NCT04603079

Brief Summary

The aim is to deliver an intervention to promote nurse leadership and decision-making in the hospital setting, by providing them with training for maintaining minimum service delivery standards for hospital infection control with respect to COVID-19; but also other infectious disease burden management.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
344

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 26, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

May 13, 2022

Status Verified

May 1, 2022

Enrollment Period

2 months

First QC Date

October 19, 2020

Last Update Submit

May 9, 2022

Conditions

Nurse's RoleInfection

Keywords

Randomized Control TrialNurse leadershipHospital Infection ControlCOVID-19

Outcome Measures

Primary Outcomes (1)

  • Core competencies in nurses for infection control and prevention (Min and Sil 2014)

    It will consist of 44 questions for core competencies of infection control and prevention, including 10 constructs of: (1) Identification of infectious disease processes, (2) Surveillance and epidemiologic investigations, (3) Preventing/controlling the transmission of infectious agents, (4) Employee/occupational health, (5) Management and communication planning, (6) Quality/performance improvement and patient safety, and (7) Education and research education, (8) Confidence with training and awareness for identification and implementation for COVID-19 prevention and control strategies, (9) confidence in training and awareness, and (10) satisfaction with workplace support. It is a five-point Likert-type scale (strongly agree - agree - neutral - disagree - strongly disagree). The highest value of the scale is 6 and the lowest value is 1; with 6 points showing strong agreement with the item statement (E.g. Q1. Can you differentiate between other infections and COVID-19).

    3 months

Study Arms (2)

Currently practicing nurses who will receive intervention

EXPERIMENTAL

An intervention for COVID-19 preventive protocols will be delivered to the nurses in the experiment group.

Behavioral: Intervention for COVID-19 preventive protocols

Currently practicing nurses who will not receive intervention

NO INTERVENTION

No intervention for COVID-19 preventive protocols will be delivered to the nurses in the control group.

Interventions

Intervention for COVID-19 preventive protocolsBEHAVIORAL

The intervention will comprise (A) digital communication of written material and (B) monthly online training and discussion through skype and zoom, to allow for physical demonstrations, Q\&A and sharing of challenges. The five specific areas covered in the intervention for COVID-19 preventive protocols will include: (1) PPE fitting, (2) PPE removal, (3) hand hygiene, (4) cleaning, disinfection and sterilization, and (5) nurse uniform sterilization.

Currently practicing nurses who will receive intervention

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The selection criteria will be all currently working staff nurses.

You may not qualify if:

  • Student nurses or nurses not part of clinical rounds.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Online sampling of nurses from public and private hospitals (confidential data)

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

InfectionsCOVID-19

Interventions

Methods

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: A total of 200 nurses will be sampled. A 100 nurses each will be randomly assigned to the control and experiment group each.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Sociology

Study Record Dates

First Submitted

October 19, 2020

First Posted

October 26, 2020

Study Start

March 1, 2021

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

May 13, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

All SPSS data files will be made publicly available. No names of participants will be shared, only participant codes.

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations

PA(1)