Decision Aid in Chronic Total Occlusion (CTO) Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronary Occlusion

Intervention / Treatment
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* Other: decision aid


Participation Criteria
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Eligibility Criteria
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Patient: Inclusion Criteria: At least one lesion occluding the coronary artery detected by angiography or MSCTA. left ventricular ejection fraction ≥ 40% on transthoracic echocardiography measurement. No major barriers to provide written consent. Exclusion Criteria: 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. Patients with cognitive impairment, severe hearing loss, or visual impairment who could not complete the survey. Cardiologist: Inclusion Criteria: Doctors who work in the department of Cardiology for more than 1 years. No major barriers to provide written consent. Exclusion Criteria: None.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>Patients in this group will receive CTO Choice (decision aid). | Other: decision aid<br>* The related information about CTO and PCI procedures will be told to the patients thoroughly.<br>|
| No Intervention: control group<br>Patients in this group will receive usual primary care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient knowledge regarding CTO of PCI or medication (risk and benefit) |  | within the first 3 days after survey | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of the decision making process for both the study subjects |  | within the first 3 days after survey | 
| subjects acceptability with the decision aid |  | within the first 3 days after survey | 
| rate of PCI or medication |  | within the first 3 days after survey | 
| ability to recruit participants |  | within the first 3 days after survey | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic total occlusion, decision aid