Decision Aid in Chronic Total Occlusion (CTO) Patients

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Coronary Occlusion

Clinical Trial Details

NCT number	NCT02963584
Study type	Interventional
Source	The First Affiliated Hospital of Dalian Medical University
Contact	Rongchong Huang, M.D.
Phone	+86 411 83635963
Email	rchuang@dlmedu.edu.cn
Status	Not yet recruiting
Phase	N/A
Start date	November 2016
Completion date	December 2016

View Details

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