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

Emergencies Clinical Trial

— Optimal@NRW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04879537
• Other study ID #: 19-019
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2023
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1600
• Est. completion date: April 30, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies

Intervention

Other:
• Telemedical support
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.

Locations

Country	Name	City	State
Germany	University Hospital RWTH Aachen	Aachen

Sponsors (2)

Lead Sponsor	Collaborator
RWTH Aachen University	Optimal@NRW Research Group

Country where clinical trial is conducted

Germany, 

References & Publications (10)

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. — View Citation

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.

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. — View 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. — View Citation

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.

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Satisfaction survey	Questionnaires to survey satisfaction about the intervention in the project	24 months
Other	Satisfaction survey	Interviews to survey satisfaction about the intervention in the project	24 months
Other	Ethic survey	Questionnaires to clarify whether the intervention is seen as ethically appropriate	24 months
Other	Ethic survey	Interviews to clarify whether the intervention is seen as ethically appropriate	24 months
Other	Acceptance survey	Questionnaires to survey acceptance about the intervention in the project	24 months
Other	Acceptance survey	Interviews to survey acceptance about the intervention in the project	24 months
Primary	Days spent at hospital	Days spent at hospital	24 months
Primary	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	Days spent at nursing home	Days spent at nursing home	24 months
Secondary	Number of medical contacts	Number of medical contacts	24 months
Secondary	Time to doctor contact	Time to doctor contact	24 months
Secondary	Number of admissions to hospital	Admission to hospital in general and to specific diagnosis	24 months
Secondary	Amount of use of medical services	Use of medical services	24 months
Secondary	Number of ambulatory sensitive hospital cases	Number of ambulatory sensitive hospital cases	24 months
Secondary	Cost effects via HCRU	Cost effects via HCRU	24 months
Secondary	Transport units used	Transport units used	24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of double prescriptions	Number of double prescriptions (drug therapy safety)	24 months
Secondary	Number of hospitalizations due to medication	Number of hospitalizations due to medication (drug therapy safety)	24 months
Secondary	Number of adverse events due to medication	Number of adverse events due to medication (drug therapy safety)	24 months
Secondary	Time-to-event concerning medication and hospitalization	Time-to-event concerning medication and hospitalization (drug therapy safety)	24 months
Secondary	Need for additional staff in case of telemedical call	Need for additional staff in case of telemedical call	24 months
Secondary	Amount of ambulance service calls	Amount of ambulance service calls	24 months
Secondary	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
Secondary	Response times in doctor-patient contact	Response times in doctor-patient contact before and after the implementation of telemedicine in nursing homes	24 months
Secondary	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
Secondary	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
Secondary	Number of incorrect suspected diagnoses compared to diagnoses after teleconsultation or admission to hospital	- Causes of inaccurate suspected diagnoses	24 months
Secondary	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
Secondary	Evaluation of the processes, NÄPA (Z) operations and tele consultations	- Number of operations	6 to 15 months depending on the cluster affiliation
Secondary	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
Secondary	Evaluation of the processes, NÄPA (Z) operations and tele consultations	- Need for hospitalization	6 to 15 months depending on the cluster affiliation
Secondary	Evaluation of the processes, NÄPA (Z) operations and tele consultations	- Misadmissions	6 to 15 months depending on the cluster affiliation
Secondary	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
Secondary	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
Secondary	Evaluation of the processes, NÄPA (Z) operations and tele consultations	- Duration of the operations	6 to 15 months depending on the cluster affiliation
Secondary	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
Secondary	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
Secondary	Applicability of an early warning score in nursing homes	- Number of false alarms	6 to 15 months depending on the cluster affiliation
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Gender differences	Gender differences	24 months