Acute Coronary Syndrome, Chest Pain
Conditions
Keywords
Chest Pain, Decision Aid, Acute Coronary Syndrome, Cardiac, Emergency Department, Cardiac Testing, Healthcare Utilization, Patient Centered Outcomes, Shared Decision Making, Unnecessary hospital admissions
Brief summary
Our long-term goal is to promote evidence-based patient-centered evaluation in the acute setting to more closely tailor testing to disease risk. To compare the use of risk stratification tools with usual clinical approaches to treatment selection or administration, we propose the following: 1. Test if Chest Pain Choice safely improves validated patient-centered outcome measures in a pragmatic parallel patient randomized trial. Hypothesis: The intervention will significantly increase patient knowledge, engagement, and satisfaction with no increase in adverse events. 2. Test if the decision aid has an effect on healthcare utilization within 30 days after enrollment. Hypothesis: The intervention will significantly reduce the rate of hospital admission, rate of cardiac testing, and total healthcare utilization.
Interventions
OTHERChest Pain Choice Decision Aid
The clinician will review the decision aid with the patient. The decision aid will be used as a tool to facilitate discussion and educate the patient regarding the rationale for their evaluation up to that point in the emergency department visit and their individual risk for a heart attack or pre-heart attack. The clinician will provide the patient with management options consistent with both the patient's values and preferences and the clinician's level of comfort.
Sponsors
Patient-Centered Outcomes Research Institute
Indiana University
University of California, Davis
Thomas Jefferson University
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18+ years of age (at least 18). 2. Admitted to emergency department for chest pain. 3. Being considered by the treating clinician for admission for cardiac testing.
Exclusion criteria
1. Ischemic changes on the electrocardiogram not known to be old as determined by the treating clinician in real time. 2. Elevated cardiac troponin (cTn) above the 99th percentile reference limit. 3. Known coronary artery disease as defined by consensus guidelines on risk stratification studies for emergency department patients with potential acute coronary syndrome (≥ 50% stenosis on cardiac catheterization; prior electrocardiographic changes indicative of ischemia, e.g., ST-segment depression, T-wave inversion, or left bundle branch block; perfusion defects or wall motion abnormalities on previous exercise, pharmacological, or rest imaging studies; previous documentation of acute myocardial infarction; or, if no records are available, patient self-report of coronary artery disease). 4. Cocaine use within the previous 72 hours by clinician history. 5. Pregnancy. 6. Referral to the emergency department by a personal physician for admission. 7. Patients who indicate that a hospital different than the site hospital is his or her hospital of choice in the event of a return emergency department visit. 8. Patients undergoing medical clearance for a detox center or any involuntary court or magistrate order. 9. Homelessness, out-of-town residence or other condition known to preclude follow-up. 10. Patients in police custody or currently incarcerated individuals. 11. Patients who have, in their clinician's best judgment, major communication barriers such as visual or hearing impairment or dementia that would compromise their ability to give written informed consent (or use the decision aid).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Test if Chest Pain Choice Safely Improves Patient Knowledge. | Directly following intervention (on day 1) | Patient knowledge was measured by immediate post-visit survey that included 8 questions about the patient's risk for acute coronary syndrome and the available management options. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Test if the Decision Aid Safely Improves Patient Engagement. | Immediately after the intervention (on day 1) | 1\) Patient engagement in the decision-making process as measured by the OPTION scale. The OPTION scale is composed of 12 items with a value of 0-4; they are summed, divided by 48, and then multiplied by 100. Scores range from 0-100, where higher scores are reflective of higher levels of patient engagement. |
| Major Adverse Cardiac Event (MACE) | within 30 days of enrollment | A MACE was defined as acute myocardial infarction, death due to a cardiac or unknown cause, emergency revascularization, ventricular arrhythmia, or cardiogenic shock. |
| Test if the Decision Aid Has an Effect on Healthcare Utilization Within 30 Days After Enrollment. | Within 30 days of study enrollment | We will measure the effect of the decision aid on the frequency of hospital admission and cardiac testing within 30 days of enrollment. |
| Decisional Conflict | Immediately after the visit (day 1) | Decisional conflict, which represents the degree of uncertainty patients experience related to feeling uninformed about the management options, is measured by the decisional conflict scale. The decisional conflict scale includes 16 items that are scored from 0-4; the items are summed, divided by 16, and then multiplied by 25. The scale is from 0-100, where higher scores are reflective of increased patient uncertainty about the choice. |
| Physician Trust | Immediately after the visit (day 1) | The trust in physician scale consists of 9 items scored from 1-5; the items are subtracted by 1, summed, divided by 9, and then multiplied by 25. The scale ranges from 0-100, where higher values are reflective of higher levels of patient trust in their physician. |
| Total Testing Within 45 Days (a Component of Healthcare Utilization) | 45 days | In addition to measuring the effect of the decision aid on the frequency of hospital admission and cardiac testing within 30 days, we measured the total number of tests of any type within 45 days. Although we pre-specified 30-day healthcare utilization, on further discussion among the investigative team the consensus was that we collected utilization data out to 45 days and reporting testing utilization at 45 days will provide more robust results. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Chest Pain Choice Decision Aid Patients randomized to the decision aid arm.
Chest Pain Choice Decision Aid: The clinician will review the decision aid with the patient. The decision aid will be used as a tool to facilitate discussion and educate the patient regarding the rationale for their evaluation up to that point in the ED visit and their individual risk for a heart attack or pre-heart attack. The clinician will provide the patient with management options consistent with both the patient's values and preferences and the clinician's level of comfort. | 451 |
| Usual Care Patients randomized to the usual care arm (no decision aid used) | 447 |
| Total | 898 |
Baseline characteristics
| Characteristic | Chest Pain Choice Decision Aid | Total | Usual Care |
|---|---|---|---|
| Age, Continuous | 50.0 years STANDARD_DEVIATION 15 | 50.3 years STANDARD_DEVIATION 14.6 | 50.6 years STANDARD_DEVIATION 14.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 15 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 155 Participants | 309 Participants | 154 Participants |
| Race (NIH/OMB) More than one race | 22 Participants | 33 Participants | 11 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 262 Participants | 531 Participants | 269 Participants |
| Region of Enrollment United States | 451 participants | 898 participants | 447 participants |
| Sex: Female, Male Female | 274 Participants | 534 Participants | 260 Participants |
| Sex: Female, Male Male | 177 Participants | 364 Participants | 187 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 451 | 1 / 447 |
| serious Total, serious adverse events | 1 / 451 | 0 / 447 |
Outcome results
Primary
Test if Chest Pain Choice Safely Improves Patient Knowledge.
Patient knowledge was measured by immediate post-visit survey that included 8 questions about the patient's risk for acute coronary syndrome and the available management options.
Time frame: Directly following intervention (on day 1)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chest Pain Choice Decision Aid | Test if Chest Pain Choice Safely Improves Patient Knowledge. | 4.2 number of questions correct | Standard Deviation 1.5 |
| Usual Care | Test if Chest Pain Choice Safely Improves Patient Knowledge. | 3.6 number of questions correct | Standard Deviation 1.5 |
95% CI: [0.46, 0.86]
Secondary
Decisional Conflict
Decisional conflict, which represents the degree of uncertainty patients experience related to feeling uninformed about the management options, is measured by the decisional conflict scale. The decisional conflict scale includes 16 items that are scored from 0-4; the items are summed, divided by 16, and then multiplied by 25. The scale is from 0-100, where higher scores are reflective of increased patient uncertainty about the choice.
Time frame: Immediately after the visit (day 1)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chest Pain Choice Decision Aid | Decisional Conflict | 43.5 units on a scale | Standard Deviation 15.3 |
| Usual Care | Decisional Conflict | 46.4 units on a scale | Standard Deviation 14.8 |
95% CI: [-4.8, -0.9]
Secondary
Major Adverse Cardiac Event (MACE)
A MACE was defined as acute myocardial infarction, death due to a cardiac or unknown cause, emergency revascularization, ventricular arrhythmia, or cardiogenic shock.
Time frame: within 30 days of enrollment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chest Pain Choice Decision Aid | Major Adverse Cardiac Event (MACE) | 1 participants |
| Usual Care | Major Adverse Cardiac Event (MACE) | 0 participants |
p-value: 0.998Regression, Logistic
Secondary
Physician Trust
The trust in physician scale consists of 9 items scored from 1-5; the items are subtracted by 1, summed, divided by 9, and then multiplied by 25. The scale ranges from 0-100, where higher values are reflective of higher levels of patient trust in their physician.
Time frame: Immediately after the visit (day 1)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chest Pain Choice Decision Aid | Physician Trust | 89.5 units on a scale | Standard Deviation 13.4 |
| Usual Care | Physician Trust | 87.7 units on a scale | Standard Deviation 16 |
95% CI: [-0.2, 3.6]
Secondary
Test if the Decision Aid Has an Effect on Healthcare Utilization Within 30 Days After Enrollment.
We will measure the effect of the decision aid on the frequency of hospital admission and cardiac testing within 30 days of enrollment.
Time frame: Within 30 days of study enrollment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chest Pain Choice Decision Aid | Test if the Decision Aid Has an Effect on Healthcare Utilization Within 30 Days After Enrollment. | Admitted to the hospital | 22 participants |
| Chest Pain Choice Decision Aid | Test if the Decision Aid Has an Effect on Healthcare Utilization Within 30 Days After Enrollment. | Cardiac stress testing | 172 participants |
| Usual Care | Test if the Decision Aid Has an Effect on Healthcare Utilization Within 30 Days After Enrollment. | Admitted to the hospital | 22 participants |
| Usual Care | Test if the Decision Aid Has an Effect on Healthcare Utilization Within 30 Days After Enrollment. | Cardiac stress testing | 204 participants |
p-value: <0.013t-test, 2 sided
Secondary
Test if the Decision Aid Safely Improves Patient Engagement.
1\) Patient engagement in the decision-making process as measured by the OPTION scale. The OPTION scale is composed of 12 items with a value of 0-4; they are summed, divided by 48, and then multiplied by 100. Scores range from 0-100, where higher scores are reflective of higher levels of patient engagement.
Time frame: Immediately after the intervention (on day 1)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chest Pain Choice Decision Aid | Test if the Decision Aid Safely Improves Patient Engagement. | 18.3 units on a scale | Standard Deviation 9.4 |
| Usual Care | Test if the Decision Aid Safely Improves Patient Engagement. | 7.9 units on a scale | Standard Deviation 5.4 |
95% CI: [9.1, 11.5]
Secondary
Total Testing Within 45 Days (a Component of Healthcare Utilization)
In addition to measuring the effect of the decision aid on the frequency of hospital admission and cardiac testing within 30 days, we measured the total number of tests of any type within 45 days. Although we pre-specified 30-day healthcare utilization, on further discussion among the investigative team the consensus was that we collected utilization data out to 45 days and reporting testing utilization at 45 days will provide more robust results.
Time frame: 45 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chest Pain Choice Decision Aid | Total Testing Within 45 Days (a Component of Healthcare Utilization) | 13.3 number of tests obtained | Standard Deviation 6.9 |
| Usual Care | Total Testing Within 45 Days (a Component of Healthcare Utilization) | 14.7 number of tests obtained | Standard Deviation 7.7 |
p-value: <0.001negative binomial model