Coronary Occlusion
Conditions
Keywords
chronic total occlusion, decision aid
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 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.
Interventions
OTHERdecision aid
The related information about CTO and PCI procedures will be told to the patients thoroughly.
Sponsors
Beijing Anzhen Hospital
First Hospital of China Medical University
Guangdong Provincial People's Hospital
Nanfang Hospital, Southern Medical University
The First Affiliated Hospital of Dalian Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| patient knowledge regarding CTO of PCI or medication (risk and benefit) | within the first 3 days after survey |
Secondary
| Measure | 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 |
Contacts
Primary ContactRongchong Huang, M.D.
Outcome results
None listed