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

Not Applicable

Completed

• Conditions: NSTEMI
• Interventions: Behavioral: Shared Decision Aid

• Registration Number: NCT04270630
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-02-13
• Study First Submitted QC: 2020-02-13
• Study First Posted: 2020-02-17
• Study Start: 2020-07-01
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-29
• Last Update Posted: 2023-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Shared decision aid	Shared Decision Aid	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.

Primary Outcome Measures

Name	Time	Method
Percent change in mean decisional conflict score between the control and interventional group	Visit 1 (Day 0)	A reduction in decisional conflict score will be measured with the DCS tool to reflect an increase in the quality of the decision.

Secondary Outcome Measures

Name	Time	Method
Descriptive Statistics in the use of the Patient Decision Aid	Visit 1 (Day 0)	Descriptive differences in the participants who use the patient decision aid and those who are in the control group will be measured with study surveys

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States