Clinical trial NCT06054048: Open Video System in Medicine (oVID)
Official title: Open Video System in Medicine (oVID) - Use Case Palliative Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Chronic Heart Failure
Chronic Obstructive Pulmonary Disease
Palliative Care
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: Palliativnetz Muenster gGmbH
name: CompuGroup Medical
First posted: 2023-09-26
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled non-inferiority trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: Currently, there are no telemedical visits between patients and/or their relatives and a palliative physician for the evaluation of symptom and progress monitoring. This is done during visits of the patient by the coordinators and palliative physicians of the palliative network/PKD Münster (PKD = Palliative Care Consultation Service) and/or the general practitioners. Upon enrollment in the Palliative Network/PKD Münster, patients receive a 24-hour emergency telephone number. This is staffed by a caregiver who coordinates the deployment of other caregivers / palliative care physicians according to the information provided by the patient / family members. If patients are randomized to the "telemedicine" group, they have the option of using ELVI (ELVI = electronic visit) in addition to conventional care, and thus the possibility of televisits with physicians or nurses. In this case, they receive access data for ELVI, i.e., an access code for a virtual waiting room. In addition, patients will be given questionnaires at discharge to be completed on the day of discharge and on days 7, and 14.

The primary objective of this randomized trial is to demonstrate that telemedically managed patients are not relevantly inferior to conventionally managed patients in terms of change in Integrated Palliative care Outcome Scale (IPOS) from the day of discharge (non-inferiority question), although the possibility of televisiting may result in less frequent physician visits to the patient's home.

Detailed description: Purpose

The increasing specialization of medicine and the growing shortage of medical professionals, especially in rural areas, call for constant networking of clinical facilities. This networking is driven not least by the medical societies. For example, networks have been established throughout Germany in the care of severely injured patients, in neurology, palliative medicine, intensive care medicine, infectious diseases, cardiology and other specialist disciplines. All of these networks aim to improve the joint care of the respective patients, even across sector boundaries.

Moreover, demographic change has been inexorably causing society to age for years. A steadily growing proportion of the population is at an age when the demand for medical treatment is increasing. At the same time, there is a shortage of qualified medical personnel. By 2030, there will be a shortage of up to 106,000 physicians and 575,000 nurses. A double-digit share of all medical positions will probably not be filled. This development is felt with particular intensity in rural areas. Here, the average age of the population and thus the need for medical services, as well as the shortage of doctors and nurses, are even higher than the national average.

In the course of digitization, a wide range of opportunities are opening up that will enable greater efficiency in the treatment of many patients, especially in rural areas. However, the individual networks use heterogeneous, technical systems and standards to a varying extent for this purpose. While the exchange of image data (e.g., X-ray, CT, and MRI examinations) between individual institutions has already become standard in some regions of Germany (e.g., West German Teleradiology Network), there is no communication system that is accessible everywhere and can be used across disciplines, that can be used by every network, that offers the necessary functions, and that can also be adapted to the needs of the respective network. A connection of many different systems is made difficult by high interface, integration and process costs, and in some cases virtually impossible. A system that enables cross-clinic, interdisciplinary communication is not comprehensively available at the present time.

The question of palliative care is becoming increasingly important both in hospitals and in the outpatient setting. Recent studies have shown that palliative care can not only improve the quality of life, but also significantly improve the outcome of treatment and thus prolong survival. Patients with incurable, advanced diseases die more often in hospital than - as often desired - in the home environment. However, both the shortage of physicians and increasing urbanization make it difficult to realize this area-wide provision of palliative care, especially in rural areas. "Communication and shared decision making" and "trust and confidence in treatment partners" are the most important factors for quality end-of-life care. For patients at the end of life, a visit to a (specialist) physician and the associated transport can be a major, energy-sapping and emotional effort. By bringing together various disciplines in one place, as is the case at University Hospital Muenster, and by using telemedical rounds, it may be possible to protect resources on the patient side as well.

Currently, there are no telemedical visits between patients and/or their relatives and a palliative physician for the evaluation of symptom and progress monitoring. This is done during visits of the patient by the coordinators and palliative physicians of the palliative network/PKD Münster and/or the general practitioners. Upon enrollment in the Palliative Network/PKD Münster, patients receive a 24-hour emergency telephone number. This is staffed by a caregiver who coordinates the deployment of other caregivers / palliative care physicians according to the information provided by the patient / family members. If patients are randomized to the "telemedicine" group, they have the option of using ELVI in addition to conventional care, and thus the possibility of televisits with physicians or nurses. In this case, they receive access data for ELVI, i.e., an access code for a virtual waiting room. In addition, patients will be given questionnaires at discharge to be completed on the day of discharge and on days 7, and 14.

The primary objective of this randomized trial is to demonstrate that telemedically managed patients are not relevantly inferior to conventionally managed patients in terms of change in IPOS from the day of discharge (non-inferiority question), although the possibility of televisiting may result in less frequent physician visits to the patient's home.

Eligibility criteria: Inclusion Criteria:

* Patients with indications to receive specialized palliative care for advanced malignant and non-malignant diseases
* Minimum age 18 years
* Signed informed consent
* Inpatient care in a normal ward or the palliative care unit at University Hospital Muenster
* Planned discharge to home environment
* Consent to participate in randomized study
* Residence in the area of responsibility of the palliative care network/PKD Münster and consent to the Connection to the palliative care network/PKD Münster
* At least one cell phone (or comparable device with camera and microphone) with wireless network connection or long data evolution (LTE) flat rate
* Basic willingness to use new media
* Disease phase "stable" / "unstable" / "deteriorating" (patients who are in the dying phase are not included in the randomized part of the study, as they will in all likelihood not be discharged home).

Exclusion Criteria:

* Pregnant or breastfeeding patients
* minors
* Language difficulties (lack of German language skills), if these cannot be compensated by family members or interpreters can be compensated
* Dependency or employment relationship to the project management or the including physician
* Persons who have been placed in an institution by court or official order

Primary outcomes:
measure: Symptom Control
timeFrame: 7 days
Secondary outcomes:
measure: Reason for request
timeFrame: up to two weeks
measure: resulting interventions
timeFrame: up to two weeks
measure: avoidance of home visits
timeFrame: up to two weeks
measure: number of telephone and visit contacts
timeFrame: up to two weeks
measure: sense of safety of patients and professional users
timeFrame: 7 and 14 days
Other outcomes:
Locations:
city: Münster
country: Germany
facility: University Hospital Muenster
Study officials:
affiliation: University Hospital Muenster
name: Philipp Lenz, MD
role: PRINCIPAL_INVESTIGATOR
References: