Visualizations to Improve Pain Communication Between Patients, Interpreters, and Providers

June 5, 2024 updated by: University of Wisconsin, Madison

Information Visualization to Improve Pain Communication Between Providers, Interpreters, and Patients With Limited English Proficiency

The purpose of this study is to pilot test a pain assessment information visualization (InfoViz) tool to facilitate communication about pain severity, location, and quality to increase mutual understanding between patients with limited English proficiency (LEP), interpreters, and providers during pain assessment. 40 participants will be enrolled and can expect to be on study for up to 4 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to pilot test a pain assessment information visualization (InfoViz) tool to facilitate communication about pain severity, location, and quality to increase mutual understanding between patients with limited English proficiency (LEP), interpreters, and providers during pain assessment.

The investigators focus on the LEP Hmong because pain is particularly problematic for this group. The Hmong describe pain using visual metaphors that are inconsistent with providers' knowledge and interpreters struggle to translate metaphors accurately between patients and providers. The goals of the study are (1) to examine the feasibility of implementing the pain InfoViz tool, (2) to explore congruency of patient-interpreter-provider triads' mutual understanding (MU) of pain severity, location, and quality, and (3) to evaluate outcome measures selected to capture satisfaction with communication, pain relief, and pain interference with life and explore variables identified in the InfoViz tool conceptual framework (MU of pain assessment information, satisfaction with communication, pain diagnosis and treatment).

The investigators will first collect data from 20 participants under the usual care control condition (i.e., interpreters verbally interpreting and communicating pain descriptions), followed by data collection from another 20 participants under the intervention condition (i.e., interpreters using verbal descriptions and the InfoViz tool).

The investigators believe that the pain assessment InfoViz tool will increase mutual understanding of pain severity, location, and quality between patients, interpreters, and providers, and consequently lead to increased satisfaction with communication, greater pain relief and reduced pain interference with daily life through better-informed diagnosis and treatment.

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin
      • Madison, Wisconsin, United States, 53704
        • Access Community Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age 18 and up
  • Hmong patients that indicate they do not speak English well (LEP)
  • self reported pain

Exclusion Criteria:

  • indicate that they speak English well

Interpreter Inclusion Criteria:

  • 13 years old or greater
  • self-identify as interpreting for a Hmong individual in the health care setting

Interpreter Exclusion Criteria:

  • telephone interpreters as they are unable to view and use the InfoViz tool

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care Control
Standard of Care
Experimental: InfoViz Intervention
Pain information visualization (InfoViz) tool, Trained interpreters will use the InfoViz tool twice, before and during the clinical encounter
The pain InfoViz tool is a two-page paper tool that consists of an explanation of how to use the tool in both Hmong and English, a culturally-appropriate Faces pain severity scale, pain body diagram, and 13 pain qualities in the form of icons representing each pain quality metaphor. The interpreter explains the instructions in Hmong, then marks the body areas corresponding to the location of pain reported by the participant, and marks the pain qualities expressed by the metaphors selected by the Hmong patient. In the clinic appointment, the interpreter communicates to the physician, in English, the pain location and qualities identified by the participant, using the medical terms identified on the InfoViz tool.
Other Names:
  • Pain Assessment Tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Eligible Patients Enrolled
Time Frame: up to 1 day
Feasibility with respect to recruitment will be measured by the percent of eligible patients who enroll.
up to 1 day
Proportion of Patients Who Complete the Study
Time Frame: up to 4 weeks
Feasibility with respect to retention will be measured by the proportion of patients who complete the study.
up to 4 weeks
Percentage of InfoViz Tools Completely Filled Out
Time Frame: up to 1 day
Feasibility with respect to tool use will be measured as the proportion of InfoViz tools with pain severity marked, at least one pain location marked, and at least one pain quality marked on the InfoViz tool.
up to 1 day
Percentage of Items Correctly Performed on the Investigator Designed Fidelity Checklist
Time Frame: up to 1 day
Feasibility will be in part measured by InfoViz tool fidelity. The percentage of items correctly performed by participants on the investigator-designed fidelity checklist will be reported.
up to 1 day
Percentage of Congruency in Mutual Understanding: Patient to Interpreter
Time Frame: up to 1 day
One question item from the 6-item Mutual Understanding Scale (MUS) asks participants about their main symptom (i.e., "What was the most important health complaint for which the physician was visited?") and providers to report participants' main symptom (e.g., "What was the most important health complaint for which the patient consulted with you?"). The percentage of congruency between the patient and interpreter response, from 0-100 where 100 is total congruency.
up to 1 day
Percentage of Congruency in Mutual Understanding: Interpreter to Provider
Time Frame: up to 1 day
One question item from the 6-item Mutual Understanding Scale (MUS) asks participants about their main symptom (i.e., "What was the most important health complaint for which the physician was visited?") and providers to report participants' main symptom (e.g., "What was the most important health complaint for which the patient consulted with you?"). The percentage of congruency between the interpreter and provider, from 0-100 where 100 is total congruency.
up to 1 day
Percentage of Congruency in Mutual Understanding: Patient to Provider
Time Frame: up to 1 day
One question item from the 6-item Mutual Understanding Scale (MUS) asks participants about their main symptom (i.e., "What was the most important health complaint for which the physician was visited?") and providers to report participants' main symptom (e.g., "What was the most important health complaint for which the patient consulted with you?"). The percentage of congruency between patient and provider, from 0-100 where 100 is total congruency.
up to 1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant Satisfaction With Communication Answer
Time Frame: up to 1 day
Satisfaction with communication will be measured using one item, "Overall, how satisfied are you with your doctor's communication with you about pain?" with response categories of very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, or very dissatisfied. Mean score between 1-5, where 5 indicate higher satisfaction and 1 indicate very dissatisfaction, was calculated across participant groups (i.e., patient, interpreter, provider).
up to 1 day
Participant Pain Relief Measured Using a 5 Point Verbal Rating Scale
Time Frame: one time post 4-6 weeks after the clinic vist
Participants will be asked to rate the amount of pain relief experienced since the clinic visit using a 5-point Verbal Rating Scale: none, slight, moderate, lots, complete. A mean score between 1-5, where higher scores equal complete pain relief.
one time post 4-6 weeks after the clinic vist
Participant Response to Pain Interference Question
Time Frame: usual care participants assessed at baseline and InfoViz participants assessed at 4 weeks
One question item derived from the 12-Item Short-Form Health Survey, "During the past 4 weeks, how much did pain interfere with your normal work including both work outside the home and housework?" with response options: "not at all," "a little bit," "moderately," "quite a bit," or "extremely." The number of participants who responded to each condition will be reported. Mean score 1-5, where higher score indicates extreme pain interference, was calculated.
usual care participants assessed at baseline and InfoViz participants assessed at 4 weeks
Quality of Communication Answer
Time Frame: up to 1 day
Quality of communication will be measured using one item, "Overall, how would you rate this doctor's communication about pain with you? " with response items of excellent, very good, good, fair, or poor. Mean scores of 1 to 5, where higher number indicates excellent quality of communication, was calculated.
up to 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Maichou Lor, PhD, RN, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2021

Primary Completion (Actual)

January 6, 2023

Study Completion (Actual)

February 23, 2023

Study Registration Dates

First Submitted

July 14, 2021

First Submitted That Met QC Criteria

July 14, 2021

First Posted (Actual)

July 23, 2021

Study Record Updates

Last Update Posted (Actual)

June 7, 2024

Last Update Submitted That Met QC Criteria

June 5, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2020-1256
  • A545000 (Other Identifier: UW Madison)
  • NUR/FACULTY AFFAIRS/ADMIN (Other Identifier: UW Madison)
  • Protocol Approved 10/11/21 (Other Identifier: UW Madison)
  • 1K23NR019289-01A1 (U.S. NIH Grant/Contract)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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