CommunicationNCT04975789
Visualizations to Improve Pain Communication Between Patients, Interpreters, and Providers
A study testing InfoViz in people with Communication and Pain, run by University of Wisconsin, Madison at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Communication, Pain
- What is being tested?
- InfoViz
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Oct 2021to 23 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age 18 and up
- Hmong patients that indicate they do not speak English well (LEP)
- self reported pain
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Access Community Health Center
Madison, Wisconsin, 53704
University of Wisconsin
Madison, Wisconsin, 53705
About this study
Official title: Information Visualization to Improve Pain Communication Between Providers, Interpreters, and Patients With Limited English Proficiency
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.
Read the 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.
- Conditions
- Communication, Pain
- Being tested
- InfoViz
- Keywords
- pain assessment, limited English proficiency, mutual understanding
- Medical subject headings
- Communication, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfoVizOther
Also called Pain Assessment Tool
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: InfoViz |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Eligible Patients Enrolled
Feasibility with respect to recruitment will be measured by the percent of eligible patients who enroll.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 1 day
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.
Measured: 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.
Measured: up to 1 day
Secondary outcomes (4)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start7 Oct 2021
- Primary completion6 Jan 2023
- Study completion23 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CommunicationStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Maichou Lor, PhD, RN, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975789
- Sponsor's protocol ID
- 2020-1256
- Other IDs
- A545000, NUR/FACULTY AFFAIRS/ADMIN, Protocol Approved 10/11/21, 1K23NR019289-01A1
- Status last verified
- Jun 2024
- First submitted
- 14 Jul 2021
- Last updated
- 7 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38175545
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Information Visualization to Improve Pain Communication Between Providers, Interpreters, and Patients With Limited English Proficiency
- ClinicalTrials.gov ID
- NCT04975789
- Acronym / sponsor ID
- 2020-1256
- Conditions
- Communication, Pain
- Keywords
- pain assessment, limited English proficiency, mutual understanding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 6 Jan 2023 (actual)
- Study completion
- 23 Feb 2023 (actual)
- First posted
- 23 Jul 2021 (actual)
- Results
- Posted 7 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Control | No intervention | –Standard of Care |
| InfoViz Intervention | Experimental | Other: InfoVizPain information visualization (InfoViz) tool, Trained interpreters will use the InfoViz tool twice, before and during the clinical encounter |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- age 18 and up
- Hmong patients that indicate they do not speak English well (LEP)
- self reported pain
Key exclusion criteria (6 listed)
- indicate that they speak English well
- 13 years old or greater
- self-identify as interpreting for a Hmong individual in the health care setting
- telephone interpreters as they are unable to view and use the InfoViz tool
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InfoVizAlso: Pain Assessment ToolThe 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. | Other | InfoViz Intervention |
Primary outcome
Percentage of Eligible Patients Enrolled
Time frame: 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
Time frame: up to 4 weeks
Feasibility with respect to retention will be measured by the proportion of patients who complete the study.
Percentage of InfoViz Tools Completely Filled Out
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 Congruency in Mutual Understanding: Patient to Provider
Time frame: 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.
4 secondary outcomes
Participant Satisfaction With Communication Answer
Time frame: up to 1 day
Participant Pain Relief Measured Using a 5 Point Verbal Rating Scale
Time frame: one time post 4-6 weeks after the clinic vist
Participant Response to Pain Interference Question
Time frame: usual care participants assessed at baseline and InfoViz participants assessed at 4 weeks
Quality of Communication Answer
Time frame: up to 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38175545Lor 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maichou Lor, PhD, RN principal investigator
University of Wisconsin, Madison
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InfoViz in people with Communication and Pain, run by University of Wisconsin, Madison at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Eligible Patients Enrolled (time frame: up to 1 day). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04975789, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.