Open Video System in Medicine (oVID)

NCT06054048 | Completed

• 1 other identifier: EFRE-0801384
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Chronic Heart Failure; Chronic Obstructive Pulmonary Disease; Palliative Care

Outcome Measures

Primary Outcomes (1)

• Symptom Control

  Change in the Integrated Palliative Care Outcome Scale (IPOS) over the first seven days after transfer (analyzed for the randomized part of the trial in a non-inferiority analysis). The total scores using IPOS can range between 0 and 68 points. The higher the score, the more severe are the patient's symptoms. IPOS was evaluated using a paper questionnaire. seven days after transfer (analyzed for the randomized part of the trial in a non-inferiority analysis).

  7 days

Secondary Outcomes (5)

• Reason for request

  up to two weeks

• resulting interventions

  up to two weeks

• avoidance of home visits

  up to two weeks

• number of telephone and visit contacts

  up to two weeks

• sense of safety of patients and professional users

  7 and 14 days

Study Arms (2)

Telemedicine

ACTIVE COMPARATOR

Those patients who received specialized outpatient palliative care plus telemedicine.

Other: Telemedicine

No telemedicine (Standard of Care)

NO INTERVENTION

Those patients who received standard specialized outpatient palliative care only.

Interventions

Telemedicine OTHER

Web Real-Time Communication (WebRTC), which enables a peer-to-peer connectivity. Communication platform for all TCs was the software "CompuGroup Medical Electronic Visit" (CGM ELVI), which provides end-to-end encrypted video conferencing between physicians and their patients.

Telemedicine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Muenster: lead
• Palliativnetz Muenster gGmbH: collaborator
• CompuGroup Medical: collaborator

Study Sites (1)

University Hospital Muenster

Münster, 48149, Germany

Location

Related Publications (1)

• Bernhardt F, Buckmann A, Kruger J, Bauer B, Hofmeister U, Juhra C, Eveslage M, Fischhuber K, Storck M, Brix TJ, Lenz P. Telemedicine Plus Standard Care Versus Standard Care Only in Specialized Outpatient Palliative Care: A Randomized Controlled Noninferiority Trial. Telemed J E Health. 2024 May;30(5):1459-1469. doi: 10.1089/tmj.2023.0621. Epub 2024 Jan 31.

  PMID: 38294865 DERIVED

MeSH Terms

Conditions

Neoplasms; Pulmonary Disease, Chronic Obstructive

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Philipp Lenz, MD

  University Hospital Muenster

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled non-inferiority trial

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: September 26, 2023
• Study Start: February 1, 2019
• Primary Completion: October 30, 2021
• Study Completion: February 28, 2022
• Last Updated: September 26, 2023

Record last verified: 2023-07

Locations

DE (1)