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Testing of a Tool to Elicit Patient Preferences for CTS

Primary Purpose

Carpal Tunnel, Carpal Tunnel Syndrome, Carpal Tunnel Syndrome Left

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Preference Elicitation tool
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Carpal Tunnel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • New patient
  • English fluency and literacy
  • Able to take informed consent
  • clinical diagnosis of carpal tunnel syndrome

Exclusion Criteria:

  • Prior diagnostic testing for carpal tunnel (nerve test, ultrasound)
  • Prior carpal tunnel release
  • Diagnosis of C5/6 radiculopathy (double crush)
  • Peripheral neuropathy (ex: diabetic)
  • Worker Compensation/EMG Required
  • Symptoms of Cubital tunnel syndrome

Sites / Locations

  • Stanford Health Care

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

None- normal care

Patients will use a preference elicitation tool to determine their preferences for diagnosis and treatment of CTS

Outcomes

Primary Outcome Measures

Decisional Conflict Scale
Name: Decisional Conflict Scale Measures: uncertainty in choosing options; modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice. 16 statements with 5 response categories Scoring: total scale-0 (no decisional conflict) to 100 (extreme decisional conflict) lower values indicate lower decisional conflict- i.e. a better outcome for use of the tool. Calculation: Summed, divided by # of items, multiplied by 25

Secondary Outcome Measures

Full Information

First Posted
May 9, 2018
Last Updated
August 4, 2022
Sponsor
Stanford University
Collaborators
Duke University, Brown University, University of Texas at Austin, Mayo Clinic, Harvard University
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1. Study Identification

Unique Protocol Identification Number
NCT03532373
Brief Title
Testing of a Tool to Elicit Patient Preferences for CTS
Official Title
Testing of a Tool to Elicit Patient Preferences for CTS
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Duke University, Brown University, University of Texas at Austin, Mayo Clinic, Harvard University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will complete a randomized controlled trial to quantitatively measure patient decisional conflict (Decisional Conflict Scale) in 150 patients treated for CTS with the tool compared to 150 patients treated with standard care. The investigators hypothesize patients treated for CTS will have lower decisional conflict with the tool.
Detailed Description
The investigators will measure decisional conflict in 150 new patients being evaluated for CTS with the tool compared to 150 patients being evaluated for CTS with standard care. Those patients randomized to receiving the tool will use it to identify their preferences for certain attributes of care. Patients will then be presented with their preference data and the surgeon will have a discussion with the patient regarding CTS. Surgeons will have their standard discussion with the patients randomized to the standard care group (no tool). The tool will be operationalized on a Health Insurance Portability and Accountability Act compliant data platform, such as Qualtrics, and no identifiable data will be collected. De-identified data will be shared from study cites with our team at Stanford. This data will be backed up on a computer encrypted by Stanford.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel, Carpal Tunnel Syndrome, Carpal Tunnel Syndrome Left, Carpal Tunnel Syndrome Right, Carpal Tunnel Syndrome Bilateral

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomly assigned to either the intervention or control group
Masking
None (Open Label)
Masking Description
No masking will occur
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
None- normal care
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patients will use a preference elicitation tool to determine their preferences for diagnosis and treatment of CTS
Intervention Type
Other
Intervention Name(s)
Preference Elicitation tool
Intervention Description
A preference elicitation tool for carpal tunnel syndrome
Primary Outcome Measure Information:
Title
Decisional Conflict Scale
Description
Name: Decisional Conflict Scale Measures: uncertainty in choosing options; modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice. 16 statements with 5 response categories Scoring: total scale-0 (no decisional conflict) to 100 (extreme decisional conflict) lower values indicate lower decisional conflict- i.e. a better outcome for use of the tool. Calculation: Summed, divided by # of items, multiplied by 25
Time Frame
Immediately after using tool

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: New patient English fluency and literacy Able to take informed consent clinical diagnosis of carpal tunnel syndrome Exclusion Criteria: Prior diagnostic testing for carpal tunnel (nerve test, ultrasound) Prior carpal tunnel release Diagnosis of C5/6 radiculopathy (double crush) Peripheral neuropathy (ex: diabetic) Worker Compensation/EMG Required Symptoms of Cubital tunnel syndrome
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin N Kamal, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Health Care
City
Redwood City
State/Province
California
ZIP/Postal Code
94061
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared with other researchers
Citations:
PubMed Identifier
27926678
Citation
Zhang S, Vora M, Harris AH, Baker L, Curtin C, Kamal RN. Cost-Minimization Analysis of Open and Endoscopic Carpal Tunnel Release. J Bone Joint Surg Am. 2016 Dec 7;98(23):1970-1977. doi: 10.2106/JBJS.16.00121.
Results Reference
background
PubMed Identifier
21606100
Citation
Atroshi I, Englund M, Turkiewicz A, Tagil M, Petersson IF. Incidence of physician-diagnosed carpal tunnel syndrome in the general population. Arch Intern Med. 2011 May 23;171(10):943-4. doi: 10.1001/archinternmed.2011.203. No abstract available.
Results Reference
background
PubMed Identifier
22727925
Citation
Fajardo M, Kim SH, Szabo RM. Incidence of carpal tunnel release: trends and implications within the United States ambulatory care setting. J Hand Surg Am. 2012 Aug;37(8):1599-605. doi: 10.1016/j.jhsa.2012.04.035. Epub 2012 Jun 23.
Results Reference
background
PubMed Identifier
25087865
Citation
Hageman MG, Kinaci A, Ju K, Guitton TG, Mudgal CS, Ring D; Science of Variation Group. Carpal tunnel syndrome: assessment of surgeon and patient preferences and priorities for decision-making. J Hand Surg Am. 2014 Sep;39(9):1799-1804.e1. doi: 10.1016/j.jhsa.2014.05.035. Epub 2014 Aug 1.
Results Reference
background
PubMed Identifier
23281971
Citation
Oshima Lee E, Emanuel EJ. Shared decision making to improve care and reduce costs. N Engl J Med. 2013 Jan 3;368(1):6-8. doi: 10.1056/NEJMp1209500. No abstract available.
Results Reference
background
PubMed Identifier
22618581
Citation
Elwyn G, Frosch D, Thomson R, Joseph-Williams N, Lloyd A, Kinnersley P, Cording E, Tomson D, Dodd C, Rollnick S, Edwards A, Barry M. Shared decision making: a model for clinical practice. J Gen Intern Med. 2012 Oct;27(10):1361-7. doi: 10.1007/s11606-012-2077-6. Epub 2012 May 23.
Results Reference
background
PubMed Identifier
27045301
Citation
Alfandre D. Clinical Recommendations in Medical Practice: A Proposed Framework to Reduce Bias and Improve the Quality of Medical Decisions. J Clin Ethics. 2016 Spring;27(1):21-7.
Results Reference
background
PubMed Identifier
23137819
Citation
Mulley AG, Trimble C, Elwyn G. Stop the silent misdiagnosis: patients' preferences matter. BMJ. 2012 Nov 8;345:e6572. doi: 10.1136/bmj.e6572. No abstract available.
Results Reference
background
PubMed Identifier
10728107
Citation
Lang F, Floyd MR, Beine KL. Clues to patients' explanations and concerns about their illnesses. A call for active listening. Arch Fam Med. 2000 Mar;9(3):222-7. doi: 10.1001/archfami.9.3.222.
Results Reference
background
PubMed Identifier
27346032
Citation
Johnson DC, Mueller DE, Deal AM, Dunn MW, Smith AB, Woods ME, Wallen EM, Pruthi RS, Nielsen ME. Integrating Patient Preference into Treatment Decisions for Men with Prostate Cancer at the Point of Care. J Urol. 2016 Dec;196(6):1640-1644. doi: 10.1016/j.juro.2016.06.082. Epub 2016 Jun 23.
Results Reference
background
PubMed Identifier
19636065
Citation
Fraenkel L, Chodkowski D, Lim J, Garcia-Tsao G. Patients' preferences for treatment of hepatitis C. Med Decis Making. 2010 Jan-Feb;30(1):45-57. doi: 10.1177/0272989X09341588. Epub 2009 Jul 27.
Results Reference
background
PubMed Identifier
27200394
Citation
Hageman MG, Bossen JK, Neuhaus V, Mudgal CS, Ring D; Science of Variation Group. Assessment of Decisional Conflict about the Treatment of carpal tunnel syndrome, Comparing Patients and Physicians. Arch Bone Jt Surg. 2016 Apr;4(2):150-5.
Results Reference
background
PubMed Identifier
27374791
Citation
Kamal RN; Hand Surgery Quality Consortium. Quality and Value in an Evolving Health Care Landscape. J Hand Surg Am. 2016 Jul;41(7):794-9. doi: 10.1016/j.jhsa.2016.05.016.
Results Reference
background
PubMed Identifier
19474449
Citation
Keith MW, Masear V, Amadio PC, Andary M, Barth RW, Graham B, Chung K, Maupin K, Watters WC 3rd, Haralson RH 3rd, Turkelson CM, Wies JL, McGowan R. Treatment of carpal tunnel syndrome. J Am Acad Orthop Surg. 2009 Jun;17(6):397-405. doi: 10.5435/00124635-200906000-00008.
Results Reference
background
PubMed Identifier
26612240
Citation
Newington L, Harris EC, Walker-Bone K. Carpal tunnel syndrome and work. Best Pract Res Clin Rheumatol. 2015 Jun;29(3):440-53. doi: 10.1016/j.berh.2015.04.026. Epub 2015 May 27.
Results Reference
background
PubMed Identifier
19047703
Citation
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.
Results Reference
background
PubMed Identifier
16793786
Citation
Graham B. The diagnosis and treatment of carpal tunnel syndrome. BMJ. 2006 Jun 24;332(7556):1463-4. doi: 10.1136/bmj.332.7556.1463. No abstract available.
Results Reference
background
PubMed Identifier
16886290
Citation
Graham B, Regehr G, Naglie G, Wright JG. Development and validation of diagnostic criteria for carpal tunnel syndrome. J Hand Surg Am. 2006 Jul-Aug;31(6):919-24.
Results Reference
background
PubMed Identifier
26631997
Citation
Fowler JR, Cipolli W, Hanson T. A Comparison of Three Diagnostic Tests for Carpal Tunnel Syndrome Using Latent Class Analysis. J Bone Joint Surg Am. 2015 Dec 2;97(23):1958-61. doi: 10.2106/JBJS.O.00476.
Results Reference
background
PubMed Identifier
27702467
Citation
Pulikkottil BJ, Schub M, Kadow TR, Wang W, Fowler JR. Correlating Median Nerve Cross-sectional Area With Nerve Conduction Studies. J Hand Surg Am. 2016 Oct;41(10):958-962. doi: 10.1016/j.jhsa.2016.08.018.
Results Reference
background
PubMed Identifier
19122780
Citation
Flynn KE, Weinfurt KP, Seils DM, Lin L, Burnett CB, Schulman KA, Meropol NJ. Decisional conflict among patients who accept or decline participation in phase I oncology studies. J Empir Res Hum Res Ethics. 2008 Sep;3(3):69-77. doi: 10.1525/jer.2008.3.3.69.
Results Reference
background
PubMed Identifier
22033742
Citation
Hyman DJ, Pavlik VN, Greisinger AJ, Chan W, Bayona J, Mansyur C, Simms V, Pool J. Effect of a physician uncertainty reduction intervention on blood pressure in uncontrolled hypertensives--a cluster randomized trial. J Gen Intern Med. 2012 Apr;27(4):413-9. doi: 10.1007/s11606-011-1888-1. Epub 2011 Oct 27.
Results Reference
background
PubMed Identifier
20671803
Citation
Wittink MN, Cary M, Tenhave T, Baron J, Gallo JJ. TOWARDS PATIENT-CENTERED CARE FOR DEPRESSION: CONJOINT METHODS TO TAILOR TREATMENT BASED ON PREFERENCES. Patient. 2010;3(3):145-157. doi: 10.2165/11530660.
Results Reference
background
PubMed Identifier
24889944
Citation
Baker LC, Bundorf MK, Kessler DP. Patients' preferences explain a small but significant share of regional variation in medicare spending. Health Aff (Millwood). 2014 Jun;33(6):957-63. doi: 10.1377/hlthaff.2013.1184.
Results Reference
background
PubMed Identifier
27645527
Citation
Hampson LA, Allen IE, Gaither TW, Lin T, Ting J, Osterberg EC, Wilson L, Breyer BN. Patient-centered Treatment Decisions for Urethral Stricture: Conjoint Analysis Improves Surgical Decision-making. Urology. 2017 Jan;99:246-253. doi: 10.1016/j.urology.2016.07.053. Epub 2016 Sep 16.
Results Reference
background

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Testing of a Tool to Elicit Patient Preferences for CTS

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