Clinical Implementation of a Novel Decision Support Tool in Patients With Ischemic Heart Disease

Study Overview
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Brief Summary
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The PM-Heart algorithm (PMHeartIHD) is an in-house developed software that predict the survival prognosis for the individual patient hospitalized with ischemic heart disease (IHD) after a coronary arteriography has been performed. The software is intended to be used as a clinical decision support system i.e. the calculated survival prognosis is expected to enhance the quality of the treating physician's therapeutic considerations concerning (minor) adjustments to the patients treatment and follow-up - all within the framework of the current medical guidelines. Thus, the algorithm does not show the physician specifically what to do, but rather ensures a better knowledgebase for the overall interpretation and choice of management of the patient.

Detailed Description
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To investigate the clinical usefulness of the developed clinical decision support system - the PMHeartIHD algorithm - we wish to investigate whether the clinical use of the algorithm will; Improve patient prognosis and, Minimize the risk of re-hospitalization, compared to patients who are treated without the attending/treating physician knowing the algorithm's prognosis?

Official Title
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Clinical Implementation of a Novel Decision Support Tool in Patients With Ischemic Heart Disease

Conditions
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Ischemic Heart Disease

Intervention / Treatment
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* Other: PM HeartIHD prediction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalized patients in one of the involved departments of cardiology (see below) with; Ischemic heart disease; the clinical presentation may be stable, worsening/unstable angina, non-ST-elevation myocardial infarction or ST-elevation myocardial infarction, and with - Significant coronary artery lesions or diffuse coronary artery disease on invasive coronary angiography during the admission Exclusion Criteria: <18 years of age Living outside Denmark

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>The one-year mortality prediction, calculated by the PM Heart algorithm, will not be available to the physician. | |
| Experimental: Intervention<br>The one-year mortality prediction, calculated by the PM Heart algorithm, will be available to the physician. | Other: PM HeartIHD prediction<br>* The calculated prediction and the explainability factors will be made available to the physician, which the physician then can decide to take into his/hers evaluation about further treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and duration of readmissions within one month after randomization | A composite outcome of a) readmissions within one month, and 2) all-cause mortality within one year - for patients randomized to the study. All the outcomes listed below will be assessed as a comparison between the intervention group and the control group. | From randomization to the study and up to 1 year hereafter | 
| Number and cause of death (all-cause mortality) within one year after randomization | A composite outcome of a) readmissions within one month, and 2) all-cause mortality within one year - for patients randomized to the study. | From randomization to the study and up to 1 year hereafter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission(s) within 30 days of the randomization | Readmission(s) within 30 days of the randomization. Incl. information on the quantity, duration, cause, outcome etc. | Up to 30 days after randomization to the study. | 
| Cardiovascular readmission(s) within 30 days of the randomization | Cardiovascular readmission(s) within 30 days of the randomization. Incl. information on the quantity, duration, cause, outcome etc. | Up to 30 days after randomization to the study. | 
| Readmission(s) with acute coronary syndrome | Readmission(s) with acute coronary syndrome. Incl. information on the quantity, duration, cause, outcome etc. | From randomization to the study and up to 1 year hereafter | 
| One-year survival | One-year survival | From randomization to the study and up to 1 year hereafter | 
| Total number of days the primary hospitalization lasts | Length (i.e. total number of days) of the primary hospitalization (i.e. when the patient is randomized to the study). | From randomization to the study and up to 1 year hereafter | 
| Total number of days at the hospital incl. hospitalizations during the first year after inclusion | Total number of days in hospital during the first year after inclusion | From randomization to the study and up to 1 year hereafter | 
| Number of hospitalizations the first year | Number of hospitalizations the first year | From randomization to the study and up to 1 year hereafter | 
| Number and type of performed cardiac investigations | Number and type of performed cardiac investigations; i.e. TTE, KAG, Heart-CT, Holter/R-tests, ECG, blood samples, etc. | From randomization to the study and up to 1 year hereafter | 
| Number of cardiac follow-up consultations at the hospital | Number of cardiac follow-up consultations at the hospital | From randomization to the study and up to 1 year hereafter | 
| Number of check-ups for cardiovascular reasons at the general practitioner | Number of check-ups for cardiovascular reasons at the general practitioner. | From randomization to the study and up to 1 year hereafter | 
| Number of cardiovascular drugs at discharge | Number of cardiovascular drugs at discharge + after 1 year. | From randomization to the study and up to 1 year hereafter | 
| Dosages (DDD) of drugs at discharge | Dosages (DDD) of drugs at discharge + after 1 year. | Up to 1 year after randomization to study. | 
| Incidence of a) new ischemic events, b) arrhythmias, c) and/or heart failure | Incidence of a) new ischemic events, b) arrhythmias, c) and/or heart failure | Up to 1 year after randomization to study. | 
| Health economic analyses of implementing the algorithm | Health economic analyses: How does implementing the algorithm alter the overall costs and resource spending, incl. e.g. social benefits, compared with standard-of-care. i.e. does knowing a more precise 1-year mortality prediction reduce/increase the resource consumption. Will be based on economic analyses of the costs related to the abovementioned outcome measurements. | Up to 1 year after randomization to study. | 
| The algorithm's reception and introduction in clinical use | We wish to investigate how the algorithm is introduced and received in the clinic, both by the medical staff but also the patients. Will be investigated using interviews. | Before start of clinical study and up to 1 year after randomization to study. | 
| The usability of the algorithm | The usability of the algorithm i.e. is it easy to use/understand, any praise or criticisms, ideas for new features etc. Will be based on questionaires and feedback from users. | Before start of clinical study and up to 1 year after randomization to study. | 
| How, and to what extend, is the algorithm used by the medical staff. | We wish to investigate how, and to what extend, the algorithm is used by the medical staff, e.g. are the medical staff inclined to use the prediction, does it alter their treatment choices etc. Will be based on questionaires, interviews, feedback from users, and assessment of look-ups. | Before start of clinical study and up to 1 year after randomization to study. |