Clinical trial NCT03901547: Emotion Regulation and Burnout Impact on Communication Documentation
Official title: An Education and Behavioral, Single-center, Observational Cohort Study Evaluating the Effect of Emotion Regulation and Burnout on Medical Trainees' Learning and Documentation of Serious Illness Communication
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Communication
Keywords: documentation
serious illness
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Both groups get the same education intervention. Tier two gets additional measurement intervention and one additional system based intervention (e.g. priming) that Tier 1 does not.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a single-institution cohort study with two tiers. All participants receive the interventions in Tier 1. Tier 1 is an education study where participants can complete electronic surveys on their pre and post intervention confidence, perform two simulated patient encounters and have their documentation of electronic template monitored longitudinally over 12 months. Participants are free to opt out of any activity related to education assessment or system-based interventions to promote the use of learned skills (e.g. priming or profile feedback). Signed informed consent will Not be required for this tier. Tier 2 includes additional measurements to the Tier 1 activities, and a priming intervention (e.g. provided the names of patients they have have). Participants in Tier 2 complete psychological inventories at three time points to measure emotion regulation and burnout, and participate in a semi-structured interview. after completing the training, they will complete a "priming" intervention. The investigators will require signed informed consent to participate in Tier 2.

Detailed description: Before Communication Training Activities Tier 1 (education-only subjects): Three to four weeks prior to the subject's two-week palliative care elective they will be sent an email to complete an online confidence survey. They will receive email reminders to complete the survey until survey is completed.

Tier 2 (education + psychological measurements of subjects): Subjects will have reviewed and signed consent documentation. In addition to the above online confidence survey, they will also receive email to complete electronic ERSQ and MBI.

Two week palliative care elective Tier 1 - Integrated into the two-week elective with the palliative care department, subjects undergo a 1) four-hour training focused on the SICG©; 2) two simulated patient encounters with trained actors and feedback provided after training, 3) participant sent electronic notification to take post intervention survey of confidence Tier 2 - In addition to above, these subjects will also complete a Priming intervention. They will receive a list of patients whom 1) the study subjected documented at least one note on in the past and 2) have a high likelihood of serious illness as determined by an electronic process. This list will be shared securely through Dartmouth secure file electronically, and participants will be asked four "yes or no" questions for each patient: 1) do they believe the patient has serious illness?; 2) would you be surprised if the patient died within the next year?, 3) Is this patient an appropriate patient to use the serious illness conversation guide? and 4) If you saw this patient again, would you use the serious illness conversation guide with him/ her? Subjects will be asked to review no more than 30 patients. Subjects will be asked to return the completed email via Dartmouth secure file share.

Electronic communication every two months following completion of elective Tier 1 - Every two months after completing the training, participants will receive email compare his or her own documentation of the taught template to top and average performers (comparison results given are anonymous). Non-top and top performers will receive different messages, customized through pre-testing with non-study residents and fellows. For example: "Talking to patients about their values is important but can take some pre-visit planning. Choose a patient you will see in the next two weeks to use the SICG" (non top-performers) or "Good job! Talking to patients about their values is important. The way we continue to improve is by having more conversations. Choose a patient you will see in the next two weeks to use the SICG." (top-performers). At four months, subjects will be asked electronically to complete their final confidence survey.

Tier 2 - For this part of the study, identical to Tier 1

Semi-structured interviews Tier 2 only - Planned to occur about three months following training. Subjects are asked a series of questions designed to assess subject perception of serious illness communication, obstacles to implementing the training in practice, barriers to documentation and coaching sessions in real patient encounters with trained faculty. Interviews will be recorded, and expected duration is 20-40 minutes.

Simulated Patient encounter at six months Tier 1 - Subject is contacted to arrange one-hour for simulated patient encounter, about 20-30 minutes for skill practice and the remainder for debrief. Subject has permission from program to have this hour to be away from their clinical duties.

Tier 2 - identical to Tier 1.

Six and 12 month ERSQ and MBI assessment Tier 2 only - emails will be sent to subject to take ERSQ and MBI at month six and 12 following training

Eligibility criteria: Inclusion Criteria:

* All second year (PGY-2) internal medicine residents
* All hematology-oncology fellows

Exclusion Criteria:

* Missed more than five days of the palliative care education elective

Primary outcomes:
measure: Template use at 12 months
timeFrame: 12 months following training
Secondary outcomes:
measure: post-intervention self-rated confidence
timeFrame: Pre intervention and 4 months post intervention
measure: performance in simulated patient encounters
timeFrame: Intervention start, 2 weeks and 6 months
measure: semi-structured interview responses
timeFrame: 4 months
measure: emotion regulation skills
timeFrame: start, 6 months and 12 months
measure: Change in Burnout
timeFrame: Baseline, 6 months and 12 months
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Garrett T Wasp, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bernacki R, Hutchings M, Vick J, Smith G, Paladino J, Lipsitz S, Gawande AA, Block SD. Development of the Serious Illness Care Program: a randomised controlled trial of a palliative care communication intervention. BMJ Open. 2015 Oct 6;5(10):e009032. doi: 10.1136/bmjopen-2015-009032.
citation: Berking M, Poppe C, Luhmann M, Wupperman P, Jaggi V, Seifritz E. Is the association between various emotion-regulation skills and mental health mediated by the ability to modify emotions? Results from two cross-sectional studies. J Behav Ther Exp Psychiatry. 2012 Sep;43(3):931-7. doi: 10.1016/j.jbtep.2011.09.009. Epub 2011 Nov 27.
citation: Ebert DD, Christ O, Berking M. Entwicklung und validierung eines fragebogens zur emotionsspezifischen selbsteinschätzung emotionaler kompetenzen (SEK-ES). Diagnostica. 2013;59(1):17-32. doi:10.1026/0012-1924/a000079.