NCT02963584

Decision Aid in Chronic Total Occlusion (CTO) Patients

A Pilot Randomized Trial of a Decision Aid in CTO Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: The First Affiliated Hospital of Dalian Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Coronary Occlusion

Interventions

Type	Name	Description
OTHER	decision aid	The related information about CTO and PCI procedures will be told to the patients thoroughly.

Timeline

• Start date: 2016-11-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2016-11-15
• Last updated: 2016-11-15