Clinical trial NCT06728254: Information Systems Connectivity to Improve Medication Process
Official title: Effects of Care Information Systems Connectivity on Medication Process Efficiency and Quality (Linked Care): Protocol for a Cluster Allocated Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Medication Management at Home
Keywords: medication process
nursing
telehealth
home care
medication order
Lead sponsor: FH Campus Wien, University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Wiener Rotes Kreuz- Rettungs-, Krankentransport-, Pflege- und Betreuungsgesellschaft m.b.H.
name: Volkshilfe Wien gemeinnützige Betriebs-GmbH
name: Volkshilfe Gesundheits- und Soziale Dienste GmbH
name: Johanniter Österreich Ausbildung und Forschung gem. GmbH
First posted: 2024-12-11
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-randomized controlled trial, with participants unequally allocated to test and control groups (factor 5) in clusters
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Linked Care aims to help healthcare professionals (nurses, doctors, pharmacists) interact efficiently and safely with IT support to improve patient information flows. It focuses on the medication ordering process, which currently involves time-consuming steps like calling doctors and traveling to get prescriptions. The project targets nursing staff, doctors, pharmacists, and patients, with indirect benefits for hospitals, social welfare organizations, and insurance bodies. This study evaluates the Linked Care solution by addressing the research question: Does an electronic ordering system improve the efficiency and quality of the regular medication process?

Detailed description: Background and rationale:

Linked Care aims to provide access to information relevant to care and support beyond the boundaries of the various care settings and primarily supports caregivers in the acquisition and transfer of information. The development of essential standards (e.g., a myCare Info) and the involvement of all affected target groups make it possible to develop practical IT tools for standardized networking in mobile care and nursing. The result will be an integrated, affordable, easy-to-use and well-connected IT system for care and support. The portal can be operated via mobile devices, PC, or tablets.

The McKinsey study demonstrates the significant potential of digitalization in the Austrian healthcare sector. According to this study, there is a 4.7-billion-euro opportunity for Austria. Approximately 70% of the potential benefits of increased productivity accrue to service providers, such as physicians and hospitals. The remaining 30% can be attributed to other players in the system, particularly health insurers, who benefit from reduced service utilization and improved care. Key factors in achieving these benefits include the implementation of the Austrian electronic health record (ELGA) and e-prescribing, which enable efficiency gains of EUR 690 million. Digitization is also sought after by regulators, patients, payers, and service providers in the Austrian healthcare system for improved efficiency and quicker access to data.

Helmcke et al. (2021) identify the following areas with the greatest potential for savings and benefits in the Austrian healthcare system:

* Online interactions, especially through teleconsultation.
* Paperless data, emphasizing standardized patient records/exchange and electronic prescriptions.
* Automated workflows, particularly the networking of mobile caregivers.
* Decision support and transparency of outcomes, including performance dashboards.
* Patient self-management, primarily through tools for managing chronic conditions like diabetes.
* Patient self-service for electronic scheduling.

Objectives:

This project aims to enable documenting healthcare professionals (such as nurses, general practitioners (GPs), and pharmacists) to interact efficiently, safely, and conveniently, with optimal IT support, to improve (or make more efficient) the patient-related information flows. The specific use cases studied are the process of ordering and in particular reordering medication. A significant time-saving potential has been identified in the transfer of medication information. The ordering process usually begins with nurses calling a GP as soon as they notice that a client has run out of medication and needs to be re-supplied when preparing the prescribed medication. The nurse then usually travels distances (e.g. by car) to obtain a prescription from the GP and collect the medication from the pharmacy. To do this, they need the client's insurance card, which has to be collected separately. The project is therefore aimed at four target groups: i) nursing staff who carry out the documentation, ii) GPs, and iii) pharmacists and finally iv) patients who make use of the care. In addition to the target groups studied in this trial, indirect beneficiaries include healthcare providers such as hospitals, social welfare organizations, rehabilitation clinics, public insurance bodies, etc. who ensure effective and efficient care. The trial aims to evaluate the entire process of data recording and data exchange via the newly created interfaces between the systems involved in practical use.

The primary research question of this study is: Does an electronic ordering system improve the efficiency and quality of the regular medication process?

Secondary research questions are:

* Does the digital ordering system receive end-user acceptance?
* Which impacts on the health and care system are generated by the implementation of the digital ordering system? (evaluated qualitatively)

Eligibility criteria: Inclusion Criteria Caregivers:

* Actively pursuing at least one of the following health professions extramurally: nurse, nursing assistant level 1 or level 2 , elderly specialist caregiver, home care assistant
* Active maintenance of nursing documentation and use of the duty cell phone
* Age 18+ years
* Willing to comply with all study-related procedures and provide informed consent

Primary outcomes:
measure: Time spent on medication related processes
timeFrame: Baseline, 3-month follow-up, 6-month follow-up
Secondary outcomes:
measure: Overall score from the "Survey on psychological stress in mobile care (BGW miab)
timeFrame: Baseline, 3-month follow-up, 6-month follow-up
measure: Overall score from a "Project-specific questionnaire on care-process quality".
timeFrame: Baseline, 3-month follow-up, 6-month follow-up
measure: Overall score from the "Usefulness, Satisfaction, and Ease of Use (PSSUQ) Questionnaire"
timeFrame: 3-month follow-up, 6-month follow-up
measure: Overall score from the "Unified Theory of Acceptance and Use of Technology 2 (UTAUT2) Questionnaire"
timeFrame: 3-month follow-up, 6-month follow-up
Other outcomes:
measure: Sample Characteristic Affiliation
timeFrame: Baseline
measure: Sample Characteristic Profession
timeFrame: Baseline
measure: Sample Characteristic Age
timeFrame: Baseline
measure: Sample Characteristic Gender
timeFrame: Baseline
measure: Sample Characteristic Employment Extent
timeFrame: Baseline
Locations:
city: Linz
country: Austria
facility: Volkshilfe Gesundheits- und Soziale Dienste GmbH
city: Vienna
country: Austria
facility: Wiener Rotes Kreuz- Rettungs-, Krankentransport-, Pflege- und Betreuungsgesellschaft m.b.H.
city: Vienna
country: Austria
facility: Johanniter Österreich Ausbildung und Forschung gem. GmbH
city: Vienna
country: Austria
facility: Volkshilfe Wien gemeinnützige Betriebs-GmbH
Study officials:
affiliation: FH Campus Wien University of Apllied Sciences
name: Elisabeth Haslinger-Baumann, FH-Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: Helmcke Stefan, Biesdorf Stefan, Bauer Florian, Berger Wernhard (2021). mckinseystudiedigitalisierung im gesundheitswesen die 47mrdeurochance fur Österreich.
citation: BGW miab für die Pflege und den stationären Wohnbereich der Behindertenhilfe Erstveröffentlichung 2002, Stand 01/2013 Hrsg. Berufsgenossenschaft für Gesundheitsdienst und Wohlfahrtspflege (BGW). Hamburg, Online: www.bgw-online.de