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

NSTEMI Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04270630
• Other study ID #: 19-01687
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: June 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Non-ST Elevated Myocardial Infarction
• NSTEMI

Intervention

Behavioral:
• Shared Decision Aid
The decision aid was developed by this study group based on the International Patient Decision Aid Standards Collaboration's minimum standards for quality, and the Ottawa Framework (a process by which patients' and clinicians' decision determinants are assessed, a decision aid is developed that is tailored to these needs, and the quality of the decision-making process with the aid is evaluated). The aid then underwent an iterative feedback process with a patient advisory panel. Adjustments to format, length, and readability were made. A final feedback session occurred with three patients over the age of 70, after which point the paper decision aid was digitalized. The intervention will be delivered in-person by one of the co-investigators of the study. The intervention will occur once, prior to the patient making a final decision regarding undergoing left heart catheterization as treatment for NSTEMI. The approximate duration of the intervention is 30 minutes.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in mean decisional conflict score between the control and interventional group	A reduction in decisional conflict score will be measured with the DCS tool to reflect an increase in the quality of the decision.	Visit 1 (Day 0)
Secondary	Descriptive Statistics in the use of the Patient Decision Aid	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	Visit 1 (Day 0)