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Telemedicine in Cardiac Surgery: A Pilot Study

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Evaluate video clinic visit prior to Face-to-Face usual care visit
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Coronary Artery Disease focused on measuring Telemedicine, Surgery, Cardiac

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Michael E. DeBakey VA Medical Center, Houston, TX

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1 - All study participants

Arm Description

Evaluate video clinic visit prior to Face-to-Face usual care visit

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Acceptability
Acceptability was assessed using a the Demeris 17-item Likert-scale questionnaire. Scale from 1 to 5 (1 = strongly disagree; 5 = strongly agree).
Feasibility

Full Information

First Posted
July 14, 2010
Last Updated
July 26, 2019
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01163474
Brief Title
Telemedicine in Cardiac Surgery: A Pilot Study
Official Title
Telemedicine in Cardiac Surgery: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Telemedicine, Surgery, Cardiac

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 - All study participants
Arm Type
Experimental
Arm Description
Evaluate video clinic visit prior to Face-to-Face usual care visit
Intervention Type
Other
Intervention Name(s)
Evaluate video clinic visit prior to Face-to-Face usual care visit
Other Intervention Name(s)
video teleconference visit
Intervention Description
Evaluate video clinic visit prior to Face-to-Face usual care visit
Primary Outcome Measure Information:
Title
Accuracy (FTF Decision on Patient Disposition vs. V-visit Decision on Patient Disposition)
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Acceptability
Description
Acceptability was assessed using a the Demeris 17-item Likert-scale questionnaire. Scale from 1 to 5 (1 = strongly disagree; 5 = strongly agree).
Time Frame
1 month
Title
Feasibility
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danny Chu, MD
Organizational Affiliation
Michael E. DeBakey VA Medical Center, Houston, TX
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael E. DeBakey VA Medical Center, Houston, TX
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Telemedicine in Cardiac Surgery: A Pilot Study

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