Clinical trial NCT04270630: A Pilot Proof of Concept, Randomized Controlled, Single-Center Study of a Decision Aid Tool for Older Patients Considering LHC as Treatment for NSTEMI
Official title: A Pilot Proof of Concept, Randomized Controlled, Single-Center Study of a Decision Aid Tool for Older Patients (Age ≥75) Considering Left Heart Catheterization as Treatment for Non-St Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: NSTEMI
Keywords: Shared decision making
Left heart catheterization
Non-ST elevation myocardial infarction
Decisional conflict
Decision aid
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 14
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent change in mean decisional conflict score between the control and interventional group
timeFrame: Visit 1 (Day 0)
Secondary outcomes:
measure: Descriptive Statistics in the use of the Patient Decision Aid
timeFrame: Visit 1 (Day 0)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: John Dodson, MD
role: PRINCIPAL_INVESTIGATOR
References: