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Clinical Trials/NCT01032551
NCT01032551
Completed
Not Applicable

Vascular Access Options in Coronary Angiogram Procedures: A Patient Decision Aid Randomized Controlled Trial

Hamilton Health Sciences Corporation1 site in 1 country100 target enrollmentJune 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Hamilton Health Sciences Corporation
Enrollment
100
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2010
End Date
December 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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)
  • Vascular access success-ability to successfully gain vascular access through the selected site (radial versus femoral).(1 Day)
  • Procedural time (minutes)(1 day)
  • Access site Complications (Significant bleeding, hematoma, pseudoaneurysm, or vascular compromise requiring intervention)(1 day)

Study Sites (1)

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