Telemedicine in Cardiac Surgery: A Pilot Study

Early Phase 1

Completed

• Conditions: Coronary Artery Disease
• Interventions: Other: Evaluate video clinic visit prior to Face-to-Face usual care visit

• Registration Number: NCT01163474
• Lead Sponsor: VA Office of Research and Development

Brief Summary

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.

Detailed Description

The specific aims are:

1. To compare surgeons' decisions on patient disposition between V-visits and FTF-visits (gold standard).

2. To assess the acceptability to patients and surgeons of using V-visits in the postoperative care of cardiac surgical patients;

3. To assess the technical feasibility of using community-based outpatient clinics (CBOCs) for delivery of postoperative cardiac surgical care;

4. 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-07-14
• Study First Submitted QC: 2010-07-14
• Study First Posted: 2010-07-15
• Study Start: 2010-10
• Primary Completion: 2011-06
• Study Completion: 2011-09
• Results First Submitted: 2014-12-09
• Results First Submitted QC: 2014-12-18
• Results First Posted: 2015-01-05
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-26
• Last Update Posted: 2019-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patients older than 18 years of age
2. Patients who have undergone one of the following cardiac surgical procedures:

Coronary artery bypass grafting (CABG) and/or Cardiac valvular operations

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Exclusion Criteria

1. Patients who have undergone aortic dissection/aneurysm operations
2. Patients who have been diagnosed with atrial fibrillation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
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

Primary Outcome Measures

Name	Time	Method
Accuracy (FTF Decision on Patient Disposition vs. V-visit Decision on Patient Disposition)	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.

Secondary Outcome Measures

Name	Time	Method
Acceptability	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).
Feasibility	1 month

Trial Locations

Locations (1)

Michael E. DeBakey VA Medical Center, Houston, TX; 🇺🇸 Houston, Texas, United States