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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07093164
Enrollment
0
Registered
2025-07-30
Start date
2025-08-31
Completion date
2025-08-31
Last updated
2025-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Musculoskeletal Diseases

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.

Interventions

BEHAVIORALVirtual visit

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

Sponsors

University of Texas at Austin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

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.

Intervention model description

. 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Guttman Satisfaction scaleAt time of initial visit and again 1 month following visitThe 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

MeasureTime frameDescription
Patient Reported Outcome Measurement Information System(PROMIS) Upper extremity Physical Function Computer Adaptive TestAt time of initial visit and again 1 month following visitPatient 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.
Jefferson scale of patient perception of physician empathyOnce only - after initial visitThe 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.
Pain intensity scaleAt time of initial visit and again 1 month following visitPain 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.

Other

MeasureTime frameDescription
Patient Health Questionnaire (PHQ-2)Once only (at time of initial visit)The Patient Health Questionnaire-2 (PHQ-2) is a brief mental health screening tool measuring the frequency of core depressive symptoms over the past two weeks. It includes 2 items scored from 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 (no depressive symptoms) to 6 (highest level of depressive symptoms). Higher scores indicate greater severity of depressive symptoms, representing a worse outcome.
Pain Catastrophizing Scale (PCS-4)Once only (at time of initial visit)The Pain Catastrophizing Scale - 4 item version (PCS-4) is a mental health measure assessing the extent of catastrophic thoughts related to pain. It consists of 4 items rated on a 5-point scale (0 = not at all to 4 = all the time), with total scores ranging from 0 (no pain catastrophizing) to 16 (highest level of pain catastrophizing). Higher scores indicate greater catastrophic thinking.
Short Health Anxiety Inventory 5 (SHAI-5)Once only (at time of initial visit)The Short Health Anxiety Inventory 5-item version (SHAI-5) is a brief questionnaire designed to assess health-related anxiety. Each item is rated on a 4-point scale (0 to 3), with total scores ranging from 0 to 15. Higher scores indicate greater health anxiety.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026