跳至主要内容
临床试验/NCT05282654
NCT05282654招募中不适用

Real-time Symptom Monitoring Using ePROs to Prevent Adverse Events During Care Transitions

Brigham and Women's Hospital3 个研究点 分布在 1 个国家目标入组 1,300 人开始时间: 2022年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
1,300
试验地点
3
主要终点
Actual adverse events (AEs)

研究概览

简要总结

This study aims to predict and minimize post-discharge adverse events (AEs) during care transitions through early identification and escalation of patient-reported symptoms to inpatient and ambulatory clinicians by way of predictive algorithms and clinically integrated digital health apps. We will (1) develop and prospectively validate a predictive model of post-discharge AEs for patients with multiple chronic conditions (MCC); (2) combine, adapt, extend, and iteratively refine our EHR-integrated digital health infrastructure in a series of design sessions with patient and clinician participants; (3) conduct a RCT to evaluate the impact of ePRO monitoring on post-discharge AEs for MCC patients discharged from the general medicine service across Brigham Health; and (4) use mixed methods to evaluate barriers and facilitators of implementation and use as we develop a plan for sustainability, scale, and dissemination.

详细描述

Adverse events (AE) during care transitions range from 19-28% and may lead to readmissions, representing an ongoing threat to patient safety. Early identification and escalation of patient-reported symptoms to inpatient and ambulatory clinicians is critical, especially for patients with multiple chronic conditions (MCC). Clinically integrated digital health apps have the potential to more accurately predict post-discharge AEs and improve communication for patients, their caregivers, and the care team. Such tools can provide individualized risk assessments of AEs by systematically collecting relevant patient-reported outcomes (PROs) and leveraging standardized application programming interfaces (API) to combine them with electronic health record (EHR) data. While patient-reported outcomes (PROs) are increasingly used in ambulatory settings, their use for real-time symptom monitoring and escalation during transitions from the hospital is novel and potentially transformative-by both empowering patients to better understand their individualized risks of post-discharge AEs, and improving monitoring while transitioning out of the hospital. Our proposed intervention is grounded in evidence-based frameworks for care transitions, and scaling and spread of digital health tools. To inform our intervention, we propose developing and validating a predictive model of post-discharge AEs for 450 MCC patients using relevant PRO questionnaires and electronic health record (EHR) derived variables during our baseline pre-implementation period. Simultaneously, we will combine, adapt, extend, and refine our previously developed EHR-integrated hospital and ambulatory-focused digital health infrastructure to support MCC patients in real-time symptom monitoring using PROs when transitioning out of the hospital. Our intervention uses interoperable, data exchange standards and APIs to seamlessly integrate with existing vendor patient portal offerings, thereby addressing critical gaps and supporting the complete continuum of care. Our multidisciplinary team uses principles of user-centered design and agile software development to rapidly identify, design, develop, refine, and implement requirements from patients and clinicians. Our team will rigorously evaluate this intervention in a large-scale randomized controlled trial of 850 in which we compare our real-time symptom monitoring intervention (425) to usual care (425) for patients with MCCs transitioning out of the hospital. Finally, we will conduct a robust mixed methods evaluation to generate new knowledge and best practices for disseminating, implementing, and using this interoperable intervention at similar institutions with different EHR vendors

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

During main trial (post-implementation period), study investigators, outcomes assessor will be masked to randomization status of all participants

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult (18 years or older)
  • Hospitalized on the general medicine services at Brigham and Women's Hospital or Brigham and Women's Faulkner Hospital for at least 24 hours
  • Have a discharge status of home, home with services, or facility
  • English-speaking patients or their English-speaking legally designated healthcare proxy or next of kin (i.e., a family caregiver)
  • Non-English-speaking patients who have an English-speaking legally designated healthcare proxy or next of kin (i.e., a family caregiver)
  • Two or more chronic conditions: Anxiety, Asthma*, Arthritis (Osteoarthritis, Rheumatoid), Atrial Fibrillation, Cancer*, Cerebral vascular accident, Chronic kidney disease*, Chronic obstructive pulmonary disease (COPD)*, Cirrhosis, Coronary artery disease/Ischemic heart disease, Dementia, Depression, Diabetes mellitus*, End-stage renal disease*, Heart failure*, Hepatitis B, C*, HIV/AIDs, Hyperlipidemia, Hypertension, Inflammatory bowel disease, Osteoporosis, Sickle cell disease, Substance abuse (Alcohol/Opioid)

排除标准

  • Less than 18 years of age
  • Less than two chronic conditions
  • Hospitalized less than 24 hours
  • No identifiable healthcare proxy or next of kin (i.e., a family caregiver)

研究组 & 干预措施

Usual Care (Arm 1)

No Intervention

During the 18-month Baseline Period (Arm 1, n=450) patients will be enrolled and receive usual care to develop the initial predictive model.

Usual Care (Arm 2)

No Intervention

During the 30-month Main Trial (RCT) Period, patients will be randomized to usual care (Arm 2, n=425). Data collection for post-discharge AE determination will occur during both periods.

Intervention (Arm 3)

Experimental

During the 30-month Main Trial (RCT) Period, patients will be randomized to the intervention (Arm 3, n=425). Data collection for post-discharge AE determination will occur during both periods.

干预措施: ePRO Application (Behavioral)

结局指标

主要结局

Actual adverse events (AEs)

时间窗: Up to 30-days after discharge from index hospitalization

The number of actual AEs during the 30-day post-discharge period

Actual preventable adverse events (AEs)

时间窗: Up to 30-days after discharge from index hospitalization

The number of actual AEs during the 30-day post-discharge period

次要结局

  • Potential adverse events (AEs)(Up to 30-days after discharge from index hospitalization)
  • Post-discharge healthcare utilization (ambulatory events)(Up to 30-days after discharge from index hospitalization)
  • Post-discharge healthcare utilization events (hospital readmissions)(Up to 30-days after discharge from index hospitalization)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anuj K. Dalal, MD

Associate Physician

Brigham and Women's Hospital

研究点 (3)

Loading locations...

相似试验

招募中
不适用
ePRO for the Timely Detection of Side Effects in Cancer Patients Undergoing CAR T ImmunotherapyPatient Reported Outcome MeasuresCAR T-Cell Therapy
NCT05354973Stiftung Swiss Tumor Institute11
已完成
不适用
Electronic Monitoring Device of Patient-Reported Outcomes and Function in Improving Patient-Centered Care in Patients With Gastrointestinal Cancer Undergoing SurgeryStage I Adult Liver CancerStage I Colorectal CancerStage IA Gastric CancerStage IA Pancreatic CancerStage IB Gastric CancerStage IB Pancreatic CancerStage II Adult Liver CancerStage IIA Colorectal CancerStage IIA Gastric CancerStage IIA Pancreatic CancerStage IIB Colorectal CancerStage IIB Gastric CancerStage IIB Pancreatic CancerStage IIC Colorectal CancerStage III Pancreatic CancerStage IIIA Adult Liver CancerStage IIIA Colorectal CancerStage IIIA Gastric CancerStage IIIB Adult Liver CancerStage IIIB Colorectal CancerStage IIIB Gastric CancerStage IIIC Adult Liver CancerStage IIIC Colorectal CancerStage IIIC Gastric CancerStage IV Gastric CancerStage IVA Colorectal CancerStage IVA Liver CancerStage IVA Pancreatic CancerStage IVB Colorectal CancerStage IVB Liver CancerStage IVB Pancreatic Cancer
NCT02511821City of Hope Medical Center22
招募中
不适用
Electronic Symptom Monitoring Program for Triggered Palliative Referrals in Patients With Thoracic CancerMalignant Thoracic Neoplasm
NCT06396598Ohio State University Comprehensive Cancer Center157
已完成
不适用
Real-time Activity Monitoring to Prevent Admissions During RadioTherapyCancer of the Head and NeckCancer of LungCancer of EsophagusCancer of Stomach
NCT03102229Montefiore Medical Center40
已完成
不适用
Tele-Health Electronic Monitoring to Reduce Post Discharge Complications and Surgical Site InfectionsPeripheral Vascular Disease
NCT02767011CAMC Health System30