- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04988009
Patient Perceptions Around Quality of Care Through Telemedicine in Neuro-Oncology
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Barbara J O'Brien, MD
- Phone Number: 713-794-4380
- Email: bjobrien@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- M D Anderson Cancer Center
-
Contact:
- Barbara J O'Brien, MD
- Phone Number: 713-794-4380
- Email: bjobrien@mdanderson.org
-
Principal Investigator:
- Barbara J O'Brien, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Observational (survey, medical chart review)
Patients complete a survey related to their perceived quality of care via telephone and have their medical chart reviewed prospectively.
|
Complete survey
Review of medical chart
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survey response to question 6 of the quality of care survey ("I felt I received good medical care during this encounter")
Time Frame: through study completion, an average of 1 year
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Care Survey
Time Frame: through study completion, an average of 1 year
|
Will separately estimate the proportion of each ordinal level of each group with 95% confidence interval.
|
through study completion, an average of 1 year
|
Patients and clinical characteristics
Time Frame: Baseline
|
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
|
Interactive time spent during visit
Time Frame: through study completion, an average of 1 year
|
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
|
Time from visit order placement to visit occurring
Time Frame: through study completion, an average of 1 year
|
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
|
Domains of patient care addressed during a visit, including treatment planning, symptom burden, and goals of care
Time Frame: through study completion, an average of 1 year
|
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
|
Incidence of acute care sought (through emergency room or urgent care clinic)
Time Frame: Within 30 days of encounter
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Barbara J O'Brien, MD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-0493 (Other Identifier: M D Anderson Cancer Center)
- NCI-2020-07493 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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