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

Study Overview
=================
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.

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

Conditions
-----------------
Emergencies

Intervention / Treatment
-----------------
* Other: Telemedical support


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Stepped-Wedge-Design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Participants in this group are routinely treated. | |
| Active Comparator: Telemedical support<br>Participants in this group are routinely treated with additional telemedical support and the use of the early warning system. | Other: Telemedical support<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days spent at hospital | Days spent at hospital | 24 months | 
| 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) | 6 to 15 months depending on the cluster affiliation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days spent at nursing home | Days spent at nursing home | 24 months | 
| Number of medical contacts | Number of medical contacts | 24 months | 
| Time to doctor contact | Time to doctor contact | 24 months | 
| Number of admissions to hospital | Admission to hospital in general and to specific diagnosis | 24 months | 
| Amount of use of medical services | Use of medical services | 24 months | 
| Number of ambulatory sensitive hospital cases | Number of ambulatory sensitive hospital cases | 24 months | 
| Cost effects via HCRU | Cost effects via HCRU | 24 months | 
| Transport units used | Transport units used | 24 months | 
| 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 | 24 months | 
| 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. | 24 months | 
| 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). | 24 months | 
| 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). | 24 months | 
| Number of double prescriptions | Number of double prescriptions (drug therapy safety) | 24 months | 
| Number of hospitalizations due to medication | Number of hospitalizations due to medication (drug therapy safety) | 24 months | 
| Number of adverse events due to medication | Number of adverse events due to medication (drug therapy safety) | 24 months | 
| Time-to-event concerning medication and hospitalization | Time-to-event concerning medication and hospitalization (drug therapy safety) | 24 months | 
| Need for additional staff in case of telemedical call | Need for additional staff in case of telemedical call | 24 months | 
| Amount of ambulance service calls | Amount of ambulance service calls | 24 months | 
| 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 | 9 to 18 months depending on the cluster affiliation | 
| Response times in doctor-patient contact | Response times in doctor-patient contact before and after the implementation of telemedicine in nursing homes | 24 months | 
| Number of incorrect suspected diagnoses compared to diagnoses after teleconsultation or admission to hospital | - Number of most diagnosed diseases with correct/incorrect suspected diagnoses | 24 months | 
| 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 | 24 months | 
| Number of incorrect suspected diagnoses compared to diagnoses after teleconsultation or admission to hospital | - Causes of inaccurate suspected diagnoses | 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)) | Reasons for deviations (lack of knowledge, individual knowledge about patient, allergies, living will, local conditions/treatment resources, patient wishes) | 24 months | 
| Evaluation of the processes, NÄPA (Z) operations and tele consultations | - Number of operations | 6 to 15 months depending on the cluster affiliation | 
| Evaluation of the processes, NÄPA (Z) operations and tele consultations | - Number of a new teleconsultation during or after a NÄPÄ (Z) operation | 6 to 15 months depending on the cluster affiliation | 
| Evaluation of the processes, NÄPA (Z) operations and tele consultations | - Need for hospitalization | 6 to 15 months depending on the cluster affiliation | 
| Evaluation of the processes, NÄPA (Z) operations and tele consultations | - Misadmissions | 6 to 15 months depending on the cluster affiliation | 
| Evaluation of the processes, NÄPA (Z) operations and tele consultations | Number of deviations between initially defined catalogue of requirements and acutal requirements | 6 to 15 months depending on the cluster affiliation | 
| Evaluation of the processes, NÄPA (Z) operations and tele consultations | - Point of time of the operations | 6 to 15 months depending on the cluster affiliation | 
| Evaluation of the processes, NÄPA (Z) operations and tele consultations | - Duration of the operations | 6 to 15 months depending on the cluster affiliation | 
| Evaluation of the processes, NÄPA (Z) operations and tele consultations | - Number of request by primary care physician, primary care emergency service, tele physician | 6 to 15 months depending on the cluster affiliation | 
| Evaluation of the processes, NÄPA (Z) operations and tele consultations | Questionnaire about the acceptance of nursing home staff | 6 to 15 months depending on the cluster affiliation | 
| Applicability of an early warning score in nursing homes | - Number of false alarms | 6 to 15 months depending on the cluster affiliation | 
| Applicability of an early warning score in nursing homes | - Number of measurements with the spot-check monitor | 6 to 15 months depending on the cluster affiliation | 
| Applicability of an early warning score in nursing homes | - rate of accuracy in detecting a deterioration in health condition | 6 to 15 months depending on the cluster affiliation | 
| Applicability of an early warning score in nursing homes | - Rate of different parameters leading to an diagnosis | 6 to 15 months depending on the cluster affiliation | 
| Applicability of an early warning score in nursing homes | - frequency of diagnosis derived from the early warning system | 6 to 15 months depending on the cluster affiliation | 
| Applicability of an early warning score in nursing homes | Questionnaire or interview to survey acceptance by caregivers and residents | 6 to 15 months depending on the cluster affiliation | 
| Applicability of an early warning score in nursing homes | 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 | Incidence of parameters leading to alarm/decisive parameters | 6 to 15 months depending on the cluster affiliation | 
| Applicability of an early warning score in nursing homes | Incidence of correct recognition of deteriorating medical conditions | 6 to 15 months depending on the cluster affiliation | 
| 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 | 6 to 15 months depending on the cluster affiliation | 
| Gender differences | Gender differences | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
telemedicine, geriatric, early warning score, acute care, nursing home, emergency department