Geriatric PatientsNCT04148027
Use of Telemedicine for Geriatric Emergency Patients
An observational study of Geriatric Patients, run by RWTH Aachen University at 1 site in Germany.
Trial summary
The aim of the present study is the implementation of a telemedical geriatric co-evaluation in the area of the emergency department. The use of telemedicine is intended to improve the care of geriatric emergency patients. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Geriatric Patients
- What is being tested?
- Treatment recommendation by emergency department physicians and Treatment recommendation by telemedical geriatric co-evaluation
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2017to 30 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Geriatric emergency patients aged ≥ 70, who showed an "Identification of Seniors at risk"-Score (ISAR-Score) ≥ 2.
Who may be able to join
- Age ≥ 70 years
- Written declaration of consent
- Indication for geriatric treatment according to "Identification of Seniors at risk" (ISAR) score screening with scores ≥ 2
- Persons who are capable and mentally able to follow the instructions of the study staff
- Legally incompetent persons with a consensual legal guardian or a person authorized by the patient to manage their affairs
Who cannot join
- Persons who are accommodated on an official or court order in an institution
- Persons who are in a dependency or employment relationship with the sponsor or examiner
- Simultaneous participation in another clinical trial
- Missing written consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Emergency department, University Hospital RWTH Aachen
Aachen, North Rhine-Westphalia, 52074
About this study
The aim of the present study is the implementation of a telemedical geriatric co-evaluation in the area of the emergency department. The use of telemedicine is intended to improve the care of geriatric emergency patients.
Primarily, it should be checked whether there is any difference at all compared to the normal standard treatment by the doctors of the emergency department. For this, the different drug recommendations are compared.
For the qualitative evaluation, the second step is an analysis of the recommended drugs with regard to the use of inadequate preparations for older patients.
Read the detailed description
Despite the changed age structure with a steady increase in life expectancy, doctors with geriatric expertise are lacking in many hospitals. In the "Rheinisch-Westfälische Technische Hochschule" (RWTH) Aachen University Hospital there is also the problem that the Department of Geriatrics is outsourced and therefore geriatric expertise is not always available in the emergency department. One way to solve this problem is to use telemedicine.
The aim of the present study is the implementation of a telemedical geriatric co-evaluation in the emergency department.
For the study it is planned to carry out a geriatric co-evaluation of geriatric emergency patients (age ≥ 70 years, "Identification of Seniors at Risk" [ISAR] -Score ≥ 2) with operative or conservative illnesses via a telemedical visit in the acute setting of the emergency department. There is a presentation of the patient by means of video transmission. The geriatrician then has the opportunity to question the patient independently or to carry out a physical assessment. Since there is no geriatrician at the Department of Geriatrics 24 hours a day, patients are included on weekdays between 8am and 5pm only.
Whenever possible, all patients in the emergency department at this time with an age ≥ 70 years and an ISAR score ≥ 2 will be enrolled at set times of the day. Due to the high number of patients in the emergency room, however, it may not be possible at times to include all patients. In order to ensure sufficient neutrality, in this constellation, the selection is made from the patients currently in the emergency room by means of randomization. Should there be age-related difficulties in communicating between patients and geriatrician during the telemedical visit, the present scientific assistant or doctor from the emergency department will assist to avoid an associated influence on the procedure.
The rationale behind the telemedicine visit is that this additional early geriatric co-assessment will result in improved geriatric follow-up beyond geriatric special care. In this pilot study, which aims at an analysis of the actual state with identification of potential problem areas, the focus is primarily on pharmacotherapeutic aspects.
The aim is to compare the diagnostic and treatment recommendations initiated in the emergency room by means of telemedical geriatric consultation with the standard treatment of the treating internist, neurologist or surgical assistant doctors of the central emergency department. The treatment plan defined in the telemedical visit is only a treatment recommendation. Prior to the implementation of the recommendations, a check is carried out by the responsible senior physician of the emergency department after completing the emergency geriatric visit. Thus, there are no risks dependent on the procedure for the patient.
Due to the high priority of the drug therapy in the emergency department, the primary endpoint is a comparison of the drug recommendations. Initially, a quantitative evaluation with determination of the number of different views per patient in the pharmacological differential therapy was performed. Secondary endpoints are to evaluate the use of medications that are considered inadequate for elderly patients. Since no special list of inadequate drugs has been validated specifically for the emergency room, the treatment recommendations are checked using a standard treatment list, the "Fit for the aged" (FORTA) classification system.
- Conditions
- Geriatric Patients
- Being tested
- Treatment recommendation by emergency department physicians, Treatment recommendation by telemedical geriatric co-evaluation
- Keywords
- emergency medicine, geriatrics, telemedicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment recommendation by emergency department physiciansOther
Standard treatment after admission in the emergency department from a team of residents in internal medicine, neurology and general surgery.
Treatment recommendation by telemedical geriatric co-evaluationOther
Treatment recommendation from a board-certified geriatrician linked for co-evaluation by means of video transmission
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in pharmacological interventions
The primary endpoint is an evaluation of the different pharmaceutical interventions between the standard emergency department treatment and the telemedicine geriatric treatment.
Number of different views per patient in the pharmacological differential therapy with regard to:
- drug replacement
- withdrawal of a pre-existing drug
- dose adjustment of a pre-existing drug are being analyzed.
Measured: within 48 hours of admission to the emergency department
Secondary outcomes (2)
Quality of pharmacological interventions
The secondary endpoint is an evaluation of the different pharmacological interventions with a focus on age-appropriate adequate medication. The treatment recommendations were checked with the FORTA classification system.
Measured: within 48 hours of admission to the emergency department
Avoidance of Polypharmacy as a quality feature for age-appropriate therapy
Another secondary endpoint is an examination of the treatment recommendations regarding especially the reduction of total medication. Polypharmacy, as well as the use of inadequate drugs in geriatric patients, is a risk factor for complications.
Measured: within 48 hours of admission to the emergency department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start1 Nov 2017
- Primary completion28 Feb 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Geriatric PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Oliver Matz, RWTH Aachen University
- Investigators
- Jörg Brokmann, PD Dr., Study director, Emergency Department, University Hospital RWTH Aachen, Aachen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148027
- Sponsor's protocol ID
- Telenotfallgeriatrie-2017
- Other IDs
- EK 243/17
- Status last verified
- Oct 2019
- First submitted
- 28 Oct 2019
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Werner H. [Drug therapy in the aged: too much and too little, what to do? A new evaluation system: fit for the aged (FORTA)]. Dtsch Med Wochenschr. 2009 Jan;134(3):95-6; author reply 96. doi: 10.1055/s-0028-1105898. Epub 2009 Jan 13. No abstract available. German.
PubMed 19142841Yao JL, Fang J, Lou QQ, Anderson RM. A systematic review of the identification of seniors at risk (ISAR) tool for the prediction of adverse outcome in elderly patients seen in the emergency department. Int J Clin Exp Med. 2015 Apr 15;8(4):4778-86. eCollection 2015.
PubMed 26131052Matz O, Villa L, Lecce C, Olaciregui Dague K, Haeger A, Bollheimer LC, Laurentius T, Rossaint R, Brokmann J. Implementation of a telemedicine geriatric co-evaluation in the emergency department: a prospective pilot study. Swiss Med Wkly. 2021 May 5;151:w20500. doi: 10.4414/smw.2021.20500. eCollection 2021 Apr 26.
PubMed 34000061
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Telemedicine for Geriatric Emergency Patients
- ClinicalTrials.gov ID
- NCT04148027
- Acronym / sponsor ID
- Telenotfallgeriatrie-2017
- Conditions
- Geriatric Patients
- Keywords
- emergency medicine, geriatrics, telemedicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 1 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study is the implementation of a telemedical geriatric co-evaluation in the area of the emergency department. The use of telemedicine is intended to improve the care of geriatric emergency patients.
Primarily, it should be checked whether there is any difference at all compared to the normal standard treatment by the doctors of the emergency department. For this, the different drug recommendations are compared.
For the qualitative evaluation, the second step is an analysis of the recommended drugs with regard to the use of inadequate preparations for older patients.
Detailed description
Despite the changed age structure with a steady increase in life expectancy, doctors with geriatric expertise are lacking in many hospitals. In the "Rheinisch-Westfälische Technische Hochschule" (RWTH) Aachen University Hospital there is also the problem that the Department of Geriatrics is outsourced and therefore geriatric expertise is not always available in the emergency department. One way to solve this problem is to use telemedicine.
The aim of the present study is the implementation of a telemedical geriatric co-evaluation in the emergency department.
For the study it is planned to carry out a geriatric co-evaluation of geriatric emergency patients (age ≥ 70 years, "Identification of Seniors at Risk" [ISAR] -Score ≥ 2) with operative or conservative illnesses via a telemedical visit in the acute setting of the emergency department. There is a presentation of the patient by means of video transmission. The geriatrician then has the opportunity to question the patient independently or to carry out a physical assessment. Since there is no geriatrician at the Department of Geriatrics 24 hours a day, patients are included on weekdays between 8am and 5pm only.
Whenever possible, all patients in the emergency department at this time with an age ≥ 70 years and an ISAR score ≥ 2 will be enrolled at set times of the day. Due to the high number of patients in the emergency room, however, it may not be possible at times to include all patients. In order to ensure sufficient neutrality, in this constellation, the selection is made from the patients currently in the emergency room by means of randomization. Should there be age-related difficulties in communicating between patients and geriatrician during the telemedical visit, the present scientific assistant or doctor from the emergency department will assist to avoid an associated influence on the procedure.
The rationale behind the telemedicine visit is that this additional early geriatric co-assessment will result in improved geriatric follow-up beyond geriatric special care. In this pilot study, which aims at an analysis of the actual state with identification of potential problem areas, the focus is primarily on pharmacotherapeutic aspects.
The aim is to compare the diagnostic and treatment recommendations initiated in the emergency room by means of telemedical geriatric consultation with the standard treatment of the treating internist, neurologist or surgical assistant doctors of the central emergency department. The treatment plan defined in the telemedical visit is only a treatment recommendation. Prior to the implementation of the recommendations, a check is carried out by the responsible senior physician of the emergency department after completing the emergency geriatric visit. Thus, there are no risks dependent on the procedure for the patient.
Due to the high priority of the drug therapy in the emergency department, the primary endpoint is a comparison of the drug recommendations. Initially, a quantitative evaluation with determination of the number of different views per patient in the pharmacological differential therapy was performed. Secondary endpoints are to evaluate the use of medications that are considered inadequate for elderly patients. Since no special list of inadequate drugs has been validated specifically for the emergency room, the treatment recommendations are checked using a standard treatment list, the "Fit for the aged" (FORTA) classification system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Geriatric emergency patients aged ≥ 70, who showed an "Identification of Seniors at risk"-Score (ISAR-Score) ≥ 2.
Key inclusion criteria (5 listed)
- Age ≥ 70 years
- Written declaration of consent
- Indication for geriatric treatment according to "Identification of Seniors at risk" (ISAR) score screening with scores ≥ 2
- Persons who are capable and mentally able to follow the instructions of the study staff
- Legally incompetent persons with a consensual legal guardian or a person authorized by the patient to manage their affairs
Key exclusion criteria (4 listed)
- Persons who are accommodated on an official or court order in an institution
- Persons who are in a dependency or employment relationship with the sponsor or examiner
- Simultaneous participation in another clinical trial
- Missing written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment recommendation by emergency department physiciansStandard treatment after admission in the emergency department from a team of residents in internal medicine, neurology and general surgery. | Other | – |
| Treatment recommendation by telemedical geriatric co-evaluationTreatment recommendation from a board-certified geriatrician linked for co-evaluation by means of video transmission | Other | – |
Primary outcome
Differences in pharmacological interventions
Time frame: within 48 hours of admission to the emergency department
The primary endpoint is an evaluation of the different pharmaceutical interventions between the standard emergency department treatment and the telemedicine geriatric treatment. Number of different views per patient in the pharmacological differential therapy with regard to: * drug replacement * withdrawal of a pre-existing drug * dose adjustment of a pre-existing drug are being analyzed.
2 secondary outcomes
Quality of pharmacological interventions
Time frame: within 48 hours of admission to the emergency department
Avoidance of Polypharmacy as a quality feature for age-appropriate therapy
Time frame: within 48 hours of admission to the emergency department
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Background: PubMed 19142841Werner H. [Drug therapy in the aged: too much and too little, what to do? A new evaluation system: fit for the aged (FORTA)]. Dtsch Med Wochenschr. 2009 Jan;134(3):95-6; author reply 96. doi: 10.1055/s-0028-1105898. Epub 2009 Jan 13. No abstract available. German.
- Background: PubMed 26131052Yao JL, Fang J, Lou QQ, Anderson RM. A systematic review of the identification of seniors at risk (ISAR) tool for the prediction of adverse outcome in elderly patients seen in the emergency department. Int J Clin Exp Med. 2015 Apr 15;8(4):4778-86. eCollection 2015.
- Derived from this study: PubMed 34000061Matz O, Villa L, Lecce C, Olaciregui Dague K, Haeger A, Bollheimer LC, Laurentius T, Rossaint R, Brokmann J. Implementation of a telemedicine geriatric co-evaluation in the emergency department: a prospective pilot study. Swiss Med Wkly. 2021 May 5;151:w20500. doi: 10.4414/smw.2021.20500. eCollection 2021 Apr 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jörg Brokmann, PD Dr. study director
Emergency Department, University Hospital RWTH Aachen, Aachen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Geriatric Patients, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in pharmacological interventions (time frame: within 48 hours of admission to the emergency department). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04148027, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2019.