Emotion Regulation and Burnout Impact on Communication Documentation

NCT03901547 | Withdrawn

• 1 other identifier: D19033
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Communication

Keywords

documentation; serious illness

Outcome Measures

Primary Outcomes (1)

• Template use at 12 months

  Documentation events in the electronic medical record using the dot-phrase or electronic template for the serious illness conversation guide

  12 months following training

Secondary Outcomes (5)

• post-intervention self-rated confidence

  Pre intervention and 4 months post intervention

• performance in simulated patient encounters

  Intervention start, 2 weeks and 6 months

• semi-structured interview responses

  4 months

• emotion regulation skills

  start, 6 months and 12 months

• Change in Burnout

  Baseline, 6 months and 12 months

Study Arms (2)

Education and Documentation (Tier 1)

OTHER

Education only. Participants who do not wish to enroll in the behavioral observation group are followed in the education only. This includes participation in a two week palliative medicine elective which is a part of the medical trainees training and training in the serious illness communication guide (SICG). Participants can opt out of the pre and post training confidence surveys, and simulated patient encounters. Electronic documentation of the SICG by these trainees will be monitored prospectively. Participants will be provided reminders and profile information on their own documentation rate of the SICG via email and have the ability to opt out of receiving emails if they wish.

Behavioral: Communication Skills Training; Behavioral: Profile feedback

Priming and additional measures (Tier 2)

OTHER

Education and behavioral observation cohort. These participants must sign an informed consent to participate in this part of the study. In addition to all of Tier 1 activities, participants also complete psychological inventories at three time points to measure emotion regulation and burnout, and participate in a semi-structured interview.

Behavioral: Communication Skills Training; Behavioral: Profile feedback; Other: Maslach burnout inventory; Other: Emotion Regulation Skills Question (ERSQ); Other: Semi-structured interview; Behavioral: Priming

Interventions

Communication Skills Training BEHAVIORAL

Education training in the serious illness communication guide (SICG) by Ariadne labs.

Education and Documentation (Tier 1); Priming and additional measures (Tier 2)

Profile feedback BEHAVIORAL

Providing participants their personal documentation rate of SICG in the electronic medical record

Education and Documentation (Tier 1); Priming and additional measures (Tier 2)

Maslach burnout inventory OTHER

Maslach burnout inventory

Priming and additional measures (Tier 2)

Emotion Regulation Skills Question (ERSQ) OTHER

This validated instrument consists of 27 items, and includes subscales related to nine competencies of coping with negative emotion (awareness, sensations, clarity, understanding, acceptance, tolerance, readiness to confront, compassionate self-support and modification) which can be summed to a total score (TOTAL). This validated instrument consists of 27 items, and includes subscales related to nine competencies of coping with negative emotion (awareness, sensations, clarity, understanding, acceptance, tolerance, readiness to confront, compassionate self-support and modification) which can be summed to a total score (TOTAL).

Priming and additional measures (Tier 2)

Semi-structured interview OTHER

Interviewer asked subjects are a series of questions based on interview guide. Current guide designed to assess subject perception of implementation of training in clinical encounters, most recent encounter with patient with serious illness, barriers to documentation and coaching by faculty on communication. Interviews will be recorded and expected duration is 20-40 minutes.

Priming and additional measures (Tier 2)

Priming BEHAVIORAL

Participants will be provided a list of 30 patients they have encountered before that 1) have at least one documented note and 2) have a high probability for having serious illness as determined by electronic medical record screening. Participants will be asked 4 "yes or no" questions on each patient. Questions: 1) do you believe this patient has serious illness?; 2) would you be surprised if this patient died in the next year?; 3) would the patient benefit from the serious illness conversation guide? and 4) If you saw this patient again, would you use the serious illness conversation guide with him/ her?

Priming and additional measures (Tier 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

Related Publications (3)

• 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.

  PMID: 26443662 BACKGROUND

• 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.

  PMID: 22406495 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Communication

Interventions

Maslach Burnout Inventory

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Garrett T Wasp, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow, GME Hematology-Oncology

Model Details: 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.

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 3, 2019
• Study Start: September 15, 2019
• Primary Completion: May 30, 2021
• Study Completion: January 1, 2022
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)