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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United Kingdom
    • Greater Manchester
      • Salford, Greater Manchester, United Kingdom, M28 3DR
        • The Gill Medical Centre

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Health and Safety Executive's (HSE) Management Standards Indicator Tool (MSIT) to measure work-related stress
Questionnaire

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dr. Faizan Awan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 29, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 29, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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