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Using NPT to Evaluate Providing PPC as ELNEC-PPC WBT for Nurses (ELNEC-PPC)

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ClinicalTrials.gov Identifier: NCT04461561
Recruitment Status : Recruiting
First Posted : July 8, 2020
Last Update Posted : July 27, 2020
Sponsor:
Collaborator:
Babylon University
Information provided by (Responsible Party):
Moustafa Ali Ghazi Al-Shammari, Altoosi University College

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer Cardiac Anomaly Cystic Fibrosis Muscular Dystrophy HIV/AIDS Batten's Disease Cerebral Palsy Genetic: end-of-life nursing education consortium-pediatric palliative care as web based-training plus usual care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: Using Normalization Process Theory to Evaluate Providing Pediatric Palliative Care at End-of-Life as Web-Based Training Intervention for Nurses:
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : September 1, 2021


Arm Intervention/treatment
Experimental: ELNEC-PPC WBT pluss usual care
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
Genetic: end-of-life nursing education consortium-pediatric palliative care as web based-training plus usual care
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
Other Name: ELNEC-PPC WBT course plus usual care

No Intervention: Usual care only
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.



Primary Outcome Measures :
  1. The NoMAD Instrument, to describe respondents' experiences of using the intervention in the workplace. [ Time Frame: 2 weeks after the end of WBT course ]
    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'.

  2. The NoMAD Instrument, to describe respondents' experiences of using the intervention in the workplace. [ Time Frame: at 3 months for both groups ]
    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'.


Secondary Outcome Measures :
  1. The interview, using framework analysis, informed by normalization process theory toolkit [ Time Frame: For 3-months post-course ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The health care centers where the intervention will be administered include 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.
  • The study population will be included all college nurses who completed their bachelor's degree and who have (master's or doctorate) degree in nursing sciences, that being employed for at least three months and not expected to be transferred to another unit within the study period during either morning or evening shifts and provides nursing care for both male and/or female of hospitalized patients 18 years.
  • Use a computer (desktop or laptop) with access to the internet at home or work (phone line or internet access), or use a smartphone (with at least Android 6.0+ or iOS11. 0+) with internet access (Wi-Fi and/or mobile data) to join the online training course.
  • Have a working email address and/or a working mobile number and have access to a computer or smartphone with internet access to complete questionnaires in a web browser.

Exclusion Criteria:

  • Not interested.
  • Not being employed for at least three months.
  • Academic nurses who employed and continuing to work with other than selecting units, due to the carefully chosen only units that provide nursing care for both pediatric and adults or for pediatric, in order to achieve the study objectives.
  • Enrolled in another experimental trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04461561


Contacts
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Contact: Moustafa Ali G Al-Shammari, Master 07816706378 Mustafa.ali@altoosi.edu.iq

Locations
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Iraq
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 Recruiting
Hilla, Babylon Province, Iraq
Contact: Moustafa Al-Shammari, Master    07816706378    Mustafa.ali@altoosi.edu.iq   
Principal Investigator: Moustafa A Al-Shammari, Master         
Sponsors and Collaborators
Altoosi University College
Babylon University
Investigators
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Study Director: Nuhad Aldoori, Ph.D Babylon University/ Nursing Faculty
Study Director: Amean A Yaser, Ph.D Babylon University/ Nursing Faculty
Additional Information:
Publications:
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Responsible Party: Moustafa Ali Ghazi Al-Shammari, Principal Investigator, Altoosi University College
ClinicalTrials.gov Identifier: NCT04461561    
Other Study ID Numbers: AltoosiUC
First Posted: July 8, 2020    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Moustafa Ali Ghazi Al-Shammari, Altoosi University College:
life-limiting illnesses
pediatric palliative care
normalization process theory
End-of-life care
Web-Based Training Intervention
Additional relevant MeSH terms:
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Muscular Dystrophies
Cystic Fibrosis
Cerebral Palsy
Neuronal Ceroid-Lipofuscinoses
Heart Defects, Congenital
Cardiovascular Abnormalities
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Lipidoses
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Lipid Metabolism Disorders
Metabolic Diseases
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities