CClinicalTrials.gg
CompletedNCT05211466Updated Sep 25, 2025

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

An observational study in Stress and Burnout, Work Environment Adverse Effects and Well-Being, Psychological, sponsored by Region Gävleborg. Completed at 1 site in Sweden. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-09-25.

Sponsored by Region Gävleborg · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
1,012
Ages
18 Years to 100 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Stress and Burnout
  • Work Environment Adverse Effects
  • Well-Being, Psychological
  • Care Givers Satisfaction
  • Workload
  • Technology Use

Keywords

  • Telemedicine
  • eHealth
  • Telecare
  • Telehealth
  • HIT
  • care quality
  • work environment
03

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
1,012 participants (actual)
Patient registry
No

Groups and cohorts

  • Digital care staff

    Staff working most of their time (20% or more) with the digital healthcare platform.

    Other: Digital healthcare platform

  • Traditional care staff

    Staff working traditionally, using the digital healthcare platform to a very little extent.

Interventions

  • OtherDigital healthcare platform

    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.

05

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Measures will be made August to December 2024.

06

Study locations

1 site
  • County of Gavleborg
    Gävle, Gävleborg County, Sweden
07

References and documents

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 ↗

Individual participant data

Plan to share: 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.

08

Registry details

Key details

Study ID
NCT05211466
Lead sponsor
Region Gävleborg
Collaborators
University of Gavle
Responsible party
Sponsor
First posted
Jan 27, 2022
Start date
Jan 17, 2022
Primary completion
Jan 12, 2025
Completion
Aug 1, 2025
Last update
Sep 25, 2025

Study contacts

Agneta C Larsson, MD, PhD
study chair · County of Gavleborg

Oversight

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

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