Open Label Randomized Clinical Trial to Assess the Safety of Teleconsultation

Study Overview
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Brief Summary
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Randomized-controlled trial to assess the safety of remote consultations (both video and teleconsultation) in the follow-up of patients in the hospital setting. A total of 6009 patients will be randomly allocated into one of the three study arms: A) face-to-face consultation (control) B) telephone consultation C) video consultation. Primary outcome will be the frequency of complications of the underlying disease, including adverse reactions to the treatment of the underlying disease. To be eligible for remote consultation, patients have to have adequate digital literacy at physician discretion, technological capacity to use the video conferencing software, and undergo a type of follow-up that, due to the moderate complexity of the pathology, do not require physical examinations. Patients followed up in more than three departments, those with visual or hearing impairments that may hamper patient-physician communication, and those enrolled in another clinical trial that requires an experimental intervention during the follow-up will be excluded from the study. Physicians can schedule and cancel appointments at their discretion. At least three visits should be scheduled in the study setting: the baseline visit (i.e., screening visit), intermediate visits (pre-defined by the physician based on the follow-up needed for managing the baseline condition), and the final visit (i.e., either the follow-up visit closest to 12 ± 2 months after enrollment or before in case of discharge or early discontinuation). The primary objective will be assessed using a non-inferiority analysis of the cumulative incidence of complications of the baseline disease between remote consultation (video and teleconsultation arms) and face-to-face consultation, using a non-inferiority margin of 2%. The analysis will be based on a modified binomial test to assess the non-inferiority of an experimental intervention vs. a control group in a three-arm trial. The primary analysis will be conducted on a per-protocol study sample, which will include all participants who have finished the study and have not been withdrawn because of non-allowed visits using modalities other than scheduled.

Official Title
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Open Label Randomized Clinical Trial to Assess the Safety of Teleconsultation, Compared to the Traditional Clinical Consultation

Conditions
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Various Clinical Conditions Commonly Followed up in a Secondary Hospital

Intervention / Treatment
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* Other: Face-to-face appointment
* Other: Teleconsultation
* Other: Video consultation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women of any age. Possibility of making consultations by telephone, at the discretion of the investigator, taking into account the severity and complexity of the baseline pathology and the objective of health care. Forecast to carry out follow-up in external consultation. Agreement to be attended through a non-face-to-face system. Ability to connect to the video consultation system. Device compatible with the video consultation system. Possibility of collaborating in the necessary evaluations. Legal capacity to give informed consent. Signature of the informed consent for inclusion of the study. Exclusion Criteria: Need to carry out physical examinations, visualize the patient in person or perform techniques that involve face-to-face visits. Need for face-to-face consultation due patient's clinical situation. Follow-up by more than three medical specialists. Visual, hearing or functional impairments that may hamper patient-physician communication. Patients enrolled in another clinical trial that requires an experimental intervention during the follow-up.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Face-to-face consultation<br> | Other: Face-to-face appointment<br>* Participants will be scheduled with face-to-face appointments as usual (control arm). All phone calls (except reminders for scheduled visits) performed by the physician during the study will be recorded. Per protocol, participants allocated in the control arm can receive up to 25% of physician-doctor interactions by phone (that is, one phone call allowed for three face-to-face appointments).<br>|
| Active Comparator: Teleconsultation<br> | Other: Teleconsultation<br>* Participants allocated in the teleconsultation arm will be scheduled phone call visits (i.e., date and time slot in which the physician will contact). The physician will call the main phone number provided by the patient and, in case of not receiving an answer, other phone numbers listed as contact numbers. Participants allocated in the teleconsultation arm cannot be visited by video.<br>|
| Active Comparator: Video consultation<br> | Other: Video consultation<br>* Participants allocated in the video consultation arm will be provided with an app, which can be installed in mobile phone, for safe videoconference. At the moment of the videoconsultation, the patient will be provided with a link to the meeting through the video conference app. Patients will remain in the virtual waiting room until the physician starts the visit. Participants allocated in video consultation arm can undergo up to 25% of phone visits in case of failure of the videoconferencing system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications of the underlying disease | Frequency of complications of the underlying disease, including adverse reactions to the treatment of the underlying disease | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe complications of the baseline disease | Frequency of severe complications of the underlying disease. | 12 months | 
| Treatment Serious Adverse Event | Frequency of Serious Adverse Events related to the underlying disease's treatment | 12 months | 
| Avoidable hospitalizations | Total and avoidable hospitalizations, secondary to ambulatory care sensitive conditions | 12 months | 
| Number of unscheduled medical contacts | Count of unscheduled medical contacts (phone calls, unscheduled visits, ER visits, and admissions) registered in the hospital information system | 12 months | 
| Care process indicators | Number of consultations made in a format different from the one initially foreseen (face-to-face, telephone consultation or video consultation) Number of empty consultations (the patient does not attend) Number of patients who interrupt their outpatient follow-up Number of prescriptions and type of prescription | 12 months | 
| Healthcare expenditure | Estimated healthcare expenditure associated with each of the three interventions | 12 months | 
| Usability of video consultation system | Usability of video consultation system, measured by using the Computer System Usability Questionnaire | 12 months | 
| Satisfaction of users (health professionals and patients) with the process of clinical care | Degree of satisfaction of users (health professionals and patients) with the process of clinical care, measured by using the satisfaction questionary of the Pla d'enquestes de satisfacció del CatSalut | 12 months |