Randomized Controlled Single-blind Non-inferiority Trial Comparing an Offer of Initial Virtual Visit and Usual Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2025-08-31

Brief Summary

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This randomized controlled trial will address whether there is a difference in satisfaction with treatment plan, satisfaction with the clinician, perceived empathy, patient reported outcomes, and psychological measures among patients randomized to the offer of an initial virtual health or telehealth visit compared to those provided an initial in person visit.

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Detailed Description

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Virtual visits (video) provide people seeking care additional options. The quality of virtual care resources has improved, making it a user-friendly way to address health concerns. The benefits of virtual visits include no travel time, less time away from work, and no need for dependent care arrangements.

Previous studies found virtual visits to be safe, efficient and accurate for selected orthopaedic patients . An RCT found telemedicine capable of providing a satisfactory standard care in the management of minor injuries. Others suggest that virtual care is an alternative to in person visits for orthopaedic patients in an outpatient setting.

There are concerns that virtual care will represent another commodity that will increase the amount and costs of care without increasing health as was observed for retail care. On the other hand, there is evidence that online care for simple conditions saves money. Also a pilot study showed that online visits appeared to reduce medical costs for patients during a 6-month period after the visit.

This randomized controlled trial will address whether there is a difference in satisfaction with treatment plan, satisfaction with the clinician, perceived empathy, patient reported outcomes, and psychological measures among patients randomized to the offer of an initial virtual health or telehealth visit compared to those provided an initial in person visit.

Conditions

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Musculoskeletal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

. Patients will be randomized using a random number generator in Microsoft Excel in 1:1 ratio to a standard in person visit OR to be called by a research assistant to offer a virtual visit in advance of an in person visit. Patients that indicate interest in a virtual visit will make a scheduled video appointment and test the website to be used in conjunction with the research assistant.

At the end of the virtual visit, if patients decide to cancel the in person visit, they will be asked to complete a REDCap survey via text link.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

We will request a waiver of informed consent in order to blind the patients for this trial. As initial visits already take place both in person and virtual, we do not feel the blinding or randomization adds risk.

Study Groups

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In person visit

Patients will be provided an initial in person visit. Patients that visit in person will complete the REDCap survey after the visit.

Group Type NO_INTERVENTION

No interventions assigned to this group

Virtual visit

Patients will be provided an initial virtual health or telehealth visit. At the end of the virtual visit, if patients decide to cancel the in person visit, they will be asked to complete a REDCap survey via text link.

Group Type EXPERIMENTAL