NSTEMINCT04270630
A Pilot Proof of Concept, Randomized Controlled, Single-Center Study of a Decision Aid Tool for Older Patients Considering LHC as Treatment for NSTEMI
A study testing Shared Decision Aid in people with NSTEMI, run by NYU Langone Health at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- NSTEMI
- What is being tested?
- Shared Decision Aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- NSTEMI
- Being tested
- Shared Decision Aid
- Keywords
- Shared decision making, Left heart catheterization, Non-ST elevation myocardial infarction, Decisional conflict, Decision aid
- Medical subject headings
- Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared Decision AidBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Patients in the control arm of the study will undergo standard of care treatment, discussing catheterization with their treating physicians. |
| Shared decision aid | Experimental | 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. Receives: Behavioral: Shared Decision Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Visit 1 (Day 0)
Secondary outcomes (1)
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
Measured: Visit 1 (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 Jul 2020
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSTEMIStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Dodson, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270630
- Sponsor's protocol ID
- 19-01687
- Status last verified
- Jun 2023
- First submitted
- 13 Feb 2020
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04270630
- Acronym / sponsor ID
- 19-01687
- Conditions
- NSTEMI
- Keywords
- Shared decision making, Left heart catheterization, Non-ST elevation myocardial infarction, Decisional conflict, Decision aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –Patients in the control arm of the study will undergo standard of care treatment, discussing catheterization with their treating physicians. |
| Shared decision aid | Experimental | Behavioral: Shared Decision AidPatients 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. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shared Decision AidThe 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. | Behavioural | Shared decision aid |
Primary outcome
Percent change in mean decisional conflict score between the control and interventional group
Time frame: 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.
1 secondary outcome
Descriptive Statistics in the use of the Patient Decision Aid
Time frame: Visit 1 (Day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Dodson, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared Decision Aid in people with NSTEMI, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in mean decisional conflict score between the control and interventional group (time frame: Visit 1 (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.