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Decision Aid in Chronic Total Occlusion (CTO) Patients

Primary Purpose

Coronary Occlusion

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

decision aid

About this trial

This is an interventional supportive care trial for Coronary Occlusion focused on measuring chronic total occlusion, decision aid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention group

control group

Arm Description

Patients in this group will receive CTO Choice (decision aid).

Patients in this group will receive usual primary care.

Outcomes

Primary Outcome Measures

patient knowledge regarding CTO of PCI or medication (risk and benefit)

Secondary Outcome Measures

quality of the decision making process for both the study subjects

subjects acceptability with the decision aid

rate of PCI or medication

ability to recruit participants

Full Information

NCT ID

NCT02963584

First Posted

October 27, 2016

Last Updated

November 14, 2016

Sponsor

The First Affiliated Hospital of Dalian Medical University

Collaborators

Beijing Anzhen Hospital, First Hospital of China Medical University, Guangdong Provincial People's Hospital, Nanfang Hospital, Southern Medical University

1. Study Identification

Unique Protocol Identification Number

NCT02963584

Brief Title

Decision Aid in Chronic Total Occlusion (CTO) Patients

Official Title

A Pilot Randomized Trial of a Decision Aid in CTO Patients

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Unknown status

Study Start Date

November 2016 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The First Affiliated Hospital of Dalian Medical University

Collaborators

Beijing Anzhen Hospital, First Hospital of China Medical University, Guangdong Provincial People's Hospital, Nanfang Hospital, Southern Medical University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Occlusion

Keywords

chronic total occlusion, decision aid

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

intervention group

Arm Type

Experimental

Arm Description

Patients in this group will receive CTO Choice (decision aid).

Arm Title

control group

Arm Type

No Intervention

Arm Description

Patients in this group will receive usual primary care.

Intervention Type

Other

Intervention Name(s)

decision aid

Intervention Description

The related information about CTO and PCI procedures will be told to the patients thoroughly.

Primary Outcome Measure Information:

Title

patient knowledge regarding CTO of PCI or medication (risk and benefit)

Time Frame