End of Life Process Clinical Trial
Official title:
Can We Improve the Quality of Care at the End of Life in Israel?
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.
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).
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research