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EmergenciesOptimal@NRWNCT04879537

Optimized Acute Care for Geriatric Patients Using an Intersectoral Telemedical Cooperation Network - Around the Clock

A study testing Telemedical support in people with Emergencies, run by RWTH Aachen University at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
1,600 participants
Where
1 siteGermany
Study dates
1 Apr 2021to 30 Apr 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

  • University Hospital RWTH Aachen

    Aachen, 52074

Other trials in Germany

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.

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 groups in NCT04879537
Study groupRoleWhat they receive
ControlNo interventionParticipants in this group are routinely treated.
Telemedical supportActive comparatorParticipants 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.

  1. Days spent at hospital

    Days spent at hospital

    Measured: 24 months

  2. Number of Intervention-related adverse events

    • Resuscitation during teleconsultation
    • Unexpected death during teleconsultation
    • Unexpected death within 24 hours after teleconsultation
    • Unexpected hospitalisation within 24 hours of teleconsultation
    • Unexpected death while wearing a biosensor (if available)

    Measured: 6 to 15 months depending on the cluster affiliation

Secondary outcomes (44)

  1. Days spent at nursing home

    Days spent at nursing home

    Measured: 24 months

  2. Number of medical contacts

    Number of medical contacts

    Measured: 24 months

  3. Time to doctor contact

    Time to doctor contact

    Measured: 24 months

  4. Number of admissions to hospital

    Admission to hospital in general and to specific diagnosis

    Measured: 24 months

  5. Amount of use of medical services

    Use of medical services

    Measured: 24 months

  6. Number of ambulatory sensitive hospital cases

    Number of ambulatory sensitive hospital cases

    Measured: 24 months

  7. Cost effects via HCRU

    Cost effects via HCRU

    Measured: 24 months

  8. Transport units used

    Transport units used

    Measured: 24 months

  9. Quality of Life - QOL-AD

    Quality of life assessed using Quality of Life-Alzheimer's Disease (QoL-AD). The total score ranges from 13 to 52, with a higher number indicating better quality of life

    Measured: 24 months

  10. Quality of Life - VR-12

    Quality of life assessed using Veterans Rand 12 Item Health Survey (VR-12). The outcome includes a physical and mental health component score (PCS and MCS, respectively). Each component score (PCS and MCS) has a range of 0-100, with a higher score on the PCS and MCS indicating better outcome, or better physical or mental health-related quality of life, respectively.

    Measured: 24 months

  11. Barthel Index

    Assessment procedures of daily living skills assessed via Barthel Index. Score of the Barthel Index ranging from 0 to 100 were collected when 0 is the minimum (worst outcome) and 100 is the maximum (best outcome).

    Measured: 24 months

  12. Dementia Screening Scale (DSS)

    Identification of people with dementia syndromes in inpatient care for the elderly using Dementia Screening Scale (DSS). Score of the DSS ranging from 0 to 14. When 0 is the minimum (no impairment) and 14 is the maximum (maximum impairment).

    Measured: 24 months

  13. Number of double prescriptions

    Number of double prescriptions (drug therapy safety)

    Measured: 24 months

  14. Number of hospitalizations due to medication

    Number of hospitalizations due to medication (drug therapy safety)

    Measured: 24 months

  15. Number of adverse events due to medication

    Number of adverse events due to medication (drug therapy safety)

    Measured: 24 months

  16. Time-to-event concerning medication and hospitalization

    Time-to-event concerning medication and hospitalization (drug therapy safety)

    Measured: 24 months

  17. Need for additional staff in case of telemedical call

    Need for additional staff in case of telemedical call

    Measured: 24 months

  18. Amount of ambulance service calls

    Amount of ambulance service calls

    Measured: 24 months

  19. hospital referrals and use of primary care physicians and physicians of the GP emergency service before and after the implementation of telemedicine in nursing homes

    hospital referrals and use of primary care physicians and physicians of the GP emergency service before and after the implementation of telemedicine in nursing homes

    Measured: 9 to 18 months depending on the cluster affiliation

  20. Response times in doctor-patient contact

    Response times in doctor-patient contact before and after the implementation of telemedicine in nursing homes

    Measured: 24 months

  21. Number of incorrect suspected diagnoses compared to diagnoses after teleconsultation or admission to hospital

    • Number of most diagnosed diseases with correct/incorrect suspected diagnoses

    Measured: 24 months

  22. Number of incorrect suspected diagnoses compared to diagnoses after teleconsultation or admission to hospital

    • Concordance rate of suspected and confirmed diagnoses related to specific diseases

    Measured: 24 months

  23. Number of incorrect suspected diagnoses compared to diagnoses after teleconsultation or admission to hospital

    • Causes of inaccurate suspected diagnoses

    Measured: 24 months

  24. Rate of guideline deviations in diagnostics and therapy for specific tracer diagnoses (e.g. hypertension/blood pressure derailment, blood sugar derailment, infections - community-acquired (urinary tract infection, bronchitis, pneumonia))

    Reasons for deviations (lack of knowledge, individual knowledge about patient, allergies, living will, local conditions/treatment resources, patient wishes)

    Measured: 24 months

  25. Evaluation of the processes, NÄPA (Z) operations and tele consultations

    • Number of operations

    Measured: 6 to 15 months depending on the cluster affiliation

  26. Evaluation of the processes, NÄPA (Z) operations and tele consultations

    • Number of a new teleconsultation during or after a NÄPÄ (Z) operation

    Measured: 6 to 15 months depending on the cluster affiliation

  27. Evaluation of the processes, NÄPA (Z) operations and tele consultations

    • Need for hospitalization

    Measured: 6 to 15 months depending on the cluster affiliation

  28. Evaluation of the processes, NÄPA (Z) operations and tele consultations

    • Misadmissions

    Measured: 6 to 15 months depending on the cluster affiliation

  29. Evaluation of the processes, NÄPA (Z) operations and tele consultations

    Number of deviations between initially defined catalogue of requirements and acutal requirements

    Measured: 6 to 15 months depending on the cluster affiliation

  30. Evaluation of the processes, NÄPA (Z) operations and tele consultations

    • Point of time of the operations

    Measured: 6 to 15 months depending on the cluster affiliation

  31. Evaluation of the processes, NÄPA (Z) operations and tele consultations

    • Duration of the operations

    Measured: 6 to 15 months depending on the cluster affiliation

  32. Evaluation of the processes, NÄPA (Z) operations and tele consultations

    • Number of request by primary care physician, primary care emergency service, tele physician

    Measured: 6 to 15 months depending on the cluster affiliation

  33. Evaluation of the processes, NÄPA (Z) operations and tele consultations

    Questionnaire about the acceptance of nursing home staff

    Measured: 6 to 15 months depending on the cluster affiliation

  34. Applicability of an early warning score in nursing homes

    • Number of false alarms

    Measured: 6 to 15 months depending on the cluster affiliation

  35. Applicability of an early warning score in nursing homes

    • Number of measurements with the spot-check monitor

    Measured: 6 to 15 months depending on the cluster affiliation

  36. Applicability of an early warning score in nursing homes

    • rate of accuracy in detecting a deterioration in health condition

    Measured: 6 to 15 months depending on the cluster affiliation

  37. Applicability of an early warning score in nursing homes

    • Rate of different parameters leading to an diagnosis

    Measured: 6 to 15 months depending on the cluster affiliation

  38. Applicability of an early warning score in nursing homes

    • frequency of diagnosis derived from the early warning system

    Measured: 6 to 15 months depending on the cluster affiliation

  39. Applicability of an early warning score in nursing homes

    Questionnaire or interview to survey acceptance by caregivers and residents

    Measured: 6 to 15 months depending on the cluster affiliation

  40. Applicability of an early warning score in nursing homes

    Questionnaire or interview to survey the usability

    Measured: 6 to 15 months depending on the cluster affiliation

  41. Applicability of an early warning score in nursing homes

    Incidence of parameters leading to alarm/decisive parameters

    Measured: 6 to 15 months depending on the cluster affiliation

  42. Applicability of an early warning score in nursing homes

    Incidence of correct recognition of deteriorating medical conditions

    Measured: 6 to 15 months depending on the cluster affiliation

  43. Rate of applicability of an early warning score in nursing homes

    • tracer-diagnoses: fever, urinary-tract infection, pneumonia, cardiac decompensation, cardiac arrhythmia, reduced vigilance, hypertension, hypo-/hyperglycaemia, pain

    Measured: 6 to 15 months depending on the cluster affiliation

  44. Gender differences

    Gender differences

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2021
  2. Study start1 Apr 2021
  3. Primary completion31 Mar 2023
  4. Study completion30 Apr 2023

Resources

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
1,600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04879537
Sponsor's protocol ID
19-019
Acronym
Optimal@NRW
Status last verified
May 2023
First submitted
31 Mar 2021
Last updated
30 May 2023
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 17092344

  • Hemming 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 25662947

  • Hoffmann 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 28103927

  • Sundmacher 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 26428441

  • Vossius 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 30226850

  • Bundesärztekammer. 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.

  • Brucken D, Unterkofler J, Pauge S, Bienzeisler J, Hubel C, Zechbauer S, Rossaint R, Greiner W, Aufenberg B, Rohrig R, Bollheimer LC; Optimal@NRW Research Group; Brokmann JC. Optimal@NRW: optimized acute care of nursing home residents using an intersectoral telemedical cooperation network - study protocol for a stepped-wedge trial. Trials. 2022 Sep 27;23(1):814. doi: 10.1186/s13063-022-06613-1.

    PubMed 36167557

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: finished, as of the sponsor's last update on 30 May 2023. 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?

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?

Days spent at hospital (time frame: 24 months). The study lists 2 primary outcomes in all. 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 NCT04879537, which also lists 11 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 30 May 2023.

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