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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06035705
Other study ID # 280936
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 7, 2024
Est. completion date September 30, 2026

Study information

Verified date May 2024
Source Region Gävleborg
Contact Karin Myrberg, PhD
Phone +46702857513
Email karin.myrberg@regiongavleborg.se
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date September 30, 2026
Est. primary completion date March 31, 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - All nurses employed by the medical wards - First-line managers at each ward Exclusion Criteria: - Travelling nurses - Nurses with <1 months employment

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Sweden Region Gävleborg Gävle

Sponsors (2)

Lead Sponsor Collaborator
Region Gävleborg University of Gavle

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Baseline measure during November 2021
Primary 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.
Measures will be made approximately in June 2024.
Primary 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.
Measures will be made approximately during December 2024.
Secondary 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. Weekly measures from November 2023 to December 2024
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