Clinical trial NCT02963584: Decision Aid in Chronic Total Occlusion (CTO) Patients
Official title: A Pilot Randomized Trial of a Decision Aid in CTO Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Occlusion
Keywords: chronic total occlusion
decision aid
Lead sponsor: The First Affiliated Hospital of Dalian Medical University
Sponsor class: OTHER
Collaborators: name: Beijing Anzhen Hospital
name: First Hospital of China Medical University
name: Guangdong Provincial People's Hospital
name: Nanfang Hospital, Southern Medical University
First posted: 2016-11-15
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Exclusion Criteria:

None.

Primary outcomes:
measure: patient knowledge regarding CTO of PCI or medication (risk and benefit)
timeFrame: within the first 3 days after survey
Secondary outcomes:
measure: quality of the decision making process for both the study subjects
timeFrame: within the first 3 days after survey
measure: subjects acceptability with the decision aid
timeFrame: within the first 3 days after survey
measure: rate of PCI or medication
timeFrame: within the first 3 days after survey
measure: ability to recruit participants
timeFrame: within the first 3 days after survey
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital of Dalian Medical University
name: Rongchong Huang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: