Computerized Medical History Taking for Acute Chest Pain

Acute Coronary Syndrome Clinical Trial

— CLEOS-CPDS  

Official title:

Computerized, Patient-entered Medical Histories for Managing Chest Pain in the Emergency Department

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03439449
• Other study ID #: KI-CLEOS-CPDS
• Status: Active, not recruiting
• Start date: May 1, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Chest Pain

Intervention

Device:
• CLEOS software program
Computer-assisted history taking program

Procedure:
• Physician taken history
Conventional history taking by physicians

Locations

Country	Name	City	State
Sweden	Danderyd University Hospital Corp.	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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	30 days
Secondary	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	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	1 year
Secondary	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	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	1 year
Secondary	Patient experience with computer-assisted patient entered history measured as he proportion of patients who complete a computer-assisted patient entered history	To evaluate the proportion of patients who complete a full computer-assisted patient entered history.	7 days
Secondary	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.	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.	7 and 30 days