EmergenciesOptimal@NRWNCT04873973
Optimized Acute Care for Geriatric Patients Using an Intersectoral Telemedical Cooperation Network - Around the Clock - Technical Performance
A study testing Telemedical support in people with Emergencies, run by RWTH Aachen University at 1 site in Germany.
Trial summary
Due to "demographic change", the composition of the population in Germany is changing. The consequence of this change is a population that is getting older on average. A key challenge is the appropriate nursing and medical care of older people in senior residences and care facilities. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Emergencies
- What is being tested?
- Telemedical support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,073 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2021to 31 Mar 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Resident of one of the participating nursing homes
- At least 18 years old
- Written informed consent
- Consent of the guardian for residents who are not legally able to give consent
Who cannot join
- Persons placed in an institution by order of an authority or court
- Persons who are in a dependent or employment relationship with the investigator
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital RWTH Aachen
Aachen, 52074
Jörg Christian Brokmann, PD Dr. med., 0241 80 88421, jbrokmann@ukaachen.de
Optimal@NRW Project Team, 0241 80 38899, optimal-nrw@ukaachen.de
About this study
Due to "demographic change", the composition of the population in Germany is changing. The consequence of this change is a population that is getting older on average. A key challenge is the appropriate nursing and medical care of older people in senior residences and care facilities. The increasing workload for nursing staff and doctors in the outpatient sector means that timely care for patients, e.g. in the form of GP visits, cannot always be guaranteed in a timely manner. The results are unnecessary or premature hospital admissions as well as ambulance and emergency care interventions, even though in many cases it is not an acute or even life-threatening event. Furthermore, it has been scientifically proven that hospital admissions can increase the risk of patients becoming confused. The aim of this project is to avoid unnecessary hospital admissions and to enable patients to remain in their familiar surroundings as far as this appears medically justifiable. At the same time, the study aims to improve the medical care of nursing home residents through better networking of medical areas, the use of tele-consultations and an early warning system.
Read the detailed description
The Optimal@NRW project represents a new cross-sectoral approach to the acute care and support of geriatric people in need of care through the implementation of an early warning system and the integration of a telemedical consultation system in 25 nursing homes in the region of Aachen in Germany. The project focuses on restructuring emergency care in nursing homes and improving cooperation between the actors involved (emergency service, emergency department, general practitioners, nursing staff, etc.). Accordingly, a central emergency number of the statutory health insurance funds is to act as a virtual hub for the care of geriatric patients.
The concrete approach of the project is that the participating nursing homes first contact the medical call centre (116 117) in case of a medical problem. The call centre is then responsible for an initial medical assessment and decides whether the respective GP can be called in or whether a teleconsultation with the "virtual digital desk" (i.e. the medical experts from the emergency department of the University Hospital RWTH Aachen) should be carried out. In addition, mobile nursing assistants (NÄPÄ (Z)) will be introduced as part of the project, who can also support the nursing staff and provide services that can be delegated by doctors - especially if the general practitioner is not available at the time.
In addition, a standardised early warning system is to be established in the nursing homes and its benefits evaluated. This will enable potentially dangerous changes in the state of health of nursing home residents to be detected earlier.
The unique and novel development of the technical concept and the interaction between a central electronic patient record, an early warning system and the telemedical equipment plays a decisive role in the success of the project.
- Conditions
- Emergencies
- Being tested
- Telemedical support
- Keywords
- telemedicine, geriatric, early warning score, acute care, nursing home, emergency department
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedical supportOther
The nursing homes participating in the project will be equipped with telemedical equipment. This will allow teleconsultations to take place when needed. In addition, an early warning system will be introduced and, within the framework of the teleconsultation, a trained medical assistant can be sent to the care facility if necessary, who can carry out medical activities on site under a physician's delegated instructions. In addition, an electronic patient file will be introduced which can be accessed by the telemedicine physician and the general practitioner.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants in this group are routinely treated. |
| Telemedical support | Active comparator | Participants in this group are routinely treated with additional telemedical support and the use of the early warning system. Receives: Other: Telemedical support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of non-realized teleconsultations by request
Number of non-realized teleconsultations by request
Measured: 6 to 15 months depending on the cluster affiliation
Secondary outcomes (16)
Number of system crash while running a teleconsultation
Number of system crash while running a teleconsultation
Measured: 6 to 15 months depending on the cluster affiliation
Number of incorrect data transmissions within the overall system
Number of incorrect data transmissions within the overall system
Measured: 6 to 15 months depending on the cluster affiliation
Duration until the realization of a teleconsultation
Duration until the realization of a teleconsultation
Measured: 6 to 15 months depending on the cluster affiliation
Number of causes that lead to system crash
A system crash is defined as a failure of one of the following three components that cannot be recovered within 5 minutes: Audio connection, visual connection, transmission of vital signs.
Measured: 6 to 15 months depending on the cluster affiliation
Data transmission rate requirement
Data transmission rate requirement
Measured: 6 to 15 months depending on the cluster affiliation
Rate of complications of the early warning system in connection with telemedicine
Rate of complications of the early warning system in connection with telemedicine
Measured: 6 to 15 months depending on the cluster affiliation
Performance of the early warning system
- Number of system errors and terminations
Measured: 6 to 15 months depending on the cluster affiliation
Performance of the early warning system
- Number of alarms in the early warning system
Measured: 6 to 15 months depending on the cluster affiliation
Performance of the early warning system
- Number of false alarms
Measured: 6 to 15 months depending on the cluster affiliation
Performance of the early warning system
- time from early warning system alarm to teleconsultation/physician contact
Measured: 6 to 15 months depending on the cluster affiliation
Performance of the early warning system
- consequences of an alarming early warning system
Measured: 6 to 15 months depending on the cluster affiliation
Performance of the teleconsultation equipment
- Number of complications
Measured: 6 to 15 months depending on the cluster affiliation
Performance of the teleconsultation equipment
- Number of disconnection error or failure of components
Measured: 6 to 15 months depending on the cluster affiliation
Performance of the teleconsultation equipment
- consultation extent
Measured: 6 to 15 months depending on the cluster affiliation
Performance of the teleconsultation equipment
- call duration
Measured: 6 to 15 months depending on the cluster affiliation
Performance of the teleconsultation equipment
- devices used
Measured: 6 to 15 months depending on the cluster affiliation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start1 Apr 2021
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for EmergenciesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stepped-Wedge-Design
- Masking
- None (open label)
- Enrolment
- 3,073 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Collaborators
- Optimal@NRW Research Group
- Responsible party
- Principal investigator, Jörg Christian Brokmann, RWTH Aachen University
- Investigators
- Jörg Christian Brokmann, PD Dr. med., Principal investigator, Uniklinik RWTH Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873973
- Sponsor's protocol ID
- 19-019-2
- Acronym
- Optimal@NRW
- Status last verified
- May 2021
- First submitted
- 31 Mar 2021
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Brown CA, Lilford RJ. The stepped wedge trial design: a systematic review. BMC Med Res Methodol. 2006 Nov 8;6:54. doi: 10.1186/1471-2288-6-54.
PubMed 17092344Hemming K, Haines TP, Chilton PJ, Girling AJ, Lilford RJ. The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting. BMJ. 2015 Feb 6;350:h391. doi: 10.1136/bmj.h391. No abstract available.
PubMed 25662947Hoffmann F, Schmiemann G. Influence of age and sex on hospitalization of nursing home residents: A cross-sectional study from Germany. BMC Health Serv Res. 2017 Jan 19;17(1):55. doi: 10.1186/s12913-017-2008-7.
PubMed 28103927Sundmacher L, Fischbach D, Schuettig W, Naumann C, Augustin U, Faisst C. Which hospitalisations are ambulatory care-sensitive, to what degree, and how could the rates be reduced? Results of a group consensus study in Germany. Health Policy. 2015 Nov;119(11):1415-23. doi: 10.1016/j.healthpol.2015.08.007. Epub 2015 Sep 2.
PubMed 26428441Vossius C, Selbaek G, Saltyte Benth J, Bergh S. Mortality in nursing home residents: A longitudinal study over three years. PLoS One. 2018 Sep 18;13(9):e0203480. doi: 10.1371/journal.pone.0203480. eCollection 2018.
PubMed 30226850Bundesärztekammer. Beschlussprotokoll des 121. Deutschen Ärztetages in Erfurt vom 08. bis 11.05.2018, Stand 08.06.2018.
Eatock D. Demografischer Ausblick für die Europäische Union 2019.
Fehr A, Lange C, Fuchs J, Neuhauser H, Schmitz R. Gesundheitsmonitoring und Gesundheitsindikatoren in Europa. Robert Koch-Institut, Epidemiologie und Gesundheitsberichterstattung; 2017.
Jacobs K, Kuhlmey A, Greß S, Klauber J, Schwinger A. Pflege-Report 2018. Berlin, Heidelberg: Springer Berlin Heidelberg; 2018.
Sachverständigenrat zur Begutachtung der Entwicklung im Gesundheitswesen. Bedarfsgerechte Steuerung der Gesundheitsversorgung. Gutachten 2018.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Acute Care for Geriatric Patients Using an Intersectoral Telemedical Cooperation Network - Around the Clock - Technical Performance
- ClinicalTrials.gov ID
- NCT04873973
- Acronym / sponsor ID
- Optimal@NRW / 19-019-2
- Conditions
- Emergencies
- Keywords
- telemedicine, geriatric, early warning score, acute care, nursing home, emergency department
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,073 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Collaborators
- Optimal@NRW Research Group
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 5 May 2021 (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.
Due to "demographic change", the composition of the population in Germany is changing. The consequence of this change is a population that is getting older on average. A key challenge is the appropriate nursing and medical care of older people in senior residences and care facilities. The increasing workload for nursing staff and doctors in the outpatient sector means that timely care for patients, e.g. in the form of GP visits, cannot always be guaranteed in a timely manner. The results are unnecessary or premature hospital admissions as well as ambulance and emergency care interventions, even though in many cases it is not an acute or even life-threatening event. Furthermore, it has been scientifically proven that hospital admissions can increase the risk of patients becoming confused. The aim of this project is to avoid unnecessary hospital admissions and to enable patients to remain in their familiar surroundings as far as this appears medically justifiable. At the same time, the study aims to improve the medical care of nursing home residents through better networking of medical areas, the use of tele-consultations and an early warning system.
Detailed description
The Optimal@NRW project represents a new cross-sectoral approach to the acute care and support of geriatric people in need of care through the implementation of an early warning system and the integration of a telemedical consultation system in 25 nursing homes in the region of Aachen in Germany. The project focuses on restructuring emergency care in nursing homes and improving cooperation between the actors involved (emergency service, emergency department, general practitioners, nursing staff, etc.). Accordingly, a central emergency number of the statutory health insurance funds is to act as a virtual hub for the care of geriatric patients.
The concrete approach of the project is that the participating nursing homes first contact the medical call centre (116 117) in case of a medical problem. The call centre is then responsible for an initial medical assessment and decides whether the respective GP can be called in or whether a teleconsultation with the "virtual digital desk" (i.e. the medical experts from the emergency department of the University Hospital RWTH Aachen) should be carried out. In addition, mobile nursing assistants (NÄPÄ (Z)) will be introduced as part of the project, who can also support the nursing staff and provide services that can be delegated by doctors - especially if the general practitioner is not available at the time.
In addition, a standardised early warning system is to be established in the nursing homes and its benefits evaluated. This will enable potentially dangerous changes in the state of health of nursing home residents to be detected earlier.
The unique and novel development of the technical concept and the interaction between a central electronic patient record, an early warning system and the telemedical equipment plays a decisive role in the success of the project.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped-Wedge-Design
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants in this group are routinely treated. |
| Telemedical support | Active comparator | Other: Telemedical supportParticipants in this group are routinely treated with additional telemedical support and the use of the early warning system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Resident of one of the participating nursing homes
- At least 18 years old
- Written informed consent
- Consent of the guardian for residents who are not legally able to give consent
Key exclusion criteria (2 listed)
- Persons placed in an institution by order of an authority or court
- Persons who are in a dependent or employment relationship with the investigator
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 |
|---|---|---|
| Telemedical supportThe nursing homes participating in the project will be equipped with telemedical equipment. This will allow teleconsultations to take place when needed. In addition, an early warning system will be introduced and, within the framework of the teleconsultation, a trained medical assistant can be sent to the care facility if necessary, who can carry out medical activities on site under a physician's delegated instructions. In addition, an electronic patient file will be introduced which can be accessed by the telemedicine physician and the general practitioner. | Other | Telemedical support |
Primary outcome
Number of non-realized teleconsultations by request
Time frame: 6 to 15 months depending on the cluster affiliation
Number of non-realized teleconsultations by request
16 secondary outcomes
Number of system crash while running a teleconsultation
Time frame: 6 to 15 months depending on the cluster affiliation
Number of incorrect data transmissions within the overall system
Time frame: 6 to 15 months depending on the cluster affiliation
Duration until the realization of a teleconsultation
Time frame: 6 to 15 months depending on the cluster affiliation
Number of causes that lead to system crash
Time frame: 6 to 15 months depending on the cluster affiliation
Data transmission rate requirement
Time frame: 6 to 15 months depending on the cluster affiliation
Rate of complications of the early warning system in connection with telemedicine
Time frame: 6 to 15 months depending on the cluster affiliation
Performance of the early warning system
Time frame: 6 to 15 months depending on the cluster affiliation
Performance of the early warning system
Time frame: 6 to 15 months depending on the cluster affiliation
Performance of the early warning system
Time frame: 6 to 15 months depending on the cluster affiliation
Performance of the early warning system
Time frame: 6 to 15 months depending on the cluster affiliation
Performance of the early warning system
Time frame: 6 to 15 months depending on the cluster affiliation
Performance of the teleconsultation equipment
Time frame: 6 to 15 months depending on the cluster affiliation
Performance of the teleconsultation equipment
Time frame: 6 to 15 months depending on the cluster affiliation
Performance of the teleconsultation equipment
Time frame: 6 to 15 months depending on the cluster affiliation
Performance of the teleconsultation equipment
Time frame: 6 to 15 months depending on the cluster affiliation
Performance of the teleconsultation equipment
Time frame: 6 to 15 months depending on the cluster affiliation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Background: PubMed 17092344Brown CA, Lilford RJ. The stepped wedge trial design: a systematic review. BMC Med Res Methodol. 2006 Nov 8;6:54. doi: 10.1186/1471-2288-6-54.
- Background: PubMed 25662947Hemming K, Haines TP, Chilton PJ, Girling AJ, Lilford RJ. The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting. BMJ. 2015 Feb 6;350:h391. doi: 10.1136/bmj.h391. No abstract available.
- Background: PubMed 28103927Hoffmann F, Schmiemann G. Influence of age and sex on hospitalization of nursing home residents: A cross-sectional study from Germany. BMC Health Serv Res. 2017 Jan 19;17(1):55. doi: 10.1186/s12913-017-2008-7.
- Background: PubMed 26428441Sundmacher L, Fischbach D, Schuettig W, Naumann C, Augustin U, Faisst C. Which hospitalisations are ambulatory care-sensitive, to what degree, and how could the rates be reduced? Results of a group consensus study in Germany. Health Policy. 2015 Nov;119(11):1415-23. doi: 10.1016/j.healthpol.2015.08.007. Epub 2015 Sep 2.
- Background: PubMed 30226850Vossius C, Selbaek G, Saltyte Benth J, Bergh S. Mortality in nursing home residents: A longitudinal study over three years. PLoS One. 2018 Sep 18;13(9):e0203480. doi: 10.1371/journal.pone.0203480. eCollection 2018.
- BackgroundBundesärztekammer. Beschlussprotokoll des 121. Deutschen Ärztetages in Erfurt vom 08. bis 11.05.2018, Stand 08.06.2018.
- BackgroundEatock D. Demografischer Ausblick für die Europäische Union 2019.
- BackgroundFehr A, Lange C, Fuchs J, Neuhauser H, Schmitz R. Gesundheitsmonitoring und Gesundheitsindikatoren in Europa. Robert Koch-Institut, Epidemiologie und Gesundheitsberichterstattung; 2017.
- BackgroundJacobs K, Kuhlmey A, Greß S, Klauber J, Schwinger A. Pflege-Report 2018. Berlin, Heidelberg: Springer Berlin Heidelberg; 2018.
- BackgroundSachverständigenrat zur Begutachtung der Entwicklung im Gesundheitswesen. Bedarfsgerechte Steuerung der Gesundheitsversorgung. Gutachten 2018.
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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.
Jörg Christian Brokmann, PD Dr. med. principal investigator
Uniklinik RWTH Aachen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedical support in people with Emergencies, run by RWTH Aachen University at 1 site in Germany.
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 2 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: status not confirmed, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jörg Christian Brokmann, PD Dr. med. (0241 80 88421, jbrokmann@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of non-realized teleconsultations by request (time frame: 6 to 15 months depending on the cluster affiliation). 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 NCT04873973, which also lists 10 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 5 May 2021.