## Protocol Section
### Identification Module
**NCT ID:** NCT03286179

**Acronym:** STEWARD

**Brief Title:** Standardizing Emergency Work-ups Around Risk Data

**Official Title:** Standardizing Emergency Work-ups Around Risk Data (STEWARD): The CREST Network Chest Pain Project

#### Organization Study ID Info
**ID:** CN-16-2648
#### Organization
**Class:** OTHER
**Full Name:** Kaiser Permanente
### Status Module
#### Completion Date
**Date:** 2020-06-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-08-12

**Type:** ACTUAL

**Last Update Submit Date:** 2020-08-11

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-12-31

**Type:** ACTUAL

#### Start Date
**Date:** 2018-07-01

**Type:** ACTUAL

**Status Verified Date:** 2020-08

#### Study First Post Date
**Date:** 2017-09-18
**Type:** ACTUAL
**Study First Submit Date:** 2017-09-13
**Study First Submit QC Date:** 2017-09-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Kaiser Permanente

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Chest pain is the second leading reason for emergency department (ED) visits in the United States. Resource utilization for this ED subpopulation is particularly high, in part due to a dearth of accepted standardized clinical approaches and general overestimation of risk on the part of both providers and patients. This prospective observational cohort study seeks to address this issue by providing externally validated risk scores for major adverse cardiac events using a web-based clinical decision support platform (RISTRA) embedded within the electronic health record at 13 Kaiser Permanente Northern California (KPNC) EDs over a 12-month period. The decision support will provide risk estimates specific to the KPNC patient population. This studies hypothesis is that the provision of more accurate risk estimation for major adverse cardiac events will improve informed decision making by both providers and patients, resulting in less provocative testing and lower ED lengths of stay amongst low risk patients, as well as improving medical management among non-low risk patients and decreasing future rates of major adverse cardiac events.

### Conditions Module

**Conditions:**

- Acute Coronary Syndrome

- Chest Pain

- Risk Reduction

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 13419

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** Provision of estimated risk for major cardiac events at 60 days based on the modified HEART and/or EDACS, using KPNC specific estimates derived from an internal validation study

**Name:** modified HEART score and/or Emergency Department Assessment of Chest pain Risk Score (EDACS)

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** A composite outcome of either acute myocardial infarction, cardiac arrest, malignant arrhythmia, cardiac-related mortality

**Measure:** Major adverse cardiac event (MACE)

**Time Frame:** 12 months

#### Secondary Outcomes

**Description:** Treadmill stress test, myocardial perfusion imaging, stress echocardiography, CT coronary angiography, catheter-based coronary angiography

**Measure:** Provocative and anatomic cardiac testing rates

**Time Frame:** 12 months

**Description:** Total hours spent in the emergency department among study eligible patients

**Measure:** Emergency department length of stay

**Time Frame:** 12 months

**Description:** Percentage of hospital admissions among study eligible patients

**Measure:** Hospital admission rate

**Time Frame:** 12 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Emergency department chief complaint of chest pain or chest discomfort
* Clinical concern for possible cardiac ischemia

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Adult patients presenting to KPNC emergency departments with above elgibilty criteria

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Antioch

**Country:** United States

**Facility:** Kaiser Permanente Antioch Emergency Department

**State:** California

**Zip:** 94531

**Location 2:**

**City:** Fremont

**Country:** United States

**Facility:** Kaiser Permanente Fremont Emergency Department

**State:** California

**Zip:** 94538

**Location 3:**

**City:** Oakland

**Country:** United States

**Facility:** Kaiser Permanente Oakland Emergency Department

**State:** California

**Zip:** 94611

**Location 4:**

**City:** Richmond

**Country:** United States

**Facility:** Kaiser Permanente Richmond Emergency Department

**State:** California

**Zip:** 94801

**Location 5:**

**City:** Roseville

**Country:** United States

**Facility:** Kaiser Permanente Roseville Emergency Department

**State:** California

**Zip:** 95661

**Location 6:**

**City:** Sacramento

**Country:** United States

**Facility:** Kaiser Permanente South Sacramento Emergency Department

**State:** California

**Zip:** 95823

**Location 7:**

**City:** Sacramento

**Country:** United States

**Facility:** Kaiser Permanente Sacramento Emergency Department

**State:** California

**Zip:** 95825

**Location 8:**

**City:** San Francisco

**Country:** United States

**Facility:** Kaiser Permanente San Francisco Emergency Department

**State:** California

**Zip:** 94115

**Location 9:**

**City:** San Leandro

**Country:** United States

**Facility:** Kaiser Permanente San Leandro Emergency Department

**State:** California

**Zip:** 94577

**Location 10:**

**City:** San Rafael

**Country:** United States

**Facility:** Kaiser Permanente San Rafael Emergency Department

**State:** California

**Zip:** 94903

**Location 11:**

**City:** South San Francisco

**Country:** United States

**Facility:** Kaiser Permanente South San Francisco Emergency Department

**State:** California

**Zip:** 94080

**Location 12:**

**City:** Walnut Creek

**Country:** United States

**Facility:** Kaiser Permanente Walnut Creek Emergency Department

**State:** California

**Zip:** 94596

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Sabbatini AK, Nallamothu BK, Kocher KE. Reducing variation in hospital admissions from the emergency department for low-mortality conditions may produce savings. Health Aff (Millwood). 2014 Sep;33(9):1655-63. doi: 10.1377/hlthaff.2013.1318.

**PMID:** 25201672

**Citation:** Venkatesh AK, Dai Y, Ross JS, Schuur JD, Capp R, Krumholz HM. Variation in US hospital emergency department admission rates by clinical condition. Med Care. 2015 Mar;53(3):237-44. doi: 10.1097/MLR.0000000000000261.

**PMID:** 25397965

**Citation:** Newman DH, Ackerman B, Kraushar ML, Lederhandler MH, Masri A, Starikov A, Tsao DT, Meyers HP, Shah KH. Quantifying Patient-Physician Communication and Perceptions of Risk During Admissions for Possible Acute Coronary Syndromes. Ann Emerg Med. 2015 Jul;66(1):13-8, 18.e1. doi: 10.1016/j.annemergmed.2015.01.027. Epub 2015 Mar 4.

**PMID:** 25748480

**Citation:** Than MP, Pickering JW, Aldous SJ, Cullen L, Frampton CM, Peacock WF, Jaffe AS, Goodacre SW, Richards AM, Ardagh MW, Deely JM, Florkowski CM, George P, Hamilton GJ, Jardine DL, Troughton RW, van Wyk P, Young JM, Bannister L, Lord SJ. Effectiveness of EDACS Versus ADAPT Accelerated Diagnostic Pathways for Chest Pain: A Pragmatic Randomized Controlled Trial Embedded Within Practice. Ann Emerg Med. 2016 Jul;68(1):93-102.e1. doi: 10.1016/j.annemergmed.2016.01.001.

**PMID:** 26947800

**Citation:** Mahler SA, Riley RF, Hiestand BC, Russell GB, Hoekstra JW, Lefebvre CW, Nicks BA, Cline DM, Askew KL, Elliott SB, Herrington DM, Burke GL, Miller CD. The HEART Pathway randomized trial: identifying emergency department patients with acute chest pain for early discharge. Circ Cardiovasc Qual Outcomes. 2015 Mar;8(2):195-203. doi: 10.1161/CIRCOUTCOMES.114.001384. Epub 2015 Mar 3.

**PMID:** 25737484

**Citation:** Mark DG, Huang J, Ballard DW, Kene MV, Sax DR, Chettipally UK, Lin JS, Bouvet SC, Cotton DM, Anderson ML, McLachlan ID, Simon LE, Shan J, Rauchwerger AS, Vinson DR, Reed ME; Kaiser Permanente CREST Network Investigators [Link]. Graded Coronary Risk Stratification for Emergency Department Patients With Chest Pain: A Controlled Cohort Study. J Am Heart Assoc. 2021 Nov 16;10(22):e022539. doi: 10.1161/JAHA.121.022539. Epub 2021 Nov 6.

**PMID:** 34743565

**Citation:** Mark DG, Huang J, Kene MV, Sax DR, Cotton DM, Lin JS, Bouvet SC, Chettipally UK, Anderson ML, McLachlan ID, Simon LE, Shan J, Rauchwerger AS, Vinson DR, Ballard DW, Reed ME; Kaiser Permanente CREST Network Investigators. Prospective Validation and Comparative Analysis of Coronary Risk Stratification Strategies Among Emergency Department Patients With Chest Pain. J Am Heart Assoc. 2021 Apr 6;10(7):e020082. doi: 10.1161/JAHA.120.020082. Epub 2021 Mar 31.

**PMID:** 33787290

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M7796

- Name: Emergencies

- Relevance: HIGH

- As Found: Emergency

- ID: M27545

- Name: Acute Coronary Syndrome

- Relevance: HIGH

- As Found: Acute Coronary Syndrome

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M5882

- Name: Chest Pain

- Relevance: HIGH

- As Found: Chest Pain

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: LOW

- As Found: Unknown

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000054058

- Term: Acute Coronary Syndrome

- ID: D000004630

- Term: Emergencies

- ID: D000002637

- Term: Chest Pain

### Misc Info Module

- Version Holder: 2024-05-24
