Clinical trial NCT04966117: Risk-guided Disease Management in Coronary Artery Disease
Official title: A Risk-guided Disease Management and Tele-rehabilitation Program to Reduce Re-admissions in Coronary Artery Disease (Risk-Guided CAD)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Chronic Disease
Nurse's Role
Keywords: Cardiac rehabilitation
Disease Management Program
Secondary Prevention
Rehospitalization
mHealth
Lead sponsor: Baker Heart and Diabetes Institute
Sponsor class: OTHER
Collaborators: name: Heartwest
name: University of Melbourne
name: Queen's University, Belfast
name: Western Health
First posted: 2021-07-19
Enrollment: 270
Sex: ALL
Minimum age (years): 30
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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)
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Aged between 30 to 74 years; AND
2. Hospitalised with CAD or other eligible cardiac procedure or condition including acute myocardial infarction (STEMI or NSTEMI), unstable angina, coronary artery bypass grafting or percutaneous coronary intervention; AND
3. Defined as higher risk (score \>= 5) by PEGASUS-TIMI 54 criteria; AND
4. Eligible for Medicare.

Exclusion Criteria:

1. Inability to provide written informed consent; OR
2. Non-English speaking; OR
3. Inability to attend clinic visits; OR
4. Inability to engage with an app due to low technical literacy or lacking access to a smart phone or wi-fi; OR
5. Hospitalised with a primary diagnosis of heart failure; OR
6. eGFR \<30 ml/min/1.73m2 (CKD stage 4 or stage 5); OR
7. Valve disease only; OR
8. Requiring palliative care; OR
9. Concomitant terminal non-cardiac illnesses that could influence 12-month prognosis (e.g. advanced malignancy); OR
10. Participating in another study with a potential but unknown effect on outcome.

Primary outcomes:
measure: Hospitalization or death
timeFrame: 90 days post discharge
Secondary outcomes:
measure: Hospitalization or death
timeFrame: 30 days post discharge
measure: Provider adherence to best practice guidelines
timeFrame: 12 months post discharge
measure: Risk factor control - lipids
timeFrame: 12 months post discharge
measure: Risk factor control - blood pressure
timeFrame: 12 months post discharge
measure: Health well-being
timeFrame: 12 months post discharge
Other outcomes:
measure: Mobile Health (mHealth) engagement
timeFrame: 12 months post discharge
Locations:
city: Melbourne
country: Australia
facility: Baker Heart and Diabetes Institute
state: Victoria
Study officials:
affiliation: Baker Heart and Diabetes Institute
name: Melinda J Carrington, PhD
role: PRINCIPAL_INVESTIGATOR
References: