Developing a Standardized Learning Curve

April 12, 2021 updated by: Amir Vahedian-Azimi, Baqiyatallah Medical Sciences University

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).

Study Overview

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Any situations and conditions will insult the inclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Clinical specific education
Providing clinical skills conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of GPA on the level of nurse expertise
Time Frame: Six months
The effect of GPA will be measured on the level of nurse expertise
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

April 12, 2021

Study Registration Dates

First Submitted

July 4, 2016

First Submitted That Met QC Criteria

July 8, 2016

First Posted (Estimate)

July 13, 2016

Study Record Updates

Last Update Posted (Actual)

April 15, 2021

Last Update Submitted That Met QC Criteria

April 12, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

After the study termination, data will be entered.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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