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
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Atherosclerosis
Behavioral: Vascular Access Decision Aid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Vascular Access Options in Coronary Angiogram Procedures: A Patient Decision Aid Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 100
Study Start Date: June 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01032551

Locations
Canada, Ontario
Hamilton Health Sciences-General Site, Heart Investigation Unit
Hamilton, Ontario, Canada, L8P 2X2
Sponsors and Collaborators
Hamilton Health Sciences Corporation
McMaster University
University of Ottawa
Investigators
Principal Investigator: Jon-David R Schwalm, BSc, MD Hamilton Health Sciences Corporation
  More Information

Additional Information:
Publications:
Jolly SS, Amlani S, Hamon M et al. Radial versus femoral access for coronary angiography or intervention and the impact on major bleeding and ischemic events: A systematic review and meta-analysis of randomized trials. Am Heart J 2009;157:132-40.
Hamon M, Mehta S, Steg G, et al. Major bleeding in patients with acute coronary syndrome undergoing early invasive management can be reduced by fondaparinux, even in the context of trans-radial coronary intervention: insights from OASIS-5 trial. Circulation 2006; 114(Supplement II):552.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jon-David Schwalm, Cardiologist, McMaster University, Hamilton Health Sciences
ClinicalTrials.gov Identifier: NCT01032551     History of Changes
Other Study ID Numbers: MU-09-340
Study First Received: December 9, 2009
Last Updated: January 17, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
Coronary Angiogram
Decision Aid
Vascular Access
Radial
Femoral

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on August 26, 2014