Understanding Patient Preferences When Deciding on a Voluntary Musculoskeletal Test

NCT ID: NCT07158892

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-10

Study Completion Date

2026-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Non-traumatic Musculoskeletal Conditions Carpal Tunnel Syndrome (CTS) Lateral Epicondylitis Osteoarthritis Trigger Digit Dupuytren Contracture Rotator Cuff Tendinopathy De Quervain Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention (Group 1)

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.

Group Type EXPERIMENTAL

Diagnostic Advance Care Planning Discussion

Intervention Type BEHAVIORAL

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.

Control (Group 2)

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.

Group Type ACTIVE_COMPARATOR

Informational Statement Only

Intervention Type BEHAVIORAL

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.

Interventions

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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, 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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ACP-style discussion Control

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas at Austin

OTHER

Sponsor Role lead

Responsible Party

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David Ring

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Ring, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Musculoskeletal Institute, UT Health Austin

Austin, Texas, United States

Site Status

Countries

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United States

Central Contacts

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Emily H Jaarsma, MD

Role: CONTACT

(833) 882-2737

Facility Contacts

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David Ring

Role: primary

833-882-2737

References

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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.

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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.

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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.

Reference Type BACKGROUND
PMID: 24861458 (View on PubMed)

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.

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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.

Reference Type BACKGROUND
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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.

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Reference Type BACKGROUND
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Reference Type BACKGROUND
PMID: 16189057 (View on PubMed)

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.

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Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
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Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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STUDY00004831(2)

Identifier Type: -

Identifier Source: org_study_id

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