout? J Clin Sleep Med. 2020 May 15;16(5):807-810. doi: 10.5664/jcsm.8412. Epub 2020 Feb 28.
  PMID: 32108567
  citation: Ekstedt M, Soderstrom M, Akerstedt T. Sleep physiology in recovery from burnout. Biol Psychol. 2009 Dec;82(3):267-73. doi: 10.1016/j.biopsycho.2009.08.006. Epub 2009 Aug 21.
  PMID: 19699775
  citation: Lyu HG, Davids JS, Scully RE, Melnitchouk N. Association of Domestic Responsibilities With Career Satisfaction for Physician Mothers in Procedural vs Nonprocedural Fields. JAMA Surg. 2019 Aug 1;154(8):689-695. doi: 10.1001/jamasurg.2019.0529.
  PMID: 30969336
  citation: Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
  PMID: 3651732
  citation: Livingston-Rosanoff D, Shubeck SP, Kanters AE, Dossett LA, Minter RM, Wilke LG. Got Milk? Design and Implementation of a Lactation Support Program for Surgeons. Ann Surg. 2019 Jul;270(1):31-32. doi: 10.1097/SLA.0000000000003269. No abstract available.
  PMID: 30921050
  citation: Trockel MT, Menon NK, Rowe SG, Stewart MT, Smith R, Lu M, Kim PK, Quinn MA, Lawrence E, Marchalik D, Farley H, Normand P, Felder M, Dudley JC, Shanafelt TD. Assessment of Physician Sleep and Wellness, Burnout, and Clinically Significant Medical Errors. JAMA Netw Open. 2020 Dec 1;3(12):e2028111. doi: 10.1001/jamanetworkopen.2020.28111.
  PMID: 33284339
  responsible party type: Principal Investigator
  investigator affiliation: Massachusetts General Hospital
  investigator full name: Erika Rangel, MD
  investigator title: Associate Surgeon, Assistant Professor of Surgery
  mesh term: Burnout, Professional
  mesh term: Burnout, Psychological
  sharing ipd: No
  ipd description: Individual participant data will not be shared as this it contains sensitive information that is best presented in aggregate to ensure anonymity of participants