xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06035705</url>
    </required_header>
    <id_info>
      <org_study_id>280936</org_study_id>
      <nct_id>NCT06035705</nct_id>
    </id_info>
    <brief_title>Patient Acuity in Somatic In-patient Care</brief_title>
    <official_title>Patient Acuity Measures as Part of Daily Managment: a Mixed-methods Study Within Somatic In-patient Care</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Region Gävleborg</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Gavle</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Region Gävleborg</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study adresses nursing acuity measures within somatic in-patient care. Quantitative and&#xD;
        qualitative analyses will be used in order to examine staffing levels and nurses' perception&#xD;
        of work enivoronment, before, during and after the implementation of a patient acuity tool as&#xD;
        a part of daily management.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Nurses' work environment is associated with both quality of care and organizational outcomes.&#xD;
        There is a clear relationship between nurse staffing and both patient outcomes and nurses'&#xD;
        percetion of work environment. The severity of patients' illness is not sufficient for making&#xD;
        nurse assignmkent descisions. One benchmark of staffing is valid measurement of patient&#xD;
        acuity (patients' nursing care needs). Patient acuity measures offer a potential for&#xD;
        real-time matching of patient demand for nursing care. It is defined as a measure of the&#xD;
        severity of illness and the nursing care needs, complexity, and workload required to provide&#xD;
        care to a patient or group of patients.&#xD;
  &#xD;
        There is a limited amount of research that examine the process of making direct nurse&#xD;
        staffing desicions in relation to patient acuity. By examining staffing levels and nurses'&#xD;
        perception of work environment in relation to measured patient acuity, we hope to contribute&#xD;
        to this field.&#xD;
  &#xD;
        The overall aim of this research project is to examine patient-acuity measures as a part of&#xD;
        daily management, as being introduced to five wards within the somatic in-patient care in&#xD;
        Gävleborg County, Sweden in autumn 2023. The studies will focus on staffing levels in&#xD;
        relation to the patient acuity scores and on nurses' perception of work environment, both&#xD;
        before, during and after the start of the new work procedures, but also on a weekly basis,&#xD;
        reated to the acuity scores of the actual work shift.&#xD;
  &#xD;
        Data will be collected before, 6 months, and12 months after the implementation of patient&#xD;
        acuity measures, using a web-based survey that reaches all the nursing staff at the wards.&#xD;
        Data will be analysed with descriptive and inference statistics to explore if the novel work&#xD;
        process has brought differences of different asopects related to the nurses' work environment&#xD;
        such as their well-being and perception of stress. As a reference, the same procedures will&#xD;
        be carried out at two wards that haven't implemented patient acuity measures.&#xD;
  &#xD;
        Patient-acuity measures will be collected two times a day (morning and evening shifts) from&#xD;
        each of the five wards. Once a week, all nurses working at a particular shift will be asked&#xD;
        to make a short estimation (through a paper-based form) of their perception of the work&#xD;
        environment during that particular shift. These estimations with single item-measures will be&#xD;
        compared with the patient acuity and actual staffing during the shift. An index will be used&#xD;
        to compare staffing and patient acuity in the five wards.&#xD;
  &#xD;
        Furthermore, semi-structured interviwes with four nurses' and the manager from each ward will&#xD;
        be conducted with the same time intevals as the web-based surveys. Results will be analysed&#xD;
        with content analysis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Workplace environment</measure>
      <time_frame>Baseline measure during November 2021</time_frame>
      <description>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).&#xD;
  CWEQ-II: Values between 1-5. Higher scores mean a better outcome in factors on percieved access to opputrunity, support, information and resources in an individual's work setting.&#xD;
  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.&#xD;
  SSC: Values between 1-7. Higher scores mean a better outcome.&#xD;
  Thriving Scale: Values between 1-7. Higher scores means a better outcome, with one item reversed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Workplace environment</measure>
      <time_frame>Measures will be made approximately in June 2024.</time_frame>
      <description>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).&#xD;
  CWEQ-II: Values between 1-5. Higher scores mean a better outcome in factors on percieved access to opputrunity, support, information and resources in an individual's work setting.&#xD;
  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.&#xD;
  SSC: Values between 1-7. Higher scores mean a better outcome.&#xD;
  Thriving Scale: Values between 1-7. Higher scores means a better outcome, with one item reversed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Workplace environment</measure>
      <time_frame>Measures will be made approximately during December 2024.</time_frame>
      <description>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).&#xD;
  CWEQ-II: Values between 1-5. Higher scores mean a better outcome in factors on percieved access to opputrunity, support, information and resources in an individual's work setting.&#xD;
  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.&#xD;
  SSC: Values between 1-7. Higher scores mean a better outcome.&#xD;
  Thriving Scale: Values between 1-7. Higher scores means a better outcome, with one item reversed.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Point estimations on workload and patient acuity</measure>
      <time_frame>Weekly measures from November 2023 to December 2024</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">250</enrollment>
    <condition>Work Related Stress</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Patient acuity tool</intervention_name>
      <description>A tool for measuring patient acuity as a part of daily management will be implemented in four somatic in-patient care units.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Nurses here refer to both trained nurses and assistant nurses.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All nurses emplyed by the medical wards&#xD;
  &#xD;
            -  First-line managers at each ward&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Travelling nurses&#xD;
  &#xD;
            -  Nurses with &lt;1 months employment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Karin Myrberg, PhD</last_name>
      <phone>+46702857513</phone>
      <email>karin.myrberg@regiongavleborg.se</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Maria Engström, Prof</last_name>
      <email>maria.engstrom@hig.se</email>
    </overall_contact_backup>
    <results_reference>
      <citation>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.</citation>
      <PMID>24948588</PMID>
    </results_reference>
    <results_reference>
      <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.</citation>
      <PMID>34643314</PMID>
    </results_reference>
    <results_reference>
      <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.</citation>
      <PMID>22875336</PMID>
    </results_reference>
    <results_reference>
      <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.</citation>
      <PMID>34818298</PMID>
    </results_reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>nurse staffing</keyword>
    <keyword>acuity</keyword>
    <keyword>workload</keyword>
    <keyword>daily management</keyword>
    <keyword>job satisfaction</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Occupational Stress</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06035705
  org study id: 280936
  nct id: NCT06035705
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study adresses 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 enivoronment, before, during and after the implementation of a patient acuity tool as
        a part of daily management.
  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'
        percetion of work environment. The severity of patients' illness is not sufficient for making
        nurse assignmkent descisions. 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 desicions 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,
        reated 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 interviwes with four nurses' and the manager from each ward will
        be conducted with the same time intevals as the web-based surveys. Results will be analysed
        with content analysis.
  observational model: Case-Only
  time perspective: Prospective
  measure: Workplace environment
  time frame: Baseline measure during November 2021
  description: 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 percieved access to opputrunity, 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.
  measure: Workplace environment
  time frame: Measures will be made approximately in June 2024.
  description: 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 percieved access to opputrunity, 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.
  measure: Workplace environment
  time frame: Measures will be made approximately during December 2024.
  description: 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 percieved access to opputrunity, 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.
  measure: Point estimations on workload and patient acuity
  time frame: Weekly measures from November 2023 to December 2024
  description: 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.
  intervention type: Other
  intervention name: Patient acuity tool
  description: A tool for measuring patient acuity as a part of daily management will be implemented in four somatic in-patient care units.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Karin Myrberg, PhD
  phone: +46702857513
  email: karin.myrberg@regiongavleborg.se
  last name: Maria Engström, Prof
  email: maria.engstrom@hig.se
  citation: 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.
  PMID: 24948588
  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.
  PMID: 34643314
  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.
  PMID: 22875336
  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.
  PMID: 34818298
  responsible party type: Sponsor
  mesh term: Occupational Stress
  sharing ipd: Undecided