Nurse's RoleNCT04603079
Nurse Leadership for Hospital Infection Control
A study testing Intervention for COVID-19 preventive protocols in people with Nurse's Role and Infection, run by Forman Christian College, Pakistan at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nurse's Role, Infection
- What is being tested?
- Intervention for COVID-19 preventive protocols
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 344 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2021to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The selection criteria will be all currently working staff nurses.
Who cannot join
- Student nurses or nurses not part of clinical rounds.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Online sampling of nurses from public and private hospitals (confidential data)
Lahore, Punjab Province, 54000
About this study
Official title: A Randomized Control Trial to Change Nurse Leadership in Maintaining Minimum Service Delivery Standards for Hospital Infection Control in the Era of COVID-19
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.
Read the detailed description
Nurses are frontline practitioners in the fight against COVID-19. Empowering nurses through training for infection prevention for COVID-19 is an essential step to facilitate nurse leadership and safety in the hospital. There is immense reliance on nurses with regard to patient safety, yet very little effort is made to invest in interventions for their leadership roles in developing countries, including Pakistan. In this study the aim is to deliver an intervention for COVID-19 preventive protocols to nurses and assess the impact of the intervention through a pre and post-test survey. A total of 200 nurses will be sampled. A 100 nurses each will be part of the control and experiment group each.
The data will be analyzed using SPSS. Pre and post test results will be presented using descriptive data and bivariate regression will be used to present higher odds of confidence in preventive and awareness literacy for COVID-19 in nurses after intervention delivery. Through this research the aim is to improve nurse leadership in maintaining minimum service delivery standards for hospital infection control with respect to COVID-19; but also other infectious disease burden management.
- Conditions
- Nurse's Role, Infection
- Being tested
- Intervention for COVID-19 preventive protocols
- Keywords
- Randomized Control Trial, Nurse leadership, Hospital Infection Control, COVID-19
- Medical subject headings
- Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention for COVID-19 preventive protocolsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start1 Mar 2021
- Primary completion1 May 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse's RoleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 200 nurses will be sampled. A 100 nurses each will be randomly assigned to the control and experiment group each.
- Masking
- None (open label)
- Enrolment
- 344 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forman Christian College, Pakistan
- Sponsor type
- University, hospital or other
- Collaborators
- King Edward Medical University
- Responsible party
- Principal investigator, Sara Rizvi Jafree, Forman Christian College, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603079
- Sponsor's protocol ID
- NurseLeadership
- Status last verified
- May 2022
- First submitted
- 19 Oct 2020
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All SPSS data files will be made publicly available. No names of participants will be shared, only participant codes.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial to Change Nurse Leadership in Maintaining Minimum Service Delivery Standards for Hospital Infection Control in the Era of COVID-19
- ClinicalTrials.gov ID
- NCT04603079
- Acronym / sponsor ID
- NurseLeadership
- Conditions
- Nurse's Role, Infection
- Keywords
- Randomized Control Trial, Nurse leadership, Hospital Infection Control, COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 344 participants (actual)
- Lead sponsor
- Forman Christian College, PakistanUniversity, hospital or other
- Collaborators
- King Edward Medical University
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 26 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Nurses are frontline practitioners in the fight against COVID-19. Empowering nurses through training for infection prevention for COVID-19 is an essential step to facilitate nurse leadership and safety in the hospital. There is immense reliance on nurses with regard to patient safety, yet very little effort is made to invest in interventions for their leadership roles in developing countries, including Pakistan. In this study the aim is to deliver an intervention for COVID-19 preventive protocols to nurses and assess the impact of the intervention through a pre and post-test survey. A total of 200 nurses will be sampled. A 100 nurses each will be part of the control and experiment group each.
The data will be analyzed using SPSS. Pre and post test results will be presented using descriptive data and bivariate regression will be used to present higher odds of confidence in preventive and awareness literacy for COVID-19 in nurses after intervention delivery. Through this research the aim is to improve nurse leadership in maintaining minimum service delivery standards for hospital infection control with respect to COVID-19; but also other infectious disease burden management.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A total of 200 nurses will be sampled. A 100 nurses each will be randomly assigned to the control and experiment group each.
| Arm | Type | Receives |
|---|---|---|
| Currently practicing nurses who will receive intervention | Experimental | Behavioral: Intervention for COVID-19 preventive protocolsAn intervention for COVID-19 preventive protocols will be delivered to the nurses in the experiment group. |
| 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The selection criteria will be all currently working staff nurses.
Key exclusion criteria (1 listed)
- Student nurses or nurses not part of clinical rounds.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention for COVID-19 preventive protocolsThe 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. | Behavioural | Currently practicing nurses who will receive intervention |
Primary outcome
Core competencies in nurses for infection control and prevention (Min and Sil 2014)
Time frame: 3 months
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Individual participant dataSharing planned: Yes. All SPSS data files will be made publicly available. No names of participants will be shared, only participant codes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention for COVID-19 preventive protocols in people with Nurse's Role and Infection, run by Forman Christian College, Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core competencies in nurses for infection control and prevention (Min and Sil 2014) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2022.