MedPath

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

Not Applicable
Withdrawn
Conditions
Musculoskeletal Diseases
Registration Number
NCT07093164
Lead Sponsor
University of Texas at Austin
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.

Detailed Description

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.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
Inclusion Criteria
  • English speaking
  • Between 17 and 90 years old
  • musculoskeletal problem
  • New and returned
Exclusion Criteria

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Guttman Satisfaction scaleAt time of initial visit and again 1 month following visit

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.

Secondary Outcome Measures
NameTimeMethod
Jefferson scale of patient perception of physician empathyOnce only - after initial visit

The Jefferson Scale of Patient's Perceptions of Physician Empathy includes five items rated on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree), with total scores ranging from 5 to 35. Higher scores indicate greater perceived physician empathy, representing a better outcome.

Patient Reported Outcome Measurement Information System(PROMIS) Upper extremity Physical Function Computer Adaptive TestAt time of initial visit and again 1 month following visit

Patient physical function will be assessed using the PROMIS Upper Extremity Computer Adaptive Test (CAT). This instrument evaluates the ability to perform daily activities requiring upper limb function, such as reaching, lifting, and fine motor tasks. Scores are reported as T-scores, ranging from 20 (indicating minimum physical ability) to 80 (maximum physical ability). Higher scores reflect better upper extremity function and therefore a better outcome.

Pain intensity scaleAt time of initial visit and again 1 month following visit

Pain intensity will be assessed using a numerical rating scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "the worst pain imaginable." Higher scores reflect greater pain intensity and therefore a worse outcome.

Number of diagnostic tests or treatmentsCumulative total at 1 month following visit)

Total number of all tests or treatments performed for patient, including: injections, imaging studies and procedures.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.