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

July 24, 2020 updated by: Moustafa Ali Ghazi Al-Shammari, Altoosi University College

Using Normalization Process Theory to Evaluate Providing Pediatric Palliative Care at End-of-Life as Web-Based Training Intervention for Nurses:

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

172

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Iraq
    • Babylon Province
      • Hilla, Babylon Province, Iraq
        • Recruiting
        • 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
        • Contact:
        • Principal Investigator:
          • Moustafa A Al-Shammari, Master

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

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 weeks after the end of WBT course
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'.
at 3 months for both groups

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
For 3-months post-course

Collaborators and Investigators

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

Sponsor

Altoosi University College

Collaborators

Babylon University

Investigators

  • Study Director: Nuhad Aldoori, Ph.D, Babylon University/ Nursing Faculty
  • Study Director: Amean A Yaser, Ph.D, Babylon University/ Nursing Faculty

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.

General Publications

Helpful Links

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 (ACTUAL)

July 1, 2020

Primary Completion (ANTICIPATED)

December 30, 2020

Study Completion (ANTICIPATED)

September 1, 2021

Study Registration Dates

First Submitted

June 28, 2020

First Submitted That Met QC Criteria

July 7, 2020

First Posted (ACTUAL)

July 8, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 27, 2020

Last Update Submitted That Met QC Criteria

July 24, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AltoosiUC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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