- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01163474
Telemedicine in Cardiac Surgery: A Pilot Study
Telemedicine has been widely used in managing patients with neurologic disorders or mental illness. Telemedicine is defined as the use of medical information exchanged from one site to another via electronic communications for the health and education of the patient or healthcare provider and for the purpose of improving patient care. According to our knowledge, it has not been used to manage cardiac patients who need postoperative care after discharge from hospitals.
The use of telemedicine has the potential to reduce the cost of unnecessary travel by assessing the patient's postoperative status prior to making decisions as to whether or not a face-to-face consultation is necessary.
In this pilot study we will compare the accuracy of surgeons' decisions during follow-up visits via video-teleconference (V-Visit) to surgeons' decisions during traditional face-to-face follow-up visits (FTF-Visits). Both the V-Visit and the FTF-Visit will take place at the Houston Michael E DeBakey VA Medical Center on the same day. We will also ask both patients and providers to complete short questionnaires after each V-Visit regarding their acceptability of using telemedicine for these post-operative follow-up visits.
Information collected as part of this pilot study will be used to design a future full randomized controlled trial (RCT) on the use of telemedicine in evaluating post-operative cardiac surgical patients.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The specific aims are:
- To compare surgeons' decisions on patient disposition between V-visits and FTF-visits (gold standard).
- To assess the acceptability to patients and surgeons of using V-visits in the postoperative care of cardiac surgical patients;
- To assess the technical feasibility of using community-based outpatient clinics (CBOCs) for delivery of postoperative cardiac surgical care;
- To determine the recruitment rate for eligible subjects.
We plan to conduct this pilot study at the Michael E. DeBakey Veterans Affairs Medical Center (MEDVAMC) in Houston, Texas, along with satellite CBOC facilities in Lufkin and Conroe. Once the accuracy, acceptability, and feasibility of the use of video conferencing (VC) in the postoperative care for cardiac surgical patients are established, we will submit a full proposal to conduct a two-arm RCT in future.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Michael E. DeBakey VA Medical Center, Houston, TX
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients older than 18 years of age
- Patients who have undergone one of the following cardiac surgical procedures:
Coronary artery bypass grafting (CABG) and/or Cardiac valvular operations
Exclusion Criteria:
- Patients who have undergone aortic dissection/aneurysm operations
- Patients who have been diagnosed with atrial fibrillation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1 - All study participants
Evaluate video clinic visit prior to Face-to-Face usual care visit
|
Evaluate video clinic visit prior to Face-to-Face usual care visit
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy (FTF Decision on Patient Disposition vs. V-visit Decision on Patient Disposition)
Time Frame: 1 month
|
Using CVT software and desktop webcams on the VA private network, "Virtual" CVT visits were conducted immediately prior to usual care of Face-to-Face (FTF) postoperative visits.
Two independent surgeons reviewed the CVT recordings and made recommendations on patient dispositions.
Accuracy was assessed by comparing the 2 reviewers' CVT decisions to the FTF decision.
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability
Time Frame: 1 month
|
Acceptability was assessed using a the Demeris 17-item Likert-scale questionnaire.
Scale from 1 to 5 (1 = strongly disagree; 5 = strongly agree).
|
1 month
|
Feasibility
Time Frame: 1 month
|
1 month
|
Collaborators and Investigators
Investigators
- Principal Investigator: Danny Chu, MD, Michael E. DeBakey VA Medical Center, Houston, TX
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PPO 10-060
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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