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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

Tracking Information
First Submitted Date  ICMJE April 28, 2014
First Posted Date  ICMJE May 2, 2014
Last Update Posted Date May 2, 2014
Study Start Date  ICMJE May 2014
Estimated Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2014)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 30, 2014)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Can We Improve the Quality of Care at the End of Life in Israel?
Official Title  ICMJE Can We Improve the Quality of Care at the End of Life in Israel?
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.
Detailed Description

This study will evaluate whether end-of-life simulation training of critical care physicians and nurses throughout Israel using standardized patients improves communication and interpersonal skills leading to improvements in ICU care process, teamwork and family satisfaction.

Design- Simulation training will include approximately 10-15 staff members from 4-5 ICUs during the first 12 months of the study (intervention group) who will be compared using a stepped wedge design to staff members from another 4-5 ICUs who will not receive initial simulation training (control group) in the first year but will receive training during the second year. To evaluate whether the simulation training with simulated standardized patients improves ICU professional's communication and interpersonal skills, a baseline evaluation before the training and an evaluation after the training will be required. Training using 9 essential skills for communication and interpersonal relationships that the study Steering Committee chose include: How to elicit patient preferences (including patient vs. family goals of care)? How does one listen? How to be more compassionate, show empathy and respect (including how to address emotions)? How to handle unrealistic patient/family expectations (including a family requesting "that everything be done")? How to handle prognostic uncertainty? How to handle decision making? How to handle conflicts between siblings or within the team? Physicians and nurses working together, and Becoming knowledgeable and understanding the Israeli Terminally Ill Law.

Simulation sessions- The simulation sessions include 6 scenarios. The simulation training is composed of several teaching sessions interspersed between clinical scenarios with simulated standardized patients (actors) performed with the ICU doctors and nurses and several subsequent debriefing sessions. The entire interchange between the trainee(s) and actor is video-taped for educational purposes and used in the subsequent debriefing.

Evaluations-

  1. Baseline evaluation will consist of a questionnaire for self-evaluation, ICU process, teamwork and family satisfaction and performance testing using a simulation evaluation of the 9 skills before the teaching and training session. The trainee questionnaire will include demographic information including age, gender, country of birth, profession, education, years practicing, hospital type (private, governmental, health fund), number of ICU beds, religion, religiosity, previous experiences with death and the Israeli Terminally Ill Law. The simulation evaluation will access level of knowledge, skills and attitude. The baseline questionnaire will be administered on the morning of the simulation training or prior to that date if possible before the training begins. The questionnaires will be for the baseline and repeat questionnaires 3-6 and 12 months after the training in their units or by mail. The control group will receive their questionnaires (for the baseline questionnaire and the repeat questionnaire 3-6 and 12 months later) during the first year of the study (before the second year when their simulation training occurs) in their ICUs or by mail.

    As this is a National Project and we hope to train most ICU doctors and nurses in Israel over the next several years, we will try to obtain baseline data for ICU professionals around the country. The Israeli Society of Critical Care Medicine has agreed to participate in this study. Therefore, we will also be obtaining baseline information from all ICUs - those included and not included in the study. ICU doctors and nurses will also answer the doctor-nurse questionnaire in their ICU or by mail. It will be important to see if there are any differences between units in the study or not. It also will be important to repeat the questionnaires in ICUs not in the study after 1-2 years.

  2. Post- training questionnaires- immediately after the simulation training and 3-6 and 12 months later for the self-assessment questionnaire and 3-6 and 12 months later for the ICU process, teamwork and family satisfaction questionnaires. The control group will also have post-training questionnaires, ICU process and teamwork evaluations 3-6 and 12 months after the first assessment during the first 12 months of the study period. It is important to evaluate whether the training intervention affects a change for a short period (3-6 months) or a more prolonged period (12 months). Potential variables for questionnaires include:

ICU process questionnaires- terminal illnesses as defined by the Law, advanced directives or durable power of attorney, designated surrogates, physician or nurse asked about patient preferences, documentation 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, time from first discussion about limitations until death; teamwork questionnaires- will include nurse initiated discussions with doctors, nurse initiated discussions with families for patient/family preferences, unrealistic family expectations, family conflicts, inappropriateness of care, decisions shared by nurses and physicians, nurse involvement in EOL decisions and work autonomy;

family satisfaction questionnaires- will be completed by family members of ICU patients 2-4 months after the patient dies or is discharged from the ICU. They include completeness of information, listening, trust, respect, asking patient preferences and family opinions, inclusion in decision making, quality and frequency of communication, adequate time for asking questions, express your fears and emotions, emotional support, compassion shown to family, support 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.

Sample size justification and statistical analyses- The power analysis shown below is not for limiting sample size to the smallest required to prove or disprove the hypothetical effectiveness of an intervention, rather to estimate our chance of reproducing a significant improvement with the sample size suggested by a limited budget and trying to best learn from the process. Power analyses will be performed using PowerAndPrecision (version 4.1) using one tail and alpha set at 0.05. The following are examples of questions that are likely to be answered with current stepped wedge design where each cluster of units will have 30 to 40 team members:

  1. knowledge of teams regarding the obligation by current law to provide support to families of dying patients- Current surveys show that only 50% of teams are aware of this legal obligation and that this clearly improves after the workshop. A power analysis shows that with an n=30 in each group (control and intervention) we will have a 91% chance of showing an increase from 50% to 85% (Chi square or Fisher's exact tests).
  2. skill for listening- If at baseline, the capacity to listen is rated by self-assessment at 3.5 on a Likert scale of 1-5, power analysis shows that with n=40 in each group (control and intervention), we will have a 84% chance of showing a statistical significant increase to 4.1 (nearly 20%) by the workshop (t-test).

We will compare the change in basic skills (self-assessment questionnaires and performance testing), ICU processes, teamwork of care and family satisfaction from the baseline period to the post-training periods which will serve as the primary outcome of this study. Professional demographic and organizational variables will be correlated with the actual improved skill performance, ICU processes of care, teamwork and family satisfaction using a multivariate analysis to determine the important variables leading to change. The variables that will be assessed include: age, gender, profession, country trained, years practicing, religion, religiosity, previous experiences with death, large or small ICU (< 10 vs. >10 beds) and hospital type (private, governmental, health fund).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE End of Life Process
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Simulation training
    End-of-life simulation training of critical care physicians and nurses using standardized patients to improve communication and interpersonal skills.
    Intervention: Behavioral: Simulation training
  • No Intervention: Control
    No simulation training
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 30, 2014)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2017
Estimated Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02129283
Other Study ID Numbers  ICMJE 0126-14-HMO
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hadassah Medical Organization
Study Sponsor  ICMJE Hadassah Medical Organization
Collaborators  ICMJE
  • Israel Center for Medical Simulation (MSR)
  • Clalit Health Services
  • The Samuel Sebba Charitable Trust
Investigators  ICMJE
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
PRS Account Hadassah Medical Organization
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP