The 4th Trimester Initiative: The Impact of Parental Support on Pregnant Trainee Wellbeing
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 156
- Locations
- 4
- Primary Endpoint
- Burnout measured by emotional exhaustion and Interpersonal Disengagement components of the Stanford Professional Fulfillment Index
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Intervention
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
Intervention: Snoo smart bassinet (Device)
Intervention
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
Intervention: Willow wearable breast pump (Device)
Intervention
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
Intervention: Maven Clinic on-demand perinatal consultation (Behavioral)
Intervention
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
Intervention: Faculty mentor (Behavioral)
Control
The control arm will receive:
Current standard in the residency training program.
Outcomes
Primary Outcomes
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
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 Outcomes
- Self reported medical error resulting in patient harm(4 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks postpartum)
- Self reported medical error resulting in near miss for patient harm(4 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks postpartum)
- Regret for a Medical Career(At enrollment, 16 weeks postpartum and 24 weeks postpartum)
- Nightly wakenings(Daily for one week after enrollment, then daily from delivery date until 24 weeks postpartum)
- Organizational and Personal Values Alignment(At Enrollment; 16 weeks postpartum; 24 weeks postpartum)
- Negative Impact of Work on Personal Relationships(At Enrollment; 16 weeks postpartum; 24 weeks postpartum)
- Fatigue(4 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks postpartum)
- Professional Fulfillment measured by the Stanford Professional Fulfillment Index(At Enrollment; 16 weeks postpartum; 24 weeks postpartum; 1 year postpartum)
- Ability to Meet Breastfeeding Goals(24 weeks postpartum)
- Regret for a Chosen Specialty(At enrollment, 16 weeks postpartum, and 24 weeks postpartum)
- Postpartum Depression Screening(At enrollment and at 16 weeks postpartum)
- Nightly sleep duration(Daily for one week after enrollment, then daily from delivery date until 24 weeks postpartum)
- Duration of Breastfeeding(24 weeks postpartum)
- Serious thoughts of quitting training program(At enrollment, 16 weeks postpartum, and 24 weeks postpartum)
Investigators
Erika Rangel, MD
Associate Surgeon, Assistant Professor of Surgery
Massachusetts General Hospital