Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02830971 |
Other study ID # |
BUMS Protocl |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 2016 |
Est. completion date |
April 12, 2021 |
Study information
Verified date |
April 2021 |
Source |
Baqiyatallah Medical Sciences University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The nurses were learned the theoretical and practical skills previously during their
studentship period. The procedures will be the first time the nurses wanted to perform in
ICU. All clinical situations including patient, procedure, and shift will be similar for
nurses. The end point will be reaching to the 95 score of learning curve. The reason for
selection less than 5 percent variation was the flattening of learning curve (the plateau
section).
Description:
All new registered nurses in intensive care unit (ICU) from 1 April 2016 until next 24 months
from 10 mixed beds ICUs will be selected through convenience sampling and according to
fulfilling the inclusion criteria.
For data collection, a specific checklist as many as selected techniques according to the
three panel of expert sessions was validated. The members of expert panel were three
intensivists, five anesthesiologists, three pulmonologists, five internists, one
nephrologist, one cardiologist, and ten highly experienced ICU nurses. Firstly, extensive
review of the literature based on the latest documents and articles for techniques was done.
The Kendal agreement coefficient between the panel of expert members for selecting the
primary materials to constitute the checklist was 0.976 (P Value <0.0001). According to the
extensive review of the literature, a primary checklist as many as selected techniques was
generated. The primary checklist as many as selected techniques generated in the first expert
panel session. After the 90 minutes discussion about the primary checklist as many as
selected techniques, the primary consensus was achieved. The primary checklist as many as
selected techniques sent to the expert members for purifying, improving and editing. The
results of the second 120 minutes distance session were analyzed meticulously by principle
investigator and two independent researchers (K=0.943 with P Value <0.0001). Based on the
results of the second session, the third version of the checklists as many as selected
techniques was prepared. According to the 120 minutes final session, the checklists as many
as selected techniques for clinical survey was prepared. The checklists had different domains
according to the selected techniques. The scoring of each checklist's questions was based on
the 3 status. Ability to perform alone (2 score), ability to perform with helping (1 score)
and inability to perform (0 score). Each question had specific importance coefficient among 1
to 5. The philosophy of the different coefficients for the questions in the domains was
related to the importance degree of question. Thus, besides the domain scores, each domain
had specific importance coefficient. The total score of the checklist comes from multiplying
the question score to question importance coefficient with percent. Then, the highest score
of the checklist was 100 percent and the lowest score was 0 percent. The nurses received full
classical education according to the final three-step checklist components by a full ICU
trainer in five 120 minutes sessions as theoretically. The trainer did not inform from the
research questions and study. During the three validation sessions, content validity ration
(CVR) with 28 panelists were 0.59 and content validity index (CVI) 0.95. Reliability of the
checklist was determined based on the inter-rate reliability with Kappa agreement test among
principle investigator and intensivists (r= 0.94), anesthesiologists (r= 0.92),
pulmonologists (r= 0.90), internists (r= 0.93), nephrologist (r= 0.97), cardiologist (r=
0.95), and three of the nurses (r= 0.91, 90, and 92), separately. Reliability of the
checklist was determined based on the intera-rate reliability with Kappa agreement test by
principle investigator (r= 0.96), intensivists (r= 0.91), anesthesiologists (r= 0.92),
pulmonologists (r= 0.94), internists (r= 0.92), nephrologist (r= 0.93), cardiologist (r=
0.90), and three of the nurses (r= 0.90, 93, and 94), separately. For decreasing the
researcher effect on the nurses, the results of two primary weeks will not be considered.
Following each nurse will be continued until achieving the flattening of the learning curve.