Non-traumatic Musculoskeletal ConditionsNCT07158892
Understanding Patient Preferences When Deciding on a Voluntary Musculoskeletal Test
A study testing Diagnostic Advance Care Planning Discussion and Informational Statement Only in people with Non-traumatic Musculoskeletal Conditions and Carpal Tunnel Syndrome (CTS), run by University of Texas at Austin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-traumatic Musculoskeletal Conditions, Carpal Tunnel Syndrome (CTS), Lateral Epicondylitis
- What is being tested?
- Diagnostic Advance Care Planning Discussion and Informational Statement Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2026to 1 Mar 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Cognitive or physical impairment or severe psychiatric illness that would interfere with participation in the scenario-based discussion or completion of the survey instruments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Musculoskeletal Institute, UT Health Austin
Austin, Texas, 78712
David Ring, (833) 882-2737, david.ring@austin.utexas.edu
About this study
Official title: Confirmation of Values and Preferences When Considering a Musculoskeletal Diagnostic Test: A Scenario-Based Study
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:
Read more
- Does having a structured conversation about the pros and cons of a test affect how much a person wants to have that test?
- 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.
- Conditions
- Non-traumatic Musculoskeletal Conditions, Carpal Tunnel Syndrome (CTS), Lateral Epicondylitis, Osteoarthritis, Trigger Digit, Dupuytren Contracture
- Being tested
- Diagnostic Advance Care Planning Discussion, Informational Statement Only
- Keywords
- Musculoskeletal disorders, Diagnostic imaging, Shared decision making, Advance care planning (ACP), Patient preferences, Health communication, Decision conflict, Scenario-Based Study, Orthopedic care
- Medical subject headings
- Carpal Tunnel Syndrome, Tennis Elbow, Osteoarthritis, Trigger Finger Disorder, Dupuytren Contracture, De Quervain Disease, Musculoskeletal Diseases, Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Advance Care Planning DiscussionBehavioural
Also called 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 OnlyBehavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (Group 1) | Experimental | Participants 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. Receives: Behavioral: Diagnostic Advance Care Planning Discussion |
| Control (Group 2) | Active comparator | Participants 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. Receives: Behavioral: Informational Statement Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enthusiasm for proposed hypothetical diagnostic test
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.
Measured: Measured using survey on tablet immediately following intervention/control (i.e., ACP-style discussion [Group 1] or informational statement [Group 2])
Secondary outcomes (1)
Decisional conflict regarding the diagnostic test
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.
Measured: Measured using survey on tablet immediately following intervention/control (i.e., ACP-style discussion [Group 1] or informational statement [Group 2])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start25 Oct 2026 (estimated)
- Primary completion20 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Non-traumatic Musculoskeletal ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Ring, University of Texas at Austin
- Investigators
- David Ring, MD, Principal investigator, Dell Medical School, University of Texas at Austin, TX, United States
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158892
- Sponsor's protocol ID
- STUDY00004831(2)
- Status last verified
- Sep 2026
- First submitted
- 25 Aug 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Slade SC, Molloy E, Keating JL. 'Listen to me, tell me': a qualitative study of partnership in care for people with non-specific chronic low back pain. Clin Rehabil. 2009 Mar;23(3):270-80. doi: 10.1177/0269215508100468.
PubMed 19218301Rossettini G, Latini TM, Palese A, Jack SM, Ristori D, Gonzatto S, Testa M. Determinants of patient satisfaction in outpatient musculoskeletal physiotherapy: a systematic, qualitative meta-summary, and meta-synthesis. Disabil Rehabil. 2020 Feb;42(4):460-472. doi: 10.1080/09638288.2018.1501102. Epub 2018 Nov 14.
PubMed 30428722Rogers CJ, Hackney ME, Zubkoff L, Echt KV. The use of patient-led goal setting in the intervention of chronic low back pain in adults: a narrative review. Pain Manag. 2022 Jul;12(5):653-664. doi: 10.2217/pmt-2021-0118. Epub 2022 Mar 30.
PubMed 35350847Stellman 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.
PubMed 36349698Schenker Y, White DB, Arnold RM. What should be the goal of advance care planning? JAMA Intern Med. 2014 Jul;174(7):1093-4. doi: 10.1001/jamainternmed.2014.1887. No abstract available.
PubMed 24861458Krones 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.
PubMed 37500354van 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.
PubMed 19273865van 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.
PubMed 21382687McDonald 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.
PubMed 8760739Kravitz 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.
PubMed 12885682van 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.
PubMed 12809320Epstein 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.
PubMed 16189057Bedson 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.
PubMed 12695159Graham 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.
PubMed 19047703Herrle 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.
PubMed 21436660