<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/NCT04461561</url>
  </required_header>
  <id_info>
    <org_study_id>AltoosiUC</org_study_id>
    <nct_id>NCT04461561</nct_id>
  </id_info>
  <brief_title>Using NPT to Evaluate Providing PPC as ELNEC-PPC WBT for Nurses</brief_title>
  <acronym>ELNEC-PPC</acronym>
  <official_title>Using Normalization Process Theory to Evaluate Providing Pediatric Palliative Care at End-of-Life as Web-Based Training Intervention for Nurses:</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Altoosi University College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Babylon University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Altoosi University College</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>
      The purpose of this study is to explain the provision of palliative care at the end of life&#xD;
      by the implementation of the ELNEC course, as WBT Program using the Normalization Process&#xD;
      Theory, that focus attention on how complex interventions become routinely embedded in&#xD;
      practice. In addition to, identify the changes implemented by the participant nurses&#xD;
      (intervention group) in their clinical practice, after participating in WBT Program to&#xD;
      provide Palliative Care alongside with usual care versus usual care only (control group) for&#xD;
      children with life-limiting conditions or in the case of accidents/sudden death, at the end&#xD;
      of life. And finally, provide findings that will assist in the interpretation of the trial&#xD;
      results.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The NoMAD Instrument, to describe respondents' experiences of using the intervention in the workplace.</measure>
    <time_frame>2 weeks after the end of WBT course</time_frame>
    <description>The data collection instrument is NoMAD [1]. The NoMAD translated into Arabic for the purpose of evaluating the normalization of the pediatric palliative care provide by web-based training concept. The Arabic-NoMAD is divided into 3 sections. It begins with section A consisting of 12 questions about the respondent, section B with 3 general questions about the intervention. Section C contains 20 specific questions about the intervention, corresponding to the 4 constructs of the normalization process theory [2], with Coherence and Cognitive Participation has 4 items, 7 items for Collective Action, and 5 items for Reflexive Monitoring. The scale consists of 31 Likert-type items. Items in section B are answered with a 10-point Likert scale ranging from &quot;Not at all&quot; to &quot;Completely&quot;. The items in part C are answered using a 5-point Likert scale, ranging from &quot;Disagree Strongly&quot; to 'Agree Strongly'. 'Neutral' and 'Not applicable'.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The NoMAD Instrument, to describe respondents' experiences of using the intervention in the workplace.</measure>
    <time_frame>at 3 months for both groups</time_frame>
    <description>The data collection instrument is NoMAD [1]. The NoMAD translated into Arabic for the purpose of evaluating the normalization of the pediatric palliative care provide by web-based training concept. The Arabic-NoMAD is divided into 3 sections. It begins with section A consisting of 12 questions about the respondent, section B with 3 general questions about the intervention. Section C contains 20 specific questions about the intervention, corresponding to the 4 constructs of the normalization process theory [2], with Coherence and Cognitive Participation has 4 items, 7 items for Collective Action, and 5 items for Reflexive Monitoring. The scale consists of 31 Likert-type items. Items in section B are answered with a 10-point Likert scale ranging from &quot;Not at all&quot; to &quot;Completely&quot;. The items in part C are answered using a 5-point Likert scale, ranging from &quot;Disagree Strongly&quot; to 'Agree Strongly'. 'Neutral' and 'Not applicable'.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The interview, using framework analysis, informed by normalization process theory toolkit</measure>
    <time_frame>For 3-months post-course</time_frame>
    <description>Semi-structured face-to-face interviews will be conducted by all nurses on how successful passing ELNEC-PPC WBT course from the selected setting. All participants had direct contact with patients. Three rounds of interviews will be conducted after 3 months. After consenting, participants will be interviewed by the main researcher (MA). All interviews will be audio-recorded and transcribed. They will be asked why they felt the change was significant. During the second round of interviews, will be asked about the most significant developments since the beginning of the program; they will be asked to share their views about pediatric palliative care and to describe the extent to which they were adopting the approach, and if not, why not. Topic guides were informed by NPT [3], it will be used the interactive NPT toolkit. It contains 16 questions, for thinking through an implementation problem. The work was embedding improved and edited statements and explanations into a web-enabled tool.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">172</enrollment>
  <condition>Cancer</condition>
  <condition>Cardiac Anomaly</condition>
  <condition>Cystic Fibrosis</condition>
  <condition>Muscular Dystrophy</condition>
  <condition>HIV/AIDS</condition>
  <condition>Batten's Disease</condition>
  <condition>Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>ELNEC-PPC WBT pluss usual care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The End-of-Life Nursing Education Consortium (ELNEC) project is a national education initiative to improve nursing education on end-of-life care. The project is administered by the American Association of Colleges of Nursing and City of Hope National Medical Center. The intervention group received training through the Relais Academy website</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care only</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants nurses deliver usual care as his/her role appropriate to neonates, infants, toddlers, preschoolers, school age, also to adolescents in selected unit of perinatal, neonatal, and settings which can be pediatric.</description>
  </arm_group>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>end-of-life nursing education consortium-pediatric palliative care as web based-training plus usual care</intervention_name>
    <description>The End-of-Life Nursing Education Consortium (ELNEC) project is a national education initiative to improve nursing education on end-of-life care. The project is administered by the American Association of Colleges of Nursing and City of Hope National Medical Center. The intervention group received training through the Relais Academy website</description>
    <arm_group_label>ELNEC-PPC WBT pluss usual care</arm_group_label>
    <other_name>ELNEC-PPC WBT course plus usual care</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The health care centers where the intervention will be administered include 1) Imam&#xD;
             Sadiq (peace be upon him) Teaching Hospital; 2) Babylon Maternity and Children&#xD;
             Teaching Hospital; 3) Al-Noor Hospital for Children; 4) Morgan Teaching Hospital, and&#xD;
             5) Babylon Oncology Center.&#xD;
&#xD;
          -  The study population will be included all college nurses who completed their&#xD;
             bachelor's degree and who have (master's or doctorate) degree in nursing sciences,&#xD;
             that being employed for at least three months and not expected to be transferred to&#xD;
             another unit within the study period during either morning or evening shifts and&#xD;
             provides nursing care for both male and/or female of hospitalized patients 18 years.&#xD;
&#xD;
          -  Use a computer (desktop or laptop) with access to the internet at home or work (phone&#xD;
             line or internet access), or use a smartphone (with at least Android 6.0+ or iOS11.&#xD;
             0+) with internet access (Wi-Fi and/or mobile data) to join the online training&#xD;
             course.&#xD;
&#xD;
          -  Have a working email address and/or a working mobile number and have access to a&#xD;
             computer or smartphone with internet access to complete questionnaires in a web&#xD;
             browser.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not interested.&#xD;
&#xD;
          -  Not being employed for at least three months.&#xD;
&#xD;
          -  Academic nurses who employed and continuing to work with other than selecting units,&#xD;
             due to the carefully chosen only units that provide nursing care for both pediatric&#xD;
             and adults or for pediatric, in order to achieve the study objectives.&#xD;
&#xD;
          -  Enrolled in another experimental trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nuhad Aldoori, Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>Babylon University/ Nursing Faculty</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Amean A Yaser, Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>Babylon University/ Nursing Faculty</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Moustafa Ali G Al-Shammari, Master</last_name>
    <phone>07816706378</phone>
    <email>Mustafa.ali@altoosi.edu.iq</email>
  </overall_contact>
  <location>
    <facility>
      <name>1) Imam Sadiq (peace be upon him) Teaching Hospital; 2) Babylon Maternity and Children Teaching Hospital; 3) Al-Noor Hospital for Children; 4) Morgan Teaching Hospital; and 5) Babylon Oncology Center</name>
      <address>
        <city>Hilla</city>
        <state>Babylon Province</state>
        <country>Iraq</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Moustafa Al-Shammari, Master</last_name>
      <phone>07816706378</phone>
      <email>Mustafa.ali@altoosi.edu.iq</email>
    </contact>
    <investigator>
      <last_name>Moustafa A Al-Shammari, Master</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Iraq</country>
  </location_countries>
  <link>
    <url>http://www.normalizationprocess.org/npt-toolkit/</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Rapley T, Girling M, Mair FS, Murray E, Treweek S, McColl E, Steen IN, May CR, Finch TL. Improving the normalization of complex interventions: part 1 - development of the NoMAD instrument for assessing implementation work based on normalization process theory (NPT). BMC Med Res Methodol. 2018 Nov 15;18(1):133. doi: 10.1186/s12874-018-0590-y.</citation>
    <PMID>30442093</PMID>
  </reference>
  <reference>
    <citation>Rifkin LH, Stojadinovic S, Stewart CH, Song KH, Maxted MC, Bell MH, Kashefi NS, Speiser MP, Saint-Cyr M, Story MD, Rohrich RJ, Brown SA, Solberg TD. An athymic rat model of cutaneous radiation injury designed to study human tissue-based wound therapy. Radiat Oncol. 2012 May 8;7:68. doi: 10.1186/1748-717X-7-68.</citation>
    <PMID>22568958</PMID>
  </reference>
  <reference>
    <citation>May CR, Finch T, Ballini L, MacFarlane A, Mair F, Murray E, Treweek S, Rapley T. Evaluating complex interventions and health technologies using normalization process theory: development of a simplified approach and web-enabled toolkit. BMC Health Serv Res. 2011 Sep 30;11:245. doi: 10.1186/1472-6963-11-245.</citation>
    <PMID>21961827</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 24, 2020</last_update_submitted>
  <last_update_submitted_qc>July 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Altoosi University College</investigator_affiliation>
    <investigator_full_name>Moustafa Ali Ghazi Al-Shammari</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>life-limiting illnesses</keyword>
  <keyword>pediatric palliative care</keyword>
  <keyword>normalization process theory</keyword>
  <keyword>End-of-life care</keyword>
  <keyword>Web-Based Training Intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscular Dystrophies</mesh_term>
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Cerebral Palsy</mesh_term>
    <mesh_term>Neuronal Ceroid-Lipofuscinoses</mesh_term>
    <mesh_term>Heart Defects, Congenital</mesh_term>
  </condition_browse>
  <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/NCT04461561
org study id: AltoosiUC
nct id: NCT04461561
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to explain the provision of palliative care at the end of life
      by the implementation of the ELNEC course, as WBT Program using the Normalization Process
      Theory, that focus attention on how complex interventions become routinely embedded in
      practice. In addition to, identify the changes implemented by the participant nurses
      (intervention group) in their clinical practice, after participating in WBT Program to
      provide Palliative Care alongside with usual care versus usual care only (control group) for
      children with life-limiting conditions or in the case of accidents/sudden death, at the end
      of life. And finally, provide findings that will assist in the interpretation of the trial
      results.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Investigator)
measure: The NoMAD Instrument, to describe respondents' experiences of using the intervention in the workplace.
time frame: 2 weeks after the end of WBT course
description: The data collection instrument is NoMAD [1]. The NoMAD translated into Arabic for the purpose of evaluating the normalization of the pediatric palliative care provide by web-based training concept. The Arabic-NoMAD is divided into 3 sections. It begins with section A consisting of 12 questions about the respondent, section B with 3 general questions about the intervention. Section C contains 20 specific questions about the intervention, corresponding to the 4 constructs of the normalization process theory [2], with Coherence and Cognitive Participation has 4 items, 7 items for Collective Action, and 5 items for Reflexive Monitoring. The scale consists of 31 Likert-type items. Items in section B are answered with a 10-point Likert scale ranging from "Not at all" to "Completely". The items in part C are answered using a 5-point Likert scale, ranging from "Disagree Strongly" to 'Agree Strongly'. 'Neutral' and 'Not applicable'.
measure: The NoMAD Instrument, to describe respondents' experiences of using the intervention in the workplace.
time frame: at 3 months for both groups
description: The data collection instrument is NoMAD [1]. The NoMAD translated into Arabic for the purpose of evaluating the normalization of the pediatric palliative care provide by web-based training concept. The Arabic-NoMAD is divided into 3 sections. It begins with section A consisting of 12 questions about the respondent, section B with 3 general questions about the intervention. Section C contains 20 specific questions about the intervention, corresponding to the 4 constructs of the normalization process theory [2], with Coherence and Cognitive Participation has 4 items, 7 items for Collective Action, and 5 items for Reflexive Monitoring. The scale consists of 31 Likert-type items. Items in section B are answered with a 10-point Likert scale ranging from "Not at all" to "Completely". The items in part C are answered using a 5-point Likert scale, ranging from "Disagree Strongly" to 'Agree Strongly'. 'Neutral' and 'Not applicable'.
measure: The interview, using framework analysis, informed by normalization process theory toolkit
time frame: For 3-months post-course
description: Semi-structured face-to-face interviews will be conducted by all nurses on how successful passing ELNEC-PPC WBT course from the selected setting. All participants had direct contact with patients. Three rounds of interviews will be conducted after 3 months. After consenting, participants will be interviewed by the main researcher (MA). All interviews will be audio-recorded and transcribed. They will be asked why they felt the change was significant. During the second round of interviews, will be asked about the most significant developments since the beginning of the program; they will be asked to share their views about pediatric palliative care and to describe the extent to which they were adopting the approach, and if not, why not. Topic guides were informed by NPT [3], it will be used the interactive NPT toolkit. It contains 16 questions, for thinking through an implementation problem. The work was embedding improved and edited statements and explanations into a web-enabled tool.
arm group label: ELNEC-PPC WBT pluss usual care
arm group type: Experimental
description: The End-of-Life Nursing Education Consortium (ELNEC) project is a national education initiative to improve nursing education on end-of-life care. The project is administered by the American Association of Colleges of Nursing and City of Hope National Medical Center. The intervention group received training through the Relais Academy website
arm group label: Usual care only
arm group type: No Intervention
description: Participants nurses deliver usual care as his/her role appropriate to neonates, infants, toddlers, preschoolers, school age, also to adolescents in selected unit of perinatal, neonatal, and settings which can be pediatric.
intervention type: Genetic
intervention name: end-of-life nursing education consortium-pediatric palliative care as web based-training plus usual care
description: The End-of-Life Nursing Education Consortium (ELNEC) project is a national education initiative to improve nursing education on end-of-life care. The project is administered by the American Association of Colleges of Nursing and City of Hope National Medical Center. The intervention group received training through the Relais Academy website
arm group label: ELNEC-PPC WBT pluss usual care
other name: ELNEC-PPC WBT course plus usual care
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nuhad Aldoori, Ph.D
role: Study Director
affiliation: Babylon University/ Nursing Faculty
last name: Amean A Yaser, Ph.D
role: Study Director
affiliation: Babylon University/ Nursing Faculty
last name: Moustafa Ali G Al-Shammari, Master
phone: 07816706378
email: Mustafa.ali@altoosi.edu.iq
facility: 
status: Recruiting
contact: 
investigator: 
country: Iraq
url: http://www.normalizationprocess.org/npt-toolkit/
description: Related Info
citation: Rapley T, Girling M, Mair FS, Murray E, Treweek S, McColl E, Steen IN, May CR, Finch TL. Improving the normalization of complex interventions: part 1 - development of the NoMAD instrument for assessing implementation work based on normalization process theory (NPT). BMC Med Res Methodol. 2018 Nov 15;18(1):133. doi: 10.1186/s12874-018-0590-y.
PMID: 30442093
citation: Rifkin LH, Stojadinovic S, Stewart CH, Song KH, Maxted MC, Bell MH, Kashefi NS, Speiser MP, Saint-Cyr M, Story MD, Rohrich RJ, Brown SA, Solberg TD. An athymic rat model of cutaneous radiation injury designed to study human tissue-based wound therapy. Radiat Oncol. 2012 May 8;7:68. doi: 10.1186/1748-717X-7-68.
PMID: 22568958
citation: May CR, Finch T, Ballini L, MacFarlane A, Mair F, Murray E, Treweek S, Rapley T. Evaluating complex interventions and health technologies using normalization process theory: development of a simplified approach and web-enabled toolkit. BMC Health Serv Res. 2011 Sep 30;11:245. doi: 10.1186/1472-6963-11-245.
PMID: 21961827
responsible party type: Principal Investigator
investigator affiliation: Altoosi University College
investigator full name: Moustafa Ali Ghazi Al-Shammari
investigator title: Principal Investigator
mesh term: Muscular Dystrophies
mesh term: Cystic Fibrosis
mesh term: Cerebral Palsy
mesh term: Neuronal Ceroid-Lipofuscinoses
mesh term: Heart Defects, Congenital
sharing ipd: No