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.
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.
- Conditions
- Registered Nurses, Nursing Personnel, Motor Skills
- 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 group | Role | What they receive |
|---|---|---|
| Clinical specific education | Other | Providing 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.
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)
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.
- First posted13 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionApr 2018
- Study completion12 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Registered NursesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Baqiyatallah Medical Sciences University
- Sponsor type
- University, hospital or other
- Collaborators
- Shahid Beheshti University, Tehran University of Medical Sciences
- Responsible party
- Principal investigator, Amir Vahedian-Azimi, Baqiyatallah Medical Sciences University
- Investigators
- Amir Vahedian-azimi, Postdoc, Principal investigator, Baqiyatallah Universiy of Medical Sciences
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Specific Training for Mastery in Doing Different Techniques in Intensive Care Unit: Developing a Standardized Learning Curve
- ClinicalTrials.gov ID
- NCT02830971
- Acronym / sponsor ID
- BUMS Protocl
- Conditions
- Registered Nurses, Nursing Personnel, Motor Skills
- Keywords
- standardized learning curve, Nurse, intensive care unit, Mastery, Training, Developing, Skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Baqiyatallah Medical Sciences UniversityUniversity, hospital or other
- Collaborators
- Shahid Beheshti University, Tehran University of Medical Sciences
- Study start
- Jul 2016
- Primary completion
- Apr 2018 (actual)
- Study completion
- 12 Apr 2021 (actual)
- First posted
- 13 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical specific education | Other | Procedure: Doing Different ICU techniques and skillsProviding clinical skills conditions |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Any situations and conditions will insult the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doing Different ICU techniques and skills | Procedure or surgery | Clinical specific education |
Primary outcome
level of nurse expertise
Time frame: Six months
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.
1 secondary outcome
Effect of GPA on the level of nurse expertise
Time frame: Six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Derived from this study: PubMed 33628776Vahedian-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.
- Individual participant dataSharing planned: Yes. After the study termination, data will be entered.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir Vahedian-azimi, Postdoc principal investigator
Baqiyatallah Universiy of Medical Sciences
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.