Work Related StressNCT06035705
Patient Acuity in Somatic In-patient Care
An observational study of Work Related Stress, run by Region Gävleborg at 1 site in Sweden.
Trial summary
This study addresses nursing acuity measures within somatic in-patient care. Quantitative and qualitative analyses will be used in order to examine staffing levels and nurses' perception of work environment, before, during and after the implementation of a patient acuity tool as a part of daily management. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Work Related Stress
- What is being tested?
- Patient acuity tool
- How many people
- 250 participants
- Where
- 1 siteSweden
- Study dates
- 30 Sep 2023to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Nurses here refer to both trained nurses and assistant nurses.
Who may be able to join
- All nurses employed by the medical wards
- First-line managers at each ward
Who cannot join
- Travelling nurses
- Nurses with <1 months employment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Maria Engström, Prof contact
Sweden1 site, 1 recruiting
- Recruiting
Region Gävleborg
Gävle, 80187
Karin Myrberg, 004626157848, karin.myrberg@regiongavleborg.se
About this study
Official title: Patient Acuity Measures as Part of Daily Managment: a Mixed-methods Study Within Somatic In-patient Care
This study addresses nursing acuity measures within somatic in-patient care. Quantitative and qualitative analyses will be used in order to examine staffing levels and nurses' perception of work environment, before, during and after the implementation of a patient acuity tool as a part of daily management.
Read the detailed description
Nurses' work environment is associated with both quality of care and organizational outcomes. There is a clear relationship between nurse staffing and both patient outcomes and nurses' perception of work environment. The severity of patients' illness is not sufficient for making nurse assignment decisions. One benchmark of staffing is valid measurement of patient acuity (patients' nursing care needs). Patient acuity measures offer a potential for real-time matching of patient demand for nursing care. It is defined as a measure of the severity of illness and the nursing care needs, complexity, and workload required to provide care to a patient or group of patients.
There is a limited amount of research that examine the process of making direct nurse staffing deicions in relation to patient acuity. By examining staffing levels and nurses' perception of work environment in relation to measured patient acuity, we hope to contribute to this field.
The overall aim of this research project is to examine patient-acuity measures as a part of daily management, as being introduced to five wards within the somatic in-patient care in Gävleborg County, Sweden in autumn 2023. The studies will focus on staffing levels in relation to the patient acuity scores and on nurses' perception of work environment, both before, during and after the start of the new work procedures, but also on a weekly basis, related to the acuity scores of the actual work shift.
Data will be collected before, 6 months, and12 months after the implementation of patient acuity measures, using a web-based survey that reaches all the nursing staff at the wards. Data will be analysed with descriptive and inference statistics to explore if the novel work process has brought differences of different asopects related to the nurses' work environment such as their well-being and perception of stress. As a reference, the same procedures will be carried out at two wards that haven't implemented patient acuity measures.
Patient-acuity measures will be collected two times a day (morning and evening shifts) from each of the five wards. Once a week, all nurses working at a particular shift will be asked to make a short estimation (through a paper-based form) of their perception of the work environment during that particular shift. These estimations with single item-measures will be compared with the patient acuity and actual staffing during the shift. An index will be used to compare staffing and patient acuity in the five wards.
Furthermore, semi-structured interviews with four nurses' and the manager from each ward will be conducted with the same time intervals as the web-based surveys. Results will be analysed with content analysis.
- Conditions
- Work Related Stress
- Being tested
- Patient acuity tool
- Keywords
- nurse staffing, acuity, workload, daily management, job satisfaction
- Medical subject headings
- Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient acuity toolOther
A tool for measuring patient acuity as a part of daily management will be implemented in four somatic in-patient care units.
What is being measured
The primary outcome is the main question the study is designed to answer.
Workplace environment
Questions on work environment will be asked through a survey. The survey contains questions from the following questionnaires: Conditions of Work Effectiveness Questionnaire (CWEQ-II), Copenhagen Psychosocial Questionnaire (COPSOQ), Thriving Scale and Staff Satisfaction with Care (SSC).
CWEQ-II: Values between 1-5. Higher scores mean a better outcome in factors on perceived access to opportunity, support, information and resources in an individual's work setting.
COPSOQ: Values between 1-5. Higher scores mean a better outcome in factors on stress and emotional demands, but a worse outcome in factors on workplace community and involvement, with one item reversed.
SSC: Values between 1-7. Higher scores mean a better outcome.
Thriving Scale: Values between 1-7. Higher scores means a better outcome, with one item reversed.
Measured: Baseline measure during November 2021
Workplace environment
Questions on work environment will be asked through a survey. The survey contains questions from the following questionnaires: Conditions of Work Effectiveness Questionnaire (CWEQ-II), Copenhagen Psychosocial Questionnaire (COPSOQ), Thriving Scale and Staff Satisfaction with Care (SSC).
CWEQ-II: Values between 1-5. Higher scores mean a better outcome in factors on perceived access to opportunity, support, information and resources in an individual's work setting.
COPSOQ: Values between 1-5. Higher scores mean a better outcome in factors on stress and emotional demands, but a worse outcome in factors on workplace community and involvement, with one item reversed.
SSC: Values between 1-7. Higher scores mean a better outcome.
Thriving Scale: Values between 1-7. Higher scores means a better outcome, with one item reversed.
Measured: Measures will be made approximately in June 2024.
Workplace environment
Questions on work environment will be asked through a survey. The survey contains questions from the following questionnaires: Conditions of Work Effectiveness Questionnaire (CWEQ-II), Copenhagen Psychosocial Questionnaire (COPSOQ), Thriving Scale and Staff Satisfaction with Care (SSC).
CWEQ-II: Values between 1-5. Higher scores mean a better outcome in factors on perceived access to opportunity, support, information and resources in an individual's work setting.
COPSOQ: Values between 1-5. Higher scores mean a better outcome in factors on stress and emotional demands, but a worse outcome in factors on workplace community and involvement, with one item reversed.
SSC: Values between 1-7. Higher scores mean a better outcome.
Thriving Scale: Values between 1-7. Higher scores means a better outcome, with one item reversed.
Measured: Measures will be made approximately during December 2024.
Secondary outcomes (1)
Point estimations on workload and patient acuity
Short protocol involving questions about patient acuity measures in relation to the workshift. The point estimation includes questions about workload, patient safety, staffing, patient acuity. Values between 1 and 10 where higher scores mean a better outcome.
Measured: Weekly measures from November 2023 to December 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start30 Sep 2023
- Primary completion31 Mar 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Work Related StressStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Gävleborg
- Sponsor type
- University, hospital or other
- Collaborators
- University of Gavle
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035705
- Sponsor's protocol ID
- 280936
- Status last verified
- Apr 2025
- First submitted
- 7 Jul 2023
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Brennan CW, Daly BJ. Methodological challenges of validating a clinical decision-making tool in the practice environment. West J Nurs Res. 2015 Apr;37(4):536-45. doi: 10.1177/0193945914539738. Epub 2014 Jun 18.
PubMed 24948588Engstrom M, Martensson G, Palsson Y, Stromberg A. What relationships can be found between nurses' working life and turnover? A mixed-methods approach. J Nurs Manag. 2022 Jan;30(1):288-297. doi: 10.1111/jonm.13494. Epub 2021 Nov 7.
PubMed 34643314Debergh DP, Myny D, Van Herzeele I, Van Maele G, Reis Miranda D, Colardyn F. Measuring the nursing workload per shift in the ICU. Intensive Care Med. 2012 Sep;38(9):1438-44. doi: 10.1007/s00134-012-2648-3. Epub 2012 Aug 9.
PubMed 22875336Eastman D, Kernan K. A New Patient Acuity Tool to Support Equitable Patient Assignments in a Progressive Care Unit. Crit Care Nurs Q. 2022 Jan-Mar 01;45(1):54-61. doi: 10.1097/CNQ.0000000000000388.
PubMed 34818298
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Acuity Measures as Part of Daily Managment: a Mixed-methods Study Within Somatic In-patient Care
- ClinicalTrials.gov ID
- NCT06035705
- Acronym / sponsor ID
- 280936
- Conditions
- Work Related Stress
- Keywords
- nurse staffing, acuity, workload, daily management, job satisfaction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Region GävleborgUniversity, hospital or other
- Collaborators
- University of Gavle
- Study start
- 30 Sep 2023 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 13 Sep 2023 (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.
This study addresses nursing acuity measures within somatic in-patient care. Quantitative and qualitative analyses will be used in order to examine staffing levels and nurses' perception of work environment, before, during and after the implementation of a patient acuity tool as a part of daily management.
Detailed description
Nurses' work environment is associated with both quality of care and organizational outcomes. There is a clear relationship between nurse staffing and both patient outcomes and nurses' perception of work environment. The severity of patients' illness is not sufficient for making nurse assignment decisions. One benchmark of staffing is valid measurement of patient acuity (patients' nursing care needs). Patient acuity measures offer a potential for real-time matching of patient demand for nursing care. It is defined as a measure of the severity of illness and the nursing care needs, complexity, and workload required to provide care to a patient or group of patients.
There is a limited amount of research that examine the process of making direct nurse staffing deicions in relation to patient acuity. By examining staffing levels and nurses' perception of work environment in relation to measured patient acuity, we hope to contribute to this field.
The overall aim of this research project is to examine patient-acuity measures as a part of daily management, as being introduced to five wards within the somatic in-patient care in Gävleborg County, Sweden in autumn 2023. The studies will focus on staffing levels in relation to the patient acuity scores and on nurses' perception of work environment, both before, during and after the start of the new work procedures, but also on a weekly basis, related to the acuity scores of the actual work shift.
Data will be collected before, 6 months, and12 months after the implementation of patient acuity measures, using a web-based survey that reaches all the nursing staff at the wards. Data will be analysed with descriptive and inference statistics to explore if the novel work process has brought differences of different asopects related to the nurses' work environment such as their well-being and perception of stress. As a reference, the same procedures will be carried out at two wards that haven't implemented patient acuity measures.
Patient-acuity measures will be collected two times a day (morning and evening shifts) from each of the five wards. Once a week, all nurses working at a particular shift will be asked to make a short estimation (through a paper-based form) of their perception of the work environment during that particular shift. These estimations with single item-measures will be compared with the patient acuity and actual staffing during the shift. An index will be used to compare staffing and patient acuity in the five wards.
Furthermore, semi-structured interviews with four nurses' and the manager from each ward will be conducted with the same time intervals as the web-based surveys. Results will be analysed with content analysis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Nurses here refer to both trained nurses and assistant nurses.
Key inclusion criteria (2 listed)
- All nurses employed by the medical wards
- First-line managers at each ward
Key exclusion criteria (2 listed)
- Travelling nurses
- Nurses with <1 months employment
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 |
|---|---|---|
| Patient acuity toolA tool for measuring patient acuity as a part of daily management will be implemented in four somatic in-patient care units. | Other | – |
Primary outcome
Workplace environment
Time frame: Baseline measure during November 2021
Questions on work environment will be asked through a survey. The survey contains questions from the following questionnaires: Conditions of Work Effectiveness Questionnaire (CWEQ-II), Copenhagen Psychosocial Questionnaire (COPSOQ), Thriving Scale and Staff Satisfaction with Care (SSC). CWEQ-II: Values between 1-5. Higher scores mean a better outcome in factors on perceived access to opportunity, support, information and resources in an individual's work setting. COPSOQ: Values between 1-5. Higher scores mean a better outcome in factors on stress and emotional demands, but a worse outcome in factors on workplace community and involvement, with one item reversed. SSC: Values between 1-7. Higher scores mean a better outcome. Thriving Scale: Values between 1-7. Higher scores means a better outcome, with one item reversed.
Workplace environment
Time frame: Measures will be made approximately in June 2024.
Questions on work environment will be asked through a survey. The survey contains questions from the following questionnaires: Conditions of Work Effectiveness Questionnaire (CWEQ-II), Copenhagen Psychosocial Questionnaire (COPSOQ), Thriving Scale and Staff Satisfaction with Care (SSC). CWEQ-II: Values between 1-5. Higher scores mean a better outcome in factors on perceived access to opportunity, support, information and resources in an individual's work setting. COPSOQ: Values between 1-5. Higher scores mean a better outcome in factors on stress and emotional demands, but a worse outcome in factors on workplace community and involvement, with one item reversed. SSC: Values between 1-7. Higher scores mean a better outcome. Thriving Scale: Values between 1-7. Higher scores means a better outcome, with one item reversed.
Workplace environment
Time frame: Measures will be made approximately during December 2024.
Questions on work environment will be asked through a survey. The survey contains questions from the following questionnaires: Conditions of Work Effectiveness Questionnaire (CWEQ-II), Copenhagen Psychosocial Questionnaire (COPSOQ), Thriving Scale and Staff Satisfaction with Care (SSC). CWEQ-II: Values between 1-5. Higher scores mean a better outcome in factors on perceived access to opportunity, support, information and resources in an individual's work setting. COPSOQ: Values between 1-5. Higher scores mean a better outcome in factors on stress and emotional demands, but a worse outcome in factors on workplace community and involvement, with one item reversed. SSC: Values between 1-7. Higher scores mean a better outcome. Thriving Scale: Values between 1-7. Higher scores means a better outcome, with one item reversed.
1 secondary outcome
Point estimations on workload and patient acuity
Time frame: Weekly measures from November 2023 to December 2024
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Results publication: PubMed 24948588Brennan CW, Daly BJ. Methodological challenges of validating a clinical decision-making tool in the practice environment. West J Nurs Res. 2015 Apr;37(4):536-45. doi: 10.1177/0193945914539738. Epub 2014 Jun 18.
- Results publication: PubMed 34643314Engstrom M, Martensson G, Palsson Y, Stromberg A. What relationships can be found between nurses' working life and turnover? A mixed-methods approach. J Nurs Manag. 2022 Jan;30(1):288-297. doi: 10.1111/jonm.13494. Epub 2021 Nov 7.
- Results publication: PubMed 22875336Debergh DP, Myny D, Van Herzeele I, Van Maele G, Reis Miranda D, Colardyn F. Measuring the nursing workload per shift in the ICU. Intensive Care Med. 2012 Sep;38(9):1438-44. doi: 10.1007/s00134-012-2648-3. Epub 2012 Aug 9.
- Results publication: PubMed 34818298Eastman D, Kernan K. A New Patient Acuity Tool to Support Equitable Patient Assignments in a Progressive Care Unit. Crit Care Nurs Q. 2022 Jan-Mar 01;45(1):54-61. doi: 10.1097/CNQ.0000000000000388.
- Individual participant dataSharing planned: Undecided
Related trials for Work Related Stress
Active, not recruiting
Online Mindfulness-Based Stress Reduction for the Mental Health of Healthcare Professionals
Occupational Stress or Workplace Stress, Burnout, Professionals
Active, not recruiting
Self-Help Plus (SH+) for Stress Reduction in Social Service Workers: A Pilot RCT
Stress, Psychological, Occupational, Stress, Psychological
Enrolling by invitation
Adaptation and Evaluation of RESTORE
Nurse, Burnout, Healthcare Workers
Enrolling by invitation
PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)
Burnout, Secondary Trauma
Active, not recruiting
A Pilot Study of RISE for Nurse Managers Retreat
Burnout, Secondary Traumatic Stress
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.
Maria Engström, Prof contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Work Related Stress, run by Region Gävleborg at 1 site in Sweden.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 10 Apr 2025. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karin Myrberg, PhD (+46702857513, karin.myrberg@regiongavleborg.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Workplace environment (time frame: Baseline measure during November 2021). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06035705, which also lists 4 linked publications.
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 10 Apr 2025.