Trial Outcomes & Findings for Visualizations to Improve Pain Communication Between Patients, Interpreters, and Providers (NCT NCT04975789)
NCT ID: NCT04975789
Last Updated: 2024-06-07
Results Overview
Feasibility with respect to recruitment will be measured by the percent of eligible patients who enroll.
COMPLETED
NA
61 participants
up to 1 day
2024-06-07
Participant Flow
Participants were enrolled from October 2021 to February 2023.
Enrolled participants have an associated participant group, which includes the patient, the interpreter, and the provider.
Participant milestones
| Measure |
Usual Care
Use interpreter but no pain information visualization tool used
|
InfoViz Intervention
Pain information visualization (InfoViz) tool, Trained interpreters will use the InfoViz tool twice, before and during the clinical encounter
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.
|
Interpreters
People able to speak both English and Hmong, part of the participant triad of with Patient, Interpreter, Provider.
|
Providers
Providers who completed surveys, part of the participant triad of with Patient, Interpreter, Provider.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
4
|
21
|
|
Overall Study
Completed Follow Up
|
15
|
13
|
4
|
21
|
|
Overall Study
COMPLETED
|
18
|
18
|
4
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Visualizations to Improve Pain Communication Between Patients, Interpreters, and Providers
Baseline characteristics by cohort
| Measure |
Usual Care
n=18 Participants
Use interpreter but no pain information visualization tool used
|
InfoViz Intervention
n=18 Participants
Pain information visualization (InfoViz) tool, Trained interpreters will use the InfoViz tool twice, before and during the clinical encounter
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.
|
Interpreters
n=4 Participants
People who speak English and Hmong, part of the Patient, Interpreter, Provider triad.
|
Providers
n=21 Participants
Providers who returned surveys, part of the Patient, Interpreter, Provider triad.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 12.43 • n=99 Participants
|
57 years
STANDARD_DEVIATION 11.82 • n=107 Participants
|
36 years
STANDARD_DEVIATION 10.78 • n=206 Participants
|
41.24 years
STANDARD_DEVIATION 11.33 • n=7 Participants
|
56 years
STANDARD_DEVIATION 11.98 • n=31 Participants
|
|
Sex/Gender, Customized
Female
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
45 Participants
n=31 Participants
|
|
Sex/Gender, Customized
Male
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
|
Sex/Gender, Customized
Unknown - Did Not Report
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
60 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
18 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
42 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=99 Participants
|
18 participants
n=107 Participants
|
4 participants
n=206 Participants
|
21 participants
n=7 Participants
|
36 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: up to 1 dayFeasibility with respect to recruitment will be measured by the percent of eligible patients who enroll.
Outcome measures
| Measure |
Usual Care
n=18 Participants
Use interpreter but no pain information visualization tool used
|
InfoViz
n=18 Participants
Pain information visualization (InfoViz) tool, Trained interpreters will use the InfoViz tool twice, before and during the clinical encounter
|
|---|---|---|
|
Percentage of Eligible Patients Enrolled
|
18 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: up to 4 weeksFeasibility with respect to retention will be measured by the proportion of patients who complete the study.
Outcome measures
| Measure |
Usual Care
n=18 Participants
Use interpreter but no pain information visualization tool used
|
InfoViz
n=18 Participants
Pain information visualization (InfoViz) tool, Trained interpreters will use the InfoViz tool twice, before and during the clinical encounter
|
|---|---|---|
|
Proportion of Patients Who Complete the Study
|
18 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: up to 1 dayPopulation: Enrolled patients have an associated participant group (a triad), which includes the patient, the interpreter, and the provider.
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.
Outcome measures
| Measure |
Usual Care
n=18 InfoViz Tools
Use interpreter but no pain information visualization tool used
|
InfoViz
Pain information visualization (InfoViz) tool, Trained interpreters will use the InfoViz tool twice, before and during the clinical encounter
|
|---|---|---|
|
Percentage of InfoViz Tools Completely Filled Out
|
100 percentage of InfoViz tool
|
—
|
PRIMARY outcome
Timeframe: up to 1 dayPopulation: This outcome is informed by the interpreter in the participant triad.
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.
Outcome measures
| Measure |
Usual Care
n=18 checklist items
Use interpreter but no pain information visualization tool used
|
InfoViz
Pain information visualization (InfoViz) tool, Trained interpreters will use the InfoViz tool twice, before and during the clinical encounter
|
|---|---|---|
|
Percentage of Items Correctly Performed on the Investigator Designed Fidelity Checklist
|
83 percent of checklist items
Standard Deviation 10
|
—
|
PRIMARY outcome
Timeframe: up to 1 dayPopulation: Enrolled participants have an associated participant group, which includes the patient, the interpreter, and the provider.
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.
Outcome measures
| Measure |
Usual Care
n=18 Participants
Use interpreter but no pain information visualization tool used
|
InfoViz
n=18 Participants
Pain information visualization (InfoViz) tool, Trained interpreters will use the InfoViz tool twice, before and during the clinical encounter
|
|---|---|---|
|
Percentage of Congruency in Mutual Understanding: Patient to Interpreter
Pain Location
|
20 percentage of total congruency
|
22 percentage of total congruency
|
|
Percentage of Congruency in Mutual Understanding: Patient to Interpreter
Pain Quality
|
20 percentage of total congruency
|
11 percentage of total congruency
|
|
Percentage of Congruency in Mutual Understanding: Patient to Interpreter
Pain Severity
|
30 percentage of total congruency
|
28 percentage of total congruency
|
PRIMARY outcome
Timeframe: up to 1 dayPopulation: Enrolled participants have an associated participant group, which includes the patient, the interpreter, and the provider.
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.
Outcome measures
| Measure |
Usual Care
n=18 Participants
Use interpreter but no pain information visualization tool used
|
InfoViz
n=18 Participants
Pain information visualization (InfoViz) tool, Trained interpreters will use the InfoViz tool twice, before and during the clinical encounter
|
|---|---|---|
|
Percentage of Congruency in Mutual Understanding: Interpreter to Provider
Pain Location
|
90 percentage of total congruency
|
56 percentage of total congruency
|
|
Percentage of Congruency in Mutual Understanding: Interpreter to Provider
Pain Quality
|
30 percentage of total congruency
|
39 percentage of total congruency
|
|
Percentage of Congruency in Mutual Understanding: Interpreter to Provider
Pain Severity
|
40 percentage of total congruency
|
39 percentage of total congruency
|
PRIMARY outcome
Timeframe: up to 1 dayPopulation: Enrolled participants have an associated participant group, which includes the patient, the interpreter, and the provider.
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.
Outcome measures
| Measure |
Usual Care
n=18 Participants
Use interpreter but no pain information visualization tool used
|
InfoViz
n=18 Participants
Pain information visualization (InfoViz) tool, Trained interpreters will use the InfoViz tool twice, before and during the clinical encounter
|
|---|---|---|
|
Percentage of Congruency in Mutual Understanding: Patient to Provider
Pain Location
|
90 percentage of total congruency
|
72 percentage of total congruency
|
|
Percentage of Congruency in Mutual Understanding: Patient to Provider
Pain Quality
|
50 percentage of total congruency
|
50 percentage of total congruency
|
|
Percentage of Congruency in Mutual Understanding: Patient to Provider
Pain Severity
|
20 percentage of total congruency
|
50 percentage of total congruency
|
SECONDARY outcome
Timeframe: up to 1 dayPopulation: Enrolled participants have an associated participant group, which includes the patient, the interpreter, and the provider (18 participant triads). Each group member are surveyed for satisfaction.
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).
Outcome measures
| Measure |
Usual Care
n=38 Participants
Use interpreter but no pain information visualization tool used
|
InfoViz
n=37 Participants
Pain information visualization (InfoViz) tool, Trained interpreters will use the InfoViz tool twice, before and during the clinical encounter
|
|---|---|---|
|
Participant Satisfaction With Communication Answer
Patient
|
3.21 score on a scale
Standard Deviation 0.78
|
3.44 score on a scale
Standard Deviation 0.61
|
|
Participant Satisfaction With Communication Answer
Interpreter
|
4.33 score on a scale
Standard Deviation 0.59
|
4.55 score on a scale
Standard Deviation 0.51
|
|
Participant Satisfaction With Communication Answer
Provider
|
4.2 score on a scale
Standard Deviation 0.51
|
4.6 score on a scale
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: one time post 4-6 weeks after the clinic vistParticipants 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.
Outcome measures
| Measure |
Usual Care
n=18 Participants
Use interpreter but no pain information visualization tool used
|
InfoViz
n=18 Participants
Pain information visualization (InfoViz) tool, Trained interpreters will use the InfoViz tool twice, before and during the clinical encounter
|
|---|---|---|
|
Participant Pain Relief Measured Using a 5 Point Verbal Rating Scale
|
1.6 score on a scale
Standard Deviation 0.99
|
1.88 score on a scale
Standard Deviation 1.21
|
SECONDARY outcome
Timeframe: usual care participants assessed at baseline and InfoViz participants assessed at 4 weeksOne 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.
Outcome measures
| Measure |
Usual Care
n=18 Participants
Use interpreter but no pain information visualization tool used
|
InfoViz
n=18 Participants
Pain information visualization (InfoViz) tool, Trained interpreters will use the InfoViz tool twice, before and during the clinical encounter
|
|---|---|---|
|
Participant Response to Pain Interference Question
|
1.6 score on a scale
Standard Deviation 0.99
|
1.84 score on a scale
Standard Deviation 1.21
|
SECONDARY outcome
Timeframe: up to 1 dayPopulation: Enrolled participants have an associated participant group, which includes the patient, the interpreter, and the provider (18 participant triads). Each group member are surveyed for satisfaction.
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.
Outcome measures
| Measure |
Usual Care
n=38 Participants
Use interpreter but no pain information visualization tool used
|
InfoViz
n=37 Participants
Pain information visualization (InfoViz) tool, Trained interpreters will use the InfoViz tool twice, before and during the clinical encounter
|
|---|---|---|
|
Quality of Communication Answer
Patient
|
3.68 score on a scale
Standard Deviation 0.58
|
4.11 score on a scale
Standard Deviation 0.67
|
|
Quality of Communication Answer
Interpreter
|
3.50 score on a scale
Standard Deviation 0.85
|
3.61 score on a scale
Standard Deviation 0.97
|
|
Quality of Communication Answer
Provider
|
3.58 score on a scale
Standard Deviation 0.87
|
3.46 score on a scale
Standard Deviation 0.99
|
Adverse Events
Usual Care
InfoViz Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Maichou Lor, PhD, RN
University of Wisconsin - Madison, School of Nursing
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place