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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04988009
Other study ID # 2020-0493
Secondary ID NCI-2020-0749320
Status Recruiting
Phase
First received
Last updated
Start date August 20, 2020
Est. completion date December 31, 2026

Study information

Verified date March 2024
Source M.D. Anderson Cancer Center
Contact Barbara J O'Brien, MD
Phone 713-794-4380
Email bjobrien@mdanderson.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study evaluates patient perceptions around quality of care through telemedicine in neuro-oncology. Studying questionnaires related to perceptions quality of care through telemedicine in patients with brain cancer may help doctors to improve the delivery of care through this modality.


Description:

PRIMARY OBJECTIVE: I. To evaluate the patient-perceived quality of care by group (telemedicine versus in-person visits) in patients with central nervous system (CNS) cancer. SECONDARY OBJECTIVES: I. To characterize the visits provided by telemedicine compared to those in-person. II. To contrast the average time spent on telemedicine visits compared to in-person visits, and the delay between visit order placement and visit occurring. III. To evaluate the domains of patient care addressed on a telemedicine visit versus in-person visit per documentation, including (1) treatment planning, (2) symptom burden, (3) goals of care. IV. To evaluate frequency of acute care sought (through emergency room or urgent care clinic) within 30 days of encounter in telemedicine visit versus (vs) in-person visit. V. The impact of patient and clinical characteristics on perceived quality of care in the context of covariate-adjusted modeling. OUTLINE: Patients complete a survey related to their perceived quality of care via telephone and have their medical chart reviewed prospectively.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with a CNS tumors: this includes patients with primary brain tumors, brain metastases, and leptomeningeal disease - Established patients with a follow up encounter with Neuro-Oncology at the Brain and Spine Center at the University of Texas MD Anderson Cancer Center; this encounter can be - An in-person visit - A telemedicine appointment Exclusion Criteria: - Encounter occurred with the assistance of official language translation support - Patients with telephone encounters (without interactive video) - New patient or consult visits - Neither patient nor caregiver present during the visit are available or able to answer survey questions

Study Design


Intervention

Other:
Electronic Health Record Review
Review of medical chart
Survey Administration
Complete survey

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 Survey response to question 6 of the quality of care survey ("I felt I received good medical care during this encounter") Survey responses will be summarized by ordinal category as counts with percentages, separately by group. Will separately estimate the proportion of each ordinal level of each group with 95% confidence interval. through study completion, an average of 1 year
Secondary Quality of Care Survey Will separately estimate the proportion of each ordinal level of each group with 95% confidence interval. through study completion, an average of 1 year
Secondary Patients and clinical characteristics Differences between groups will be assessed by 2-sample 2-sided t-test and Mann-Whitney test, Fisher's exact test, or chi-square test. Baseline
Secondary Interactive time spent during visit Will be summarized by group per mean, median, standard deviation, and range. Differences between groups will be assessed by t-test and Mann-Whitney test. through study completion, an average of 1 year
Secondary Time from visit order placement to visit occurring Will be summarized by group per mean, median, standard deviation, and range. Differences between groups will be assessed by t-test and Mann-Whitney test. through study completion, an average of 1 year
Secondary Domains of patient care addressed during a visit, including treatment planning, symptom burden, and goals of care Will be summarized as counts with percentages by group. Differences between groups will be assessed by chi-square test. through study completion, an average of 1 year
Secondary Incidence of acute care sought (through emergency room or urgent care clinic) Will be summarized as counts with percentages by group. Differences between groups will be provisionally assessed by Fisher's exact test. Within 30 days of encounter
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