- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04879537
Optimized Acute Care for Geriatric Patients Using an Intersectoral Telemedical Cooperation Network - Around the Clock (Optimal@NRW)
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Aachen, Germany, 52074
- University Hospital RWTH Aachen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Persons placed in an institution by order of an authority or court
- Persons who are in a dependent or employment relationship with the investigator
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Participants in this group are routinely treated.
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Active Comparator: Telemedical support
Participants in this group are routinely treated with additional telemedical support and the use of the early warning system.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Days spent at hospital
Time Frame: 24 months
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Days spent at hospital
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24 months
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Number of Intervention-related adverse events
Time Frame: 6 to 15 months depending on the cluster affiliation
|
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6 to 15 months depending on the cluster affiliation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Days spent at nursing home
Time Frame: 24 months
|
Days spent at nursing home
|
24 months
|
Number of medical contacts
Time Frame: 24 months
|
Number of medical contacts
|
24 months
|
Time to doctor contact
Time Frame: 24 months
|
Time to doctor contact
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24 months
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Number of admissions to hospital
Time Frame: 24 months
|
Admission to hospital in general and to specific diagnosis
|
24 months
|
Amount of use of medical services
Time Frame: 24 months
|
Use of medical services
|
24 months
|
Number of ambulatory sensitive hospital cases
Time Frame: 24 months
|
Number of ambulatory sensitive hospital cases
|
24 months
|
Cost effects via HCRU
Time Frame: 24 months
|
Cost effects via HCRU
|
24 months
|
Transport units used
Time Frame: 24 months
|
Transport units used
|
24 months
|
Quality of Life - QOL-AD
Time Frame: 24 months
|
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
|
24 months
|
Quality of Life - VR-12
Time Frame: 24 months
|
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.
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24 months
|
Barthel Index
Time Frame: 24 months
|
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).
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24 months
|
Dementia Screening Scale (DSS)
Time Frame: 24 months
|
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).
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24 months
|
Number of double prescriptions
Time Frame: 24 months
|
Number of double prescriptions (drug therapy safety)
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24 months
|
Number of hospitalizations due to medication
Time Frame: 24 months
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Number of hospitalizations due to medication (drug therapy safety)
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24 months
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Number of adverse events due to medication
Time Frame: 24 months
|
Number of adverse events due to medication (drug therapy safety)
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24 months
|
Time-to-event concerning medication and hospitalization
Time Frame: 24 months
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Time-to-event concerning medication and hospitalization (drug therapy safety)
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24 months
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Need for additional staff in case of telemedical call
Time Frame: 24 months
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Need for additional staff in case of telemedical call
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24 months
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Amount of ambulance service calls
Time Frame: 24 months
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Amount of ambulance service calls
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24 months
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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
Time Frame: 9 to 18 months depending on the cluster affiliation
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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
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9 to 18 months depending on the cluster affiliation
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Response times in doctor-patient contact
Time Frame: 24 months
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Response times in doctor-patient contact before and after the implementation of telemedicine in nursing homes
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24 months
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Number of incorrect suspected diagnoses compared to diagnoses after teleconsultation or admission to hospital
Time Frame: 24 months
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- Number of most diagnosed diseases with correct/incorrect suspected diagnoses
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24 months
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Number of incorrect suspected diagnoses compared to diagnoses after teleconsultation or admission to hospital
Time Frame: 24 months
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- Concordance rate of suspected and confirmed diagnoses related to specific diseases
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24 months
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Number of incorrect suspected diagnoses compared to diagnoses after teleconsultation or admission to hospital
Time Frame: 24 months
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- Causes of inaccurate suspected diagnoses
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24 months
|
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))
Time Frame: 24 months
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Reasons for deviations (lack of knowledge, individual knowledge about patient, allergies, living will, local conditions/treatment resources, patient wishes)
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24 months
|
Evaluation of the processes, NÄPA (Z) operations and tele consultations
Time Frame: 6 to 15 months depending on the cluster affiliation
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- Number of operations
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6 to 15 months depending on the cluster affiliation
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Evaluation of the processes, NÄPA (Z) operations and tele consultations
Time Frame: 6 to 15 months depending on the cluster affiliation
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- Number of a new teleconsultation during or after a NÄPÄ (Z) operation
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6 to 15 months depending on the cluster affiliation
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Evaluation of the processes, NÄPA (Z) operations and tele consultations
Time Frame: 6 to 15 months depending on the cluster affiliation
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- Need for hospitalization
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6 to 15 months depending on the cluster affiliation
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Evaluation of the processes, NÄPA (Z) operations and tele consultations
Time Frame: 6 to 15 months depending on the cluster affiliation
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- Misadmissions
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6 to 15 months depending on the cluster affiliation
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Evaluation of the processes, NÄPA (Z) operations and tele consultations
Time Frame: 6 to 15 months depending on the cluster affiliation
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Number of deviations between initially defined catalogue of requirements and acutal requirements
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6 to 15 months depending on the cluster affiliation
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Evaluation of the processes, NÄPA (Z) operations and tele consultations
Time Frame: 6 to 15 months depending on the cluster affiliation
|
- Point of time of the operations
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6 to 15 months depending on the cluster affiliation
|
Evaluation of the processes, NÄPA (Z) operations and tele consultations
Time Frame: 6 to 15 months depending on the cluster affiliation
|
- Duration of the operations
|
6 to 15 months depending on the cluster affiliation
|
Evaluation of the processes, NÄPA (Z) operations and tele consultations
Time Frame: 6 to 15 months depending on the cluster affiliation
|
- Number of request by primary care physician, primary care emergency service, tele physician
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6 to 15 months depending on the cluster affiliation
|
Evaluation of the processes, NÄPA (Z) operations and tele consultations
Time Frame: 6 to 15 months depending on the cluster affiliation
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Questionnaire about the acceptance of nursing home staff
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6 to 15 months depending on the cluster affiliation
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Applicability of an early warning score in nursing homes
Time Frame: 6 to 15 months depending on the cluster affiliation
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- Number of false alarms
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6 to 15 months depending on the cluster affiliation
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Applicability of an early warning score in nursing homes
Time Frame: 6 to 15 months depending on the cluster affiliation
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- Number of measurements with the spot-check monitor
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6 to 15 months depending on the cluster affiliation
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Applicability of an early warning score in nursing homes
Time Frame: 6 to 15 months depending on the cluster affiliation
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- rate of accuracy in detecting a deterioration in health condition
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6 to 15 months depending on the cluster affiliation
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Applicability of an early warning score in nursing homes
Time Frame: 6 to 15 months depending on the cluster affiliation
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- Rate of different parameters leading to an diagnosis
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6 to 15 months depending on the cluster affiliation
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Applicability of an early warning score in nursing homes
Time Frame: 6 to 15 months depending on the cluster affiliation
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- frequency of diagnosis derived from the early warning system
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6 to 15 months depending on the cluster affiliation
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Applicability of an early warning score in nursing homes
Time Frame: 6 to 15 months depending on the cluster affiliation
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Questionnaire or interview to survey acceptance by caregivers and residents
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6 to 15 months depending on the cluster affiliation
|
Applicability of an early warning score in nursing homes
Time Frame: 6 to 15 months depending on the cluster affiliation
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Questionnaire or interview to survey the usability
|
6 to 15 months depending on the cluster affiliation
|
Applicability of an early warning score in nursing homes
Time Frame: 6 to 15 months depending on the cluster affiliation
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Incidence of parameters leading to alarm/decisive parameters
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6 to 15 months depending on the cluster affiliation
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Applicability of an early warning score in nursing homes
Time Frame: 6 to 15 months depending on the cluster affiliation
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Incidence of correct recognition of deteriorating medical conditions
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6 to 15 months depending on the cluster affiliation
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Rate of applicability of an early warning score in nursing homes
Time Frame: 6 to 15 months depending on the cluster affiliation
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- tracer-diagnoses: fever, urinary-tract infection, pneumonia, cardiac decompensation, cardiac arrhythmia, reduced vigilance, hypertension, hypo-/hyperglycaemia, pain
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6 to 15 months depending on the cluster affiliation
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Gender differences
Time Frame: 24 months
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Gender differences
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24 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satisfaction survey
Time Frame: 24 months
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Questionnaires to survey satisfaction about the intervention in the project
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24 months
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Satisfaction survey
Time Frame: 24 months
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Interviews to survey satisfaction about the intervention in the project
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24 months
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Ethic survey
Time Frame: 24 months
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Questionnaires to clarify whether the intervention is seen as ethically appropriate
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24 months
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Ethic survey
Time Frame: 24 months
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Interviews to clarify whether the intervention is seen as ethically appropriate
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24 months
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Acceptance survey
Time Frame: 24 months
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Questionnaires to survey acceptance about the intervention in the project
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24 months
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Acceptance survey
Time Frame: 24 months
|
Interviews to survey acceptance about the intervention in the project
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24 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jörg Christian Brokmann, PD Dr. med., Uniklinik RWTH Aachen
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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