ClinicalTrials.gg
RecruitingNCT06035705Updated Apr 10, 2025

Patient Acuity in Somatic In-patient Care

An observational study in Work Related Stress, sponsored by Region Gävleborg. Recruiting at 1 site in Sweden. Per ClinicalTrials.gov, last updated 2025-04-10.

Sponsored by Region Gävleborg · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 7 months ago, but the record still lists the study as recruiting.
  • Started Sep 2023; still recruiting 3 years 1 month later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
250
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 11 studies in Occupational Stress with a site in Sweden — 4 open to participants now, 4 under way, none of them phase 3. Occupational Stress · Sweden.

Started
2023
the only one that year
Observational
3 of 11
1 open now
Registered
7th of 11
by date
Lead sponsor
2 of 11
Region Gävleborg

Among the 11 studies in Occupational Stress with a site in Sweden, this one is the only one that started in 2023, is one of 3 observational ones, and was the 7th registered.

By phase

11 studies; the count open now beside each. This study's row is marked.

No phase8 · 3 open
Observationalthis study3 · 1 open

By the year they started

First in 2015; this study’s year is marked. 1 started in 2023.

Size and results

Median enrollment 154 across the 8 interventional studies, 250 across the 3 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 11 studies in Occupational Stress with a site in Sweden, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Work Related Stress

Browse trials for

Keywords

  • nurse staffing
  • acuity
  • workload
  • daily management
  • job satisfaction
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Nurses here refer to both trained nurses and assistant nurses.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All nurses employed by the medical wards
  • managers at each ward

Exclusion criteria

Exclusion Criteria:

  • Travelling nurses
  • Nurses with \<1 months employment
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
250 participants (estimated)
Patient registry
No

Interventions

  • OtherPatient acuity tool

    A tool for measuring patient acuity as a part of daily management will be implemented in four somatic in-patient care units.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline measure during November 2021

  2. 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.

    Time frame: Measures will be made approximately in June 2024.

  3. 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.

    Time frame: 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.

    Time frame: Weekly measures from November 2023 to December 2024

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 24948588 ↗
  • Engstrom 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 34643314 ↗
  • Debergh 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 22875336 ↗
  • Eastman 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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2023 (actual). Primary completion is estimated for Mar 2025, 18 months after the start.

Of 27 observational studies under Occupational Stress, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 41. This study's planned 18 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 7, 2023
First posted
Sep 13, 2023
StartActual
Sep 30, 2023
Primary completionEst.
Mar 31, 2025
CompletionEst.
Sep 30, 2026
Last update
Apr 10, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06035705
Lead sponsor
Region Gävleborg
Collaborators
University of Gavle
Responsible party
Sponsor
First posted
Sep 13, 2023
Start date
Sep 30, 2023
Primary completion
Mar 31, 2025 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Apr 10, 2025

Study contacts

Karin Myrberg, PhD
Contact
karin.myrberg@regiongavleborg.se
+46702857513
Maria Engström, Prof
Contact
maria.engstrom@hig.se

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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