Decision Aid in Chronic Total Occlusion (CTO) Patients

The First Affiliated Hospital of Dalian Medical University160 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

160

Conditions

Coronary Occlusion

Interventions

decision aidOTHER

The related information about CTO and PCI procedures will be told to the patients thoroughly.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Patient: Inclusion Criteria: 1. At least one lesion occluding the coronary artery detected by angiography or MSCTA. 2. left ventricular ejection fraction ≥ 40% on transthoracic echocardiography measurement. 3. No major barriers to provide written consent. Exclusion Criteria: 1. Severe coexisting conditions, such as severe renal insufficiency (GFR \< 30 ml/min•1.73m2), severe hepatic dysfunction \[elevated glutamic-pyruvic transaminase or glutamic-oxal acetic transaminase level by more than three-fold of the normal limitation\], acute or chronic heart failure (NYHA III-IV), acute infectious diseases, immune disorders, malignancy, etc. 2. Patients with cognitive impairment, severe hearing loss, or visual impairment who could not complete the survey. Cardiologist: Inclusion Criteria: 1. Doctors who work in the department of Cardiology for more than 1 years. 2. No major barriers to provide written consent. Exclusion Criteria: None.