Measuring and Displaying the Subjective

NCT ID: NCT06490224

Last Updated: 2024-07-08

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

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-19

Study Completion Date

2024-04-06

Brief Summary

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The investigators developed a brief set of subjective health measures designed to feel more relevant to patients seeking musculoskeletal specialty care, presented the scores to patients and clinicians using an easy-to-understand visual display, and measured whether or not this process harmed patient experience.

Detailed Description

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Musculoskeletal patient-reported outcome measures (PROMs; measures of levels of discomfort and incapability) were originally designed as tools for clinical research as were other self-reported measures of the subjective aspects of illness such as mental health measures. PROMs and mental health measures are increasingly used in clinical practice with individual patients. A few areas for improvement are noted in the use of questionnaires in musculoskeletal specialty care, including relevancy, understandability, and their confusing use in heath strategies. The investigators sought to assess the impact of an enhanced and more personalized self-reported health measurement strategy to address some of these opportunities by developing a brief set of items addressing levels of discomfort, incapability, mental, and social health designed to feel relevant to musculoskeletal specialty care and resulting in an easy-to-understand display that can be a communication tool for patients and clinicians.

Conditions

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Physician-Patient Relations Communication Research

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

Usual patient reported outcome measures

Group Type PLACEBO_COMPARATOR

Relevant Patient Reported Outcome Measures (PROMs)

Intervention Type BEHAVIORAL

Depending on the participant's complaint: Hip disability and osteoarthritis outcome score JR (HOOS JR), Knee disability and osteoarthritis outcome score JR (KOOS JR), Quick Disabilities of the Arm, Shoulder, and Hand, Quick Disabilities of the Arm, Shoulder, and Hand (QUICKDASH), Patient Health Questionnaire 9 (PHQ-9), General Anxiety Disorder-7 (GAD7), Patient Self-Efficacy Questionnaire (PSEQ-2), Patient-Reported Outcomes Measurement Information System (PROMIS Global 10)

Experimental

Usual patient reported outcome measures + new visual display of responses to subjective health questions

Group Type EXPERIMENTAL

Relevant Patient Reported Outcome Measures (PROMs)

Intervention Type BEHAVIORAL

Depending on the participant's complaint: Hip disability and osteoarthritis outcome score JR (HOOS JR), Knee disability and osteoarthritis outcome score JR (KOOS JR), Quick Disabilities of the Arm, Shoulder, and Hand, Quick Disabilities of the Arm, Shoulder, and Hand (QUICKDASH), Patient Health Questionnaire 9 (PHQ-9), General Anxiety Disorder-7 (GAD7), Patient Self-Efficacy Questionnaire (PSEQ-2), Patient-Reported Outcomes Measurement Information System (PROMIS Global 10)

My Whole Health Map

Intervention Type OTHER

Short visual map of responses to 10 questions of subjective measures.

Interventions

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Relevant Patient Reported Outcome Measures (PROMs)

Depending on the participant's complaint: Hip disability and osteoarthritis outcome score JR (HOOS JR), Knee disability and osteoarthritis outcome score JR (KOOS JR), Quick Disabilities of the Arm, Shoulder, and Hand, Quick Disabilities of the Arm, Shoulder, and Hand (QUICKDASH), Patient Health Questionnaire 9 (PHQ-9), General Anxiety Disorder-7 (GAD7), Patient Self-Efficacy Questionnaire (PSEQ-2), Patient-Reported Outcomes Measurement Information System (PROMIS Global 10)

Intervention Type BEHAVIORAL

My Whole Health Map

Short visual map of responses to 10 questions of subjective measures.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All new and return patients
* English and Spanish speakers

Exclusion Criteria

* Cognitive deficiency precluding PROM completion
* Language other than English or Spanish
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Texas at Austin

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prakash Jayakumar, MD. PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Locations

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University of Texas at Austin

Austin, Texas, United States

Site Status

Countries

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United States

References

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Neil W. Wagle MM (2017) Implementing Patient-Reported Outcome Measures. NEJM Catal

Reference Type BACKGROUND

Elwyn G, Barr PJ, Grande SW, Thompson R, Walsh T, Ozanne EM. Developing CollaboRATE: a fast and frugal patient-reported measure of shared decision making in clinical encounters. Patient Educ Couns. 2013 Oct;93(1):102-7. doi: 10.1016/j.pec.2013.05.009. Epub 2013 Jun 12.

Reference Type BACKGROUND
PMID: 23768763 (View on PubMed)

Amini M, Oemrawsingh A, Verweij LM, Lingsma HF, Hazelzet JA, Eijkenaar F, van Leeuwen N. Facilitators and barriers for implementing patient-reported outcome measures in clinical care: An academic center's initial experience. Health Policy. 2021 Sep;125(9):1247-1255. doi: 10.1016/j.healthpol.2021.07.001. Epub 2021 Jul 8.

Reference Type BACKGROUND
PMID: 34311981 (View on PubMed)

Other Identifiers

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PROM Prototyping

Identifier Type: -

Identifier Source: org_study_id

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