Vascular Access Decision Aid

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Atherosclerosis
• Interventions: Behavioral: Vascular Access Decision Aid

• Registration Number: NCT01032551
• Lead Sponsor: Hamilton Health Sciences Corporation

Brief Summary

Coronary angiogram (CA) procedures, with and without angioplasty, can be performed via vascular access in the wrist (radial artery) or leg (femoral artery). Both radial and femoral artery vascular access have their advantages and disadvantages, but neither has yet been proven to have superior health outcomes. Often patients are eligible for both access sites but are not well informed regarding the potential advantages and disadvantages of each site. Vascular access in cardiac catheterization can be considered a "grey zone", where the benefits and harms may have different levels of significance depending on the individual's preferences and values. For example, patients with significant back pain may not prefer the femoral approach as it requires the patient to lie flay for an extended period of time compared to the radial approach.

For "grey zone" health care options, Patient Decision Aids (PtDA) have been demonstrated to improve the quality of decision making by significantly improving knowledge of the patient's health care options, improving the patient's accurate risk perception, and improving value congruence with the chosen options.

The investigators propose a randomized controlled trial (RCT) to evaluate the decision quality impact of a vascular access PtDA compared to "usual care" in eligible patient's undergoing elective CA procedures. If the PtDA is demonstrated to positively impact the decision quality of patients prior to CA procedures, it would be an invaluable bedside tool to promote patient informed medical decision making.

Hypothesis:

The investigators believe that a PtDA, when compared to usual care, will positively impact the decision quality and the process of decision making, relating to vascular access options in eligible patients undergoing elective CA procedures.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-12
• Study First Submitted: 2009-12-09
• Study First Submitted QC: 2009-12-12
• Study First Posted: 2009-12-15
• Study Start: 2010-06
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Last Update Submitted: 2011-01-17
• Last Update Posted: 2011-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• age > 18 years old
• English speaking
• able to provide informed consent
• is able to read the English language (however, if a patient is not able to read due to visual impairment, they may still be considered for enrollment if a family member is present to read and relay the content of the PtDA)
• candidates for both femoral and radial access as defined by the pre-assessment checklist and subsequently approved by their treating physician

Exclusion Criteria

• any patients not meeting the inclusion criteria
• the interventional cardiologist performing the procedure does not feel comfortable or believes the patient is ineligible for either access (may include reason's not specifically outlined in the pre-assessment checklist)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vascular Access Patient Decision Aid	Vascular Access Decision Aid	The intervention group will receive a PtDA addressing vascular access for CA procedures. The PtDA is a brief lay summary that outlines, the purpose of the PtDA, a description of both femoral and radial approaches for CA procedures, what to expect from both approaches, the known risks/benefits of each access site (including a grading of the evidence), and a short assessment of the patients values. The values assessment is included in the PtDA as a means to help guide the patient through the decision making process. This section will ask the patient to explicitly state which features, risks, and benefits of each approach are important to them.

Primary Outcome Measures

Name	Time	Method
The primary outcome involves evaluation of the decision process leading to decision quality as assessed by the Decisional Conflict Scale (DCS). The DCS is a validated scale that has been used in more than 30 PtDA studies across different decisions.	1 Day

Secondary Outcome Measures

Name	Time	Method
Improved knowledge and accurate risk perception of the patient's health care option assessed by a pre-discharge questionnaire.	1 Day
Improved value congruence with the patient's chosen option as assessed by a pre-discharge questionnaire.	1 Day
Angiographic Success (PCI) as determined by interventionalist performing the procedure.	1 day	Impact of patients choosing their vascular access with the help of a PtDA versus usual care as evidenced by various procedural outcomes
Vascular access success-ability to successfully gain vascular access through the selected site (radial versus femoral).	1 Day	Impact of patients choosing their vascular access with the help of a PtDA versus usual care as evidenced by procedural outcomes
Procedural time (minutes)	1 day	Impact of patients choosing their vascular access with the help of a PtDA versus usual care as evidenced by procedural outcomes
Access site Complications (Significant bleeding, hematoma, pseudoaneurysm, or vascular compromise requiring intervention)	1 day	Hematoma, bleeding, thrombosis

Trial Locations

Locations (1)

Hamilton Health Sciences-General Site, Heart Investigation Unit; 🇨🇦 Hamilton, Ontario, Canada