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Trial record 7 of 176 for:    Recruiting, Not yet recruiting, Available Studies | Chest pain

Computerized Medical History Taking for Acute Chest Pain (CLEOS-CPDS)

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ClinicalTrials.gov Identifier: NCT03439449
Recruitment Status : Recruiting
First Posted : February 20, 2018
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Kahan, Karolinska Institutet

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.

Condition or disease Intervention/treatment
Chest Pain Acute Coronary Syndrome Device: CLEOS software program Procedure: Physician taken history

Detailed Description:

The purpose of this study is to determine the value of a detailed medical history, acquired by computer-directed, patient self-entry of data, for efficient disposition of patients presenting to the emergency department (ED) with chest pain and non-diagnostic first ECG and/or serum markers for acute coronary syndrome (ACS). The research questions posed are: will the added data and systems-based analysis of the data provided by computerization of these processes, as compared with routine physician-acquired histories and analysis; (1) safely risk stratify patients with chest pain, and (2) save time and resources?

Computerized, patient-entered histories will be collected with the software program CLEOS running on tablets (iPad®, Apple Inc, Cupertino, California, USA). The histories to be collected include demographic data, present illness, systems review, past medical history, prescription drugs, previous adverse drug reactions, social history, life-style risks, and family history. Histories will be collected during wait times in the ED, e.g., before patients are seen by a physician and while patients wait for reports of laboratory data collected by routine care.

Data acquired by CLEOS will be related to clinical outcomes in the acute setting and at 30 days and 1 year post-presentation for patients without documented ACS in the acute setting. Outcomes for all patients will be extracted from hospital records and national registries.

For the validation and future development of CLEOS, interviews with patients for the evaluation of patient experience regarding feasibility, acceptance, comprehensiveness and technical aspects of answering the CLEOS interview will take place within one to three months after the ED visit.

This is an exploratory study in which the calculation of the number of participating patients is based on the desired precision of sensitivity and specificity. Assuming that the prevalence is 0.5 (50 %), a power calculation with nQuery® version 7.0 (Statistical Solutions Ltd, Boston, Massachusetts, USA) shows that with 1000 patients the estimated precision of sensitivity and specificity is ±0.03 (3 %). The more the extreme the result, i.e. sensitivity or specificity approaching 0 or 1 (100 %), the higher the precision. The models will be developed in the first 50% of the data acquired (training data set) and validated in the last 50% of the data acquired (validation data set). We also intend to make estimates in subgroups. To ascertain that such estimates can be done, an even larger number of patients must be recruited. Thus, the study intends to recruit data from approximately 2000 patients.

Taken together, this study:

  1. will evaluate established clinical guidelines risk scores, as populated with CLEOS data, and compare these results with data obtained during the concurrent ED visit and made available in the standard hospital medical records;
  2. will assess how data collected with CLEOS in combination with established risk scores can rule-in and rule-out a diagnosis of an ACS, we will calculate sensitivity, specificity and negative and positive predictive value;
  3. aim to develop new risk prediction scores for patients with chest pain, based on data collected with CLEOS; and
  4. will evaluate economic aspects of routine care, as compared with management by CLEOS by using standard health economy procedures and analyses to determine the resource utilization and cost differences between management according to guidelines, based on data collected with CLEOS, and current clinical practice.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Computerized, Patient-entered Medical Histories for Managing Chest Pain in the Emergency Department
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain


Intervention Details:
  • Device: CLEOS software program
    Computer-assisted history taking program
  • Procedure: Physician taken history
    Conventional history taking by physicians


Primary Outcome Measures :
  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 [ Time Frame: 7 days ]
    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


Secondary Outcome Measures :
  1. 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 [ Time Frame: 30 days ]
    To determine whether the use of computer-assisted patient entered history is better than a standard history obtained by the cardiologist in attendance to exclude an acute coronary syndrome (ACS) in the acute setting in patients with non-diagnostic ECG and/or serum markers. Thus, this secondary endpoint is the comparison between the two methods for the proportion of patients with a correct exclusion of ACS in the acute setting, The diagnosis of ACS is defined as a validated clinical endpoint within 30 days

  2. 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 [ Time Frame: 1 year ]
    To determine whether the use of computer-assisted patient entered history is better than a standard history obtained by the cardiologist in attendance to exclude an acute coronary syndrome (ACS) in the acute setting in patients with non-diagnostic ECG and/or serum markers. Thus, this secondary endpoint is the comparison between the two methods for the proportion of patients with a correct exclusion of ACS in the acute setting, The diagnosis of ACS is defined as a validated clinical endpoint within 1 year

  3. 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 [ Time Frame: 1 year ]
    To measure 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. Costs will be obtained patient-by-patient from medical records

  4. Patient experience with computer-assisted patient entered history measured as he proportion of patients who complete a computer-assisted patient entered history [ Time Frame: 7 days ]
    To evaluate the proportion of patients who complete a full computer-assisted patient entered history.

  5. 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. [ Time Frame: 7 and 30 days ]
    To compare the proportions of patients with computer-assisted patient entered history, as compared to standard history obtained by the cardiologist in attendance, where there is sufficient information documented to calculate the Thrombolysis In Myocardial Infarction (TIMI) score. The TIMI score contains the following information: Age, risk factors for coronary artery disease (family history, hypertension, hypercholesterolemia, diabetes, current smoker), a significant coronary artery stenosis, ST segment deviation on the ECG, 2 or more anginal attacks within 24 h, use of aspirin within 7 days, and elevated serum cardiac biomarkers.


Biospecimen Retention:   Samples Without DNA
Blood samples with markers of cardiovascular risk.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients presenting at the emergency department with chest pain as presenting complaint.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03439449


Contacts
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Contact: Thomas Kahan, MD, PhD +46 (0) 123 568 61 thomas.kahan@ki.se

Locations
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Sweden
Danderyd University Hospital Corp. Recruiting
Stockholm, Sweden, 18288
Contact: Thomas Kahan, MD, PhD    +46 (0) 123 568 61    thomas.kahan@ki.se   
Sub-Investigator: Helge Brandberg, MD         
Sub-Investigator: Jonas Spaak, MD, PhD         
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Study Chair: Thomas Kahan, MD, PhD Karolinska Institutet
Study Director: 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

Additional Information:

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Responsible Party: Thomas Kahan, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03439449     History of Changes
Other Study ID Numbers: KI-CLEOS-CPDS
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thomas Kahan, Karolinska Institutet:
History taking, Risk stratification
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Chest Pain
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pain
Neurologic Manifestations
Signs and Symptoms