NCT07158892

Brief 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:

  • 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 8, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

September 10, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

September 8, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

August 25, 2025

Last Update Submit

September 2, 2025

Conditions

Keywords

Musculoskeletal disordersDiagnostic imagingShared decision makingAdvance care planning (ACP)Patient preferencesHealth communicationDecision conflictScenario-Based StudyOrthopedic care

Outcome Measures

Primary Outcomes (1)

  • 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 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

    Measured using survey on tablet immediately following intervention/control (i.e., ACP-style discussion [Group 1] or informational statement [Group 2])

Study Arms (2)

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.

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.

Behavioral: Informational Statement Only

Interventions

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.

Also known as: ACP-style discussion
Intervention (Group 1)

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.

Also known as: Control
Control (Group 2)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Musculoskeletal Institute, UT Health Austin

Austin, Texas, 78712, United States

Location

Related Publications (16)

  • 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: 19218301BACKGROUND
  • 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: 30428722BACKGROUND
  • 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: 35350847BACKGROUND
  • 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: 36349698BACKGROUND
  • 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: 24861458BACKGROUND
  • 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: 37500354BACKGROUND
  • 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: 19273865BACKGROUND
  • 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: 21382687BACKGROUND
  • 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: 8760739BACKGROUND
  • 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: 12885682BACKGROUND
  • 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: 12809320BACKGROUND
  • 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: 16189057BACKGROUND
  • 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: 12695159BACKGROUND
  • 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: 19047703BACKGROUND
  • 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: 21436660BACKGROUND
  • 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: 26186812BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel SyndromeTennis ElbowOsteoarthritisTrigger Finger DisorderDupuytren ContractureDe Quervain DiseaseMusculoskeletal DiseasesPatient Preference

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and InjuriesElbow TendinopathyTendinopathyMuscular DiseasesElbow InjuriesArm InjuriesTendon InjuriesArthritisJoint DiseasesRheumatic DiseasesTendon EntrapmentFibromaNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsContractureConnective Tissue DiseasesSkin and Connective Tissue DiseasesPatient SatisfactionTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • David Ring, MD

    Dell Medical School, University of Texas at Austin, TX, United States

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Dean for Comprehensive Care; Professor and Associate Chair for Faculty Academic Affairs, Department of Surgery and Perioperative Care; Courtesy Professor of Psychiatry and Behavioral Sciences

Study Record Dates

First Submitted

August 25, 2025

First Posted

September 8, 2025

Study Start

September 10, 2025

Primary Completion

December 30, 2025

Study Completion

March 1, 2026

Last Updated

September 8, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations