search
Back to results

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

Primary Purpose

Cancer, Cardiac Anomaly, Cystic Fibrosis

Status
Unknown status
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
end-of-life nursing education consortium-pediatric palliative care as web based-training plus usual care
Sponsored by
Altoosi University College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cancer focused on measuring life-limiting illnesses, pediatric palliative care, normalization process theory, End-of-life care, Web-Based Training Intervention

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • 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 CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ELNEC-PPC WBT pluss usual care

Usual care only

Arm 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

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.

Outcomes

Primary Outcome Measures

The NoMAD Instrument, to describe respondents' experiences of using the intervention in the workplace.
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'.
The NoMAD Instrument, to describe respondents' experiences of using the intervention in the workplace.
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

The interview, using framework analysis, informed by normalization process theory toolkit
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.

Full Information

First Posted
June 28, 2020
Last Updated
July 24, 2020
Sponsor
Altoosi University College
Collaborators
Babylon University
search

1. Study Identification

Unique Protocol Identification Number
NCT04461561
Brief Title
Using NPT to Evaluate Providing PPC as ELNEC-PPC WBT for Nurses
Acronym
ELNEC-PPC
Official Title
Using Normalization Process Theory to Evaluate Providing Pediatric Palliative Care at End-of-Life as Web-Based Training Intervention for Nurses:
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Altoosi University College
Collaborators
Babylon University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Cardiac Anomaly, Cystic Fibrosis, Muscular Dystrophy, HIV/AIDS, Batten's Disease, Cerebral Palsy
Keywords
life-limiting illnesses, pediatric palliative care, normalization process theory, End-of-life care, Web-Based Training Intervention

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
172 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ELNEC-PPC WBT pluss usual care
Arm Type
Experimental
Arm 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 Title
Usual care only
Arm Type
No Intervention
Arm 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(s)
end-of-life nursing education consortium-pediatric palliative care as web based-training plus usual care
Other Intervention Name(s)
ELNEC-PPC WBT course plus usual care
Intervention 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
Primary Outcome Measure Information:
Title
The NoMAD Instrument, to describe respondents' experiences of using the intervention in the workplace.
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'.
Time Frame
2 weeks after the end of WBT course
Title
The NoMAD Instrument, to describe respondents' experiences of using the intervention in the workplace.
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'.
Time Frame
at 3 months for both groups
Secondary Outcome Measure Information:
Title
The interview, using framework analysis, informed by normalization process theory toolkit
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.
Time Frame
For 3-months post-course

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moustafa Ali G Al-Shammari, Master
Phone
07816706378
Email
Mustafa.ali@altoosi.edu.iq
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nuhad Aldoori, Ph.D
Organizational Affiliation
Babylon University/ Nursing Faculty
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Amean A Yaser, Ph.D
Organizational Affiliation
Babylon University/ Nursing Faculty
Official's Role
Study Director
Facility Information:
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
City
Hilla
State/Province
Babylon Province
Country
Iraq
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moustafa Al-Shammari, Master
Phone
07816706378
Email
Mustafa.ali@altoosi.edu.iq
First Name & Middle Initial & Last Name & Degree
Moustafa A Al-Shammari, Master

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30442093
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.
Results Reference
background
PubMed Identifier
22568958
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.
Results Reference
background
PubMed Identifier
21961827
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.
Results Reference
background
PubMed Identifier
36367759
Citation
Al-Shammari MA, Yasir A, Aldoori N, Mohammad H. Using Normalization Process Theory to Evaluate an End-of-Life Pediatric Palliative Care Web-Based Training Program for Nurses: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Nov 11;11(11):e23783. doi: 10.2196/23783.
Results Reference
derived
Links:
URL
http://www.normalizationprocess.org/npt-toolkit/
Description
Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs