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

May 25, 2023 updated by: Jörg Christian Brokmann, RWTH Aachen University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
      • Aachen, Germany, 52074
        • University Hospital RWTH Aachen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Participants in this group are routinely treated.
Active Comparator: Telemedical support
Participants in this group are routinely treated with additional telemedical support and the use of the early warning system.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Days spent at hospital
Time Frame: 24 months
Days spent at hospital
24 months
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)
6 to 15 months depending on the cluster affiliation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
24 months
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.
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).
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).
24 months
Number of double prescriptions
Time Frame: 24 months
Number of double prescriptions (drug therapy safety)
24 months
Number of hospitalizations due to medication
Time Frame: 24 months
Number of hospitalizations due to medication (drug therapy safety)
24 months
Number of adverse events due to medication
Time Frame: 24 months
Number of adverse events due to medication (drug therapy safety)
24 months
Time-to-event concerning medication and hospitalization
Time Frame: 24 months
Time-to-event concerning medication and hospitalization (drug therapy safety)
24 months
Need for additional staff in case of telemedical call
Time Frame: 24 months
Need for additional staff in case of telemedical call
24 months
Amount of ambulance service calls
Time Frame: 24 months
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
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
9 to 18 months depending on the cluster affiliation
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
24 months
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
24 months
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
24 months
Number of incorrect suspected diagnoses compared to diagnoses after teleconsultation or admission to hospital
Time Frame: 24 months
- 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))
Time Frame: 24 months
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
Time Frame: 6 to 15 months depending on the cluster affiliation
- Number of 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 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
Time Frame: 6 to 15 months depending on the cluster affiliation
- Need for hospitalization
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
- Misadmissions
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 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
Time Frame: 6 to 15 months depending on the cluster affiliation
- 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
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
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
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
Time Frame: 6 to 15 months depending on the cluster affiliation
- Number of false alarms
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
- 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
Time Frame: 6 to 15 months depending on the cluster affiliation
- 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
Time Frame: 6 to 15 months depending on the cluster affiliation
- 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
Time Frame: 6 to 15 months depending on the cluster affiliation
- 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
Time Frame: 6 to 15 months depending on the cluster affiliation
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
Time Frame: 6 to 15 months depending on the cluster affiliation
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
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
Time Frame: 6 to 15 months depending on the cluster affiliation
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
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
6 to 15 months depending on the cluster affiliation
Gender differences
Time Frame: 24 months
Gender differences
24 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Satisfaction survey
Time Frame: 24 months
Questionnaires to survey satisfaction about the intervention in the project
24 months
Satisfaction survey
Time Frame: 24 months
Interviews to survey satisfaction about the intervention in the project
24 months
Ethic survey
Time Frame: 24 months
Questionnaires to clarify whether the intervention is seen as ethically appropriate
24 months
Ethic survey
Time Frame: 24 months
Interviews to clarify whether the intervention is seen as ethically appropriate
24 months
Acceptance survey
Time Frame: 24 months
Questionnaires to survey acceptance about the intervention in the project
24 months
Acceptance survey
Time Frame: 24 months
Interviews to survey acceptance about the intervention in the project
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RWTH Aachen University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Optimal@NRW Research Group

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jörg Christian Brokmann, PD Dr. med., Uniklinik RWTH Aachen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19-019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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Conditions

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