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NCT05102656 Clinical Trial

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

Malignant Solid Neoplasm Clinical Trial

Official title:
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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05102656
Other study ID # 2020-1298
Secondary ID NCI-2021-1096020
Status Active, not recruiting
Phase
First received
Last updated
Start date June 2, 2021
Est. completion date February 2, 2027

Study information
Verified date April 2024
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 107
Est. completion date February 2, 2027
Est. primary completion date February 2, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Best Practice
Physician conversations occur in-person
Procedure:
• Discussion
Physician conversations occur via video call
Other:
• Questionnaire Administration
Ancillary studies

Locations
Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patients' perceptions of healthcare provider empathy 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
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