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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04975789
Other study ID # 2020-1256
Secondary ID A545000NUR/FACUL
Status Completed
Phase N/A
First received
Last updated
Start date October 7, 2021
Est. completion date February 23, 2023

Study information

Verified date March 2023
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date February 23, 2023
Est. primary completion date January 6, 2023
Accepts healthy volunteers No
Gender All
Age group 13 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
InfoViz
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.

Locations

Country Name City State
United States Access Community Health Center Madison Wisconsin
United States University of Wisconsin Madison Wisconsin

Sponsors (2)

Lead Sponsor Collaborator
University of Wisconsin, Madison National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of Eligible Participants Enrolled Feasibility with respect to recruitment will be measured by the proportion of eligible participant who enroll. up to 1 day
Primary Proportion of Participants Who Complete the Study Feasibility with respect to retention will be measured by the proportion of participants who complete the study. up to 4 weeks
Primary Proportion of InfoViz tools Completely Filled Out 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
Primary Proportion of items correctly performed on the investigator designed fidelity checklist Feasibility will be in part measured by InfoViz tool fidelity. The proportion of items correctly performed on the investigator designed fidelity checklist will be reported. up to 1 day
Primary Percentage of Participants that Experienced Mutual Understanding 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 participants for which their physician reports the same health complaint as they do will be reported. up to 1 day
Secondary Participant Satisfaction with Communication Answer 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 up to 1 day
Secondary Participant Pain Relief Measured Using a 5 point Verbal Rating Scale 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. up to 4 weeks
Secondary Participant Response to Pain Interference Question 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. baseline and 4 weeks
Secondary Quality of Communication Answer 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. up to 1 day
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