A Pilot Proof of Concept, Randomized Controlled, Single-Center Study of a Decision Aid Tool for Older Patients Considering LHC as Treatment for NSTEMI

NYU Langone Health

Status: Completed

Conditions: NSTEMI

Treatments: Behavioral: Shared Decision Aid

Study type: Interventional

Funder types: Other

Identifiers

NCT04270630

19-01687

Details and patient eligibility

About

This study will be a single-center, prospective, un-blinded, randomized controlled trial evaluating a decision aid tool for older patients considering left heart catheterization (LHC) as treatment for non-ST elevation myocardial infarction (NSTEMI). The study population is 50 total inpatients (25 per study arm) with NSTEMI eligible for elective LHC. The first arm is the control group that will receive standard of care, while the second arm will have access to the decision aid and shared-decision making conversation with one of the co-investigators. Baseline characteristics and surveys/questionnaire data will be collected after study intervention (as applicable), and prior to final decision regarding LHC. Statistical analyses will be conducted on the primary endpoint, decisional conflict score, as well as on various secondary endpoints.

Full description

A single-center, prospective, un-blinded, randomized controlled trial. Primary objective: To pilot a coronary revascularization decision aid in older adults with NSTEMI who are candidates for elective LHC in order to determine its effectiveness in lowering decisional conflict by the decisional conflict scale (DCS).

Secondary objectives: To determine decision aid feasibility by measuring time of administration and percentage of patients agreeing to use. Also, to assess efficacy of the decision aid in decreasing patient feelings of anxiety and depression (by the Hospital Anxiety and Depression Scale), increasing decision self-efficacy (by the Ottawa Decision Self-Efficacy Scale), and increasing medical knowledge.

Enrollment: 14 patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must be admitted to the hospital, and there must be clinical suspicion for type I NSTEMI
• Must be eligible for non-urgent revascularization
• Must have capacity to consent for the study based on the judgment of the study investigators
• Must speak English

Exclusion criteria

• Does not meet all of the inclusion criteria listed above
• Has significant vision or hearing impairment that prohibits use of the decision aid
• Unable to read
• Has a clinical diagnosis of dementia and/or severe cognitive impairment documented in the electronic medical record

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Standard of care

No Intervention group

Description:

Patients in the control arm of the study will undergo standard of care treatment, discussing catheterization with their treating physicians.

Shared decision aid

Experimental group

Description:

Patients in the interventional arm of the study will discuss catheterization with their treating physicians, in addition to having access to the shared decision aid tool and a shared decision conversation with a co-investigator clinician.

Treatment:

Behavioral: Shared Decision Aid