- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05617560
Hospital@Home: Telemedical Care After Inpatient Hospital Stay
Study Overview
Detailed Description
This pilot study is to investigate a patient transfer path from the hospital to Hospital@Home to their general practitioners (GPs) using telemedical procedures.
The following study procedures are depicted:
Visit 1 (screening): Patients provide the name of their GP, the means of transport that they usually take to him, demographic data, past medical history and current medications.
The study team contacts the GP afterwards by phone to get his/her consent. The study team informs Medgate about the participant and the procedure. Next to that it will link Medgate technically to the case of the patient that Medgate can see the patient's documentation in the University Hospital Basel (USB) -ePortal.
Visit 2 (transfer): Before leaving the hospital, the participant will be instructed by a member of the study team on how and when to fill out the questionnaires. At this time, the participant and the USB physician will answer the first one. After Medgate has received the information from USB that the patient has been included in the study and has left the hospital, the patient will be contacted by Medgate and the appointment for the first teleconsultation will be made according to information from USB. The patient will be called by Medgate physician at the agreed time and the teleconsultation will be performed. Depending on the patient's condition and health status, further appointments are scheduled. The patient has the possibility to contact Medgate at any time (24/7) in case of an urgent medical matter. The patient receives the physician's recommendations in written form after each teleconsultation as their treatment plan via app or e-mail.
Visit 3...x (telecare): In advance of the first consultation via Medgate, the Medgate physician will log in into the USB-ePortal to get all important medical information about the patient. After that consultation the patient and the Medgate physician will answer a questionnaire. Depending on the clinical condition, health status and from this resulted procedure, the participant will be contacted several times. After the last consultation the Medgate physician will answer a questionnaire and will refer the patient back to the GP. The documentation will be sent to the GP and the USB. The GP will get a questionnaire as well.
Visit 4 (follow-up): On day x after the last consultation via Medgate the GP and the participant will answer the last questionnaire.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Basel, Switzerland, 4031
- University Hospital Basel, Division of Internal Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Written informed consent as documented by signature from the patient
- Planned hospital discharge
- Intended follow-up care, that is manageable with telemedicine
Exclusion Criteria:
- Significant mental or cognitive impairment
- Unable or not willing to sign informed consent
- Unable to understand German
- No possibility of telecommunication or use of such (app or phone)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Telemedical care
|
Telemedical care will be provided to all participants after stationary hospital stay.
This care will be in form of telephone consultations and / or videocall consultations with a medical physician.
Depending on the individual medical history and the planned aftercare and procedure of the participants it will comprise of one or more such telephone consultations.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in PROMS (patient-reported outcome measures survey)
Time Frame: From Visit 2 (Transfer) up to Visit 4 (Follow up), approx. 2 weeks
|
PROMS (patient-reported outcome measures survey): measure to asses a patient's quality of life affected by state of health.
6 standardized questions for self-assessment of the patient's state of health by the patient.
The content of the questions relates to mobility, self-care, general activities, pain, anxiety and health in general.
Questions are answered using Likert scales and qualitative free text answers.
Scoring: 5 multiple choice questions (example pain: no pain, mild -, moderate -, severe -, extreme pain); (example general health: Scale from 0 - 100 (0 = worst health, 100 = best health imaginable)).
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From Visit 2 (Transfer) up to Visit 4 (Follow up), approx. 2 weeks
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PREMS (patient reported experience measure survey) conducted by patients
Time Frame: From Visit 2 (Transfer) up to Visit 4 (Follow up), approx. 2 weeks
|
PREMS (patient reported experience measure survey): satisfaction related questionnaire.
Questions are answered using Likert scales (Format: 1: You completely disagree with this statement.
2: - not to.
3: - rather not to.
4: - neither accept nor reject them.
5: - a little too.
6: - majority to 7: You very much agree with this statement)
|
From Visit 2 (Transfer) up to Visit 4 (Follow up), approx. 2 weeks
|
|
PREMS (patient reported experience measure survey) conducted by physicians
Time Frame: From Visit 2 (Transfer) up to Visit 4 (Follow up), approx. 2 weeks
|
PREMS (patient reported experience measure survey): satisfaction related questionnaire.
Questions are answered using Likert scales (Format: 1: You completely disagree with this statement.
2: - not to.
3: - rather not to.
4: - neither accept nor reject them.
5: - a little too.
6: - majority to 7: You very much agree with this statement)
|
From Visit 2 (Transfer) up to Visit 4 (Follow up), approx. 2 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in self-care index (Selbstpflegeindex (SPI))
Time Frame: From Visit 1 (Screening) up to Visit 3 (Telecare), approx. 1 week
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The SPI shows the need for care in each patient.
The SPI ranges from values between 0 - 40, whereas a low SPI corresponds to more extensive need for care.
It is the numeric score outcome of the ePA-AC, which is calculated from 10 ePA-AC questions.
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From Visit 1 (Screening) up to Visit 3 (Telecare), approx. 1 week
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Change in result-oriented patient assessment (ergebnisorientiertes Patientenassessment - AcuteCare (ePA-AC))
Time Frame: From Visit 1 (Screening) up to Visit 2 (Transfer) assessed daily at the hospital, approx. 1 week
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The ePA-AC is focused on the nursing process and sub classifies activities of daily life.
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From Visit 1 (Screening) up to Visit 2 (Transfer) assessed daily at the hospital, approx. 1 week
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jens Eckstein, Prof. Dr. med., University Hospital Basel, Division of Internal Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2022-01440; am22Eckstein2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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