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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

61 participants

Primary outcome timeframe

up to 1 day

Results posted on

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

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

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 day

Feasibility with respect to recruitment will be measured by the percent of eligible patients who enroll.

Outcome measures

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 weeks

Feasibility with respect to retention will be measured by the proportion of patients who complete the study.

Outcome measures

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 day

Population: 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

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 day

Population: 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

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 day

Population: 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

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 day

Population: 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

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 day

Population: 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

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 day

Population: 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

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 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.

Outcome measures

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 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.

Outcome measures

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 day

Population: 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

InfoViz Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: 608-265-4248

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place