Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| Indiana University | OTHER |
| University of California, Davis | OTHER |
| Thomas Jefferson University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chest Pain Choice Decision Aid | Active Comparator | Patients randomized to the decision aid arm. |
|
| Usual Care | No Intervention | Patients randomized to the usual care arm (no decision aid used) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chest Pain Choice Decision Aid | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Directly following intervention (on day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 30 days of study enrollment |
| Test if the Decision Aid Safely Improves Patient Engagement. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Erik Hess, MD, MSc | Mayo Clinic, Rochester, MN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis | Sacramento | California | 95817 | United States | ||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27919865 | Derived | Hess EP, Hollander JE, Schaffer JT, Kline JA, Torres CA, Diercks DB, Jones R, Owen KP, Meisel ZF, Demers M, Leblanc A, Shah ND, Inselman J, Herrin J, Castaneda-Guarderas A, Montori VM. Shared decision making in patients with low risk chest pain: prospective randomized pragmatic trial. BMJ. 2016 Dec 5;355:i6165. doi: 10.1136/bmj.i6165. | |
| 24884807 |
Not provided
Not provided
A link to the pre-test probability web tool and the Chest Pain Choice decision aid (DA) can be accessed at the Mayo Clinic Shared Decision Making National Resource Center at http://shareddecisions.mayoclinic.org/decision-aid-information/chest-pain-choice-decision-aid/. De-identified patient level data and statistical code can be requested from the corresponding author at hess.erik@mayo.edu and provided to investigators who agree to adhere to a signed research data use agreement with the Mayo Clinic after 12/31/2017.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Usual Care | Patients randomized to the usual care arm (no decision aid used) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients presenting to a participating emergency department for evaluation of chest pain.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | number of questions correct | Directly following intervention (on day 1) |
|
30 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Major adverse cardiac event | Cardiac disorders | Systematic Assessment | This intervention patient was admitted to the hospital, had a negative nuclear perfusion stress test, was discharged, and returned to the ED within 30 days with a NSTEMI. The DSMB classified this event as not related to the intervention. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | Systematic Assessment | These patients were appropriately diagnosed with an acute myocardial infarction during their index visit to the emergency department. |
The study had 78% power to detect a 5% difference in major adverse cardiac event (MACE) rate between study arms, using a 1-sided non-inferiority test with an alpha of 0.05.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Erik Hess | Mayo Clinic | 507-284-7221 | hess.erik@mayo.edu |
Not provided
| ID | Term |
|---|---|
| D002637 | Chest Pain |
| D054058 | Acute Coronary Syndrome |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
Not provided
|
|
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. |
| Immediately after the intervention (on day 1) |
| 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. | within 30 days of enrollment |
| 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. | 45 days |
| 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. | Immediately after the visit (day 1) |
| 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. | Immediately after the visit (day 1) |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| Indiana University Hospital: IU | Indianapolis | Indiana | 46202 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Anderson RT, Montori VM, Shah ND, Ting HH, Pencille LJ, Demers M, Kline JA, Diercks DB, Hollander JE, Torres CA, Schaffer JT, Herrin J, Branda M, Leblanc A, Hess EP. Effectiveness of the Chest Pain Choice decision aid in emergency department patients with low-risk chest pain: study protocol for a multicenter randomized trial. Trials. 2014 May 10;15:166. doi: 10.1186/1745-6215-15-166. |
| BG001 | Usual Care | Patients randomized to the usual care arm (no decision aid used) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Usual Care | Patients randomized to the usual care arm (no decision aid used) |
|
|
|
| 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. | Posted | Number | participants | Within 30 days of study enrollment |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Immediately after the intervention (on day 1) |
|
|
|
|
| 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. | Posted | Number | participants | within 30 days of enrollment |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | number of tests obtained | 45 days |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Immediately after the visit (day 1) |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Immediately after the visit (day 1) |
|
|
|
|
| 1 |
| 451 |
| 4 |
| 451 |
| EG001 | Usual Care | Patients randomized to the usual care arm (no decision aid used) | 0 | 447 | 1 | 447 |
|
|
Not provided
Not provided
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |