NCT02129283

Brief Summary

The purpose of this study is to determine whether end-of-life training of ICU professionals leads to improvements in ICU care process, teamwork and family satisfaction.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2014

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 2, 2014

Status Verified

April 1, 2014

Enrollment Period

2 years

First QC Date

April 28, 2014

Last Update Submit

April 30, 2014

Conditions

Keywords

physicians, nurses, ICU, end-of-life, simulation training

Outcome Measures

Primary Outcomes (1)

  • Change in ICU care process in an ICU from baseline

    Additional information about the outcome measure- Other parameters for ICU care process include physician or nurse asking about patient preferences, documentation of patient and/or surrogate preferences, documented family conferences, receiving CPR, ventilation, vasopressors or dialysis, deaths preceded by DNRs, limitations of life-sustaining treatments or CPR, time from ICU admission to first discussion about limitations, to DNR and to death and time from first discussion about limitations until death.

    3-6 months and 12 months post-training

Secondary Outcomes (1)

  • Change in Family satisfaction in an ICU from baseline

    3-6 months and 12 months post-training

Other Outcomes (1)

  • Change in Teamwork in an ICU from baseline

    3-6 months and 12 months post-training

Study Arms (2)

Simulation training

EXPERIMENTAL

End-of-life simulation training of critical care physicians and nurses using standardized patients to improve communication and interpersonal skills.

Behavioral: Simulation training

Control

NO INTERVENTION

No simulation training

Interventions

End-of-life simulation training. The simulation training will include training with standardized patients (actors) using 9 essential skills for communication and interpersonal relationships. The control group will have no training.

Simulation training

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Critical care physicians and nurses working in Israeli ICUs.
  • Consent to participate in the study whether they undergo the simulation training or not.

You may not qualify if:

  • Physicians and nurses NOT working in Israeli ICUs.
  • Refuse to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Hebrew University Medical Center

Jerusalem, 91120, Israel

Location

Related Publications (11)

  • Meyer EC, Sellers DE, Browning DM, McGuffie K, Solomon MZ, Truog RD. Difficult conversations: improving communication skills and relational abilities in health care. Pediatr Crit Care Med. 2009 May;10(3):352-9. doi: 10.1097/PCC.0b013e3181a3183a.

    PMID: 19325506BACKGROUND
  • Sprung CL, Maia P, Bulow HH, Ricou B, Armaganidis A, Baras M, Wennberg E, Reinhart K, Cohen SL, Fries DR, Nakos G, Thijs LG; Ethicus Study Group. The importance of religious affiliation and culture on end-of-life decisions in European intensive care units. Intensive Care Med. 2007 Oct;33(10):1732-9. doi: 10.1007/s00134-007-0693-0. Epub 2007 Jun 1.

    PMID: 17541550BACKGROUND
  • Azoulay E, Chevret S, Leleu G, Pochard F, Barboteu M, Adrie C, Canoui P, Le Gall JR, Schlemmer B. Half the families of intensive care unit patients experience inadequate communication with physicians. Crit Care Med. 2000 Aug;28(8):3044-9. doi: 10.1097/00003246-200008000-00061.

    PMID: 10966293BACKGROUND
  • Embriaco N, Azoulay E, Barrau K, Kentish N, Pochard F, Loundou A, Papazian L. High level of burnout in intensivists: prevalence and associated factors. Am J Respir Crit Care Med. 2007 Apr 1;175(7):686-92. doi: 10.1164/rccm.200608-1184OC. Epub 2007 Jan 18.

    PMID: 17234905BACKGROUND
  • Wall RJ, Curtis JR, Cooke CR, Engelberg RA. Family satisfaction in the ICU: differences between families of survivors and nonsurvivors. Chest. 2007 Nov;132(5):1425-33. doi: 10.1378/chest.07-0419. Epub 2007 Jun 15.

    PMID: 17573519BACKGROUND
  • Selph RB, Shiang J, Engelberg R, Curtis JR, White DB. Empathy and life support decisions in intensive care units. J Gen Intern Med. 2008 Sep;23(9):1311-7. doi: 10.1007/s11606-008-0643-8.

    PMID: 18574641BACKGROUND
  • Ziv A, Ben-David S, Ziv M. Simulation based medical education: an opportunity to learn from errors. Med Teach. 2005 May;27(3):193-9. doi: 10.1080/01421590500126718.

    PMID: 16011941BACKGROUND
  • McGaghie WC, Issenberg SB, Petrusa ER, Scalese RJ. A critical review of simulation-based medical education research: 2003-2009. Med Educ. 2010 Jan;44(1):50-63. doi: 10.1111/j.1365-2923.2009.03547.x.

    PMID: 20078756BACKGROUND
  • McGaghie WC, Issenberg SB, Cohen ER, Barsuk JH, Wayne DB. Does simulation-based medical education with deliberate practice yield better results than traditional clinical education? A meta-analytic comparative review of the evidence. Acad Med. 2011 Jun;86(6):706-11. doi: 10.1097/ACM.0b013e318217e119.

    PMID: 21512370BACKGROUND
  • Alexander SC, Keitz SA, Sloane R, Tulsky JA. A controlled trial of a short course to improve residents' communication with patients at the end of life. Acad Med. 2006 Nov;81(11):1008-12. doi: 10.1097/01.ACM.0000242580.83851.ad.

    PMID: 17065871BACKGROUND
  • Ziv A, Erez D, Munz Y, Vardi A, Barsuk D, Levine I, Benita S, Rubin O, Berkenstadt H. The Israel Center for Medical Simulation: a paradigm for cultural change in medical education. Acad Med. 2006 Dec;81(12):1091-7. doi: 10.1097/01.ACM.0000246756.55626.1b.

    PMID: 17122476BACKGROUND

MeSH Terms

Conditions

Death

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Charles L Sprung, MD

    Hadassah Medical Organization

    STUDY CHAIR
  • Amiram Lev, MD

    Afula Hospital, Afula, Israel

    PRINCIPAL INVESTIGATOR
  • Moti Klein, MD

    Soroka Hospital, Beer Sheva

    PRINCIPAL INVESTIGATOR
  • Nimrod Adi

    Kaplan Hospital, Rechovot, Israel

    PRINCIPAL INVESTIGATOR
  • Pierre Singer, MD

    Beilinson Hospital, Petach Tikva,Israel

    PRINCIPAL INVESTIGATOR
  • Arik Eden, MD

    Carmel Hospital, Haifa, Israel

    PRINCIPAL INVESTIGATOR
  • Nissim Yifrach, MD

    Meir Hospital, Kfar Saba, Israel

    PRINCIPAL INVESTIGATOR
  • Shaul Lev, MD

    Sharon Hospital, Herzilia, Israel

    PRINCIPAL INVESTIGATOR
  • Amitai Ziv, MD

    Israel Center for Medical Simulation (MSR), The Sheba Medical Center, Tel Hashomer , Ramat Gan, Israel

    PRINCIPAL INVESTIGATOR
  • Yigal Shoshan, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR
  • Mayer Brezis, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR
  • Eyal Jacobson, MD

    Ministry of Health, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2014

First Posted

May 2, 2014

Study Start

May 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2017

Last Updated

May 2, 2014

Record last verified: 2014-04

Locations