NCT04975789

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 23, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

October 7, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2023

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

June 7, 2024

Completed
Last Updated

June 7, 2024

Status Verified

June 1, 2024

Enrollment Period

1.2 years

First QC Date

July 14, 2021

Results QC Date

December 12, 2023

Last Update Submit

June 5, 2024

Conditions

Keywords

pain assessmentlimited English proficiencymutual understanding

Outcome Measures

Primary Outcomes (7)

  • 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

    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

Secondary Outcomes (4)

  • Participant Satisfaction With Communication Answer

    up to 1 day

  • Participant Pain Relief Measured Using a 5 Point Verbal Rating Scale

    one time post 4-6 weeks after the clinic vist

  • Participant Response to Pain Interference Question

    usual care participants assessed at baseline and InfoViz participants assessed at 4 weeks

  • Quality of Communication Answer

    up to 1 day

Study Arms (2)

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

Other: InfoViz

Interventions

InfoVizOTHER

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.

Also known as: Pain Assessment Tool
InfoViz Intervention

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 and up
  • Hmong patients that indicate they do not speak English well (LEP)
  • self reported pain

You may not qualify if:

  • indicate that they speak English well
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Access Community Health Center

Madison, Wisconsin, 53704, United States

Location

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

CommunicationPain

Condition Hierarchy (Ancestors)

BehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Maichou Lor, PhD, RN
Organization
University of Wisconsin - Madison, School of Nursing

Study Officials

  • Maichou Lor, PhD, RN

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2021

First Posted

July 23, 2021

Study Start

October 7, 2021

Primary Completion

January 6, 2023

Study Completion

February 23, 2023

Last Updated

June 7, 2024

Results First Posted

June 7, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations