Improving Outcomes in Patients With Cardiovascular Seasonality (RESILIENCE)

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Behavioral: RESILIENCE Program

Detailed Description

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:

1. 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.

2. 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.
3. 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.

• Study Type: Interventional
• Enrollment (Actual): 203
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Heidelberg, Victoria, Australia, 3084
      • Austin Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Individual aged 18 years and over.
2. 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
3. Multimorbidity (defined as two or more chronic conditions requiring active treatment/management).
4. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Care Group; Participants will receive the standard care provided by their institution.
Active Comparator: RESILIENCE Program group; Participants will receive the RESILIENCE Program on top of the standard care provided by their institution.	Behavioral: RESILIENCE Program; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sheila Patel
• Collaborators: University of Melbourne
• Investigators: Principal Investigator: Louise M Burrell, MD, University of Melbourne

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2020
• Primary Completion (Actual): July 28, 2023
• Study Completion (Actual): July 28, 2023

Study Registration Dates

• First Submitted: October 29, 2020
• First Submitted That Met QC Criteria: October 29, 2020
• First Posted (Actual): November 4, 2020

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: CT19026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Trial data will be disseminated in the form of a publication to a relevant clinical journal and presentation at appropriate scientific conferences. Individual participant data that underlie the published results, may be shared on request by the RESILIENCE TRIAL Investigators at the completion of the trial and reporting of the endpoints.
• IPD Sharing Time Frame: Beginning following main results publication; no end date determined
• IPD Sharing Access Criteria: Case-by-case basis at the discretion of the Primary Sponsor and RESILIENCE TRIAL Investigators and provide a methodologically sound proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No