Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04305886
Other study ID # 2018P000415
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2018
Est. completion date September 30, 2018

Study information

Verified date March 2020
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A randomized trial of an interprofessional intervention to reduce burnout and enhance professional engagement in physicians, certified nurse midwives, and nurse practitioners.


Description:

To test the hypothesis that an intervention involving self-facilitated interprofessional group meetings would result in improvement in wellbeing and to determine whether use of a written curriculum provided increased benefit, the following study is conducted:

Practicing clinical faculty in the Department of Obstetrics and Gynecology at the Massachusetts General Hospital were recruited to participate in three monthly small groups over dinner. Participants were randomized to a control group, which met without any specified guidelines for discussion content, or to receive an intervention which consisted of a one-page discussion guide addressing themes relevant to challenges in the healthcare environment: reframing challenging patient interactions; embracing uncertainty in work; and coping with errors, near misses, and bad outcomes. Outcomes included burnout, empowerment and engagement in work, stress from uncertainty assessed using validated metrics, and perception of of collegiality and community.

All participants were also offered the option of participating in evaluation of biomarkers. To test the hypothesis that an increased sense of bonding and relational connection, and reduced stress levels would be reflected by changes in hormone levels during the meeting and over the course of the study. Faculty who opted into this portion of the study gave the following samples:

Urine Oxytocin before and after the first and third group meetings Salivary Oxytocin before and after the first and third group meetings Salivary Cortisol before and after the first and third group meetings Hair Cortisol at the beginning of the study and at the end of the study (a roughly three month interval).

An optional focus group was conducted after the three monthly sessions.

All participants signed a consent form prior to participating in the study.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date September 30, 2018
Est. primary completion date September 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Physican in the Department of Obstetrics and Gynecology at Massachusetts General Hospital

- Nurse Practitioner in the Department of Obstetrics and Gynecology at Massachusetts General Hospital

- Certified Nurse Midwife in the Department of Obstetrics and Gynecology at Massachusetts General Hospital

Exclusion Criteria:

- None

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Discussion Guide
Written list of prompts to facilitate discussion

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Burnout Change from baseline in 2 item Maslach Burnout Inventory scores before and after the intervention.
Minimum score: 2; Maximum score: 14 Higher score = more burnt out (worse outcome)
Change over the three month study period. Baseline measurement and immediately after final intervention.
Primary Stress from Uncertainty Change in scores on Physician Response to Uncertainty Scale before and after intervention Minimum score: 6; Maximum score: 90 Higher score = increased stress due to uncertainty (worse outcome) Change over the three month study period. Baseline measurement and immediately after final intervention.
Primary Work Engagement Change in scores on Utrecht Work Engagement Scale before and after intervention Minimum score: 0; Maximum score: 54 Higher score = higher engagement at work (better outcome) Change over the three month study period. Baseline measurement and immediately after final intervention.
Primary Urine oxytocin Change from baseline in the level of urine oxytocin before and after each intervention. This is an exploratory study so the maximum and minimum values are not known, and any change up or down is interesting. Two samples were taken one hour apart at baseline, and this was repeated three months later.
Primary Salivary Oxytocin Change from baseline in the level of salivary oxytocin before and after each intervention. This is an exploratory study so the maximum and minimum values are not known, and any change up or down is interesting. Two samples were taken one hour apart at baseline, and this was repeated three months later
Primary Salivary Cortisol Change from baseline in the level of salivary cortisol before and after each intervention. This is an exploratory study so the maximum and minimum values are not known, and any change up or down is interesting. Two samples were taken one hour apart at baseline, and this was repeated three months later
Primary Hair Cortisol Change from baseline in hair cortisol levels. Maximum and minimum levels are not known and any change up or down is interesting. Change over the three month study period. Baseline measurement and immediately after final intervention.
Primary Work Empowerment Scale Minimum score: 12; Maximum score: 84 Change from baseline on Work Empowerment Scale before and after intervention. Higher score = higher empowerment at work (better outcome) Change over the three month study period. Baseline measurement and immediately after final intervention.
See also
  Status Clinical Trial Phase
Completed NCT03614390 - Mindfulness for Medical Students N/A
Completed NCT05472935 - Asynchronous Mindfulness Based Stress Reduction to Reduce Burnout in Licensed Clinical Social Workers N/A
Completed NCT03473353 - Doctor-Parent Interactions With Medical Scribes N/A
Recruiting NCT05483335 - Assessing Burnout in Medical Students in Clerkship Years in United Arab Emirates
Terminated NCT04132141 - VR Breaks on Shift-worker Alertness N/A
Completed NCT05519267 - Mindfulness-based Social Work and Self-Care (MBSWSC) N/A
Not yet recruiting NCT04665505 - Resource Optimization in the Intensive Care Unit Setting N/A
Completed NCT02455947 - IBSR Meditation Technique for Teachers' Burnout N/A
Completed NCT01234961 - Outcome Study of the ReDO Intervention for Women With Stress-related Disorders N/A
Completed NCT04004806 - Tracking Device Guided Feedback to Enhance Patient Physician Interaction N/A
Completed NCT04129632 - Evaluation of Institutional Resources and a Novel Mindfulness Tool on Burnout Intensity N/A
Completed NCT03303482 - A Randomized Controlled Trial of Trauma-awareness Training for Early Childhood Educators N/A
Recruiting NCT05011435 - Assessment of the Feasibility of Using a Smartphone Application for the Prevention and Screening of Burnout (BURNOUT ADVICE)
Active, not recruiting NCT04517136 - Impact of Perceived Control on Operational Strain: a Study of COVID-19 Pandemic Caregivers and Military Personnel on Operational Missions
Active, not recruiting NCT05387746 - Integrative Self-care Approaches for HCP Wellbeing N/A
Completed NCT05222685 - Better Together Physician Coaching: An Innovative Solution to Medical Trainee Burnout N/A
Completed NCT02544412 - A Well-being Training for Preservice Teachers N/A
Completed NCT04466423 - Intervention Trial to Increase Meaning in Work and Reduce Burnout N/A
Completed NCT03475290 - Internet-Based Intervention for Occupational Stress Among Medical Professionals N/A
Completed NCT05538650 - RCT: Mindfulness for Social Work and Self-care N/A