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The 4th Trimester Initiative: The Impact of Parental Support on Pregnant Trainee Wellbeing

Primary Purpose

Pregnancy Related, Burnout, Professional, Wellness, Psychological

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Snoo smart bassinet
Willow wearable breast pump
Maven Clinic on-demand perinatal consultation
Faculty mentor
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pregnancy Related focused on measuring burnout, postpartum depression, lactation, resident attrition

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Currently pregnant Part of a residency or fellowship training program at MGH, BWH, BCH, or BIDMC during pregnancy and for 6 months postpartum Clinically active and will remain clinically active until 6 months postpartum Exclusion Criteria: significant cardiopulmonary, gastrointestinal, or neurologic comorbidities in participant or her fetus on research elective or dedicated research time from time of enrollment until 6 months postpartum.

Sites / Locations

  • Massachusetts General HospitalRecruiting
  • Beth Israel Deaconess Medical CenterRecruiting
  • Boston Children's HospitalRecruiting
  • Brigham and Women's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm 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

The control arm will receive: Current standard in the residency training program.

Outcomes

Primary Outcome Measures

Burnout measured by emotional exhaustion and Interpersonal Disengagement components of the Stanford Professional Fulfillment Index
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)

Secondary Outcome Measures

Professional Fulfillment measured by the Stanford Professional Fulfillment Index
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)
Self reported medical error resulting in patient harm
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".
Self reported medical error resulting in near miss for patient harm
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".
Organizational and Personal Values Alignment
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).
Negative Impact of Work on Personal Relationships
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)
Postpartum Depression Screening
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)
Ability to Meet Breastfeeding Goals
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.
Duration of Breastfeeding
measured in months
Serious thoughts of quitting training program
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
Regret for a Medical Career
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
Regret for a Chosen Specialty
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
Nightly wakenings
The total number of minutes spent awake per sleep episode will be measured by a wearable Fitbit
Nightly sleep duration
The total number of minutes spent asleep per 24 hours will be measured by a wearable Fitbit
Fatigue
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).

Full Information

First Posted
August 11, 2023
Last Updated
August 22, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Brigham and Women's Hospital, Boston Children's Hospital, Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT06014892
Brief Title
The 4th Trimester Initiative: The Impact of Parental Support on Pregnant Trainee Wellbeing
Official Title
The 4th Trimester Initiative: The Impact of Parental Support on Pregnant Trainee Wellbeing
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2023 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Brigham and Women's Hospital, Boston Children's Hospital, Beth Israel Deaconess Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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: 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 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: decreased rates of burnout increased professional fulfillment decreased thoughts of leaving the profession increased perception of organizational and personal value alignment increased sleep decreased risk of medical errors increased personal fulfillment of breastfeeding goals decreased risk of postpartum depression
Detailed Description
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: 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 The control group will receive standard parental support currently offered by training programs. Researchers will compare the following between intervention and control groups: burnout professional fulfillment thoughts of leaving the profession perception of organizational and personal value alignment sleep and fatigue self-reported medical errors personal fulfillment of breastfeeding goals 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related, Burnout, Professional, Wellness, Psychological
Keywords
burnout, postpartum depression, lactation, resident attrition

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
152 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm 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 Title
Control
Arm Type
No Intervention
Arm Description
The control arm will receive: Current standard in the residency training program.
Intervention Type
Device
Intervention Name(s)
Snoo smart bassinet
Intervention 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
Intervention Type
Device
Intervention Name(s)
Willow wearable breast pump
Intervention 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
Intervention Type
Behavioral
Intervention Name(s)
Maven Clinic on-demand perinatal consultation
Intervention Description
Participants in the intervention arm will receive immediate access to Maven Clinic for 24/7 on-demand consultation with perinatal specialists.
Intervention Type
Behavioral
Intervention Name(s)
Faculty mentor
Intervention 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.
Primary Outcome Measure Information:
Title
Burnout measured by emotional exhaustion and Interpersonal Disengagement components of the Stanford Professional Fulfillment Index
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)
Time Frame
At Enrollment; 16 weeks postpartum; 24 weeks postpartum
Secondary Outcome Measure Information:
Title
Professional Fulfillment measured by the Stanford Professional Fulfillment Index
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)
Time Frame
At Enrollment; 16 weeks postpartum; 24 weeks postpartum; 1 year postpartum
Title
Self reported medical error resulting in patient harm
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".
Time Frame
4 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks postpartum
Title
Self reported medical error resulting in near miss for patient harm
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".
Time Frame
4 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks postpartum
Title
Organizational and Personal Values Alignment
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).
Time Frame
At Enrollment; 16 weeks postpartum; 24 weeks postpartum
Title
Negative Impact of Work on Personal Relationships
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)
Time Frame
At Enrollment; 16 weeks postpartum; 24 weeks postpartum
Title
Postpartum Depression Screening
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)
Time Frame
At enrollment and at 16 weeks postpartum
Title
Ability to Meet Breastfeeding Goals
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.
Time Frame
24 weeks postpartum
Title
Duration of Breastfeeding
Description
measured in months
Time Frame
24 weeks postpartum
Title
Serious thoughts of quitting training program
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
Time Frame
At enrollment, 16 weeks postpartum, and 24 weeks postpartum
Title
Regret for a Medical Career
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
Time Frame
At enrollment, 16 weeks postpartum and 24 weeks postpartum
Title
Regret for a Chosen Specialty
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
Time Frame
At enrollment, 16 weeks postpartum, and 24 weeks postpartum
Title
Nightly wakenings
Description
The total number of minutes spent awake per sleep episode will be measured by a wearable Fitbit
Time Frame
Daily for one week after enrollment, then daily from delivery date until 24 weeks postpartum
Title
Nightly sleep duration
Description
The total number of minutes spent asleep per 24 hours will be measured by a wearable Fitbit
Time Frame
Daily for one week after enrollment, then daily from delivery date until 24 weeks postpartum
Title
Fatigue
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).
Time Frame
4 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks postpartum
Other Pre-specified Outcome Measures:
Title
Burnout measured by emotional exhaustion and Interpersonal Disengagement components of the Stanford Professional Fulfillment Index
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)
Time Frame
12 months postpartum
Title
Professional Fulfillment measured by the Stanford Professional Fulfillment Index
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)
Time Frame
12 months postpartum
Title
Organization and personal values alignment
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).
Time Frame
12 months postpartum
Title
Negative Impact of Work on Personal Relationships
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)
Time Frame
12 months postpartum
Title
Ability to meet breastfeeding goals
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.
Time Frame
12 months postpartum
Title
Duration of breastfeeding
Description
measured in months
Time Frame
12 months postpartum
Title
Serious thoughts of quitting training program
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
Time Frame
12 months postpartum
Title
Regret for a Medical Career
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
Time Frame
12 months postpartum
Title
Regret for a Chosen Specialty
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
Time Frame
12 months postpartum

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Currently pregnant Part of a residency or fellowship training program at MGH, BWH, BCH, or BIDMC during pregnancy and for 6 months postpartum Clinically active and will remain clinically active until 6 months postpartum Exclusion Criteria: significant cardiopulmonary, gastrointestinal, or neurologic comorbidities in participant or her fetus on research elective or dedicated research time from time of enrollment until 6 months postpartum.
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
The 4th Trimester Initiative Study Team
Phone
617-831-7824
Email
the4thtrimesterinitiative@mgb.org
First Name & Middle Initial & Last Name & Degree
Erika Rangel, MD
Phone
617-831-7824
Email
erangel@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Erika Rangel, MD
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huma Farid, MD
Phone
781-453-7240
Email
hfarid@bidmc.harvard.edu
First Name & Middle Initial & Last Name & Degree
Huma Farid, MD
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ariel Winn, MD
Phone
617-355-7584
Email
Ariel.Winn@childrens.harvard.edu
First Name & Middle Initial & Last Name & Degree
Ariel Winn, MD
First Name & Middle Initial & Last Name & Degree
Christopher Landrigan, MD
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Douglas S Smink, MD
Phone
617-983-7862
Email
dsmink@bwh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Douglas S Smink, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan 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
Citations:
PubMed Identifier
34319353
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.
Results Reference
background
PubMed Identifier
29562068
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.
Results Reference
background
PubMed Identifier
30073246
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.
Results Reference
background
PubMed Identifier
34009280
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.
Results Reference
background
PubMed Identifier
29505159
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.
Results Reference
background
PubMed Identifier
24448053
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.
Results Reference
background
PubMed Identifier
23117833
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.
Results Reference
background
PubMed Identifier
30554173
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.
Results Reference
background
PubMed Identifier
30422299
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.
Results Reference
background
PubMed Identifier
26776357
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.
Results Reference
background
PubMed Identifier
29554184
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.
Results Reference
background
PubMed Identifier
33297993
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.
Results Reference
background
PubMed Identifier
32108567
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.
Results Reference
background
PubMed Identifier
19699775
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.
Results Reference
background
PubMed Identifier
30969336
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.
Results Reference
background
PubMed Identifier
3651732
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.
Results Reference
background
PubMed Identifier
30921050
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.
Results Reference
background
PubMed Identifier
33284339
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.
Results Reference
background

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The 4th Trimester Initiative: The Impact of Parental Support on Pregnant Trainee Wellbeing

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