NCT04461561

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
172

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

July 27, 2020

Status Verified

July 1, 2020

Enrollment Period

6 months

First QC Date

June 28, 2020

Last Update Submit

July 24, 2020

Conditions

Keywords

life-limiting illnessespediatric palliative carenormalization process theoryEnd-of-life careWeb-Based Training Intervention

Outcome Measures

Primary Outcomes (2)

  • 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'.

    2 weeks after the end of WBT course

  • 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'.

    at 3 months for both groups

Secondary Outcomes (1)

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

    For 3-months post-course

Study Arms (2)

ELNEC-PPC WBT pluss usual care

EXPERIMENTAL

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

Usual care only

NO INTERVENTION

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.

Interventions

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

Also known as: ELNEC-PPC WBT course plus usual care
ELNEC-PPC WBT pluss usual care

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hillah, Babylon Province, Iraq

RECRUITING

Related Publications (4)

  • 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: 30442093BACKGROUND
  • 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: 22568958BACKGROUND
  • 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: 21961827BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

NeoplasmsHeart Defects, CongenitalCystic FibrosisMuscular DystrophiesAcquired Immunodeficiency SyndromeNeuronal Ceroid-LipofuscinosesCerebral Palsy

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornInfant, Newborn, DiseasesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesLipidosesLipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBrain Damage, ChronicBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Nuhad Aldoori, Ph.D

    Babylon University/ Nursing Faculty

    STUDY DIRECTOR
  • Amean A Yaser, Ph.D

    Babylon University/ Nursing Faculty

    STUDY DIRECTOR

Central Study Contacts

Moustafa Ali G Al-Shammari, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 28, 2020

First Posted

July 8, 2020

Study Start

July 1, 2020

Primary Completion

December 30, 2020

Study Completion

September 1, 2021

Last Updated

July 27, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations