<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04474769</url>
  </required_header>
  <id_info>
    <org_study_id>PreceptOR2014</org_study_id>
    <nct_id>NCT04474769</nct_id>
  </id_info>
  <brief_title>Supporting New Graduated Nurse's Professional Competence, a Theoretical Model for Optimal Orientation</brief_title>
  <official_title>Supporting New Graduated Nurse's Professional Competence, a Theoretical Model for Optimal Orientation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tampere University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tampere University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research is a longitudinal quasi-experimental intervention study which aim is to study&#xD;
      education intervention's impact on new graduate nurses' orientation period, professional&#xD;
      competence and organizational commitment. The study hypothesis is that new graduate nurses&#xD;
      who start to work at the nursing unit which belong to the intervention group are more&#xD;
      satisfied on received orientation, their professional competence develops faster and they are&#xD;
      more committed to the organization than new graduate nurses at the units of the control&#xD;
      group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research is a dissertation which aim is to study nursing orientation from the&#xD;
      preceptors' and new graduate nurses' point of view. The purpose is to develop a theoretical&#xD;
      model for optimal orientation.&#xD;
&#xD;
      The aim is to study whether it is possible to affect new graduate nurses' professional&#xD;
      competence development and their organizational commitment by educating preceptors. The aim&#xD;
      is also to study new graduate nurses' perceptions of their clinical learning environment and&#xD;
      received orientation and supporting and impeding factors of the successful orientation from&#xD;
      the preceptors' point of view.&#xD;
&#xD;
      In order to measure the effectiveness of the education intervention on new graduate nurses'&#xD;
      professional competence and commitment, participating nursing units is randomized by simple&#xD;
      random sampling into the intervention group and the control group. Intervention group's&#xD;
      preceptors is given an eight-hour education entity about orientation and preceptorship. The&#xD;
      objective is to enhance preceptors' knowledge and skills about the orientation and to give&#xD;
      preceptors means to precept new graduate nurses better. Nursing units at the control group&#xD;
      continue to precept as before. The unit managers recruit participants (preceptors to the&#xD;
      education intervention and new graduate nurses in both groups) to the study. No blinding has&#xD;
      been made.&#xD;
&#xD;
      The independent variables are preceptors, work community, supervisors and new graduate nurses&#xD;
      sociodemographic characteristics. The dependent variables are new graduate nurses'&#xD;
      professional competence and commitment.&#xD;
&#xD;
      The data will be collected by using an electronical questionnaires. The Nurse Competence&#xD;
      Scale (NCS©) will be used to study new graduate nurses' professional competence at the&#xD;
      baseline, three months and nine months, a modified Clinical Learning Environment Scale&#xD;
      (CLES+T©) will be used to study new graduate nurses' clinical learning environment and their&#xD;
      orientation period at three months and Nurse Engagement Survey© will be used to study new&#xD;
      graduate nurses' commitment at nine months. The same evaluations will be made in both groups.&#xD;
      Preceptors' perceptions of the enhancing and impeding factors of the successful orientation&#xD;
      is measured by open-ended questionnaire at the beginning of the education intervention.&#xD;
&#xD;
      The study results will be published on international nursing research journals and the&#xD;
      theoretical model for optimal orientation will be published on doctoral dissertation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2015</start_date>
  <completion_date type="Actual">November 30, 2017</completion_date>
  <primary_completion_date type="Actual">November 30, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Longitudinal quasi-experimental intervention study</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Professional competence, the change of the professional competence is being assessed</measure>
    <time_frame>Baseline</time_frame>
    <description>Nurse Competence Scale, min 0 to max 100. Higher scores means better outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Professional competence, the change of the professional competence is being assessed</measure>
    <time_frame>Three months</time_frame>
    <description>Nurse Competence Scale, min 0 to max 100. Higher scores means better outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Professional competence, the change of the professional competence is being assessed</measure>
    <time_frame>Nine months</time_frame>
    <description>Nurse Competence Scale, min 0 to max 100. Higher scores means better outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Precepting experience</measure>
    <time_frame>Three months</time_frame>
    <description>Clinical Learning Environment Scale, min 1 to max 10. Higher scores means better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Organizational commitment</measure>
    <time_frame>Nine months</time_frame>
    <description>Nurse Engament Survey, min 1 to max 5. Higher scores means better outcome</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">114</enrollment>
  <condition>Competence</condition>
  <condition>Nurse's Role</condition>
  <arm_group>
    <arm_group_label>Educational intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention group's preceptors is given an eight-hour education entity about orientation and preceptorship. The objective is to enhance preceptors' knowledge and skills about the orientation and to give preceptors means to precept new graduate nurses better.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Nursing units at the control group continue to precept as before.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational intervention for preceptors</intervention_name>
    <arm_group_label>Educational intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Less than one year from the graduation, willingness to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Already a registered nurse, more than one year from the graduation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eija Paavilainen, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Tampere University</affiliation>
  </overall_official>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tampere University</investigator_affiliation>
    <investigator_full_name>Kirsi Lindfors</investigator_full_name>
    <investigator_title>Pricipal Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04474769
org study id: PreceptOR2014
nct id: NCT04474769
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This research is a longitudinal quasi-experimental intervention study which aim is to study
      education intervention's impact on new graduate nurses' orientation period, professional
      competence and organizational commitment. The study hypothesis is that new graduate nurses
      who start to work at the nursing unit which belong to the intervention group are more
      satisfied on received orientation, their professional competence develops faster and they are
      more committed to the organization than new graduate nurses at the units of the control
      group.
This research is a dissertation which aim is to study nursing orientation from the
      preceptors' and new graduate nurses' point of view. The purpose is to develop a theoretical
      model for optimal orientation.

      The aim is to study whether it is possible to affect new graduate nurses' professional
      competence development and their organizational commitment by educating preceptors. The aim
      is also to study new graduate nurses' perceptions of their clinical learning environment and
      received orientation and supporting and impeding factors of the successful orientation from
      the preceptors' point of view.

      In order to measure the effectiveness of the education intervention on new graduate nurses'
      professional competence and commitment, participating nursing units is randomized by simple
      random sampling into the intervention group and the control group. Intervention group's
      preceptors is given an eight-hour education entity about orientation and preceptorship. The
      objective is to enhance preceptors' knowledge and skills about the orientation and to give
      preceptors means to precept new graduate nurses better. Nursing units at the control group
      continue to precept as before. The unit managers recruit participants (preceptors to the
      education intervention and new graduate nurses in both groups) to the study. No blinding has
      been made.

      The independent variables are preceptors, work community, supervisors and new graduate nurses
      sociodemographic characteristics. The dependent variables are new graduate nurses'
      professional competence and commitment.

      The data will be collected by using an electronical questionnaires. The Nurse Competence
      Scale (NCS©) will be used to study new graduate nurses' professional competence at the
      baseline, three months and nine months, a modified Clinical Learning Environment Scale
      (CLES+T©) will be used to study new graduate nurses' clinical learning environment and their
      orientation period at three months and Nurse Engagement Survey© will be used to study new
      graduate nurses' commitment at nine months. The same evaluations will be made in both groups.
      Preceptors' perceptions of the enhancing and impeding factors of the successful orientation
      is measured by open-ended questionnaire at the beginning of the education intervention.

      The study results will be published on international nursing research journals and the
      theoretical model for optimal orientation will be published on doctoral dissertation.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Longitudinal quasi-experimental intervention study
primary purpose: Health Services Research
masking: None (Open Label)
measure: Professional competence, the change of the professional competence is being assessed
time frame: Baseline
description: Nurse Competence Scale, min 0 to max 100. Higher scores means better outcome
measure: Professional competence, the change of the professional competence is being assessed
time frame: Three months
description: Nurse Competence Scale, min 0 to max 100. Higher scores means better outcome
measure: Professional competence, the change of the professional competence is being assessed
time frame: Nine months
description: Nurse Competence Scale, min 0 to max 100. Higher scores means better outcome
measure: Precepting experience
time frame: Three months
description: Clinical Learning Environment Scale, min 1 to max 10. Higher scores means better outcome
measure: Organizational commitment
time frame: Nine months
description: Nurse Engament Survey, min 1 to max 5. Higher scores means better outcome
arm group label: Educational intervention
arm group type: Experimental
description: Intervention group's preceptors is given an eight-hour education entity about orientation and preceptorship. The objective is to enhance preceptors' knowledge and skills about the orientation and to give preceptors means to precept new graduate nurses better.
arm group label: No intervention
arm group type: No Intervention
description: Nursing units at the control group continue to precept as before.
intervention type: Other
intervention name: Educational intervention for preceptors
arm group label: Educational intervention
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
last name: Eija Paavilainen, PhD
role: Study Director
affiliation: Tampere University
responsible party type: Principal Investigator
investigator affiliation: Tampere University
investigator full name: Kirsi Lindfors
investigator title: Pricipal Investigator
sharing ipd: No