Communication, Pain
Conditions
Keywords
pain assessment, limited English proficiency, mutual understanding
Brief 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.
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.
Interventions
OTHERInfoViz
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.
Sponsors
National Institute of Nursing Research (NINR)
University of Wisconsin, Madison
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Congruency in Mutual Understanding: Patient to Provider | 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. |
| Percentage of InfoViz Tools Completely Filled Out | 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. |
| Percentage of Items Correctly Performed on the Investigator Designed Fidelity Checklist | 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. |
| Percentage of Congruency in Mutual Understanding: Patient to Interpreter | 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. |
| Percentage of Congruency in Mutual Understanding: Interpreter to Provider | 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. |
| Percentage of Eligible Patients Enrolled | up to 1 day | Feasibility with respect to recruitment will be measured by the percent of eligible patients who enroll. |
| Proportion of Patients Who Complete the Study | up to 4 weeks | Feasibility with respect to retention will be measured by the proportion of patients who complete the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Pain Relief Measured Using a 5 Point Verbal Rating Scale | 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. |
| Participant Response to Pain Interference Question | 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. |
| Quality of Communication Answer | 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. |
| Participant Satisfaction With Communication Answer | 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). |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from October 2021 to February 2023.
Pre-assignment details
Enrolled participants have an associated participant group, which includes the patient, the interpreter, and the provider.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Use interpreter but no pain information visualization tool used | 18 |
| 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. | 18 |
| Interpreters People who speak English and Hmong, part of the Patient, Interpreter, Provider triad. | 4 |
| Providers Providers who returned surveys, part of the Patient, Interpreter, Provider triad. | 21 |
| Total | 61 |
Baseline characteristics
| Characteristic | Usual Care | InfoViz Intervention | Interpreters | Providers | Total |
|---|---|---|---|---|---|
| Age, Continuous | 56 years STANDARD_DEVIATION 12.43 | 57 years STANDARD_DEVIATION 11.82 | 36 years STANDARD_DEVIATION 10.78 | 41.24 years STANDARD_DEVIATION 11.33 | 56 years STANDARD_DEVIATION 11.98 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 18 Participants | 4 Participants | 20 Participants | 60 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 18 Participants | 18 Participants | 4 Participants | 2 Participants | 42 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 19 Participants | 19 Participants |
| Region of Enrollment United States | 18 participants | 18 participants | 4 participants | 21 participants | 36 participants |
| Sex/Gender, Customized Female | 14 Participants | 15 Participants | 1 Participants | 15 Participants | 45 Participants |
| Sex/Gender, Customized Male | 4 Participants | 3 Participants | 3 Participants | 5 Participants | 15 Participants |
| Sex/Gender, Customized Unknown - Did Not Report | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Percentage of Congruency in Mutual Understanding: Interpreter to 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.
Time frame: up to 1 day
Population: Enrolled participants have an associated participant group, which includes the patient, the interpreter, and the provider.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usual Care | Percentage of Congruency in Mutual Understanding: Interpreter to Provider | Pain Location | 90 percentage of total congruency |
| Usual Care | Percentage of Congruency in Mutual Understanding: Interpreter to Provider | Pain Quality | 30 percentage of total congruency |
| Usual Care | Percentage of Congruency in Mutual Understanding: Interpreter to Provider | Pain Severity | 40 percentage of total congruency |
| InfoViz | Percentage of Congruency in Mutual Understanding: Interpreter to Provider | Pain Location | 56 percentage of total congruency |
| InfoViz | Percentage of Congruency in Mutual Understanding: Interpreter to Provider | Pain Quality | 39 percentage of total congruency |
| InfoViz | Percentage of Congruency in Mutual Understanding: Interpreter to Provider | Pain Severity | 39 percentage of total congruency |
Primary
Percentage of Congruency in Mutual Understanding: Patient to Interpreter
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.
Time frame: up to 1 day
Population: Enrolled participants have an associated participant group, which includes the patient, the interpreter, and the provider.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usual Care | Percentage of Congruency in Mutual Understanding: Patient to Interpreter | Pain Location | 20 percentage of total congruency |
| Usual Care | Percentage of Congruency in Mutual Understanding: Patient to Interpreter | Pain Quality | 20 percentage of total congruency |
| Usual Care | Percentage of Congruency in Mutual Understanding: Patient to Interpreter | Pain Severity | 30 percentage of total congruency |
| InfoViz | Percentage of Congruency in Mutual Understanding: Patient to Interpreter | Pain Location | 22 percentage of total congruency |
| InfoViz | Percentage of Congruency in Mutual Understanding: Patient to Interpreter | Pain Quality | 11 percentage of total congruency |
| InfoViz | Percentage of Congruency in Mutual Understanding: Patient to Interpreter | Pain Severity | 28 percentage of total congruency |
Primary
Percentage of Congruency in Mutual Understanding: Patient to 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.
Time frame: up to 1 day
Population: Enrolled participants have an associated participant group, which includes the patient, the interpreter, and the provider.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usual Care | Percentage of Congruency in Mutual Understanding: Patient to Provider | Pain Location | 90 percentage of total congruency |
| Usual Care | Percentage of Congruency in Mutual Understanding: Patient to Provider | Pain Quality | 50 percentage of total congruency |
| Usual Care | Percentage of Congruency in Mutual Understanding: Patient to Provider | Pain Severity | 20 percentage of total congruency |
| InfoViz | Percentage of Congruency in Mutual Understanding: Patient to Provider | Pain Location | 72 percentage of total congruency |
| InfoViz | Percentage of Congruency in Mutual Understanding: Patient to Provider | Pain Quality | 50 percentage of total congruency |
| InfoViz | Percentage of Congruency in Mutual Understanding: Patient to Provider | Pain Severity | 50 percentage of total congruency |
Primary
Percentage of Eligible Patients Enrolled
Feasibility with respect to recruitment will be measured by the percent of eligible patients who enroll.
Time frame: up to 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Percentage of Eligible Patients Enrolled | 18 Participants |
| InfoViz | Percentage of Eligible Patients Enrolled | 18 Participants |
Primary
Percentage 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.
Time frame: up to 1 day
Population: Enrolled patients have an associated participant group (a triad), which includes the patient, the interpreter, and the provider.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Percentage of InfoViz Tools Completely Filled Out | 100 percentage of InfoViz tool |
Primary
Percentage of Items Correctly Performed on the Investigator Designed Fidelity Checklist
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.
Time frame: up to 1 day
Population: This outcome is informed by the interpreter in the participant triad.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Percentage of Items Correctly Performed on the Investigator Designed Fidelity Checklist | 83 percent of checklist items | Standard Deviation 10 |
Primary
Proportion of Patients Who Complete the Study
Feasibility with respect to retention will be measured by the proportion of patients who complete the study.
Time frame: up to 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Proportion of Patients Who Complete the Study | 18 Participants |
| InfoViz | Proportion of Patients Who Complete the Study | 18 Participants |
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. A mean score between 1-5, where higher scores equal complete pain relief.
Time frame: one time post 4-6 weeks after the clinic vist
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Participant Pain Relief Measured Using a 5 Point Verbal Rating Scale | 1.6 score on a scale | Standard Deviation 0.99 |
| InfoViz | Participant Pain Relief Measured Using a 5 Point Verbal Rating Scale | 1.88 score on a scale | Standard Deviation 1.21 |
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. Mean score 1-5, where higher score indicates extreme pain interference, was calculated.
Time frame: usual care participants assessed at baseline and InfoViz participants assessed at 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Participant Response to Pain Interference Question | 1.6 score on a scale | Standard Deviation 0.99 |
| InfoViz | Participant Response to Pain Interference Question | 1.84 score on a scale | Standard Deviation 1.21 |
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. 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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Participant Satisfaction With Communication Answer | Interpreter | 4.33 score on a scale | Standard Deviation 0.59 |
| Usual Care | Participant Satisfaction With Communication Answer | Patient | 3.21 score on a scale | Standard Deviation 0.78 |
| Usual Care | Participant Satisfaction With Communication Answer | Provider | 4.2 score on a scale | Standard Deviation 0.51 |
| InfoViz | Participant Satisfaction With Communication Answer | Patient | 3.44 score on a scale | Standard Deviation 0.61 |
| InfoViz | Participant Satisfaction With Communication Answer | Interpreter | 4.55 score on a scale | Standard Deviation 0.51 |
| InfoViz | Participant Satisfaction With Communication Answer | Provider | 4.6 score on a scale | Standard Deviation 0.63 |
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. Mean scores of 1 to 5, where higher number indicates excellent quality of communication, was calculated.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Quality of Communication Answer | Patient | 3.68 score on a scale | Standard Deviation 0.58 |
| Usual Care | Quality of Communication Answer | Interpreter | 3.50 score on a scale | Standard Deviation 0.85 |
| Usual Care | Quality of Communication Answer | Provider | 3.58 score on a scale | Standard Deviation 0.87 |
| InfoViz | Quality of Communication Answer | Patient | 4.11 score on a scale | Standard Deviation 0.67 |
| InfoViz | Quality of Communication Answer | Interpreter | 3.61 score on a scale | Standard Deviation 0.97 |
| InfoViz | Quality of Communication Answer | Provider | 3.46 score on a scale | Standard Deviation 0.99 |