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Telemedicine in Cardiac Surgery: A Pilot Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01163474
First Posted: July 15, 2010
Last Update Posted: April 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease Other: Evaluate video clinic visit prior to Face-to-Face usual care visit Early Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Telemedicine in Cardiac Surgery: A Pilot Study

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).

  • Feasibility [ Time Frame: 1 month ]

Enrollment: 40
Study Start Date: October 2010
Study Completion Date: September 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 - All study participants
Evaluate video clinic visit prior to Face-to-Face usual care visit
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
Other Name: video teleconference visit

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01163474


Locations
United States, Texas
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Danny Chu, MD Michael E. DeBakey VA Medical Center, Houston, TX
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01163474     History of Changes
Other Study ID Numbers: PPO 10-060
First Submitted: July 14, 2010
First Posted: July 15, 2010
Results First Submitted: December 9, 2014
Results First Posted: January 5, 2015
Last Update Posted: April 28, 2015
Last Verified: April 2015

Keywords provided by VA Office of Research and Development:
Telemedicine
Surgery, Cardiac

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases