AzTrials
AzTrials

Registered NursesNCT02830971

Developing a Standardized Learning Curve

A study testing Doing Different ICU techniques and skills in people with Registered Nurses and Nursing Personnel, run by Baqiyatallah Medical Sciences University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 35 years
Conditions the study is for
Registered Nurses, Nursing Personnel, Motor Skills
What is being tested?
Doing Different ICU techniques and skills
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
Jul 2016to 12 Apr 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Consent to participate in the study
  • nothing already done the technique in ICU
  • Not having the preventing physical deformity for doing the skills
  • Working as the newly registered nurse in the unit as long as the study is progress

Who cannot join

  • Any situations and conditions will insult the inclusion criteria.

About this study

Official title: Effect of Specific Training for Mastery in Doing Different Techniques in Intensive Care Unit: Developing a Standardized Learning Curve

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).

Read the detailed 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.

Being tested
Doing Different ICU techniques and skills
Keywords
standardized learning curve, Nurse, intensive care unit, Mastery, Training, Developing, Skills

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Doing Different ICU techniques and skillsProcedure or surgery

Study groups in NCT02830971
Study groupRoleWhat they receive
Clinical specific educationOtherProviding clinical skills conditions
Receives: Procedure: Doing Different ICU techniques and skills

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. level of nurse expertise

    The checklist contained steps for performance skills rated on a 1 to 3 scoring scale (1= The researcher used the checklist to assess the nurse's mastery level while changing a skills and recorded his/her score on the learning curve based on a 0 (no mastery) to 100 (complete mastery) scoring scale.Required Standard frequency for skills performance based on learning curve plateau, achievement of 75% of expertise and, 75 percent of nurses who achieved 75% of expertise in the following skills.

    Measured: Six months

Secondary outcomes (1)
  1. Effect of GPA on the level of nurse expertise

    The effect of GPA will be measured on the level of nurse expertise

    Measured: Six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionApr 2018
  4. Study completion12 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02830971
Sponsor's protocol ID
BUMS Protocl
Status last verified
Apr 2021
First submitted
4 Jul 2016
Last updated
15 Apr 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: After the study termination, data will be entered.

Publications

  • Vahedian-Azimi A, Rahimi-Bashar F, Pourhoseingholi MA, Salesi M, Shamsizadeh M, Jamialahmadi T, Gohari-Moghadam K, Sahebkar A. Effect of the Specific Training Course for Competency in Doing Arterial Blood Gas Sampling in the Intensive Care Unit: Developing a Standardized Learning Curve according to the Procedure's Time and Socioprofessional Predictors. Biomed Res Int. 2021 Feb 13;2021:2989213. doi: 10.1155/2021/2989213. eCollection 2021.

    PubMed 33628776

Questions about this trial

What is this clinical trial studying?

A study testing Doing Different ICU techniques and skills in people with Registered Nurses and Nursing Personnel, run by Baqiyatallah Medical Sciences University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

level of nurse expertise (time frame: Six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02830971, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2021; AzTrials last refreshed its copy on 27 Oct 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in