Decision Aid in Chronic Total Occlusion (CTO) Patients

Coronary Occlusion Clinical Trial

Official title:

A Pilot Randomized Trial of a Decision Aid in CTO Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02963584
• Other study ID #: LCKY2015-22-2
• Status: Not yet recruiting
• Phase: N/A
• First received: October 27, 2016
• Last updated: November 14, 2016
• Start date: November 2016
• Est. completion date: December 2016

Study information

• Verified date: October 2016
• Source: The First Affiliated Hospital of Dalian Medical University
• Contact: Rongchong Huang, M.D.
• Phone: +86 411 83635963
• Email: rchuang[@]dlmedu.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Coronary Occlusion

Intervention

Other:
• decision aid
The related information about CTO and PCI procedures will be told to the patients thoroughly.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Dalian Medical University	Beijing Anzhen Hospital, First Hospital of China Medical University, Guangdong General Hospital, Nanfang Hospital of Southern Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient knowledge regarding CTO of PCI or medication (risk and benefit)		within the first 3 days after survey	No
Secondary	quality of the decision making process for both the study subjects		within the first 3 days after survey	No
Secondary	subjects acceptability with the decision aid		within the first 3 days after survey	No
Secondary	rate of PCI or medication		within the first 3 days after survey	No
Secondary	ability to recruit participants		within the first 3 days after survey	No