Clinical trial NCT06014892: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pregnancy Related
Burnout, Professional
Wellness, Psychological
Keywords: burnout
postpartum depression
lactation
resident attrition
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Boston Children's Hospital
name: Beth Israel Deaconess Medical Center
First posted: 2023-08-28
Enrollment: 152
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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:

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

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:

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.

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.

Primary outcomes:
measure: Burnout measured by emotional exhaustion and Interpersonal Disengagement components of the Stanford Professional Fulfillment Index
timeFrame: At Enrollment; 16 weeks postpartum; 24 weeks postpartum
Secondary outcomes:
measure: Professional Fulfillment measured by the Stanford Professional Fulfillment Index
timeFrame: At Enrollment; 16 weeks postpartum; 24 weeks postpartum; 1 year postpartum
measure: Self reported medical error resulting in patient harm
timeFrame: 4 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks postpartum
measure: Self reported medical error resulting in near miss for patient harm
timeFrame: 4 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks postpartum
measure: Organizational and Personal Values Alignment
timeFrame: At Enrollment; 16 weeks postpartum; 24 weeks postpartum
measure: Negative Impact of Work on Personal Relationships
timeFrame: At Enrollment; 16 weeks postpartum; 24 weeks postpartum
measure: Postpartum Depression Screening
timeFrame: At enrollment and at 16 weeks postpartum
measure: Ability to Meet Breastfeeding Goals
timeFrame: 24 weeks postpartum
measure: Duration of Breastfeeding
timeFrame: 24 weeks postpartum
measure: Serious thoughts of quitting training program
timeFrame: At enrollment, 16 weeks postpartum, and 24 weeks postpartum
measure: Regret for a Medical Career
timeFrame: At enrollment, 16 weeks postpartum and 24 weeks postpartum
measure: Regret for a Chosen Specialty
timeFrame: At enrollment, 16 weeks postpartum, and 24 weeks postpartum
measure: Nightly wakenings
timeFrame: Daily for one week after enrollment, then daily from delivery date until 24 weeks postpartum
measure: Nightly sleep duration
timeFrame: Daily for one week after enrollment, then daily from delivery date until 24 weeks postpartum
measure: Fatigue
timeFrame: 4 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks postpartum
Other outcomes:
measure: Burnout measured by emotional exhaustion and Interpersonal Disengagement components of the Stanford Professional Fulfillment Index
timeFrame: 12 months postpartum
measure: Professional Fulfillment measured by the Stanford Professional Fulfillment Index
timeFrame: 12 months postpartum
measure: Organization and personal values alignment
timeFrame: 12 months postpartum
measure: Negative Impact of Work on Personal Relationships
timeFrame: 12 months postpartum
measure: Ability to meet breastfeeding goals
timeFrame: 12 months postpartum
measure: Duration of breastfeeding
timeFrame: 12 months postpartum
measure: Serious thoughts of quitting training program
timeFrame: 12 months postpartum
measure: Regret for a Medical Career
timeFrame: 12 months postpartum
measure: Regret for a Chosen Specialty
timeFrame: 12 months postpartum
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
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.
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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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.