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Not yet recruiting NCT07158892

Understanding Patient Preferences When Deciding on a Voluntary Musculoskeletal Test

No phase Interventional Non-traumatic Musculoskeletal Conditions Carpal Tunnel Syndrome (CTS) Lateral Epicondylitis Osteoarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Diagnostic Advance Care Planning Discussion, Informational Statement Only.
Who it may be relevant to
Registry conditions: Non-traumatic Musculoskeletal Conditions, Carpal Tunnel Syndrome (CTS), Lateral Epicondylitis, Osteoarthritis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Behavioral Diagnostic Advance Care Planning 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,
  • Behavioral Informational Statement Only
    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.

Primary outcome measures

  • Enthusiasm for proposed hypothetical diagnostic test [Time frame: Measured using survey on tablet immediately following intervention/control (i.e., ACP-style discussion [Group 1] or informational statement [Group 2])]
Secondary outcome measures (1)
  • Decisional conflict regarding the diagnostic test [Time frame: Measured using survey on tablet immediately following intervention/control (i.e., ACP-style discussion [Group 1] or informational statement [Group 2])]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Musculoskeletal Institute, UT Health Austin — Austin

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. PMID 19218301
  • Rossettini 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. PMID 30428722
  • Rogers 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. PMID 35350847
  • 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
  • Schenker 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. PMID 24861458
  • 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

Identifiers

NCT: NCT07158892 · STUDY00004831(2)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗