Understanding Patient Preferences When Deciding on a Voluntary Musculoskeletal Test

NCT07158892 — Not applicable, Not yet recruiting, 220 participants, University of Texas at Austin

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Confirmation of Values and Preferences When Considering a Musculoskeletal Diagnostic Test: A Scenario-Based Study

RegistryNCT07158892
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, health services research
Enrollment220 (Estimated)
SponsorUniversity of Texas at Austin (Other)
ConditionsNon-traumatic Musculoskeletal Conditions, Carpal Tunnel Syndrome (CTS), Lateral Epicondylitis, Osteoarthritis, Trigger Digit, Dupuytren Contracture, Rotator Cuff Tendinopathy, De Quervain Disease
InterventionsDiagnostic Advance Care Planning Discussion, Informational Statement Only (Behavioral)
Datesstart 2026-10-25 (estimated), primary completion 2027-01-20 (estimated), completion 2027-03-01 (estimated), first posted 2025-09-08, last updated 2026-09-22
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Non-traumatic Musculoskeletal Conditions All trials for Carpal Tunnel Syndrome (CTS) All trials of Diagnostic Advance Care Planning Discussion All trials of Informational Statement Only

-Summary

The goal of this clinical trial is to understand how people make decisions about imaging tests for common musculoskeletal problems (like arthritis, tendon problems, or nerve compression). The study involves adult patients attending a musculoskeletal specialty clinic.

The main questions it aims to answer are:

1. Does having a structured conversation about the pros and cons of a test affect how much a person wants to have that test?
2. Does that conversation help people feel more confident and less conflicted about their decision?

Researchers will compare patients who have a values-based discussion with a researcher to those who receive brief written information about the test, to see if these approaches affect how people feel about having the test.

Participants will:

* Read a brief scenario about a proposed diagnostic imaging test (like an X-ray, MRI, CT, or ultrasound).
* Either take part in a short structured conversation or read brief information about the test.
* Answer a short survey about their thoughts on the test.

This study does not involve actual medical testing or affect your clinical care. It is for research purposes only.

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
Intervention (Group 1)ExperimentalBehavioral: Diagnostic Advance Care Planning DiscussionParticipants randomized to the intervention group will engage in a structured, scenario-based conversation simulating a diagnostic decision-making discussion. This conversation will be guided by a trained researcher using branching scripted prompts designed to reflect an Advance Care Planning (ACP)-style approach. The discussion will explore the participant's values, goals, and understanding of potential benefits and harms of the proposed hypothetical imaging test. No actual diagnostic tests will be ordered.
Control (Group 2)Active comparatorBehavioral: Informational Statement OnlyParticipants randomized to the control group will receive the same hypothetical clinical scenario, including mention of a proposed diagnostic imaging test. Instead of a structured discussion, they will be presented with a brief, standardized informational statement describing what the test involves, what it may show, and general risks or limitations. No values-based discussion or simulated conversation will occur.
  • Diagnostic Advance Care Planning Discussion (Behavioral), also known as ACP-style discussion: The intervention consists of a structured, values-based conversation modeled after Advance Care Planning (ACP) principles, adapted for diagnostic decision-making. Participants will receive a hypothetical clinical vignette involving a musculoskeletal diagnostic test (e.g., MRI, X-ray, CT, or ultrasound), followed by a simulated discussion facilitated by a trained researcher. The conversation is guided by branching scripted prompts designed to elicit the participant's values, goals, expectations, and understanding of the potential benefits and harms of testing. Responses are transcribed using verbal-to-text technology. Unlike standard decision aids or educational materials, this intervention emphasizes patient reflection and shared decision-making by prompting participants to consider what matters most to them before making a decision about the test. The discussion does not involve actual test ordering or clinical decisions but is intended to simulate a real-world ACP discussion process.
  • Informational Statement Only (Behavioral), also known as Control: Participants will be presented with a brief, standardized informational statement describing what the test involves, what it may show, and general risks or limitations. No individualized values-based discussion or simulated conversation will occur.

+Outcome measures

Primary outcomes

  • Enthusiasm for proposed hypothetical diagnostic test [Measured using survey on tablet immediately following intervention/control (i.e., ACP-style discussion [Group 1] or informational statement [Group 2])]: Measured using 11-point Likert scale: 0=I would definitely decline this test, 5=I am not sure if I would accept this test, 10=I would definitely proceed with this test.

Secondary outcomes

  • Decisional conflict regarding the diagnostic test [Measured using survey on tablet immediately following intervention/control (i.e., ACP-style discussion [Group 1] or informational statement [Group 2])]: Assessed using the validated 'SURE' scale (0-4 score; higher scores indicate greater certainty and lower decisional conflict). Please refer to Appendix 2 of PDF study protocol.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Adults (18+ years)
* English literacy
* Seeking musculoskeletal specialty care
* Diagnosis of non-traumatic musculoskeletal condition (including but not limited to: carpal tunnel syndrome, lateral epicondylitis, osteoarthritis, trigger digit, Dupuytren's, De Quervain, or rotator cuff tendinopathy)

Exclusion Criteria:

* Cognitive or physical impairment or severe psychiatric illness that would interfere with participation in the scenario-based discussion or completion of the survey instruments

+Locations (1)

FacilityCityCountryStatus
Musculoskeletal Institute, UT Health AustinAustin, TexasUnited States

+Publications

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  • Stellman S, Ellis B, Dawson H, Kocsis A, Mundra J, Hill C, Sahota K, Douglas S. Piloting a new model of personalised care for people with fibromyalgia in primary care with secondary care multidisciplinary support. Musculoskeletal Care. 2023 Jun;21(2):582-591. doi: 10.1002/msc.1708. Epub 2022 Nov 9. PMID 36349698
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  • Krones T, Anderson S, Borenko C, Fromme E, Gotze K, Lasmarias C, Lin CP, Neves Forte D, Ng R, Simon J, Sinclair C. Editorial: Advance Care Planning as Key to Person Centered Care: Evidence and Experiences, Programmes and Perspectives. Z Evid Fortbild Qual Gesundhwes. 2023 Aug;180:1-6. doi: 10.1016/j.zefq.2023.07.001. Epub 2023 Jul 26. No abstract available. PMID 37500354
  • van Bokhoven MA, Koch H, van der Weijden T, Grol RP, Kester AD, Rinkens PE, Bindels PJ, Dinant GJ. Influence of watchful waiting on satisfaction and anxiety among patients seeking care for unexplained complaints. Ann Fam Med. 2009 Mar-Apr;7(2):112-20. doi: 10.1370/afm.958. PMID 19273865
  • van Ravesteijn H, van Dijk I, Darmon D, van de Laar F, Lucassen P, Olde Hartman T, van Weel C, Speckens A. The reassuring value of diagnostic tests: a systematic review. Patient Educ Couns. 2012 Jan;86(1):3-8. doi: 10.1016/j.pec.2011.02.003. Epub 2011 Mar 6. PMID 21382687
  • McDonald IG, Daly J, Jelinek VM, Panetta F, Gutman JM. Opening Pandora's box: the unpredictability of reassurance by a normal test result. BMJ. 1996 Aug 10;313(7053):329-32. doi: 10.1136/bmj.313.7053.329. PMID 8760739
  • Kravitz RL, Bell RA, Azari R, Kelly-Reif S, Krupat E, Thom DH. Direct observation of requests for clinical services in office practice: what do patients want and do they get it? Arch Intern Med. 2003 Jul 28;163(14):1673-81. doi: 10.1001/archinte.163.14.1673. PMID 12885682
  • van der Weijden T, van Velsen M, Dinant GJ, van Hasselt CM, Grol R. Unexplained complaints in general practice: prevalence, patients' expectations, and professionals' test-ordering behavior. Med Decis Making. 2003 May-Jun;23(3):226-31. doi: 10.1177/0272989X03023003004. PMID 12809320
  • Epstein RM, Franks P, Shields CG, Meldrum SC, Miller KN, Campbell TL, Fiscella K. Patient-centered communication and diagnostic testing. Ann Fam Med. 2005 Sep-Oct;3(5):415-21. doi: 10.1370/afm.348. PMID 16189057
  • Bedson J, Jordan K, Croft P. How do GPs use x rays to manage chronic knee pain in the elderly? A case study. Ann Rheum Dis. 2003 May;62(5):450-4. doi: 10.1136/ard.62.5.450. PMID 12695159
  • Graham B. The value added by electrodiagnostic testing in the diagnosis of carpal tunnel syndrome. J Bone Joint Surg Am. 2008 Dec;90(12):2587-93. doi: 10.2106/JBJS.G.01362. PMID 19047703
  • Herrle SR, Corbett EC Jr, Fagan MJ, Moore CG, Elnicki DM. Bayes' theorem and the physical examination: probability assessment and diagnostic decision making. Acad Med. 2011 May;86(5):618-27. doi: 10.1097/ACM.0b013e318212eb00. PMID 21436660
  • Karel YH, Verkerk K, Endenburg S, Metselaar S, Verhagen AP. Effect of routine diagnostic imaging for patients with musculoskeletal disorders: A meta-analysis. Eur J Intern Med. 2015 Oct;26(8):585-95. doi: 10.1016/j.ejim.2015.06.018. Epub 2015 Jul 15. PMID 26186812

+Study documents

+Investigators

  • David Ring, MD, Principal investigator, Dell Medical School, University of Texas at Austin, TX, United States