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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05211466
• Other study ID #: Digital Care Chains
• Status: Active, not recruiting
• Start date: January 17, 2022
• Est. completion date: November 1, 2025

Study information

• Verified date: July 2023
• Source: Region Gävleborg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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 consumption, healthcare outcomes, care quality and patient safety as well as explore the digital work environment 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 care consumption, healthcare outcomes, care quality and patient safety as well as in work environment aspects such as the staffs' well-being.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1200
• Est. completion date: November 1, 2025
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria in the patient study:

• severe depression

• has received inpatient care in the County of Gavleborg during two given time-periods

Exclusion Criteria in the patient study:

• stress-related exhaustion disorder

• substance use disorder

• neuropsychiatric disorder

• psychosis

• postpartum depression.

Inclusion Criteria in the staff study:

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

• staff with permanent employment

Exclusion Criteria in the staff study:

• 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

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depression, Bipolar
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Other:
• Digital 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.

Locations

Country	Name	City	State
Sweden	County of Gavleborg	Gävle	Gävleborg

Sponsors (2)

Lead Sponsor	Collaborator
Region Gävleborg	University of Gavle

Country where clinical trial is conducted

Sweden, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healthcare search patterns for depressed patients before the digital healthcare platform has been introduced.	Search patterns will be examined 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).Three subgroups will be studied: recurring, bipolar, and major depression. CMR will be examined retroactively for a six-month period prior to admission to inpatient care. Approximately 250 individuals' CMR will be examined and categorized in groups based on type of depression, gender, age and municipality and if possible; civil and employment status and birth country. Analysis will be made of how, when and why the patient contacted healthcare. 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.	January 2019 - December 2019
Primary	Outcome of healthcare contacts for depressed patients before the digital healthcare platform has been introduced.	Outcomes will be examined by reviewing CMR from inpatients who have received care for severe depression before the introduction of the DHP. Three subgroups will be studied: recurring, bipolar, and major depression.The subgroups have different acuity and outcomes should differ. CMR will be examined retroactively for a six-month period prior to inpatient admission.The CMR will be categorized into groups based on type of depression and demographic factors. Analysis will be made of several outcomes, such as triage outcome, diagnostic screenings and time to treatment. After 2 years, measurement will be made of time to follow-up in outpatient care, readmissions within a month, and possible suicides. Data will be analyzed in whole groups as well as differences between depression subgroups and demographic groups over time, and interaction time and group. Descriptive and inference statistics will be studied using statistics such as ANCOVA.	January 2019 - December 2019
Primary	Healthcare search patterns for depressed patients after the digital healthcare platform has been introduced.	Search patterns will be examined through reviews of CMR from inpatients who have received care for severe depression during a given time period after the introduction of the DHP. Three subgroups will be studied: recurring, bipolar, and major depression. CMR will be examined retroactively for a six-month period prior to admission to inpatient care. Approximately 250 patients' CMR will be examined. The same categorizations and analysis will be made as in Outcome 1, but in this measurement period, the DHP will be an additional option for the patients to contact healthcare. 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.	September 2022 - August 2023
Primary	Outcome of healthcare contacts for depressed patients after the digital healthcare platform has been introduced.	Outcomes will be examined by reviewing CMR from inpatients who have received care for severe depression after the introduction of the DHP. The same subgroups will be studied as in description for Outcome 2. CMR will be examined retroactively for a six-month period prior to inpatient admission using the same categorizations as in Outcome 2, but this time the DHP will be an additional option for patients to contact healthcare. After 2 years, measurements will be made of time to follow-up in outpatient care, readmissions within a month, and possible suicides. Data will be analyzed in whole groups as well as differences between depression subgroups and demographic groups over time, and interaction time and group. Descriptive and inference statistics will be studied using statistics such as ANCOVA. Additional analysis will be made of the quantity of these diagnoses in outpatient and inpatient care in each measurement period, compared to each other and to the population.	September 2022 - August 2023
Primary	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.	Baseline measure during January - April 2022.
Primary	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.	Baseline measure during January - April 2022.
Primary	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.	Baseline measure during January - April 2022.
Primary	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.	Measures will be made approximately in December 2023.
Primary	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.	Measures will be made approximately in December 2023.
Primary	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.	Measures will be made approximately in December 2023.
Secondary	Somatic healthcare search patterns for depressed patients before the digital healthcare platform has been introduced.	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.	January 2019 - December 2019
Secondary	Somatic healthcare search patterns for depressed patients after the digital healthcare platform has been introduced.	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.	September 2022 - August 2023
Secondary	Suicide attempts before admission to inpatient care, before the introduction of the digital healthcare platform.	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.	January 2019 - December 2019
Secondary	Suicide attempts before admission to inpatient care, after the introduction of the digital healthcare platform.	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.	September 2022 - August 2023
Secondary	Type of admission to inpatient care, after the introduction of the digital healthcare platform.	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.	January 2019 - December 2019
Secondary	Type of admission to inpatient care, before the introduction of the digital healthcare platform.	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.	September 2022 - August 2023