Trial Outcomes & Findings for Shared Decision Making in the Emergency Department: Chest Pain Choice Trial (NCT NCT01969240)

NCT ID: NCT01969240

Last Updated: 2018-08-06

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 898 participants
• Primary outcome timeframe: Directly following intervention (on day 1)
• Results posted on: 2018-08-06

Participant Flow

Participant milestones

Measure	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.	Usual Care Patients randomized to the usual care arm (no decision aid used)
Overall Study STARTED	451	447
Overall Study COMPLETED	451	447
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Shared Decision Making in the Emergency Department: Chest Pain Choice Trial

Baseline characteristics by cohort

Measure	Chest Pain Choice Decision Aid n=451 Participants 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.	Usual Care n=447 Participants Patients randomized to the usual care arm (no decision aid used)	Total n=898 Participants Total of all reporting groups
Age, Continuous	50.0 years STANDARD_DEVIATION 15.0 • n=5 Participants	50.6 years STANDARD_DEVIATION 14.1 • n=7 Participants	50.3 years STANDARD_DEVIATION 14.6 • n=5 Participants
Sex: Female, Male Female	274 Participants n=5 Participants	260 Participants n=7 Participants	534 Participants n=5 Participants
Sex: Female, Male Male	177 Participants n=5 Participants	187 Participants n=7 Participants	364 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	155 Participants n=5 Participants	154 Participants n=7 Participants	309 Participants n=5 Participants
Race (NIH/OMB) White	262 Participants n=5 Participants	269 Participants n=7 Participants	531 Participants n=5 Participants
Race (NIH/OMB) More than one race	22 Participants n=5 Participants	11 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	451 participants n=5 Participants	447 participants n=7 Participants	898 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Chest Pain Choice Decision Aid n=451 Participants 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.	Usual Care n=447 Participants Patients randomized to the usual care arm (no decision aid used)
Test if Chest Pain Choice Safely Improves Patient Knowledge.	4.2 number of questions correct Standard Deviation 1.5	3.6 number of questions correct Standard Deviation 1.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Chest Pain Choice Decision Aid n=451 Participants 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.	Usual Care n=447 Participants Patients randomized to the usual care arm (no decision aid used)
Test if the Decision Aid Has an Effect on Healthcare Utilization Within 30 Days After Enrollment. Admitted to the hospital	22 participants	22 participants
Test if the Decision Aid Has an Effect on Healthcare Utilization Within 30 Days After Enrollment. Cardiac stress testing	172 participants	204 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Chest Pain Choice Decision Aid n=451 Participants 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.	Usual Care n=447 Participants Patients randomized to the usual care arm (no decision aid used)
Test if the Decision Aid Safely Improves Patient Engagement.	18.3 units on a scale Standard Deviation 9.4	7.9 units on a scale Standard Deviation 5.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Chest Pain Choice Decision Aid n=451 Participants 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.	Usual Care n=447 Participants Patients randomized to the usual care arm (no decision aid used)
Major Adverse Cardiac Event (MACE)	1 participants	0 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Chest Pain Choice Decision Aid n=451 Participants 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.	Usual Care n=447 Participants Patients randomized to the usual care arm (no decision aid used)
Total Testing Within 45 Days (a Component of Healthcare Utilization)	13.3 number of tests obtained Standard Deviation 6.9	14.7 number of tests obtained Standard Deviation 7.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Chest Pain Choice Decision Aid n=451 Participants 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.	Usual Care n=447 Participants Patients randomized to the usual care arm (no decision aid used)
Decisional Conflict	43.5 units on a scale Standard Deviation 15.3	46.4 units on a scale Standard Deviation 14.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Chest Pain Choice Decision Aid n=451 Participants 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.	Usual Care n=447 Participants Patients randomized to the usual care arm (no decision aid used)
Physician Trust	89.5 units on a scale Standard Deviation 13.4	87.7 units on a scale Standard Deviation 16.0

Adverse Events

Chest Pain Choice Decision Aid

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Chest Pain Choice Decision Aid n=451 participants at risk 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.	Usual Care n=447 participants at risk Patients randomized to the usual care arm (no decision aid used)
Cardiac disorders Major adverse cardiac event	0.22% 1/451 • Number of events 1 • 30 days	0.00% 0/447 • 30 days

Other adverse events

Measure	Chest Pain Choice Decision Aid n=451 participants at risk 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.	Usual Care n=447 participants at risk Patients randomized to the usual care arm (no decision aid used)
Cardiac disorders Acute myocardial infarction	0.89% 4/451 • Number of events 4 • 30 days	0.22% 1/447 • Number of events 1 • 30 days

Additional Information

Dr. Erik Hess

Mayo Clinic

Phone: 507-284-7221

Email: hess.erik@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place