Using Personalized Risk and Digital Tools to Guide Transitions Following Acute Kidney Events - Virtual Care: Virtual Home Hospital With Remote Monitoring to Reduce Acute Care Hospitalization
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 354
- 试验地点
- 2
- 主要终点
- the number of days alive out of hospital
研究概览
简要总结
Method: Randomized Controlled Trial Study Duration: 3 Years Study Centre(s) University of Calgary and University of Alberta Objectives: To fill care gaps by implementing strategies to reduce length of hospital stay, readmission rates, and improve long-term outcomes after Acute Kidney Injury (AKI). Number of Participants: Three Hundred and fifty four (n=354) Diagnosis and Main Inclusion Criteria: Hospitalized adults with AKI at high risk of hospital readmission or death
Study Intervention: Multi-component Digital Health Solutions, including:
- Computerized Clinical Decision Support (CDS) and
- Virtual Care Delivered through Hospital at Home (VC) Duration of administration: Determined by the Patient's clinical team Reference therapy: Usual Care Statistical Analyses: Descriptive Analysis, Regression
详细描述
- Background and Rationale
Acute kidney injury (AKI) is a common and serious complication in hospitals. A major care gap for survivors of AKI is the fragmentation of care that exists as they transition from the hospital to their home. This contributes to a high risk of adverse long-term outcomes, including prolonged hospitalization, high rates of readmission, cardiovascular events, infections, progression to chronic kidney disease (CKD), kidney failure requiring dialysis, and death.
To address this challenge, the investigators are implementing multi-component digital health solutions including Computerized Clinical Decision Support (CDS) and Digital Remote Patient Monitoring (dRPM) through Virtual Care (VC) programs in Alberta to reduce length of hospital stay and readmission rates and improve long-term outcomes after AKI.
Evidence of the effectiveness of the two digital health solutions is available from Alberta and international clinical trials. Our team previously implemented a computerized CDS intervention for AKI risk assessment and prevention and achieved improved AKI prevention and reduced AKI incidence after cardiac procedures across the province. The investigators will use a similar approach to identify high risk patients with AKI and provide recommendations to improve the quality of their care, which is well suited to the evolving digital health infrastructure in Alberta.
Providing hospital-level care at home through Virtual Care (VC) teams has been shown to reduce mortality and readmission rates. Alberta's VC program have existed in both Edmonton and Calgary since 2018 and have reported lower readmission rates, Emergency Department (ED) visits and use of Emergency Medical Services than observed with usual care. Patients reported that the program helped them regain their independence and function. Alberta's VC programs have implemented dRPM technology, which has been further associated with fewer days in hospital and emergency department visits. Patients reported better quality of care using this technology. The framework for dRPM and complex care planning is already in place in Alberta's Virtual Care programs. The investigators intend to utilize these programs to improve transitions of care through early facilitated discharge and enhanced follow-up of patients with AKI at high risk of hospital readmission, who require frequent monitoring and more intensive care strategies during this vulnerable period of transition in care. 2. Research Question and Objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants will be randomized in either arm, will be coded such that the outcome assessor is blinded to the arm assignment of the participant.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old.
- •AKI identified in hospital using Kidney Disease Improving Global Outcomes (KDIGO) criteria
- •Hospitalization > 48 hours.
- •LACE (L= Length patient Stay in the hospital, A= Acuity of Admission of patient in the hospital, C= Comorbidity and E= Emergency Visit.) Score 12 or higher.
- •Meets all inclusion criteria of Virtual Home Hospital programs of Calgary and Edmonton zones.
排除标准
- •Non-Alberta residents.
- •Resides outside the catchment areas for the Calgary and Edmonton Virtual Home Hospital programs.
- •C1 or C2 goals of care.
- •Hospitalization > 30 days.
- •Will be discharged to long-term care.
- •Kidney failure receiving dialysis.
- •Already admitted in Virtual Home Hospital Program
研究组 & 干预措施
Virtual Care
Participants will receive virtual care through Virtual Home Hospital programs in Alberta for their hospital to home transition of care.
干预措施: Virtual Care (Other)
Usual Care
Participants will be discharged as per usual care practices from hospital to their home.
结局指标
主要结局
the number of days alive out of hospital
时间窗: Up to 45 days from the date of randomization
the number of days alive out of hospital
次要结局
- Estimated Glomerular Filtration (eGFR)(At 90 days after the date of randomization)
- patient experience care transition measure(At 45 days after the date of randomization)
- Emergency Department visits(Up to 45 days from the date of randomization)
- number of physician visits by specialty(Up to 45 days from the date of randomization)
- the time as inpatient in hospital(Up to 45 days from the date of randomization)
- death(from the date of randomization up to 45 days, or date of death from any cause, whichever came first,)
- total number of physician visits(Up to 45 days from the date of randomization)
- hospital readmission(Up to 45 days from the date of randomization)
- Urine Albumin Creatinine Ration (ACR)(At 90 days after the date of randomization)
- Changes to medication prescription(Up to 45 days from the date of randomization)
- laboratory testing(Up to 45 days from the date of randomization)
- Euro Qol- 5 Dimension (EQ5D)(At 45 days after the date of randomization)