Medication Management at HomeLinkedCareNCT06728254
Information Systems Connectivity to Improve Medication Process
A study testing medication management in people with Medication Management at Home, run by Peter Putz at 4 sites in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Management at Home
- What is being tested?
- medication management
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 4 sitesAustria
- Study dates
- 7 Jan 2025to 29 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
Austria4 sites
Volkshilfe Gesundheits- und Soziale Dienste GmbH
Linz, 4200
Wiener Rotes Kreuz- Rettungs-, Krankentransport-, Pflege- und Betreuungsgesellschaft m.b.H.
Vienna, 1030
Johanniter Österreich Ausbildung und Forschung gem. GmbH
Vienna, 1210
Volkshilfe Wien gemeinnützige Betriebs-GmbH
Vienna
About this study
Official title: Effects of Care Information Systems Connectivity on Medication Process Efficiency and Quality (Linked Care): Protocol for a Cluster Allocated Controlled Trial
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?
Read the 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)
- Conditions
- Medication Management at Home
- Being tested
- medication management, Usual Care Group
- Keywords
- medication process, nursing, telehealth, home care, medication order
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medication managementDevice
The test system consists of:
- Linked care platform (backend) which provides a new possibility of data exchange for IT systems of caregivers, pharmacies, and GPs
- User interfaces for caregivers as well as for the systems myneva.carecenter and mynevaTOgo
- An extension of the user interface for GPs in their IT system (in the test only for the physician software PCPO by CompoGroup Medical )
- An extension of the user interface for pharmacists in their IT system (in the test only for pharmacies with software from Apothekerverlag)
Functionally, the solution should, coordinate the medication requirements between pharmacies, GPs, and caregivers (subarea medication).
Usual Care GroupOther
Usual care.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (using Linked Care system) | Experimental | 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). Receives: Device: medication management |
| Control | Active comparator | Care professionals in the convenience sampled control group continue to handle the usual medication process. Receives: Other: Usual Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent on medication related processes
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.
Measured: Baseline, 3-month follow-up, 6-month follow-up
Secondary outcomes (4)
Overall score from the "Survey on psychological stress in mobile care (BGW miab)
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.
Measured: Baseline, 3-month follow-up, 6-month follow-up
Overall score from a "Project-specific questionnaire on care-process quality".
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.
Measured: Baseline, 3-month follow-up, 6-month follow-up
Overall score from the "Usefulness, Satisfaction, and Ease of Use (PSSUQ) Questionnaire"
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.
Measured: 3-month follow-up, 6-month follow-up
Overall score from the "Unified Theory of Acceptance and Use of Technology 2 (UTAUT2) Questionnaire"
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.
Measured: 3-month follow-up, 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start7 Jan 2025
- Primary completion29 Jun 2025
- Study completion29 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Medication Management at HomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-randomized controlled trial, with participants unequally allocated to test and control groups (factor 5) in clusters
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Putz
- Sponsor type
- University, hospital or other
- Collaborators
- Wiener Rotes Kreuz- Rettungs-, Krankentransport-, Pflege- und Betreuungsgesellschaft m.b.H., Volkshilfe Wien gemeinnützige Betriebs-GmbH, Volkshilfe Gesundheits- und Soziale Dienste GmbH, Johanniter Österreich Ausbildung und Forschung gem. GmbH
- Responsible party
- Sponsor-investigator, Peter Putz, Hochschule Campus Wien (University of Applied Sciences Campus Vienna)
- Investigators
- Elisabeth Haslinger-Baumann, FH-Prof. Dr., Study director, FH Campus Wien University of Apllied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728254
- Sponsor's protocol ID
- FHCW EC Nr. 130/2023
- Acronym
- LinkedCare
- Status last verified
- Sep 2025
- First submitted
- 6 Dec 2024
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because the trial deals with sensitive health-related data, neither person-identifiable nor coded raw data will be made publicly available or shared upon request from other researchers.
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 at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Care Information Systems Connectivity on Medication Process Efficiency and Quality (Linked Care): Protocol for a Cluster Allocated Controlled Trial
- ClinicalTrials.gov ID
- NCT06728254
- Acronym / sponsor ID
- LinkedCare / FHCW EC Nr. 130/2023
- Conditions
- Medication Management at Home
- Keywords
- medication process, nursing, telehealth, home care, medication order
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Peter PutzUniversity, hospital or other
- Collaborators
- Wiener Rotes Kreuz- Rettungs-, Krankentransport-, Pflege- und Betreuungsgesellschaft m.b.H., Volkshilfe Wien gemeinnützige Betriebs-GmbH, Volkshilfe Gesundheits- und Soziale Dienste GmbH, Johanniter Österreich Ausbildung und Forschung gem. GmbH
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 29 Jun 2025 (actual)
- Study completion
- 29 Jun 2025 (actual)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-randomized controlled trial, with participants unequally allocated to test and control groups (factor 5) in clusters
| Arm | Type | Receives |
|---|---|---|
| Intervention (using Linked Care system) | Experimental | Device: medication managementAll 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). |
| Control | Active comparator | Other: Usual Care GroupCare professionals in the convenience sampled control group continue to handle the usual medication process. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medication managementThe test system consists of: * Linked care platform (backend) which provides a new possibility of data exchange for IT systems of caregivers, pharmacies, and GPs * User interfaces for caregivers as well as for the systems myneva.carecenter and mynevaTOgo * An extension of the user interface for GPs in their IT system (in the test only for the physician software PCPO by CompoGroup Medical ) * An extension of the user interface for pharmacists in their IT system (in the test only for pharmacies with software from Apothekerverlag) Functionally, the solution should, coordinate the medication requirements between pharmacies, GPs, and caregivers (subarea medication). | Device | Intervention (using Linked Care system) |
| Usual Care GroupUsual care. | Other | Control |
Primary outcome
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.
4 secondary outcomes
Overall score from the "Survey on psychological stress in mobile care (BGW miab)
Time frame: 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
Overall score from the "Usefulness, Satisfaction, and Ease of Use (PSSUQ) Questionnaire"
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- BackgroundHelmcke Stefan, Biesdorf Stefan, Bauer Florian, Berger Wernhard (2021). mckinseystudiedigitalisierung im gesundheitswesen die 47mrdeurochance fur Österreich.
- BackgroundBGW 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
- Individual participant dataSharing planned: No. Because the trial deals with sensitive health-related data, neither person-identifiable nor coded raw data will be made publicly available or shared upon request from other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Haslinger-Baumann, FH-Prof. Dr. study director
FH Campus Wien University of Apllied Sciences
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing medication management in people with Medication Management at Home, run by Peter Putz at 4 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time spent on medication related processes (time frame: Baseline, 3-month follow-up, 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06728254, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.