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| ID | Type | Description | Link |
|---|---|---|---|
| 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 | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care Control | No Intervention | Standard of Care | |
| InfoViz Intervention | Experimental | Pain information visualization (InfoViz) tool, Trained interpreters will use the InfoViz tool twice, before and during the clinical encounter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InfoViz | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Eligible Patients Enrolled | Feasibility with respect to recruitment will be measured by the percent of eligible patients who enroll. | up to 1 day |
| Proportion of Patients Who Complete the Study | Feasibility with respect to retention will be measured by the proportion of patients who complete the study. | up to 4 weeks |
| 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. | up to 1 day |
| 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. | up to 1 day |
| 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. | up to 1 day |
| Percentage of Congruency in Mutual Understanding: Interpreter to Provider |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
Interpreter Inclusion Criteria:
Interpreter Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maichou Lor, PhD, RN | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Access Community Health Center | Madison | Wisconsin | 53704 | United States | ||
| University of Wisconsin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38175545 | Result | Lor M, Li A, Brown R, Swedlund MP, Hawkins JG, Nolander ET, Chewning B. Improving pain communication between limited English-speaking Hmong patients, medical interpreters, and health care providers in primary care: A pilot study. Res Nurs Health. 2024 Jun;47(3):289-301. doi: 10.1002/nur.22363. Epub 2024 Jan 4. |
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Enrolled participants have an associated participant group, which includes the patient, the interpreter, and the provider.
Participants were enrolled from October 2021 to February 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Use interpreter but no pain information visualization tool used |
| FG001 | 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. |
| FG002 | Interpreters | People able to speak both English and Hmong, part of the participant triad of with Patient, Interpreter, Provider. |
| FG003 | Providers | Providers who completed surveys, part of the participant triad of with Patient, Interpreter, Provider. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Use interpreter but no pain information visualization tool used |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The total mean age reported is for the 36 patients involved in the study and excludes the mean age of interpreters and providers. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Eligible Patients Enrolled | Feasibility with respect to recruitment will be measured by the percent of eligible patients who enroll. | Posted | Count of Participants | Participants | up to 1 day |
|
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adverse were were not monitored/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Use interpreter but no pain information visualization tool used | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maichou Lor, PhD, RN | University of Wisconsin - Madison, School of Nursing | 608-265-4248 | mlor2@wisc.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 18, 2020 | Dec 12, 2023 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 10, 2021 | Dec 12, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003142 | Communication |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
| up to 1 day |
| 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. | up to 1 day |
| up to 1 day |
| 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. | one time post 4-6 weeks after the clinic vist |
| 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. | usual care participants assessed at baseline and InfoViz participants assessed at 4 weeks |
| 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. | up to 1 day |
| Madison |
| Wisconsin |
| 53705 |
| United States |
| BG002 | Interpreters | People who speak English and Hmong, part of the Patient, Interpreter, Provider triad. |
| BG003 | Providers | Providers who returned surveys, part of the Patient, Interpreter, Provider triad. |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
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| 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. | Posted | Count of Participants | Participants | up to 4 weeks |
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| 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. | Enrolled patients have an associated participant group (a triad), which includes the patient, the interpreter, and the provider. | Posted | Number | percentage of InfoViz tool | up to 1 day | InfoViz Tools | InfoViz Tools |
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| 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. | This outcome is informed by the interpreter in the participant triad. | Posted | Mean | Standard Deviation | percent of checklist items | up to 1 day | checklist items | checklist items |
|
|
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| 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. | Enrolled participants have an associated participant group, which includes the patient, the interpreter, and the provider. | Posted | Number | percentage of total congruency | up to 1 day |
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| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | up to 1 day |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | one time post 4-6 weeks after the clinic vist |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | usual care participants assessed at baseline and InfoViz participants assessed at 4 weeks |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | up to 1 day |
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| 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. | Enrolled participants have an associated participant group, which includes the patient, the interpreter, and the provider. | Posted | Number | percentage of total congruency | up to 1 day |
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| 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. | Enrolled participants have an associated participant group, which includes the patient, the interpreter, and the provider. | Posted | Number | percentage of total congruency | up to 1 day |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | InfoViz Intervention | Pain information visualization (InfoViz) tool, Trained interpreters will use the InfoViz tool twice, before and during the clinical encounter | 0 | 0 | 0 | 0 | 0 | 0 |
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| Pain Severity |
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| Interpreter |
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| Provider |
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| Interpreter |
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| Provider |
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| Pain Severity |
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| Pain Severity |
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