Patient Perceptions of the Relational Empathy of Healthcare Practitioners From the Department of Emergency Medicine During the COVID-19 Pandemic

April 11, 2024 updated by: M.D. Anderson Cancer Center

Patient Perceptions of the Relational Empathy of Healthcare Practitioners From the Department of Emergency Medicine During COVID-19: A Randomized, Controlled Trial Comparing In-Person Interaction With Personal Protective Equipment (PPE) Versus Video Interaction Without PPE

This study investigates patients' perceptions of their doctor's or nurse's empathy during an in-person interaction with the doctor or nurse wearing personal protective equipment (PPE) compared to during a video interaction with the doctor or nurse without PPE. The goal of this research study is to learn whether patients who visit the Acute Cancer Care Center at MD Anderson believe they get better (more empathetic) care from doctors who visit them in person wearing PPE or from doctors who visit them by video call and do not wear PPE.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To determine whether patients perceive their healthcare practitioner as more empathetic during an in-person interaction with the practitioner wearing personal protective equipment (PPE), or during a video interaction without the need for PPE.

SECONDARY OBJECTIVES:

I. To assess whether certain physicians perform better with video whereas others perform better in person.

II. To characterize generational differences in patient perception of healthcare practitioner empathy during an in person interaction with the practitioner wearing PPE, or during a video interaction without the need for PPE.

OUTLINE: After initial visit, patients are randomized to 1 of 2 groups.

GROUP A (NO PPE): Patients receive standard of care via video call with treating physician.

GROUP B (WEARING PPE): Patients receive standard of care in-person physician visits.

Study Type

Observational

Enrollment (Actual)

107

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients in the Department of Emergency Medicine at The University of Texas MD Anderson Cancer Center

Description

Inclusion Criteria:

  • >= 18 years old
  • Able to speak and write in English
  • Able to understand and willing to sign a written informed consent document
  • Willing and able to complete the study assessment(s)

Exclusion Criteria:

  • Refuses to participate
  • Too ill to participate, in the estimation of the patient's physician

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A (video call)
Patients receive standard of care via video call with treating physician.
Other: Questionnaire Administration
Ancillary studies
Procedure: Discussion
Physician conversations occur via video call
Other Names:
  • Discuss
Group B (in-person)
Patients receive standard of care in-person physician visits.
Other: Questionnaire Administration
Ancillary studies
Other: Best Practice
Physician conversations occur in-person
Other Names:
  • standard of care
  • standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients' perceptions of healthcare provider empathy
Time Frame: Through study completion, an average of 1 year
Univariate linear regression analysis will be used to determine the association between the approach (in-person interaction/with personal protective equipment [PPE] versus video interaction/without PPE) and the composite scores or scores for each question (for each of the two tools [the CARE Measure and the linear empathy tool]).
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Kumar Alagappan, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2021

Primary Completion (Estimated)

February 2, 2027

Study Completion (Estimated)

February 2, 2027

Study Registration Dates

First Submitted

October 29, 2021

First Submitted That Met QC Criteria

October 29, 2021

First Posted (Actual)

November 1, 2021

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-1298 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2021-10960 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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