Decision Aid in Chronic Total Occlusion (CTO) Patients

Not Applicable

• Conditions: Coronary Occlusion
• Interventions: Other: decision aid

• Registration Number: NCT02963584
• Lead Sponsor: The First Affiliated Hospital of Dalian Medical University

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.

Study Timeline

• Status Verified: 2016-10
• Study First Submitted: 2016-10-27
• Study Start: 2016-11
• Study First Submitted QC: 2016-11-14
• Last Update Submitted: 2016-11-14
• Study First Posted: 2016-11-15
• Last Update Posted: 2016-11-15
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	decision aid	Patients in this group will receive CTO Choice (decision aid).

Primary Outcome Measures

Name	Time	Method
patient knowledge regarding CTO of PCI or medication (risk and benefit)	within the first 3 days after survey

Secondary Outcome Measures

Name	Time	Method
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