Clinical trial NCT01032551: Vascular Access Decision Aid
Official title: Vascular Access Options in Coronary Angiogram Procedures: A Patient Decision Aid Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Atherosclerosis
Keywords: Coronary Angiogram
Decision Aid
Vascular Access
Radial
Femoral
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: McMaster University
name: University of Ottawa
First posted: 2009-12-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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)

Primary outcomes:
measure: 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.
timeFrame: 1 Day
Secondary outcomes:
measure: Improved knowledge and accurate risk perception of the patient's health care option assessed by a pre-discharge questionnaire.
timeFrame: 1 Day
measure: Improved value congruence with the patient's chosen option as assessed by a pre-discharge questionnaire.
timeFrame: 1 Day
measure: Angiographic Success (PCI) as determined by interventionalist performing the procedure.
timeFrame: 1 day
measure: Vascular access success-ability to successfully gain vascular access through the selected site (radial versus femoral).
timeFrame: 1 Day
measure: Procedural time (minutes)
timeFrame: 1 day
measure: Access site Complications (Significant bleeding, hematoma, pseudoaneurysm, or vascular compromise requiring intervention)
timeFrame: 1 day
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences-General Site, Heart Investigation Unit
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Jon-David R Schwalm, BSc, MD
role: PRINCIPAL_INVESTIGATOR
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