- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04948255
Measuring Work-Related Stress in Primary Care in the Covid-19 Pandemic (WRS)
June 29, 2021 updated by: Dr. Faizan Awan
Work-Related Stress Amongst a Primary Care Workforce in Greater Manchester, United Kingdom Before and During the Covid-19 Pandemic
This prospective cohort study was designed to assess WRS amongst clinical and non-clinical staff in a primary healthcare setting using a validated tool with a view to developing an evidence base to form a historical and comparative record during the Covid-19 pandemic.
Study Overview
Status
Completed
Conditions
Detailed Description
Work-related stress (WRS) is the second most common cause of occupational ill health in the United Kingdom.
Studies suggest that during the Covid-19 pandemic, an increased prevalence of stress-related disorders was reported amongst healthcare workers.
WRS can be assessed using the Health and Safety Executive's (HSE) Management Standards Indicator Tool (MSIT) and is used to compare changes to WRS across six domains over time.
Lower scores in domains indicate higher WRS experienced by workers.
Increases in the score in subsequent assessments indicate improvements to WRS.
The MSIT was distributed to 23 primary care clinical and non-clinical staff in a medical centre in Greater Manchester, United Kingdom in March, 2019.
18 responses were received from 23 staff (78% response rate), establishing a baseline.
In May, 2020, the authors decided to reanalyse the effect of the Covid-19 pandemic on WRS upon the same population.
The MSIT was redistributed in March 2021, with 14 responses from 20 staff (70% response rate).
Microsoft Excel's data analysis was applied to the results.
WRS across the practice increased by 7% in demands, 4% in control and 2% in role domains and improved by 3% in support, 3% in relationships and 2% in change domains.
The results are in keeping with the global picture of evolving WRS amongst healthcare staff during the pandemic.
Monitoring and addressing WRS regularly helps maintain system-wide resilience when faced with unexpected or unprecedented change.
Comparing these results with WRS in other healthcare systems would be a useful next step.
Study Type
Observational
Enrollment (Actual)
18
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Greater Manchester
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Salford, Greater Manchester, United Kingdom, M28 3DR
- The Gill Medical Centre
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-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adult health professionals and administration staff
Description
Inclusion Criteria:
- Primary healthcare staff working at the Gill Medical Centre for at least two months prior to assessment.
Exclusion Criteria:
- Any staff member employed for less than two months, those who were off work due to non- stress related long-term leave or incomplete submissions.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Healthcare Workers at the Gill Medical Centre
Clinical and non-clinical staff at the Gill Medical Centre will complete a validated stress questionnaire during the Covid-19 pandemic.
A baseline was established in May, 2019.
|
Questionnaire
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measurement of stress across the workforce
Time Frame: 24 months
|
Work-related stress (WRS) is measured using the Management Standards Indicator Tool (MSIT) on a Likert scale of 1-5 with a higher number indicating less WRS.
A measurement is made at baseline and during the Covid-19 pandemic.
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measurement of stress by type of role
Time Frame: 24 months
|
WRS measured using MSIT across three different primary healthcare roles - doctors, other clinicians and administrators - at baseline from 2019 and during the Covid-19 pandemic
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ashleigh Ward, MBChB, Salford Royal Hospital
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)
April 1, 2019
Primary Completion (Actual)
March 29, 2021
Study Completion (Actual)
June 29, 2021
Study Registration Dates
First Submitted
June 29, 2021
First Submitted That Met QC Criteria
June 29, 2021
First Posted (Actual)
July 1, 2021
Study Record Updates
Last Update Posted (Actual)
July 1, 2021
Last Update Submitted That Met QC Criteria
June 29, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Stress, Psychological
- Occupational Diseases
- COVID-19
- Occupational Stress
Other Study ID Numbers
- 302893
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Sharing of collected data with researchers using the same tool to assess work-related stress.
IPD Sharing Time Frame
Data available now 29/06/2021 to 29/06/2031.
IPD Sharing Access Criteria
E-mail: faizan@doctors.org.uk with name, contact details and study purpose.
IPD Sharing Supporting Information Type
- SAP
- CSR
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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