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Optimized Acute Care for Geriatric Patients Using an Intersectoral Telemedical Cooperation Network - Around the Clock (Optimal@NRW)

Primary Purpose

Emergencies

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Telemedical support
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Emergencies focused on measuring telemedicine, geriatric, early warning score, acute care, nursing home, emergency department

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital RWTH Aachen

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

Telemedical support

Arm Description

Participants in this group are routinely treated.

Participants in this group are routinely treated with additional telemedical support and the use of the early warning system.

Outcomes

Primary Outcome Measures

Days spent at hospital
Days spent at hospital
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)

Secondary Outcome Measures

Days spent at nursing home
Days spent at nursing home
Number of medical contacts
Number of medical contacts
Time to doctor contact
Time to doctor contact
Number of admissions to hospital
Admission to hospital in general and to specific diagnosis
Amount of use of medical services
Use of medical services
Number of ambulatory sensitive hospital cases
Number of ambulatory sensitive hospital cases
Cost effects via HCRU
Cost effects via HCRU
Transport units used
Transport units used
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
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.
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).
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).
Number of double prescriptions
Number of double prescriptions (drug therapy safety)
Number of hospitalizations due to medication
Number of hospitalizations due to medication (drug therapy safety)
Number of adverse events due to medication
Number of adverse events due to medication (drug therapy safety)
Time-to-event concerning medication and hospitalization
Time-to-event concerning medication and hospitalization (drug therapy safety)
Need for additional staff in case of telemedical call
Need for additional staff in case of telemedical call
Amount of ambulance service calls
Amount of ambulance service calls
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
Response times in doctor-patient contact
Response times in doctor-patient contact before and after the implementation of telemedicine in nursing homes
Number of incorrect suspected diagnoses compared to diagnoses after teleconsultation or admission to hospital
- Number of most diagnosed diseases with correct/incorrect suspected diagnoses
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
Number of incorrect suspected diagnoses compared to diagnoses after teleconsultation or admission to hospital
- Causes of inaccurate suspected diagnoses
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)
Evaluation of the processes, NÄPA (Z) operations and tele consultations
- Number of operations
Evaluation of the processes, NÄPA (Z) operations and tele consultations
- Number of a new teleconsultation during or after a NÄPÄ (Z) operation
Evaluation of the processes, NÄPA (Z) operations and tele consultations
- Need for hospitalization
Evaluation of the processes, NÄPA (Z) operations and tele consultations
- Misadmissions
Evaluation of the processes, NÄPA (Z) operations and tele consultations
Number of deviations between initially defined catalogue of requirements and acutal requirements
Evaluation of the processes, NÄPA (Z) operations and tele consultations
- Point of time of the operations
Evaluation of the processes, NÄPA (Z) operations and tele consultations
- Duration of the operations
Evaluation of the processes, NÄPA (Z) operations and tele consultations
- Number of request by primary care physician, primary care emergency service, tele physician
Evaluation of the processes, NÄPA (Z) operations and tele consultations
Questionnaire about the acceptance of nursing home staff
Applicability of an early warning score in nursing homes
- Number of false alarms
Applicability of an early warning score in nursing homes
- Number of measurements with the spot-check monitor
Applicability of an early warning score in nursing homes
- rate of accuracy in detecting a deterioration in health condition
Applicability of an early warning score in nursing homes
- Rate of different parameters leading to an diagnosis
Applicability of an early warning score in nursing homes
- frequency of diagnosis derived from the early warning system
Applicability of an early warning score in nursing homes
Questionnaire or interview to survey acceptance by caregivers and residents
Applicability of an early warning score in nursing homes
Questionnaire or interview to survey the usability
Applicability of an early warning score in nursing homes
Incidence of parameters leading to alarm/decisive parameters
Applicability of an early warning score in nursing homes
Incidence of correct recognition of deteriorating medical conditions
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
Gender differences
Gender differences

Full Information

First Posted
March 31, 2021
Last Updated
May 25, 2023
Sponsor
RWTH Aachen University
Collaborators
Optimal@NRW Research Group
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1. Study Identification

Unique Protocol Identification Number
NCT04879537
Brief Title
Optimized Acute Care for Geriatric Patients Using an Intersectoral Telemedical Cooperation Network - Around the Clock
Acronym
Optimal@NRW
Official Title
Optimized Acute Care for Geriatric Patients Using an Intersectoral Telemedical Cooperation Network - Around the Clock
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
April 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RWTH Aachen University
Collaborators
Optimal@NRW Research Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergencies
Keywords
telemedicine, geriatric, early warning score, acute care, nursing home, emergency department

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Stepped-Wedge-Design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants in this group are routinely treated.
Arm Title
Telemedical support
Arm Type
Active Comparator
Arm Description
Participants in this group are routinely treated with additional telemedical support and the use of the early warning system.
Intervention Type
Other
Intervention Name(s)
Telemedical support
Intervention Description
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.
Primary Outcome Measure Information:
Title
Days spent at hospital
Description
Days spent at hospital
Time Frame
24 months
Title
Number of Intervention-related adverse events
Description
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)
Time Frame
6 to 15 months depending on the cluster affiliation
Secondary Outcome Measure Information:
Title
Days spent at nursing home
Description
Days spent at nursing home
Time Frame
24 months
Title
Number of medical contacts
Description
Number of medical contacts
Time Frame
24 months
Title
Time to doctor contact
Description
Time to doctor contact
Time Frame
24 months
Title
Number of admissions to hospital
Description
Admission to hospital in general and to specific diagnosis
Time Frame
24 months
Title
Amount of use of medical services
Description
Use of medical services
Time Frame
24 months
Title
Number of ambulatory sensitive hospital cases
Description
Number of ambulatory sensitive hospital cases
Time Frame
24 months
Title
Cost effects via HCRU
Description
Cost effects via HCRU
Time Frame
24 months
Title
Transport units used
Description
Transport units used
Time Frame
24 months
Title
Quality of Life - QOL-AD
Description
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
Time Frame
24 months
Title
Quality of Life - VR-12
Description
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.
Time Frame
24 months
Title
Barthel Index
Description
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).
Time Frame
24 months
Title
Dementia Screening Scale (DSS)
Description
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).
Time Frame
24 months
Title
Number of double prescriptions
Description
Number of double prescriptions (drug therapy safety)
Time Frame
24 months
Title
Number of hospitalizations due to medication
Description
Number of hospitalizations due to medication (drug therapy safety)
Time Frame
24 months
Title
Number of adverse events due to medication
Description
Number of adverse events due to medication (drug therapy safety)
Time Frame
24 months
Title
Time-to-event concerning medication and hospitalization
Description
Time-to-event concerning medication and hospitalization (drug therapy safety)
Time Frame
24 months
Title
Need for additional staff in case of telemedical call
Description
Need for additional staff in case of telemedical call
Time Frame
24 months
Title
Amount of ambulance service calls
Description
Amount of ambulance service calls
Time Frame
24 months
Title
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
Description
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
Title
Response times in doctor-patient contact
Description
Response times in doctor-patient contact before and after the implementation of telemedicine in nursing homes
Time Frame
24 months
Title
Number of incorrect suspected diagnoses compared to diagnoses after teleconsultation or admission to hospital
Description
- Number of most diagnosed diseases with correct/incorrect suspected diagnoses
Time Frame
24 months
Title
Number of incorrect suspected diagnoses compared to diagnoses after teleconsultation or admission to hospital
Description
- Concordance rate of suspected and confirmed diagnoses related to specific diseases
Time Frame
24 months
Title
Number of incorrect suspected diagnoses compared to diagnoses after teleconsultation or admission to hospital
Description
- Causes of inaccurate suspected diagnoses
Time Frame
24 months
Title
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))
Description
Reasons for deviations (lack of knowledge, individual knowledge about patient, allergies, living will, local conditions/treatment resources, patient wishes)
Time Frame
24 months
Title
Evaluation of the processes, NÄPA (Z) operations and tele consultations
Description
- Number of operations
Time Frame
6 to 15 months depending on the cluster affiliation
Title
Evaluation of the processes, NÄPA (Z) operations and tele consultations
Description
- Number of a new teleconsultation during or after a NÄPÄ (Z) operation
Time Frame
6 to 15 months depending on the cluster affiliation
Title
Evaluation of the processes, NÄPA (Z) operations and tele consultations
Description
- Need for hospitalization
Time Frame
6 to 15 months depending on the cluster affiliation
Title
Evaluation of the processes, NÄPA (Z) operations and tele consultations
Description
- Misadmissions
Time Frame
6 to 15 months depending on the cluster affiliation
Title
Evaluation of the processes, NÄPA (Z) operations and tele consultations
Description
Number of deviations between initially defined catalogue of requirements and acutal requirements
Time Frame
6 to 15 months depending on the cluster affiliation
Title
Evaluation of the processes, NÄPA (Z) operations and tele consultations
Description
- Point of time of the operations
Time Frame
6 to 15 months depending on the cluster affiliation
Title
Evaluation of the processes, NÄPA (Z) operations and tele consultations
Description
- Duration of the operations
Time Frame
6 to 15 months depending on the cluster affiliation
Title
Evaluation of the processes, NÄPA (Z) operations and tele consultations
Description
- Number of request by primary care physician, primary care emergency service, tele physician
Time Frame
6 to 15 months depending on the cluster affiliation
Title
Evaluation of the processes, NÄPA (Z) operations and tele consultations
Description
Questionnaire about the acceptance of nursing home staff
Time Frame
6 to 15 months depending on the cluster affiliation
Title
Applicability of an early warning score in nursing homes
Description
- Number of false alarms
Time Frame
6 to 15 months depending on the cluster affiliation
Title
Applicability of an early warning score in nursing homes
Description
- Number of measurements with the spot-check monitor
Time Frame
6 to 15 months depending on the cluster affiliation
Title
Applicability of an early warning score in nursing homes
Description
- rate of accuracy in detecting a deterioration in health condition
Time Frame
6 to 15 months depending on the cluster affiliation
Title
Applicability of an early warning score in nursing homes
Description
- Rate of different parameters leading to an diagnosis
Time Frame
6 to 15 months depending on the cluster affiliation
Title
Applicability of an early warning score in nursing homes
Description
- frequency of diagnosis derived from the early warning system
Time Frame
6 to 15 months depending on the cluster affiliation
Title
Applicability of an early warning score in nursing homes
Description
Questionnaire or interview to survey acceptance by caregivers and residents
Time Frame
6 to 15 months depending on the cluster affiliation
Title
Applicability of an early warning score in nursing homes
Description
Questionnaire or interview to survey the usability
Time Frame
6 to 15 months depending on the cluster affiliation
Title
Applicability of an early warning score in nursing homes
Description
Incidence of parameters leading to alarm/decisive parameters
Time Frame
6 to 15 months depending on the cluster affiliation
Title
Applicability of an early warning score in nursing homes
Description
Incidence of correct recognition of deteriorating medical conditions
Time Frame
6 to 15 months depending on the cluster affiliation
Title
Rate of applicability of an early warning score in nursing homes
Description
- tracer-diagnoses: fever, urinary-tract infection, pneumonia, cardiac decompensation, cardiac arrhythmia, reduced vigilance, hypertension, hypo-/hyperglycaemia, pain
Time Frame
6 to 15 months depending on the cluster affiliation
Title
Gender differences
Description
Gender differences
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Satisfaction survey
Description
Questionnaires to survey satisfaction about the intervention in the project
Time Frame
24 months
Title
Satisfaction survey
Description
Interviews to survey satisfaction about the intervention in the project
Time Frame
24 months
Title
Ethic survey
Description
Questionnaires to clarify whether the intervention is seen as ethically appropriate
Time Frame
24 months
Title
Ethic survey
Description
Interviews to clarify whether the intervention is seen as ethically appropriate
Time Frame
24 months
Title
Acceptance survey
Description
Questionnaires to survey acceptance about the intervention in the project
Time Frame
24 months
Title
Acceptance survey
Description
Interviews to survey acceptance about the intervention in the project
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jörg Christian Brokmann, PD Dr. med.
Organizational Affiliation
Uniklinik RWTH Aachen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital RWTH Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
17092344
Citation
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Results Reference
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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.
Results Reference
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PubMed Identifier
28103927
Citation
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.
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PubMed Identifier
26428441
Citation
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.
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PubMed Identifier
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Citation
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.
Results Reference
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Bundesärztekammer. Beschlussprotokoll des 121. Deutschen Ärztetages in Erfurt vom 08. bis 11.05.2018, Stand 08.06.2018.
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Eatock D. Demografischer Ausblick für die Europäische Union 2019.
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Fehr A, Lange C, Fuchs J, Neuhauser H, Schmitz R. Gesundheitsmonitoring und Gesundheitsindikatoren in Europa. Robert Koch-Institut, Epidemiologie und Gesundheitsberichterstattung; 2017.
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Jacobs K, Kuhlmey A, Greß S, Klauber J, Schwinger A. Pflege-Report 2018. Berlin, Heidelberg: Springer Berlin Heidelberg; 2018.
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Citation
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.
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Optimized Acute Care for Geriatric Patients Using an Intersectoral Telemedical Cooperation Network - Around the Clock

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