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

NCT07093164 | Withdrawn

• 1 other identifier: 2019-11-0170
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Musculoskeletal Diseases

Outcome Measures

Primary Outcomes (1)

• Guttman Satisfaction scale

  The Guttman Satisfaction Scale is a unidimensional questionnaire designed to measure the degree of patient satisfaction with the care they received. It consists of a series of hierarchically ordered yes/no items, with each successive item indicating a higher level of satisfaction. Total scores range from 0 to 7, with higher scores reflecting greater satisfaction, representing a better outcome.

  At time of initial visit and again 1 month following visit

Secondary Outcomes (4)

• Jefferson scale of patient perception of physician empathy

  Once only - after initial visit

• Patient Reported Outcome Measurement Information System(PROMIS) Upper extremity Physical Function Computer Adaptive Test

  At time of initial visit and again 1 month following visit

• Pain intensity scale

  At time of initial visit and again 1 month following visit

• Number of diagnostic tests or treatments

  Cumulative total at 1 month following visit)

Other Outcomes (3)

• Short Health Anxiety Inventory 5 (SHAI-5)

  Once only (at time of initial visit)

• Pain Catastrophizing Scale (PCS-4)

  Once only (at time of initial visit)

• Patient Health Questionnaire (PHQ-2)

  Once only (at time of initial visit)

Study Arms (2)

In person visit

NO INTERVENTION

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

Virtual visit

EXPERIMENTAL

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.

Behavioral: Virtual visit

Interventions

Virtual visit BEHAVIORAL

Patients will be provided an initial virtual health or telehealth visit instead of an in person visit.

Virtual visit

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking
• Between 17 and 90 years old
• musculoskeletal problem
• New and returned

Sponsors & Collaborators

• University of Texas at Austin: lead

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of surgery and perioperative care

Model Details: . 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.

Study Record Dates

• First Submitted: February 1, 2020
• First Posted: July 30, 2025
• Study Start: August 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share