Telemedicine in Cardiac Surgery: A Pilot Study

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01163474
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Duration (Months): 11
• Patients Per Site Per Month: 3.6

Study Details

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.

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

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• 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
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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 Names: video teleconference visit

Outcome Measures

Primary Outcome Measures

1. Accuracy (FTF Decision on Patient Disposition vs. V-visit Decision on Patient Disposition) [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

1. Acceptability [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).

2. Feasibility [1 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01163474
• Other Study ID Numbers: PPO 10-060
• First Posted: Jul 15, 2010
• Last Update Posted: Aug 6, 2019
• Last Verified: Jul 1, 2019

• Keywords provided by VA Office of Research and Development: Telemedicine; Surgery, Cardiac
• Additional relevant MeSH terms: Coronary Artery Disease

Study Results

Participant Flow

Recruitment Details	Patients were recruited after coronary artery bypass or cardiac valvular surgery.
Pre-assignment Detail	All participants were assigned to both the intervention (post-surgical evaluation by video-teleconference) and control (face-to-face visit) groups.

Arm/Group Title	Arm 1 - Evaluate Video Clinic Visit Prior to Face-to-Face Usua
Arm/Group Description	Evaluate video clinic visit prior to Face-to-Face usual care visit
Period Title: Overall Study
STARTED	40
COMPLETED	24
NOT COMPLETED	16

Baseline Characteristics

Arm/Group Title	Arm 1 - Evaluate Video Clinic Visit
Arm/Group Description	Evaluate video clinic visit prior to Face-to-Face usual care visit
Overall Participants	24
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64 (8.3)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	24 100%
Race/Ethnicity, Customized (participants) [Number]
White	16 66.7%
African American	4 16.7%
Hispanic	4 16.7%
Region of Enrollment (participants) [Number]
United States	24 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1 - Evaluate Video Conferencing
Arm/Group Description	Evaluate virtual video conference follow-up clinic visit Evaluative process: Evaluative process using video conferencing
Measure Participants	24
Number [percentage of agreement]	89

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1 - Provider Evaluate Video Conferencing
Arm/Group Description	Evaluate virtual video conference follow-up clinic visit Evaluative process: Evaluative process using video conferencing
Measure Participants	23
Mean (Standard Deviation) [units on a scale]	68 (6.7)

3. Secondary Outcome

Title	Feasibility
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

Data for this outcome are no longer available.

Arm/Group Title	Arm 1 - Evaluate Video Clinic Visit Prior to Face-to-Face Usua
Arm/Group Description	Evaluate video clinic visit prior to Face-to-Face usual care visit
Measure Participants	0

Adverse Events

Time Frame	1 year
Arm/Group Title	Arm 1 - Evaluate Video Conferencing		Arm 2
Arm/Group Description	Evaluate virtual video conference follow-up clinic visit Evaluative process: Evaluative process using video conferencing		Face-to-face follow up for subjects (control)
All Cause Mortality
	Arm 1 - Evaluate Video Conferencing		Arm 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm 1 - Evaluate Video Conferencing		Arm 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/24 (0%)
Other (Not Including Serious) Adverse Events
	Arm 1 - Evaluate Video Conferencing		Arm 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/24 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.