Telemedicine in Cardiac Surgery: A Pilot Study

Coronary Artery Disease Clinical Trial

Official title:

Telemedicine in Cardiac Surgery: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01163474
• Other study ID #: PPO 10-060
• Status: Completed
• Phase: Early Phase 1
• Start date: October 2010
• Est. completion date: September 2011

Study information

• Verified date: July 2019
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

1. Patients who have undergone aortic dissection/aneurysm operations

2. Patients who have been diagnosed with atrial fibrillation

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• Evaluate video clinic visit prior to Face-to-Face usual care visit
Evaluate video clinic visit prior to Face-to-Face usual care visit

Locations

Country	Name	City	State
United States	Michael E. DeBakey VA Medical Center, Houston, TX	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy (FTF Decision on Patient Disposition vs. V-visit Decision on Patient Disposition)	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	Acceptability	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
Secondary	Feasibility		1 month