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Stress and BurnoutNCT05211466

Digital Care Chains in Health Care - a Study of Care Consumption, Care Quality, Work Environment and Well-being

An observational study of Stress and Burnout and Work Environment Adverse Effects, run by Region Gävleborg at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Digital healthcare has developed rapidly to meet demands for accessible healthcare, streamline care and meet future challenges with increasing healthcare needs and reduced labour force in Sweden. Read more about this study

Who is it for?
Ages 18 to 100 years
What is being tested?
Digital healthcare platform
How many people
1,012 participants
Where
1 siteSweden
Study dates
17 Jan 2022to 1 Aug 2025
Phase
Observational
Are there results?
None posted in the registry

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 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population will be recruited from both public and private healthcare units (amendment of ethical approval number 2021-04696).The study population will consist of professions such as nurses, physicians, physiotherapists and psychologists and will be recruited from in-patient and out-patient care units. 1000-2000 persons will be offered paticipation in each time period.

Who may be able to join

  • healthcare staff from all clinical areas in the County of Gavleborg
  • staff with permanent employment

Who cannot join

  • administrative staff
  • managers
  • staff on long term leave
  • staff on long term sick leave
  • staff on parent leave
  • staff expected to retire or resign within a year

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • County of Gavleborg

    Gävle, Gävleborg County

Other trials in Sweden

About this study

Digital healthcare has developed rapidly to meet demands for accessible healthcare, streamline care and meet future challenges with increasing healthcare needs and reduced labour force in Sweden. Developers and stakeholders in Sweden want to exchange the praxis of phone triage to digital or semi-digital triaging tools, to relieve staff's workload and utilize better resource use that would benefit all patient groups. However, previous studies have showed demographic differences in utilization rate and an increase of simpler care matters when digital healthcare options are offered. Also, little is known of medical accuracy of digital triage tools and of the work environment in digital healthcare. More research is needed on this, as well as on care consumption, care quality and of patients' experiences of digital healthcare. The overall aim of the research project is to study a new digital healthcare platform being introduced in 2021/2022 in the County of Gävleborg, Sweden. The studies will focus on care quality and patient safety as well as explore the digital work environment and staff well-being in the digital healthcare platform. Data will be collected before and after the introduction of the digital healthcare platform, using register data and questionnaires. The data from the two time periods will be analyzed with descriptive and inference statistics, to explore if the digital healthcare platform has brought differences on group levels in staff estimates of care quality and patient safety as well as in work environment aspects such as the staffs' well-being.

Being tested
Digital healthcare platform
Keywords
Telemedicine, eHealth, Telecare, Telehealth, HIT, care quality, work environment
Medical subject headings
Burnout, Psychological, Occupational Stress, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Digital healthcare platformOther

    In this specific digital healthcare platform, patients can enter symptoms and get an initial digital triage by artificial intelligence (AI). After the artificial intelligence (AI) has assessed the symptoms, the patient can be triaged to digital healthcare advices, or a chat with a healthcare professional. If needed, the healthcare professional can convert the chat to a telephone or video assessment, or book the patient to a healthcare specialist. The platform can also administer planned consultations with patients or between professionals, it can be used as a tool for the patient to book healthcare appointments, get diagnostics and assessments done, and receive treatment through.

Study groups in NCT05211466
Study groupRoleWhat they receive
Digital care staffStaff working most of their time (20% or more) with the digital healthcare platform.
Receives: Other: Digital healthcare platform
Traditional care staffStaff working traditionally, using the digital healthcare platform to a very little extent.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Staff-reported work environment in digital healthcare compared to traditional healthcare work.

    Questions on work environment will be asked through a survey. The survey contains questions from the following questionnaires: Safety, Communication, Operational Reliability, and Engagement (SCORE) Copenhagen Psychosocial Questionnaire (COPSOQ) Surveys on Patient Safety Culture™ Hospital Survey (SOPS®) and Staff Satisfaction with Care (SSC).

    SCORE: Values between 1-5. Higher scores mean a better outcome in factors on patient safety, working climate and personal growth, with some items reversed. Higher scores mean a worse outcome in factors on workload, burnout and stress.

    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.

    SOPS Hospital Survey: Values between 1-5. Higher scores mean a worse outcome. SSC: Values between 1-7. Higher scores mean a better outcome.

    Measured: Baseline measure during January - April 2022.

  2. Staff-reported well-being in digital healthcare compared to traditional healthcare work.

    Questions on well-being will be asked through a survey. The survey contains questions from the following questionnaires: Safety, Communication, Operational Reliability, and Engagement (SCORE) Copenhagen Psychosocial Questionnaire (COPSOQ) Surveys on Patient Safety Culture™ Hospital Survey (SOPS®) and Staff Satisfaction with Care (SSC).

    SCORE: Values between 1-5. Higher scores mean a better outcome in factors on patient safety, working climate and personal growth, with some items reversed. Higher scores mean a worse outcome in factors on workload, burnout and stress.

    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.

    SOPS Hospital Survey: Values between 1-5. Higher scores mean a worse outcome. SSC: Values between 1-7. Higher scores mean a better outcome.

    Measured: Baseline measure during January - April 2022.

  3. Staff-reported quality of care given through a digital platform compared to traditional healthcare.

    Questions on quality of care will be asked through a survey. The survey contains questions from the following questionnaires: Safety, Communication, Operational Reliability, and Engagement (SCORE) Copenhagen Psychosocial Questionnaire (COPSOQ) Surveys on Patient Safety Culture™ Hospital Survey (SOPS®) and Staff Satisfaction with Care (SSC).

    SCORE: Values between 1-5. Higher scores mean a better outcome in factors on patient safety, working climate and personal growth, with some items reversed. Higher scores mean a worse outcome in factors on workload, burnout and stress.

    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.

    SOPS Hospital Survey: Values between 1-5. Higher scores mean a worse outcome. SSC: Values between 1-7. Higher scores mean a better outcome.

    Measured: Baseline measure during January - April 2022.

  4. Staff-reported work environment in digital healthcare compared to traditional healthcare work.

    Questions on work environment will be asked through a survey. The survey contains questions from the following questionnaires: Safety, Communication, Operational Reliability, and Engagement (SCORE) Copenhagen Psychosocial Questionnaire (COPSOQ) Surveys on Patient Safety Culture™ Hospital Survey (SOPS®) and Staff Satisfaction with Care (SSC). Comparisons will be made between time and groups.

    SCORE: Values between 1-5. Higher scores mean a better outcome in factors on patient safety, working climate and personal growth with some items reversed. Higher scores mean a worse outcome in factors on workload, burnout and stress.

    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.

    SOPS Hospital Survey: Values between 1-5. Higher scores mean a worse outcome. SSC: Values between 1-7. Higher scores mean a better outcome.

    Measured: Measures will be made August to December 2024.

  5. Staff-reported well-being in digital healthcare compared to traditional healthcare work.

    Questions on well-being will be asked through a survey. The survey contains questions from the following questionnaires: Safety, Communication, Operational Reliability, and Engagement (SCORE) Copenhagen Psychosocial Questionnaire (COPSOQ) Surveys on Patient Safety Culture™ Hospital Survey (SOPS®) and Staff Satisfaction with Care (SSC).

    Comparisons will be made between time and groups. SCORE: Values between 1-5. Higher scores mean a better outcome in factors on patient safety, working climate and personal growth, with some items reversed. Higher scores mean a worse outcome in factors on workload, burnout and stress.

    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.

    SOPS Hospital Survey: Values between 1-5. Higher scores mean a worse outcome. SSC: Values between 1-7. Higher scores mean a better outcome.

    Measured: Measures will be made August to December 2024.

  6. Staff-reported quality of care given through a digital platform compared to traditional health care.

    Questions on quality of care will be asked through a survey. The survey contains questions from the following questionnaires: Safety, Communication, Operational Reliability, and Engagement (SCORE) Copenhagen Psychosocial Questionnaire (COPSOQ) Surveys on Patient Safety Culture™ Hospital Survey (SOPS®) and Staff Satisfaction with Care (SSC).

    Comparisons will be made between time and groups. SCORE: Values between 1-5. Higher scores mean a better outcome in factors on patient safety, working climate and personal growth, with some items reversed. Higher scores mean a worse outcome in factors on workload, burnout and stress.

    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.

    SOPS Hospital Survey: Values between 1-5. Higher scores mean a worse outcome. SSC: Values between 1-7. Higher scores mean a better outcome.

    Measured: Measures will be made August to December 2024.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2022
  2. Study start17 Jan 2022
  3. Primary completion12 Jan 2025
  4. Study completion1 Aug 2025

Resources

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
Cohort
Time perspective
Other
Enrolment
1,012 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05211466
Sponsor's protocol ID
Digital Care Chains
Status last verified
Aug 2025
First submitted
4 Jan 2022
Last updated
25 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Due to the General Data Protection Regulation (GDPR) and restrictions in ethical approvement, individual data can not be shared. Protocols and statistics not including individual data, can be shared eventually. Informed consent forms can be shared.

Publications

  • Ekman B, Thulesius H, Wilkens J, Lindgren A, Cronberg O, Arvidsson E. Utilization of digital primary care in Sweden: Descriptive analysis of claims data on demographics, socioeconomics, and diagnoses. Int J Med Inform. 2019 Jul;127:134-140. doi: 10.1016/j.ijmedinf.2019.04.016. Epub 2019 Apr 22.

    PubMed 31128825
  • Gabrielsson-Jarhult F, Kjellstrom S, Josefsson KA. Telemedicine consultations with physicians in Swedish primary care: a mixed methods study of users' experiences and care patterns. Scand J Prim Health Care. 2021 Jun;39(2):204-213. doi: 10.1080/02813432.2021.1913904. Epub 2021 May 11.

    PubMed 33974502
  • Ashwood JS, Mehrotra A, Cowling D, Uscher-Pines L. Direct-To-Consumer Telehealth May Increase Access To Care But Does Not Decrease Spending. Health Aff (Millwood). 2017 Mar 1;36(3):485-491. doi: 10.1377/hlthaff.2016.1130.

    PubMed 28264950
  • Shah SJ, Schwamm LH, Cohen AB, Simoni MR, Estrada J, Matiello M, Venkataramani A, Rao SK. Virtual Visits Partially Replaced In-Person Visits In An ACO-Based Medical Specialty Practice. Health Aff (Millwood). 2018 Dec;37(12):2045-2051. doi: 10.1377/hlthaff.2018.05105.

    PubMed 30633681
  • Totten AM, Womack DM, Eden KB, McDonagh MS, Griffin JC, Grusing S, Hersh WR. Telehealth: Mapping the Evidence for Patient Outcomes From Systematic Reviews [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2016 Jun. Report No.: 16-EHC034-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK379320/

    PubMed 27536752
  • Fraser H, Coiera E, Wong D. Safety of patient-facing digital symptom checkers. Lancet. 2018 Nov 24;392(10161):2263-2264. doi: 10.1016/S0140-6736(18)32819-8. Epub 2018 Nov 6. No abstract available.

    PubMed 30413281
  • Kroth PJ, Morioka-Douglas N, Veres S, Babbott S, Poplau S, Qeadan F, Parshall C, Corrigan K, Linzer M. Association of Electronic Health Record Design and Use Factors With Clinician Stress and Burnout. JAMA Netw Open. 2019 Aug 2;2(8):e199609. doi: 10.1001/jamanetworkopen.2019.9609.

    PubMed 31418810
  • Alami H, Gagnon MP, Fortin JP. Some Multidimensional Unintended Consequences of Telehealth Utilization: A Multi-Project Evaluation Synthesis. Int J Health Policy Manag. 2019 Jun 1;8(6):337-352. doi: 10.15171/ijhpm.2019.12.

    PubMed 31256566

Questions about this trial

What is this clinical trial studying?

An observational study of Stress and Burnout and Work Environment Adverse Effects, 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 6 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: finished, as of the sponsor's last update on 25 Sep 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Staff-reported work environment in digital healthcare compared to traditional healthcare work. (time frame: Baseline measure during January - April 2022.). The study lists 6 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 NCT05211466, which also lists 8 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 25 Sep 2025.

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