- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06728254
Information Systems Connectivity to Improve Medication Process (LinkedCare)
Effects of Care Information Systems Connectivity on Medication Process Efficiency and Quality (Linked Care): Protocol for a Cluster Allocated Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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)
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Linz, Austria, 4200
- Volkshilfe Gesundheits- und Soziale Dienste GmbH
-
Vienna, Austria, 1210
- Johanniter Österreich Ausbildung und Forschung gem. GmbH
-
Vienna, Austria, 1030
- Wiener Rotes Kreuz- Rettungs-, Krankentransport-, Pflege- und Betreuungsgesellschaft m.b.H.
-
Vienna, Austria
- Volkshilfe Wien gemeinnützige Betriebs-GmbH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention (using Linked Care system)
All nurses and caregivers participating in the intervention group use the newly installed mynevaToGo app to reorder medication. Nurses and nursing assistant level 2 also use the myneva Care Center software to keep the medication list prescribed by the GP. The solution is installed in advance on the duty cell phones by the IT department of the relevant care organization. Participating nurses and caregivers in the intervention group are instructed to handle the medication ordering process electronically (i.e., medication orders will be sent to the GPs via the Linked Care platform). |
The test system consists of:
Functionally, the solution should, coordinate the medication requirements between pharmacies, GPs, and caregivers (subarea medication). |
|
Active Comparator: Control
Care professionals in the convenience sampled control group continue to handle the usual medication process.
|
Usual care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time spent on medication related processes
Time Frame: Baseline, 3-month follow-up, 6-month follow-up
|
Measure of time efficiency recorded on a project-specific 14-day medication log.
/ Minimum value: 0 [minutes], maximum value: N/A.
Higher scores mean a worse outcome.
/ Analysis metric: difference test vs. control, test group trend analysis.
/ Method of aggregation: mean.
|
Baseline, 3-month follow-up, 6-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall score from the "Survey on psychological stress in mobile care (BGW miab)
Time Frame: Baseline, 3-month follow-up, 6-month follow-up
|
Self-reported indications on 6 subitems on a 5-point Likert pseudometric scale.
/ Minimum value: 1, maximum value: 5. Higher scores mean a worse outcome.
/ Analysis metric: Difference test vs. control & test group trend analysis.
/ Method of aggregation: mean score.
|
Baseline, 3-month follow-up, 6-month follow-up
|
|
Overall score from a "Project-specific questionnaire on care-process quality".
Time Frame: Baseline, 3-month follow-up, 6-month follow-up
|
Self-reported indications on 21 subitems on a 5-point Likert pseudometric scale.
/ Minimum value: 1, maximum value: 5. Higher scores mean a worse outcome.
/ Analysis metric: Difference test vs. control & test group trend analysis.
/ Method of aggregation: weighted mean score.
|
Baseline, 3-month follow-up, 6-month follow-up
|
|
Overall score from the "Usefulness, Satisfaction, and Ease of Use (PSSUQ) Questionnaire"
Time Frame: 3-month follow-up, 6-month follow-up
|
Self-reported indications on 16 subitems on a 7-point Likert pseudometric scale.
/ Minimum value: 1, maximum value: 7. Higher scores mean a worse outcome.
/ Analysis metric: Difference test vs. control & test group trend analysis.
/ Method of aggregation: mean score.
|
3-month follow-up, 6-month follow-up
|
|
Overall score from the "Unified Theory of Acceptance and Use of Technology 2 (UTAUT2) Questionnaire"
Time Frame: 3-month follow-up, 6-month follow-up
|
Self-reported indications on a 7-point Likert pseudometric scale with subitems in 4 domains: i) performance expectancy, ii) effort expectancy, iii) social influence, and iv) facilitating conditions.
/ Minimum value: 1, maximum value: 7. Higher scores mean a worse outcome.
/ Analysis metric: Difference test vs. control & test group trend analysis.
/ Method of aggregation: mean score.
|
3-month follow-up, 6-month follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sample Characteristic Affiliation
Time Frame: Baseline
|
Affiliation to a care-providing organization (selection from 4 participating organizations GSD, VHW, WRK, JOHA).
Scale: nominal.
|
Baseline
|
|
Sample Characteristic Profession
Time Frame: Baseline
|
Profession (selection from 5 options: certified nurse, specialist nursing assistant, nursing assistant level 1 or level 2 , home care assistant.
Scale: nominal.
|
Baseline
|
|
Sample Characteristic Age
Time Frame: Baseline
|
Age (years). Scale: metric.
|
Baseline
|
|
Sample Characteristic Gender
Time Frame: Baseline
|
Gender (selection from 3 options: male, female, divers).
Scale: nominal.
|
Baseline
|
|
Sample Characteristic Employment Extent
Time Frame: Baseline
|
Employment extent (weekly contractual hours).
Scale: metric.
|
Baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Elisabeth Haslinger-Baumann, FH-Prof. Dr., FH Campus Wien University of Apllied Sciences
Publications and helpful links
General Publications
- Helmcke Stefan, Biesdorf Stefan, Bauer Florian, Berger Wernhard (2021). mckinseystudiedigitalisierung im gesundheitswesen die 47mrdeurochance fur Österreich.
- 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
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
Other Study ID Numbers
- FHCW EC Nr. 130/2023
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.
Clinical Trials on Medication Management at Home
-
University of WaterlooCompletedMedication Therapy Management | Home Care | PharmacistsCanada
-
Tan Tock Seng HospitalMonash University; National Healthcare Group, SingaporeCompletedMedication Therapy Management | Fall in Nursing HomeSingapore
-
University GhentUniversiteit AntwerpenCompleted
-
Ohio State UniversityWithdrawnMedication Therapy Management | Medication Management | Estimated Cost Avoidance | MTM
-
University Hospital, Basel, SwitzerlandUniversity of BaselCompletedPolymedication-Check With Insight in Patients' Medication Organisation and Comprehension of GenericsMedication Adherence | Medication Therapy ManagementSwitzerland
-
Vanderbilt University Medical CenterThe Gerber FoundationCompleted
-
University Hospital, ToulouseInstitut National de la Santé Et de la Recherche Médicale, FranceCompletedMedication Therapy ManagementFrance
-
University Hospital, ToulouseCompletedMedication Therapy ManagementFrance
-
Tabula Rasa HealthCareCompletedPharmacogenomics | Medication Therapy ManagementUnited States
Clinical Trials on medication management
-
Tabula Rasa HealthCareCompletedPharmacogenomics | Medication Therapy ManagementUnited States
-
University of Illinois at ChicagoDuke University; Baylor Research Institute; RTI International; Agency for Healthcare...CompletedElderly Patients | Chronic Illness | Adverse Effects | Medication ErrorsUnited States
-
University of PittsburghWithdrawnMedication Adherence | Adverse Reaction to Drug | Medication NonadherenceUnited States
-
University of North Texas Health Science CenterUniversity of California, San Francisco; University of Minnesota; Walgreens Boots...TerminatedHypertension | Diabetes Mellitus, Type 2 | HIV/AIDSUnited States
-
Washington University School of MedicineCompleted
-
Leiden University Medical CenterRWTH Aachen University; University of Patras; University of LjubljanaRecruitingPolypharmacyGermany, Greece, Slovenia
-
Ohio State UniversityWithdrawnMedication Therapy Management | Medication Management | Estimated Cost Avoidance | MTM
-
Prof. Iman BashetiCompletedHypertension | Diabetes | Dyslipidemias | Asthma | Cardiac Disease
-
Applied Science Private UniversityCompletedDepression, Anxiety | Adherence, Patient
-
HealthEast Care SystemUniversity of MinnesotaCompleted