Clinical Implementation of a Novel Decision Support Tool in Patients With Ischemic Heart Disease
- Conditions
- Ischemic Heart Disease
- Interventions
- Other: PM HeartIHD prediction
- Registration Number
- NCT06033014
- Lead Sponsor
- Rigshospitalet, Denmark
- Brief Summary
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
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?
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 8000
- 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
- <18 years of age
- Living outside Denmark
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention PM HeartIHD prediction The one-year mortality prediction, calculated by the PM Heart algorithm, will be available to the physician.
- Primary Outcome Measures
Name Time Method Number and duration of readmissions within one month after randomization From randomization to the study and up to 1 year hereafter 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".Number and cause of death (all-cause mortality) within one year after randomization From randomization to the study and up to 1 year hereafter A composite outcome of a) readmissions within one month, and 2) all-cause mortality within one year - for patients randomized to the study.
- Secondary Outcome Measures
Name Time Method Cardiovascular readmission(s) within 30 days of the randomization Up to 30 days after randomization to the study. Cardiovascular readmission(s) within 30 days of the randomization. Incl. information on the quantity, duration, cause, outcome etc.
Total number of days at the hospital incl. hospitalizations during the first year after inclusion From randomization to the study and up to 1 year hereafter Total number of days in hospital during the first year after inclusion
Readmission(s) with acute coronary syndrome From randomization to the study and up to 1 year hereafter Readmission(s) with acute coronary syndrome. Incl. information on the quantity, duration, cause, outcome etc.
One-year survival From randomization to the study and up to 1 year hereafter One-year survival
Total number of days the primary hospitalization lasts From randomization to the study and up to 1 year hereafter Length (i.e. total number of days) of the primary hospitalization (i.e. when the patient is randomized to the study).
Dosages (DDD) of drugs at discharge Up to 1 year after randomization to study. Dosages (DDD) of drugs at discharge + after 1 year.
Number of hospitalizations the first year From randomization to the study and up to 1 year hereafter Number of hospitalizations the first year
Number of cardiac follow-up consultations at the hospital From randomization to the study and up to 1 year hereafter Number of cardiac follow-up consultations at the hospital
Readmission(s) within 30 days of the randomization Up to 30 days after randomization to the study. Readmission(s) within 30 days of the randomization. Incl. information on the quantity, duration, cause, outcome etc.
Number and type of performed cardiac investigations From randomization to the study and up to 1 year hereafter Number and type of performed cardiac investigations; i.e. TTE, KAG, Heart-CT, Holter/R-tests, ECG, blood samples, etc.
Number of check-ups for cardiovascular reasons at the general practitioner From randomization to the study and up to 1 year hereafter Number of check-ups for cardiovascular reasons at the general practitioner.
Number of cardiovascular drugs at discharge From randomization to the study and up to 1 year hereafter Number of cardiovascular drugs at discharge + after 1 year.
The algorithm's reception and introduction in clinical use Before start of clinical study and up to 1 year after randomization to study. 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.The usability of the algorithm Before start of clinical study and up to 1 year after randomization to study. 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.How, and to what extend, is the algorithm used by the medical staff. Before start of clinical study and up to 1 year after randomization to study. 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".Incidence of a) new ischemic events, b) arrhythmias, c) and/or heart failure Up to 1 year after randomization to study. Incidence of a) new ischemic events, b) arrhythmias, c) and/or heart failure
Health economic analyses of implementing the algorithm Up to 1 year after randomization to study. 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.
Trial Locations
- Locations (1)
Department of Cardiology, The Heart Centre, Rigshospitalet Copenhagen University Hospital.
🇩🇰Copenhagen Ø, Denmark