- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05211466
Digital Care Chains in Health Care - a Study of Care Consumption, Care Quality, Work Environment and Well-being
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Gävleborg County
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Gävle, Gävleborg County, Sweden
- County of Gavleborg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- healthcare staff from all clinical areas in the County of Gavleborg
- staff with permanent employment
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Digital care staff
Staff working most of their time (20% or more) with the digital healthcare platform.
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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.
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|
Traditional care staff
Staff working traditionally, using the digital healthcare platform to a very little extent.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Staff-reported work environment in digital healthcare compared to traditional healthcare work.
Time Frame: Baseline measure during January - April 2022.
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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. |
Baseline measure during January - April 2022.
|
|
Staff-reported well-being in digital healthcare compared to traditional healthcare work.
Time Frame: Baseline measure during January - April 2022.
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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. |
Baseline measure during January - April 2022.
|
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Staff-reported quality of care given through a digital platform compared to traditional healthcare.
Time Frame: Baseline measure during January - April 2022.
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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. |
Baseline measure during January - April 2022.
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Staff-reported work environment in digital healthcare compared to traditional healthcare work.
Time Frame: Measures will be made August to December 2024.
|
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. |
Measures will be made August to December 2024.
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Staff-reported well-being in digital healthcare compared to traditional healthcare work.
Time Frame: Measures will be made August to December 2024.
|
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. |
Measures will be made August to December 2024.
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Staff-reported quality of care given through a digital platform compared to traditional health care.
Time Frame: Measures will be made August to December 2024.
|
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. |
Measures will be made August to December 2024.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Somatic healthcare search patterns for depressed patients before the digital healthcare platform has been introduced.
Time Frame: January 2019 - December 2019
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Patients with depression often contact healthcare months before the actual depression is being discovered, for physical ailments or sleep disorders.
Through reviews of computerized medical records (CMR) from inpatients who have received care for severe depression during a given time period before the introduction of the digital healthcare platform (DHP) search patterns will be analyzed and categorized according to what somatic ailment the patient contacted healthcare for.
CMR will be analyzed in a six months time period before admission to inpatient care.
Data will be analyzed in whole groups as well as differences between depression subgroups and demographic groups over time, and interaction time and group.
Based on several secondary outcome measures, descriptive and inference statistics will be studied using statistics such as ANCOVA.
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January 2019 - December 2019
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Somatic healthcare search patterns for depressed patients after the digital healthcare platform has been introduced.
Time Frame: September 2022 - August 2023
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Patients with depression often contact healthcare months before the actual depression is being discovered, for physical ailments or sleep disorders.
Through reviews of computerized medical records (CMR) from inpatients who have received care for severe depression during a given time period after the introduction of the digital healthcare platform (DHP) search patterns will be analyzed and categorized according to what somatic ailment the patient contacted healthcare for.
CMR will be analyzed in a six months time period before admission to inpatient care.
Data will be analyzed in whole groups as well as differences between depression subgroups and demographic groups over time, and interaction time and group.
Based on several secondary outcome measures, descriptive and inference statistics will be studied using statistics such as ANCOVA.
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September 2022 - August 2023
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Suicide attempts before admission to inpatient care, before the introduction of the digital healthcare platform.
Time Frame: January 2019 - December 2019
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Through reviews of computerized medical records (CMR) from inpatients who have received care for severe depression during a given time period before the introduction of the digital healthcare platform (DHP) the number of suicide attempts before admission to inpatient care, will be counted and analyzed.
CMR will be analyzed in a six months time period before admission to inpatient care.
Data will be analyzed in whole groups as well as differences between depression subgroups and demographic groups over time, and interaction time and group.
Based on several secondary outcome measures, descriptive and inference statistics will be studied using statistics such as ANCOVA.
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January 2019 - December 2019
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Suicide attempts before admission to inpatient care, after the introduction of the digital healthcare platform.
Time Frame: September 2022 - August 2023
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Through reviews of computerized medical records (CMR) from inpatients who have received care for severe depression during a given time period after the introduction of the digital healthcare platform (DHP) the number of suicide attempts before admission to inpatient care, will be counted and analyzed.
CMR will be analyzed in a six months time period before admission to inpatient care.
Data will be analyzed in whole groups as well as differences between depression subgroups and demographic groups over time, and interaction time and group.
Based on several secondary outcome measures, descriptive and inference statistics will be studied using statistics such as ANCOVA.
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September 2022 - August 2023
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Type of admission to inpatient care, after the introduction of the digital healthcare platform.
Time Frame: January 2019 - December 2019
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Admission to inpatient care can be made voluntarily or involuntarily.
Through reviews of computerized medical records (CMR) from inpatients who have received care for severe depression during a given time period before the introduction of the digital healthcare platform (DHP) the number of patients receiving care voluntarily and involuntarily, will be counted respectively and analyzed.
Data will be analyzed in whole groups as well as differences between depression subgroups and demographic groups over time, and interaction time and group.
Based on several secondary outcome measures, descriptive and inference statistics will be studied using statistics such as ANCOVA.
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January 2019 - December 2019
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Type of admission to inpatient care, before the introduction of the digital healthcare platform.
Time Frame: September 2022 - August 2023
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Admission to inpatient care can be made voluntarily or involuntarily.
Through reviews of computerized medical records (CMR) from inpatients who have received care for severe depression during a given time period after the introduction of the digital healthcare platform (DHP) the number of patients receiving care voluntarily and involuntarily, will be counted respectively and analyzed.
Data will be analyzed in whole groups as well as differences between depression subgroups and demographic groups over time, and interaction time and group.
Based on several secondary outcome measures, descriptive and inference statistics will be studied using statistics such as ANCOVA.
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September 2022 - August 2023
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Agneta C Larsson, MD, PhD, County of Gavleborg
Publications and helpful links
General Publications
- 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.
- 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/
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Digital Care Chains
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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