Measuring and Displaying the Subjective

NCT06490224 | Completed

• 1 other identifier: PROM Prototyping
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Physician-Patient Relations; Communication Research

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Control

PLACEBO COMPARATOR

Usual patient reported outcome measures

Behavioral: Relevant Patient Reported Outcome Measures (PROMs)

Experimental

EXPERIMENTAL

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

Behavioral: Relevant Patient Reported Outcome Measures (PROMs); Other: My Whole Health Map

Interventions

Relevant Patient Reported Outcome Measures (PROMs) 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)

Control; Experimental

My Whole Health Map OTHER

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

Experimental

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All new and return patients
• English and Spanish speakers

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78701, United States

Location

Related Publications (3)

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

  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.

  PMID: 23768763 BACKGROUND

• 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.

  PMID: 34311981 BACKGROUND

Study Officials

• Prakash Jayakumar, MD. PhD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 8, 2024
• Study Start: November 19, 2023
• Primary Completion: February 27, 2024
• Study Completion: April 6, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)