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| Name | Class |
|---|---|
| Heartwest | UNKNOWN |
| University of Melbourne | OTHER |
| Queen's University, Belfast | OTHER |
| Western Health |
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Coronary artery disease (CAD) is the number one killer of Australians with a high risk for a recurrent event(s) and hospital readmission. Many of these readmissions can be prevented with better management to control the problem of CAD. A disease management program, led by nurses who interact with other health professionals/providers, can help with education and counselling, taking medications correctly and making healthy lifestyle changes for higher risk patients. Newer models of disease management programs make use of mobile devices (such as an "app") and telehealth (by phone or video call) to monitor and manage health which could facilitate CAD management. Therefore, the aim of this study is to test this type of disease management program (DMP) compared to standard care for reducing hospital readmissions or death in people with CAD who are at high risk of being readmitted. The Investigators envisage that a novel Risk-Guided DMP will be favorable to patients and associated with high-level participation. The Investigators hypothesize that high-risk patients randomized to Risk-Guided CAD will have reduced hospital readmissions or death compared with those randomized to usual care.
The Investigators aim to test a nurse-led, technology-enabled model of health care delivery, called Risk-Guided DMP, to reduce readmissions following CAD, thereby enhancing recovery and survivorship.
The Investigators envisage that a novel Risk-Guided DMP will be favorable to patients and associated with high-level participation. The Investigators hypothesize reduced hospital readmissions or death for high-risk patients randomized to Risk-Guided DMP compared to usual care.
Methods
This proposed study is an effectiveness and feasibility trial of a risk guided DMP to reduce hospital readmissions in CAD patients. The Investigators seek to do this by adopting innovative approaches to:
i) a community-based secondary prevention DMP, ii) supported by a novel m-Health app (SmartCR developed by CardiHab) to address components of a Cardiac Rehabilitation (CR) program, and iii) selection of higher risk patients for appropriate management by validated (PEGASUS-TIMI 54) criteria.
Patients aged 30-74 years who have been hospitalised with CAD will be recruited. Electronic medical records from Western Health (Sunshine or Footscray hospital) will be routinely screened (twice per week) to invite patients to participate. Heartwest cardiologists will also identify patients from their surgical lists.
Baseline measures will include clinical features (including severity and number of affected vessels) and biochemistry (troponin, B-type natriuretic protein, renal function) from medical records; patient self-reported socio-demographic features, cognitive function using the Montreal Cognitive Assessment as an important predictor of readmission, mental health via the Patient Health Questionnaire (PHQ-9) and Generalised Anxiety Disorder (GAD-7) questionnaire and quality of life using the Assessment of Quality of Life (AQoL-8D) questionnaire. Exercise capacity will be quantified by peak oxygen uptake (VO2 peak) and cardiac function will be assessed via two-dimensional echocardiography.
Risk evaluation will be performed by PEGASUS-TIMI 54 criteria for selection of high risk patients [score ≥5] who have an increased risk of a secondary event.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risk-Guided DMP | Experimental | The intervention is a 12 month disease management program after hospital discharge for coronary artery disease that is overseen by a cardiac nurse. |
|
| Usual Care | Active Comparator | Usual care patients will receive standard cardiology care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risk-Guided DMP | Behavioral | Patients will be assigned a cardiac nurse to help manage their heart condition who will:
|
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization or death | Unplanned all-cause hospital readmission or death | 90 days post discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization or death | Short term unplanned all-cause hospital readmission or death | 30 days post discharge |
| Provider adherence to best practice guidelines | Increased prescription of lipid-lowering, anti-hypertensive (e.g. beta-blocker) and antiplatelet agents |
| Measure | Description | Time Frame |
|---|---|---|
| Mobile Health (mHealth) engagement | SmartCR (cardiac rehabilitation app) will be evaluated by measures of app engagement by quantifying data entry events and other indicators of program participation/week | 12 months post discharge |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melinda J Carrington, PhD | Baker Heart and Diabetes Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baker Heart and Diabetes Institute | Melbourne | Victoria | 3004 | Australia |
The data to be shared will be all of the individual participant data collected during the trial, after de-identification and underlying published results only. The data will be available to only researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Principal Investigator. The data will be available for any approved purpose.
Immediately following publication; no end date.
Access subject to approvals by Principal Investigator.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 19, 2021 | Jun 28, 2021 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 28, 2021 | Jun 28, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| UNKNOWN |
Single site, open, parallel-group randomized controlled trial of a disease management program (intervention group) to reduce hospital readmissions or death compared to usual care (control group)
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There are no other parties who will be masked in the clinical trial.
|
| Usual Care | Behavioral | Usual care patients will receive standard cardiology care as scheduled that includes adherence to guideline-based care (medications and physical activity), education (self-care), a treatment plan to manage co-morbidities, early post-discharge follow-up/support and routine preventative care. |
|
| 12 months post discharge |
| Risk factor control - lipids | Change in LDL-cholesterol (mmol/L) | 12 months post discharge |
| Risk factor control - blood pressure | Change in systolic and diastolic blood pressure (mmHg) | 12 months post discharge |
| Health well-being | Change in quality of life (via AQoL-8D total scores and 8 dimension scores) | 12 months post discharge |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |