Telemedicine in Cardiac Surgery: A Pilot Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01163474
First received: July 14, 2010
Last updated: September 30, 2014
Last verified: September 2014

July 14, 2010
September 30, 2014
October 2010
June 2011   (final data collection date for primary outcome measure)
Accuracy (FTF decision on patient disposition vs. V-visit decision on patient disposition) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Accuracy [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01163474 on ClinicalTrials.gov Archive Site
  • Acceptability [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Feasibility [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Telemedicine in Cardiac Surgery: A Pilot Study
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.

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.

Interventional
Phase 0
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Coronary Artery Disease
Procedure: Evaluative process
Evaluative process using video conferencing
  • Experimental: Arm 1
    This arm will include the virtual visit clinic follow up for subjects
    Intervention: Procedure: Evaluative process
  • No Intervention: Arm 2
    This arm will include face-to-face follow up for subjects (control)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
September 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01163474
PPO 10-060
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Danny Chu, MD Michael E DeBakey VA Medical Center
Department of Veterans Affairs
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP