Improving Outcomes in Patients With Cardiovascular Seasonality

Study Overview
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Brief Summary
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Despite a range of evidence-based programs to identify high-risk patients and apply strategies to keep them out of hospital, a growing number of cases are resistant to such programs. These seasonal frequent flyers routinely overwhelm hospital services. The investigators have identified vulnerability to provocation of seasonal and acute weather changes (seasonality) as a major driver of preventable/costly hospitalisations in typically older patients with heart disease and multimorbidity subject to gold-standard care. From this research the investigators developed the RESILIENCE Program which is tailored to each person and designed to assist the participants to become more resilient to changes in the weather. The overall aim of the RESILIENCE Trial is to demonstrate the cost-effectiveness of an individually tailored, interventional health care program designed to address the debilitating, costly and deadly phenomenon of seasonal vulnerability in a growing number of individuals admitted to hospital with chronic heart disease and multimorbidity.

Detailed Description
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After informed written consent, a total of 203 participants (of an initially planned 300 participants prior to the COVID pandemic) had comprehensive sociodemographic and clinical profiling to establish extent of multi-morbidity. Baseline demographic, lifestyle and medical history profiling were also completed - including anthropometric measurements, and blood pressure, handgrip strength test and sit-stand tests. The Montreal Cognitive Assessment, depression, anxiety and quality of life questionnaires were also applied. Blood biochemistry will be assessed for vitamin D, blood counts, thyroid and renal function, hemoglobin and glycated hemoglobin levels. After the initial profiling, 203 participants were randomized to standard care or the RESILIENCE Program group and discharged alive to home. In addition to the standard care participants would normally receive, the one in two participants assigned to the RESILIENCE Program group will receive a structured follow-up over the next 12 months to monitor and adjust the participant's status and management from a seasonal perspective. These will include a combination of strategies designed to promote seasonal resilience. Specifically, this will include: Profiling of the participants seasonal vulnerability: prior to hospital discharge, participants will be clinically profiled and then fitted with an physiological monitor (to measure heart rate, physical activity levels) at the point of hospital discharge. Within 7-14 days after discharge a 60-80-minute home visit will be conducted by a dedicated RESILIENCE Nurse to assess: Physiological Status: The physiological monitor will be collected for analysis at this visit and blood pressure will be measured. Environment: A formal home environment assessment including presence/type of heating and/or cooling equipment, air quality and any other factors that might contribute to seasonal instability (e.g. lack of home insulation). Indoor versus outdoor temperature and humidity will also be measured. Behaviour: Participants will be asked to describe the adaptive changes they make to activity levels, diet, clothing and heating/cooling behaviours during winter versus summer and acute weather events; with an immediate assessment relevant to ambient weather conditions. Modulating Factors: The (socio-economic) capacity for the participant/family to apply resources/funds to maintain thermoregulatory control (including clothing choices and ability to pay power bills) throughout the year will be assessed; alongside those personal factors/decisions that potentially determine how they prioritize other forms of expenditure. Participants with the capacity and/or preference for videoconferencing will be offered virtual/remote attendance or a standard outpatient clinic appointment at the Austin Hospital RESILIENCE Clinic with a dedicated RESILIENCE physician to develop a long-term plan to help promote/maintain seasonal resilience. The clinic appointments will occur with the individual at 21 days, 6 months and 12 months post hospital discharge. At 12 months, the comprehensive socio-demographic and clinical profiling will be repeated in the RESILIENCE Program group. Due to the impact of the COVID epidemic (with extensive lockdowns in Melbourne, Victoria and clinical restrictions at the Austin Hospital), a reduced study cohort was recruited (203 of planned 300 eligible and randomised participants) with follow-up extended beyond 12 months to (partially) restore study power to examine the potential impact of the study intervention on the same health outcomes.

Official Title
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Tailored, Interventional Health Care Program Designed to Address Seasonal Vulnerability in Patients With Chronic Heart Disease and Multimorbidity: the REsilience to Seasonal ILlness and Increased Emergency admissioNs CarE (RESILIENCE) Trial

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Behavioral: RESILIENCE Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individual aged 18 years and over. Admitted to hospital due to a medical emergency for any reason but with a chronic form of heart disease (i.e. including. coronary artery disease, atrial fibrillation and/or heart failure) requiring treatment Multimorbidity (defined as two or more chronic conditions requiring active treatment/management). A planned discharge to home within a 10km radius of the hospital. Exclusion Criteria: Living in residential aged care Terminal illness and/or unable to give informed consent Died during index admission

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised control trial of two parallel groups; Standard Care Standard Care + RESILIENCE Program
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care Group<br>Participants will receive the standard care provided by their institution. | |
| Active Comparator: RESILIENCE Program group<br>Participants will receive the RESILIENCE Program on top of the standard care provided by their institution. | Behavioral: RESILIENCE Program<br>* In addition to the standard care participants would normally receive (including exposure to any standard hospital avoidance programs), the 150 participants assigned to the RESILIENCE Program group will receive a combination of strategies designed to promote seasonal resilience. This includes profiling of seasonal vulnerability; a 60-80 minute home visit by the RESILIENCE Nurse to assess physiological status, behavioural adaptations, environment, and modulating factors; a dedicated RESILIENCE Clinic with a dedicated RESILIENCE physician to develop a long-term plan to help promote/maintain seasonal resilience and; a structured follow-up over the next 12 months to monitor and adjust the participant's status and management from a seasonal perspective.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days-alive-out-of-hospital (DAOH) | Defined as the proportion of maximal days follow-up where the study participant was not admitted to hospital and alive. DAOH data will be collected from hospital records. During minimum 12-month follow-up, the pre-specified threshold for a clinically significant effect in favour of the RESILIENCE Program is a 10% increase in DOAH compared to standard care. | 12-months (minimum) post randomisation to study census (July 2023) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall pattern of hospitalization | Frequency and causes of unplanned hospitalization plus Emergency Service and out-patient visits and related bed-days will be determined from hospital medical records. | 12-months (minimum) post randomisation to study census | 
| Number of community care visits | Including visits to the General Practitioner, pharmacist consultations, allied health services, supported-care and pharmacotherapy determined through the RESILIENCE Clinic. | 12-months (minimum) post randomisation to study census | 
| Healthcare costs | Healthcare costs assessed for extending days-alive-out-of-hospital, transport and other costs due to clinic attendance as well as co-payments for clinic visits and drug therapy. All expenditure will be standardized for the reporting year and an extrapolation of the potential impact of the RESILIENCE Program from the perspective of the Australian health care system will be made. QALYs will be calculated from survival and the AQoL-8D as the primary outcome for cost-utility analysis. | 12-months (minimum) post randomisation to study census |