Telemedicine in Cardiac Surgery: A Pilot Study

NCT01163474 | Completed Early Phase 1 Results

• 1 other identifier: PPO 10-060
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Telemedicine; Surgery, Cardiac

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Acceptability

  1 month

• Feasibility

  1 month

Study Arms (1)

Arm 1 - All study participants

EXPERIMENTAL

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

Interventions

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

Also known as: video teleconference visit

Arm 1 - All study participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who have undergone aortic dissection/aneurysm operations
• Patients who have been diagnosed with atrial fibrillation

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Donna Smith/Project Coordinator
• Organization: Houston VA HSR&D

Donna.Smithd19d7@va.gov

(713)440-4423

Study Officials

• Danny Chu, MD

  Michael E. DeBakey VA Medical Center, Houston, TX

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2010
• First Posted: July 15, 2010
• Study Start: October 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: September 1, 2011
• Last Updated: August 6, 2019
• Results First Posted: January 5, 2015

Record last verified: 2019-07

Locations

US (1)