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Can We Improve the Quality of Care at the End of Life in Israel? (ISRAEOLC)

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ClinicalTrials.gov Identifier: NCT02129283
Recruitment Status : Unknown
Verified April 2014 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : May 2, 2014
Last Update Posted : May 2, 2014
Sponsor:
Collaborators:
Israel Center for Medical Simulation (MSR)
Clalit Health Services
The Samuel Sebba Charitable Trust
Information provided by (Responsible Party):
Hadassah Medical Organization

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.

Condition or disease Intervention/treatment Phase
End of Life Process Behavioral: Simulation training Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Can We Improve the Quality of Care at the End of Life in Israel?
Study Start Date : May 2014
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : May 2017

Arm Intervention/treatment
Experimental: Simulation training
End-of-life simulation training of critical care physicians and nurses using standardized patients to improve communication and interpersonal skills.
Behavioral: Simulation training
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.

No Intervention: Control
No simulation training



Primary Outcome Measures :
  1. Change in ICU care process in an ICU from baseline [ Time Frame: 3-6 months and 12 months post-training ]
    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.


Secondary Outcome Measures :
  1. Change in Family satisfaction in an ICU from baseline [ Time Frame: 3-6 months and 12 months post-training ]
    Additional information about the outcome measure- Other parameters for family satisfaction iclude- adequate time for asking questions, expressing fears and emotions, emotional support , compassion shown to family, supporting family decisions, consideration of family needs, achieving appropriate level of care and perceptions of the quality of palliative care and quality of death and dying.


Other Outcome Measures:
  1. Change in Teamwork in an ICU from baseline [ Time Frame: 3-6 months and 12 months post-training ]
    Additional information about the outcome measure- Other parameters for teamwork include family conflicts, inappropriateness of care, decisions shared by nurses and physicians, nurse involvement in EOL decisions and work autonomy.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129283


Contacts
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Contact: Charles L Sprung, MD 972 2 677 8060 charles.sprung@ekmd.huji.ac.il

Locations
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Israel
Hadassah Hebrew University Medical Center Not yet recruiting
Jerusalem, Israel, 91120
Contact: Charles L Sprung, MD    972 2 677 8060    charles.sprung@ekmd.huji.ac.il   
Sponsors and Collaborators
Hadassah Medical Organization
Israel Center for Medical Simulation (MSR)
Clalit Health Services
The Samuel Sebba Charitable Trust
Investigators
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Study Chair: Charles L Sprung, MD Hadassah Medical Organization
Principal Investigator: 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

Publications:

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Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT02129283     History of Changes
Other Study ID Numbers: 0126-14-HMO
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: May 2, 2014
Last Verified: April 2014

Keywords provided by Hadassah Medical Organization:
physicians, nurses, ICU, end-of-life, simulation training