Clinical trial NCT05211466: Digital Care Chains in Health Care - a Study of Care Consumption, Care Quality, Work Environment and Well-being
Official title: Digital Care Chains in Health Care - a Study of Care Consumption, Care Quality, Work Environment and Well-being
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Depression
Depressive Disorder
Depressive Disorder, Major
Depression, Bipolar
Depression Recurrent
Keywords: Telemedicine
eHealth
Telecare
Telehealth
HIT
Lead sponsor: Region Gävleborg
Sponsor class: OTHER
Collaborators: name: University of Gavle
First posted: 2022-01-27
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: In the patient study three subgroups of severe depression will be studied: recurring, bipolar, and major depression. The subgroups have different symptom acuity so healthcare triage and outcome should differ. The investigator will also study differences in healthcare outcomes based on gender and age. Approximately 250 patients' computerized medical records will be analyzed in each time period.

In the staff study, 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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Healthcare search patterns for depressed patients before the digital healthcare platform has been introduced.
timeFrame: January 2019 - December 2019
measure: Outcome of healthcare contacts for depressed patients before the digital healthcare platform has been introduced.
timeFrame: January 2019 - December 2019
measure: Healthcare search patterns for depressed patients after the digital healthcare platform has been introduced.
timeFrame: September 2022 - August 2023
measure: Outcome of healthcare contacts for depressed patients after the digital healthcare platform has been introduced.
timeFrame: September 2022 - August 2023
measure: Staff-reported work environment in digital healthcare compared to traditional healthcare work.
timeFrame: Baseline measure during January - April 2022.
measure: Staff-reported well-being in digital healthcare compared to traditional healthcare work.
timeFrame: Baseline measure during January - April 2022.
measure: Staff-reported quality of care given through a digital platform compared to traditional healthcare.
timeFrame: Baseline measure during January - April 2022.
measure: Staff-reported work environment in digital healthcare compared to traditional healthcare work.
timeFrame: Measures will be made approximately in December 2023.
measure: Staff-reported well-being in digital healthcare compared to traditional healthcare work.
timeFrame: Measures will be made approximately in December 2023.
measure: Staff-reported quality of care given through a digital platform compared to traditional health care.
timeFrame: Measures will be made approximately in December 2023.
Secondary outcomes:
measure: Somatic healthcare search patterns for depressed patients before the digital healthcare platform has been introduced.
timeFrame: January 2019 - December 2019
measure: Somatic healthcare search patterns for depressed patients after the digital healthcare platform has been introduced.
timeFrame: September 2022 - August 2023
measure: Suicide attempts before admission to inpatient care, before the introduction of the digital healthcare platform.
timeFrame: January 2019 - December 2019
measure: Suicide attempts before admission to inpatient care, after the introduction of the digital healthcare platform.
timeFrame: September 2022 - August 2023
measure: Type of admission to inpatient care, after the introduction of the digital healthcare platform.
timeFrame: January 2019 - December 2019
measure: Type of admission to inpatient care, before the introduction of the digital healthcare platform.
timeFrame: September 2022 - August 2023
Other outcomes:
Locations:
city: Gävle
country: Sweden
facility: County of Gavleborg
state: Gävleborg
Study officials:
affiliation: County of Gavleborg
name: Agneta C Larsson, MD, PhD
role: STUDY_CHAIR
References:
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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/
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.
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.
citation: 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.