An interventional study of Vascular Access Decision Aid in Coronary Artery Disease and Atherosclerosis, sponsored by Hamilton Health Sciences Corporation. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-01-19.
Sponsored by Hamilton Health Sciences Corporation · Not applicable and Interventional
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.
5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.
This study's planned enrollment of 100 is below the median of 123 across 3,481 interventional studies indexed under Coronary Artery Disease.
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Exclusion Criteria:
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.
Behavioral: Vascular Access Decision Aid
The control group (those not randomized to the PtDA) will have "usual care". Usual care involves a brief discussion, just prior to the CA procedure, with the treating physician, regarding the patient's eligibility for both vascular accesses, followed by the advantages and disadvantages of both. The details and duration of the discussion is left to the discretion of the treating physician as per their individual standard of care. There will be no access to a formal PtDA in this group.
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.
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.
Time frame: 1 Day
Improved knowledge and accurate risk perception of the patient's health care option assessed by a pre-discharge questionnaire.
Time frame: 1 Day
Improved value congruence with the patient's chosen option as assessed by a pre-discharge questionnaire.
Time frame: 1 Day
Angiographic Success (PCI) as determined by interventionalist performing the procedure.
Impact of patients choosing their vascular access with the help of a PtDA versus usual care as evidenced by various procedural outcomes
Time frame: 1 day
Vascular access success-ability to successfully gain vascular access through the selected site (radial versus femoral).
Impact of patients choosing their vascular access with the help of a PtDA versus usual care as evidenced by procedural outcomes
Time frame: 1 Day
Procedural time (minutes)
Impact of patients choosing their vascular access with the help of a PtDA versus usual care as evidenced by procedural outcomes
Time frame: 1 day
Access site Complications (Significant bleeding, hematoma, pseudoaneurysm, or vascular compromise requiring intervention)
Hematoma, bleeding, thrombosis
Time frame: 1 day
This study is completed, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.
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