Clinical Trial: Decision Aid in Chronic Total Occlusion (CTO) Patients

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Pilot Randomized Trial of a Decision Aid in CTO Patients

Brief Summary: The aim of this study is to assess the feasibility and validity of patient-level randomization (vs. cluster randomization) in pilot trials of decision aid efficacy.

Detailed Summary: This is a parallel, 2-arm, randomized trial to compare an intervention group receiving CTO Choice (decision aid) to a control group receiving usual primary care. 100 patients and 60 cardiologists will be randomize by computer. The investigators will measure the effect of CTO Choice on five outcomes: (a) patient knowledge regarding CTO of PCI or medication (risk and benefit); (b) quality of the decision making process for both the patient and clinician; (c) patient and clinician acceptability and satisfaction with the decision aid; (d) rate of percutaneous coronary intervention (PCI) or medication; and (e) trial processes (e.g., ability to recruit participants, collect patient outcomes). To capture these outcomes, the investigators will use patient and clinician surveys following each visit and video recordings of the clinical encounters. These video recordings will also allow us to determine the extent to which clinicians exposed to the decision aid were able to recreate elements of the decision aid which control patients.
Sponsor: The First Affiliated Hospital of Dalian Medical University

Current Primary Outcome: patient knowledge regarding CTO of PCI or medication (risk and benefit) [ Time Frame: within the first 3 days after survey ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • quality of the decision making process for both the study subjects [ Time Frame: within the first 3 days after survey ]
  • subjects acceptability with the decision aid [ Time Frame: within the first 3 days after survey ]
  • rate of PCI or medication [ Time Frame: within the first 3 days after survey ]
  • ability to recruit participants [ Time Frame: within the first 3 days after survey ]


Original Secondary Outcome: Same as current

Information By: The First Affiliated Hospital of Dalian Medical University

Dates:
Date Received: October 27, 2016
Date Started: November 2016
Date Completion: December 2016
Last Updated: November 14, 2016
Last Verified: October 2016