Decision Aid in Chronic Total Occlusion (CTO) Patients

A Pilot Randomized Trial of a Decision Aid in CTO Patients

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Occlusion
• Intervention / Treatment: Other: decision aid

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 Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rongchong Huang, M.D.; Phone Number: 7127 +86 411 83635963; Email: rchuang@dlmedu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Dalian Medical University
• Collaborators: Nanfang Hospital of Southern Medical University; Guangdong Provincial People's Hospital; Beijing Anzhen Hospital; First Hospital of China Medical University

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: October 27, 2016
• First Submitted That Met QC Criteria: November 14, 2016
• First Posted (Estimate): November 15, 2016

Study Record Updates

• Last Update Posted (Estimate): November 15, 2016
• Last Update Submitted That Met QC Criteria: November 14, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: chronic total occlusion; decision aid
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Coronary Occlusion
• Other Study ID Numbers: LCKY2015-22-2