- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04975789
Visualizations to Improve Pain Communication Between Patients, Interpreters, and Providers
Information Visualization to Improve Pain Communication Between Providers, Interpreters, and Patients With Limited English Proficiency
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Wisconsin
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Madison, Wisconsin, United States, 53705
- University of Wisconsin
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Madison, Wisconsin, United States, 53704
- Access Community Health Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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 |
|---|---|
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No Intervention: Usual Care Control
Standard of Care
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Experimental: InfoViz Intervention
Pain information visualization (InfoViz) tool, Trained interpreters will use the InfoViz tool twice, before and during the clinical encounter
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Percentage of Eligible Patients Enrolled
Time Frame: up to 1 day
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Feasibility with respect to recruitment will be measured by the percent of eligible patients who enroll.
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up to 1 day
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Proportion of Patients Who Complete the Study
Time Frame: up to 4 weeks
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Feasibility with respect to retention will be measured by the proportion of patients who complete the study.
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up to 4 weeks
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Percentage of InfoViz Tools Completely Filled Out
Time Frame: up to 1 day
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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.
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up to 1 day
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Percentage of Items Correctly Performed on the Investigator Designed Fidelity Checklist
Time Frame: up to 1 day
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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.
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up to 1 day
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Percentage of Congruency in Mutual Understanding: Patient to Interpreter
Time Frame: up to 1 day
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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.
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up to 1 day
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Percentage of Congruency in Mutual Understanding: Interpreter to Provider
Time Frame: up to 1 day
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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.
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up to 1 day
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Percentage of Congruency in Mutual Understanding: Patient to Provider
Time Frame: up to 1 day
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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.
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up to 1 day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Participant Satisfaction With Communication Answer
Time Frame: up to 1 day
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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).
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up to 1 day
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Participant Pain Relief Measured Using a 5 Point Verbal Rating Scale
Time Frame: one time post 4-6 weeks after the clinic vist
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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.
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one time post 4-6 weeks after the clinic vist
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Participant Response to Pain Interference Question
Time Frame: usual care participants assessed at baseline and InfoViz participants assessed at 4 weeks
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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.
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usual care participants assessed at baseline and InfoViz participants assessed at 4 weeks
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Quality of Communication Answer
Time Frame: up to 1 day
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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.
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up to 1 day
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Maichou Lor, PhD, RN, University of Wisconsin, Madison
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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