Computerized Medical History Taking for Acute Chest Pain

NCT03439449 | Active Not Recruiting

• 1 other identifier: KI-CLEOS-CPDS
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

The aim is to determine the additional value of computerized, patient-entered medical histories for the management of patients presenting at the emergency department with chest pain.

Conditions

Chest Pain; Acute Coronary Syndrome

Keywords

History taking, Risk stratification

Outcome Measures

Primary Outcomes (1)

• A correct diagnosis of an acute coronary syndrome by use of computer-assisted patient entered history or standard history obtained by the cardiologist in attendance

  The primary objective is to determine whether the use of computer-assisted patient entered history is better than a standard history obtained by the cardiologist in attendance for the prediction and safe exclusion of an acute coronary syndrome (ACS) in the acute setting in patients with non-diagnostic ECG and/or serum markers. Thus, the primary endpoint is the comparison between the two methods for the proportion of patients with a correct diagnosis of ACS or not ACS in the acute setting, The diagnosis of ACS or not ACS is defined as a validated clinical endpoint within 7 days

  7 days

Secondary Outcomes (5)

• A correct exclusion of an acute coronary syndrome up to 30 days by use of computer-assisted patient entered history or standard history obtained by the cardiologist in attendance

  30 days

• A correct exclusion of an acute coronary syndrome up to 1 year by use of computer-assisted patient entered history or standard history obtained by the cardiologist in attendance

  1 year

• Direct costs for a patient with a diagnosis of an acute coronary syndrome when patient selection is based on computer-assisted patient entered history, as compared to standard history obtained by the cardiologist in attendance

  1 year

• Patient experience with computer-assisted patient entered history measured as he proportion of patients who complete a computer-assisted patient entered history

  7 days

• The ability of computer-assisted patient entered history, as compared to standard history obtained by the cardiologist in attendance to provide information required to calculate a TIMI risk score for an ACS.

  7 and 30 days

Interventions

CLEOS software program DEVICE

Computer-assisted history taking program

Physician taken history PROCEDURE

Conventional history taking by physicians

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients presenting at the emergency department with chest pain as presenting complaint.

You may qualify if:

• Chest pain recorded by a triage nurse or registrar
• Fluency in Swedish or English
• Non-diagnostic first ECG and/or serum markers
• Manchester triage 2-5
• Informed consent

You may not qualify if:

• Inability to carry out computerized history-taking on the dedicated device

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Danderyd University Hospital Corp.

Stockholm, 18288, Sweden

Location

Related Publications (6)

• Brandberg H, Sundberg CJ, Spaak J, Koch S, Kahan T. Are medical history data fit for risk stratification of patients with chest pain in emergency care? Comparing data collected from patients using computerized history taking with data documented by physicians in the electronic health record in the CLEOS-CPDS prospective cohort study. J Am Med Inform Assoc. 2024 Jun 20;31(7):1529-1539. doi: 10.1093/jamia/ocae110.

  PMID: 38781350 RESULT

• Sundberg K, Adeli A, Brandberg H, Spaak J, Koch S, Sundberg CJ, Zakim D, Kahan T, Fritzell K. User experience of self-reported computerized medical history taking for acute chest pain: The Clinical Expert Operating System Chest Pain Danderyd Study. Health Expect. 2022 Dec;25(6):3053-3061. doi: 10.1111/hex.13612. Epub 2022 Sep 23.

  PMID: 36148691 RESULT

• Brandberg H, Schierenbeck F, Sundberg CJ, Koch S, Spaak J, Kahan T. Performance of computerized self-reported medical history taking and HEAR score for safe early rule-out of cardiac events in acute chest pain patients: the CLEOS-CPDS prospective cohort study. Eur Heart J Digit Health. 2024 Nov 12;6(1):104-114. doi: 10.1093/ehjdh/ztae087. eCollection 2025 Jan.

  PMID: 39846077 DERIVED

• Zakim D, Brandberg H, El Amrani S, Hultgren A, Stathakarou N, Nifakos S, Kahan T, Spaak J, Koch S, Sundberg CJ. Computerized history-taking improves data quality for clinical decision-making-Comparison of EHR and computer-acquired history data in patients with chest pain. PLoS One. 2021 Sep 27;16(9):e0257677. doi: 10.1371/journal.pone.0257677. eCollection 2021.

  PMID: 34570811 DERIVED

• Brandberg H, Sundberg CJ, Spaak J, Koch S, Zakim D, Kahan T. Use of Self-Reported Computerized Medical History Taking for Acute Chest Pain in the Emergency Department - the Clinical Expert Operating System Chest Pain Danderyd Study (CLEOS-CPDS): Prospective Cohort Study. J Med Internet Res. 2021 Apr 27;23(4):e25493. doi: 10.2196/25493.

  PMID: 33904821 DERIVED

• Brandberg H, Kahan T, Spaak J, Sundberg K, Koch S, Adeli A, Sundberg CJ, Zakim D. A prospective cohort study of self-reported computerised medical history taking for acute chest pain: protocol of the CLEOS-Chest Pain Danderyd Study (CLEOS-CPDS). BMJ Open. 2020 Jan 21;10(1):e031871. doi: 10.1136/bmjopen-2019-031871.

  PMID: 31969363 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples with markers of cardiovascular risk.

MeSH Terms

Conditions

Chest Pain; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Thomas Kahan, MD, PhD

  Karolinska Institutet

  STUDY CHAIR

• Helge Brandberg, MD

  Karolinska Institutet

  STUDY DIRECTOR

• Sabine Koch, PhD

  Karolinska Institutet

  STUDY DIRECTOR

• Jonas Spaak, MD, PhD

  Karolinska Institutet

  STUDY DIRECTOR

• Carl Johan Sundberg, MD, PhD

  Karolinska Institutet

  STUDY DIRECTOR

• David Zakim, MD, PhD

  Karolinska Institutet

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: February 20, 2018
• Study Start: May 1, 2017
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: March 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)