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Completed

NCT Number: NCT04879537

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital RWTH Aachen

Aachen, 52074, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telemedical support

Other

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 outcomes

  1. Days spent at hospital

    Time frame: 24 months

    Days spent at hospital

  2. Number of Intervention-related adverse events

    Time frame: 6 to 15 months depending on the cluster affiliation

    • 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 outcomes

  1. Days spent at nursing home

    Time frame: 24 months

    Days spent at nursing home

  2. Number of medical contacts

    Time frame: 24 months

    Number of medical contacts

  3. Time to doctor contact

    Time frame: 24 months

    Time to doctor contact

  4. Number of admissions to hospital

    Time frame: 24 months

    Admission to hospital in general and to specific diagnosis

  5. Amount of use of medical services

    Time frame: 24 months

    Use of medical services

  6. Number of ambulatory sensitive hospital cases

    Time frame: 24 months

    Number of ambulatory sensitive hospital cases

  7. Cost effects via HCRU

    Time frame: 24 months

    Cost effects via HCRU

  8. Transport units used

    Time frame: 24 months

    Transport units used

  9. 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

  10. 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.

  11. 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).

  12. 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).

  13. Number of double prescriptions

    Time frame: 24 months

    Number of double prescriptions (drug therapy safety)

  14. Number of hospitalizations due to medication

    Time frame: 24 months

    Number of hospitalizations due to medication (drug therapy safety)

  15. Number of adverse events due to medication

    Time frame: 24 months

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

  16. Time-to-event concerning medication and hospitalization

    Time frame: 24 months

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

  17. Need for additional staff in case of telemedical call

    Time frame: 24 months

    Need for additional staff in case of telemedical call

  18. Amount of ambulance service calls

    Time frame: 24 months

    Amount of ambulance service calls

  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

    Time frame: 9 to 18 months depending on the cluster affiliation

    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

  20. Response times in doctor-patient contact

    Time frame: 24 months

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

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

    Time frame: 24 months

    • Number of most diagnosed diseases with correct/incorrect suspected diagnoses
  22. Number of incorrect suspected diagnoses compared to diagnoses after teleconsultation or admission to hospital

    Time frame: 24 months

    • Concordance rate of suspected and confirmed diagnoses related to specific diseases
  23. Number of incorrect suspected diagnoses compared to diagnoses after teleconsultation or admission to hospital

    Time frame: 24 months

    • Causes of inaccurate suspected diagnoses
  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))

    Time frame: 24 months

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

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

    Time frame: 6 to 15 months depending on the cluster affiliation

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

    Time frame: 6 to 15 months depending on the cluster affiliation

    • Number of a new teleconsultation during or after a NÄPÄ (Z) operation
  27. Evaluation of the processes, NÄPA (Z) operations and tele consultations

    Time frame: 6 to 15 months depending on the cluster affiliation

    • Need for hospitalization
  28. Evaluation of the processes, NÄPA (Z) operations and tele consultations

    Time frame: 6 to 15 months depending on the cluster affiliation

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

    Time frame: 6 to 15 months depending on the cluster affiliation

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

  30. 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
  31. 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
  32. 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
  33. Evaluation of the processes, NÄPA (Z) operations and tele consultations

    Time frame: 6 to 15 months depending on the cluster affiliation

    Questionnaire about the acceptance of nursing home staff

  34. Applicability of an early warning score in nursing homes

    Time frame: 6 to 15 months depending on the cluster affiliation

    • Number of false alarms
  35. Applicability of an early warning score in nursing homes

    Time frame: 6 to 15 months depending on the cluster affiliation

    • Number of measurements with the spot-check monitor
  36. Applicability of an early warning score in nursing homes

    Time frame: 6 to 15 months depending on the cluster affiliation

    • rate of accuracy in detecting a deterioration in health condition
  37. Applicability of an early warning score in nursing homes

    Time frame: 6 to 15 months depending on the cluster affiliation

    • Rate of different parameters leading to an diagnosis
  38. Applicability of an early warning score in nursing homes

    Time frame: 6 to 15 months depending on the cluster affiliation

    • frequency of diagnosis derived from the early warning system
  39. Applicability of an early warning score in nursing homes

    Time frame: 6 to 15 months depending on the cluster affiliation

    Questionnaire or interview to survey acceptance by caregivers and residents

  40. Applicability of an early warning score in nursing homes

    Time frame: 6 to 15 months depending on the cluster affiliation

    Questionnaire or interview to survey the usability

  41. Applicability of an early warning score in nursing homes

    Time frame: 6 to 15 months depending on the cluster affiliation

    Incidence of parameters leading to alarm/decisive parameters

  42. Applicability of an early warning score in nursing homes

    Time frame: 6 to 15 months depending on the cluster affiliation

    Incidence of correct recognition of deteriorating medical conditions

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

    Time frame: 6 to 15 months depending on the cluster affiliation

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

    Time frame: 24 months

    Gender differences

Other outcomes

  1. Satisfaction survey

    Time frame: 24 months

    Questionnaires to survey satisfaction about the intervention in the project

  2. Satisfaction survey

    Time frame: 24 months

    Interviews to survey satisfaction about the intervention in the project

  3. Ethic survey

    Time frame: 24 months

    Questionnaires to clarify whether the intervention is seen as ethically appropriate

  4. Ethic survey

    Time frame: 24 months

    Interviews to clarify whether the intervention is seen as ethically appropriate

  5. Acceptance survey

    Time frame: 24 months

    Questionnaires to survey acceptance about the intervention in the project

  6. Acceptance survey

    Time frame: 24 months

    Interviews to survey acceptance about the intervention in the project

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Collaborators

  • Optimal@NRW Research Group

Registry information

Acronym: Optimal@NRW

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 10, 2021
Registry last updated
May 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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