Vascular Access Decision Aid (VADAS)

This study has been completed.
Sponsor:
Collaborators:
McMaster University
University of Ottawa
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT01032551
First received: December 9, 2009
Last updated: January 17, 2011
Last verified: December 2009

December 9, 2009
January 17, 2011
June 2010
December 2010   (final data collection date for primary outcome 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. [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01032551 on ClinicalTrials.gov Archive Site
  • Improved knowledge and accurate risk perception of the patient's health care option assessed by a pre-discharge questionnaire. [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
  • Improved value congruence with the patient's chosen option as assessed by a pre-discharge questionnaire. [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
  • Angiographic Success (PCI) as determined by interventionalist performing the procedure. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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). [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
    Impact of patients choosing their vascular access with the help of a PtDA versus usual care as evidenced by procedural outcomes
  • Procedural time (minutes) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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) [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
    Hematoma, bleeding, thrombosis
  • Improved knowledge and accurate risk perception of the patient's health care option. [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
  • Improved value congruence with the patient's chosen option. [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Vascular Access Decision Aid
Vascular Access Options in Coronary Angiogram Procedures: A Patient Decision Aid Randomized Controlled Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
  • Coronary Artery Disease
  • Atherosclerosis
Behavioral: 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.
  • Experimental: Vascular Access Patient 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.
    Intervention: Behavioral: Vascular Access Decision Aid
  • No Intervention: Usual Care
    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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
December 2010
December 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01032551
MU-09-340
No
Jon-David Schwalm, Cardiologist, McMaster University, Hamilton Health Sciences
Hamilton Health Sciences Corporation
  • McMaster University
  • University of Ottawa
Principal Investigator: Jon-David R Schwalm, BSc, MD Hamilton Health Sciences Corporation
McMaster University
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP