None listed
Conditions
Brief summary
Heart Failure (HF), often accompanied by comorbidities, is characterised by high rates of death and hospital readmissions. Hospital readmissions consume beds and resources. There has been a lot of effort in the USA (less to date in Australia) to reduce them. This seems to vary from >30% at one month in Victoria and Tasmania, to 20% in South Australia. (CSANZ 2017). The disease management program (DMP) is one of the variables most associated with readmissions following index admission for HF. DMPs are expensive making their availability difficult, hence if applied uniformly to all patients, they may prove wasteful in low-risk, and insufficient, in high-risk patients. Data from the TasHELP study have shown that such readmissions can be predicted (JAMA Cardiol 2016;1:362-4) and possibly prevented, opening the possibility of risk-based targeting of DMP. This proposed PhD project, that will follow a prospective randomised controlled trial, will apply TAS-HELP risk algorithm focusing on intensities of HF DMPs to investigate its effectiveness in reducing 30-day readmission following HF diagnosis and lowering costs. Consecutive patients admitted for HF from July 2019 will be screened for eligibility and asked to participate following their informed consent. Enrolled patients will undergo evaluation of readmission risk and those 50% or more risk will be randomnised to usual care or intervention arm. The Victorian hospitals participating will include The Alfred Hospital and Western Health Footscray and Sunshine Hospitals. The impact of comorbidities on readmission will also be evaluated. A secondary outcome of this RCT will focus on quality of life (QoL) measures and fluid status. Patients in the control arm will receive hospital's usual care while those in the intervention arm will receive hospital care plus the following: DMP intensity adjusted for risk, based on five steps: i) adequate pre-discharge review of fluid status, ii) continuity of transitional care to the community, iii) a nurse-based home DMP lead by independent HF- Nurse, iv) surveillance and v) home-based pre-crisis management. In addition, the intervention group will be offered our HF app. This app is designed to deliver education for HF patients. It also measures QoL, HF Knowledge and self-care behaviors. Throughout the duration of the program which is 52 days, the patient records daily weight and is being given tasks and goals to achieve. The HF app is designed based on Heart Foundation guidelines. This proposed RCT will provide the strongest possible evidence for a home based nursing follow up base on risk for hospital readmission. The novelty of this study is the intervention delivered by an independent health practitioner, ensuring external validity and the application of both an avatar style patient education program, as well as the addition of a portable echo assessment in patient’s home.
Interventions
Enrolled patients will undergo evaluation of risk for hospital readmission or death. Those at high risk ( 33% or more) will be randomized into usual care or our intervention DMP-Plus program. Our risk calculation is based on established algorithm developed with the ETHELRED trial and is based on social, clinical and imaging parameters.
Intervention Plan:
Hospitals standard usual care for outpatient follow up plus:
A Heart Failure nurse who will be working for this study and will be independe
Enrolled patients will undergo evaluation of risk for hospital readmission or death. Those at high risk ( 33% or more) will be randomized into usual care or our intervention DMP-Plus program. Our risk calculation is based on established algorithm developed with the ETHELRED trial and is based on social, clinical and imaging parameters. Intervention Plan: Hospitals standard usual care for outpatient follow up plus: A Heart Failure nurse who will be working for this study and will be independent from patient’s usual care, will be delivering our DMP-Plus. The HF Nurse will follow the patient for a period of three months, as both an inpatient and outpatient and will act as a ’transition coach ‘to visit the patient in the hospital prior to discharge and ensure appropriate medication reconciliation, follow-up plans, and education. Pre- discharge Lung and Inferior Vena Cava (IVC) assessment (LUICA) will be performed by obtaining images from patients chest from 9 spots, as per study operations manual, with a portable Ultra sound Device. The HF nurse will follow up the patients once a fortnight at home for one month, for approximate 90minutes, to assess patient’s condition and protocol adherence. The nurse will also detect any problems and will determine if there are any gaps in patients HF education. The intervention includes: - A phone call assessment within a week post discharge, to provide post-discharge support and ask patient about his/hers condition. This support will be in addition to any potential scheduled follow ups by the hospital. -Evaluation of coexisting comorbidities. - Assessment of psychosocial risk factors including depression, anxiety and social factors. (e.g. Financial changes or relationship changes) Intensified interaction with patients for three months. This includes assessment of functional capacity, fluid status, cardiac rhythm, cognitive, mood and nutritional status. During home visits assessment of volume/fluid status using our handheld echo (Lung Ultra Sound and IVC congestion), following the same procedures as our initial assessment. If there are changes in volume status, the study personnel will liaise with the care team to guide optimal diuretic treatment. Weight and vital signs records and assessments by the HF nurse. Medication review, including need for titration or change, and possible side effects. The HF nurse will respond to changes by assessment of the precipitant, drug titration (especially diuretics and fluid restriction), and interaction with the hospital HF care team, patients GP, specialist and ED. The HF nurse will also try to develop engagement strategy and built appropriate rapport with the patients. Patient’s adherence is critical, therefore engagement strategies need to be developed. Engagement strategies will include phone call support, tele monitoring with a diary that will have reminders or sms reminders and on line HF education. Online- Heart Failure education Staying Strong and Healthy with Heart Failure. An educational program that is available online was designed by the Baker heart and Diabetes Institute; University of Tasmania and Menzies Institute (https://www.youtube.com/watch?v=M_7lSKleczQ&t=364s) will be offered to patients to enhance education and HF knowledge. This video emphasizes in HF education main points and it will be offered in conjunction with other information and/or educational materials that will be given by the hospitals. The duration of the video is 8 minutes. A brief questionnaire of five multiple-choice questions will be administered at the end of the video. A point of care assessment of Hb/Ht will be done using a Nova Stat Strip point of care device that uses plasma volume to assess the levels Hb and Ht. It assesses capillary blood drawn for the prick of the finger. During our follow up period LUICA and PoC Hb/Ht findings will be discussed with clinicians if patients are showing signs of congestion. Patients that found to be at 32% risk or lower will be followed up at 90 days for primary and secondary outcome measures.
Sponsors
Baker Institute for Heart and Diabetes
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age or older 2. Emergency Department admission with a primary diagnosis of Acute Decompensated Heart Failure confirmed by the treating physicians, in accordance with the HF guidelines.
Exclusion criteria
1. Unable to provide written informed consent to participate in this study 2. Patients that need palliative care. Discussion with the physician and assessment of palliative care needs. 3. Participating in another clinical research trial where randomisation to study arms would be unacceptable 4. Patients who live in an aged care facility (eg. Nursing Home) 5. Moderate to severe primary mitral or aortic valve disease 6. Concomitant unstable angina, acute myocardial infarction 7. Cardiac device malfunction 8. Endocarditis 9. Patients with Left Ventricular Assistant Device (LVAD) 10. Patients with asymptomatic Left Ventricular (LV) dysfunction 11. Potentially reversible LV dysfunction, such as post-partum, alcoholic cardiomyopathy, hyperthyroidism. 12. Abuse of alcohol or drugs 13. Concomitant terminal non-cardiac illnesses that could influence 12 month prognosis (e.g. advanced malignancy) 14. Inability to acquire interpretable images (identified from baseline echo) Risk-guided strategy for reducing readmission for Acute Decompensated Heart Failure, 15. In the investigators opinion any other condition that may affect the safety procedures of the study. (patient and personnel)
Outcome results
None listed