Measuring and Displaying the Subjective

Can the Subjective Aspects of Health be Measured and Visually Displayed Without Harming Patient Experience: A Randomized Control Trial

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.

Study Overview

• Status: Completed
• Conditions: Communication Research; Physician-Patient Relations
• Intervention / Treatment: Behavioral: Relevant Patient Reported Outcome Measures (PROMs); Other: My Whole Health Map

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78701
      • University of Texas at Austin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• All new and return patients
• English and Spanish speakers

Exclusion Criteria:

• Cognitive deficiency precluding PROM completion
• Language other than English or Spanish

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; Usual patient reported outcome measures	Behavioral: 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)
Experimental: Experimental; Usual patient reported outcome measures + new visual display of responses to subjective health questions	Behavioral: 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); Other: My Whole Health Map; Short visual map of responses to 10 questions of subjective measures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CollaboRATE survey	Quality of shared decision-making (Numerical scale from 1-27; Higher scores equal better outcome)	Immediately after the intervention
Jefferson Scale Patient Perceptions of Physician Empathy (JSPPPE)	Patient perceived clinician empathy (Numerical scale from 1-35; Higher scores equal better outcome)	Immediately after the intervention

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Investigators: Principal Investigator: Prakash Jayakumar, MD. PhD, University of Texas at Austin

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2023
• Primary Completion (Actual): February 27, 2024
• Study Completion (Actual): April 6, 2024

Study Registration Dates

• First Submitted: June 25, 2024
• First Submitted That Met QC Criteria: June 28, 2024
• First Posted (Actual): July 8, 2024

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: PROM Prototyping

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No