跳至主要内容
临床试验/NCT05765903
NCT05765903撤回不适用

Readmission Risk Score (RecuR Score) Pilot at The University of Maryland Charles Regional Medical Center (UM CRMC)

University of Maryland, Baltimore1 个研究点 分布在 1 个国家开始时间: 2024年3月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Number of moderate-high risk participants with 30-day post-discharge hospital readmission

研究概览

简要总结

This study will look to implement a plan for enhanced transitional care for patients at high risk of unplanned hospital readmission in hopes of reducing their risk for readmission in the first 30 days post discharge from an inpatient encounter. Hospital readmissions are an undesirable occurrence that can increase cost for hospitals, and can cause further negative outcomes for patients. Identifying factors that increase a patient's chances of being readmitted to the hospital, as well as developing an intervention to effectively reduce this risk, has historically been challenging.

Our new method uses a combination of common features such as diagnosis and length of hospital stay, with a novel artificial intelligence (AI) algorithm, the RecuR Score model developed by the University of Maryland Medical System, that identifies patients at the highest risk of having an unplanned hospital readmission. Participants identified as higher risk will then be enrolled into our pilot where they will be randomized to receive either the standard of care treatment or an enhanced protocol that includes additional disease education, coordination of home health services, and a focus on their readmission during existing multidisciplinary team huddles.

The main goal of this study is to reduce unplanned hospital readmission within 30 days of initial discharge, in those most at risk of being readmitted, using the aforementioned novel methods for identifying these participants and a transitional care intervention. This success of this goal will be analyzed across different readmission risk levels in the study population. Secondary goals of this study include reducing unplanned hospital readmission within 90 days, reducing 30-day post-discharge mortality, and reducing 30- and 90-day emergency department (ED) usage after an initial hospitalization.

详细描述

  1. BACKGROUND Hospital readmission is an adverse health outcome that incurs significant cost to the healthcare ecosystem. While undesired, unplanned hospital readmission within 30 days of discharge is not uncommon. To improve care quality and reduce unnecessary healthcare costs, in 2013, the Center for Medicare and Medicaid Services (CMS) launched the Hospital Readmissions Reduction Program (HRRP) as part of the Value Based Purchasing (VBP) program to encourage better discharge care coordination. Under the HRRP program, hospitals with high readmission rate incur a payment reduction of up to 3 percent. Since the launch of the HRRP program, reducing hospital readmissions has elevated to a strategic priority of hospitals. Best practices to effectively reduce hospital readmissions while maintaining a healthy operating margin are sought after by hospitals across the country. Studies on most optimal intervention structure and intensity have yet to identify a single effective strategy, and the effectiveness and external validity of interventions in the literature remains uncertain.

Across all patients at University of Maryland Charles Regional Medical Center (UM CRMC) between January 2019 and January 2022, the unplanned hospital readmission rate was 11% and this value is as high as 30% across certain highest risk groups. UM CRMC has implemented a Transitional Care Program with Nurse Navigators since 2011 that focuses on patients that are typically known to have a higher rate of readmission (patients whose primary reason for admission is Diabetes, Congestive Heart Failure [CHF], Chronic Obstructive Pulmonary Disease [COPD] and Hypertension). Despite genuine efforts to manage these patients and provide additional support to these patients prior to discharge and post-discharge, the readmission rate at UM CRMC has remained relatively unchanged over the past five years between 7-15% (mean 11% ± 1.5%) with no sustained year-over-year improvement.

At the University of Maryland Medical System (UMMS), we have developed an artificial intelligence (AI)-powered risk score called the RecuR Score (Readmission Risk Score). The RecuR Score estimates the risk of 30-day unplanned readmission for patients both in-house and during the 30 days after inpatient discharge. Patients are grouped in one of five score levels (1-5), where a RecuR Score of 1 indicates the lowest risk of readmission and a RecuR Score of 5 indicates the highest risk of readmission. This risk score is retrained monthly using data from patients with encounters at UMMS hospitals. The target population is inpatients, currently in-house non-inpatients (Emergency Department, Observation Unit) who might become inpatients, and previous inpatients within 30 days of discharge. The score uses data from the UMMS electronic health record system (EHR), CRISP (Chesapeake Regional Information System for our Patients - the state-designated Health Information Exchange for Maryland), commercial and non-commercial claims, and the U.S. Census Bureau. A comparison of the performance of the RecuR Score compared to LACE and HOSPITAL on the same patients showed that the Area Under the Receiver Operating Characteristic Curve, sometimes known as the Area Under the Curve (AUC), of the RecuR Score significantly outperforms the other two metrics, even prior to discharge. While LACE is only available at discharge, HOSPITAL is described as most accurate at discharge, and even then, it is outperformed by the RecuR Score at 48 hours post-arrival when the RecuR Score is not at its best The literature review shows that efforts to reduce readmission rates are not consistently effective, and it has been difficult to extract a set of interventions that reliably reduces readmissions. Our team theorizes that efforts to reduce readmission rates are not effective because the patients are not adequately stratified into risk categories resulting in interventions not being used on the patients who will benefit the most from the interventions. This pilot addresses this issue by identifying patients at higher risk of readmission using the RecuR Score. The RecuR Score accurately identifies patients at high risk of readmission with an area under the ROC curve of 0.83. This higher risk population (limited to selected principal diagnoses and other inclusion and exclusion criteria) has a higher readmission rate (19.4%) than the hospital's overall readmission rate (11%), which results in a greater opportunity to reduce the readmission rate for the target population.

To address the issue of identifying the most effective interventions, our team also theorizes that the interventions used are not robust, meaning that the impact of the intervention is insufficient. For example, most readmission intervention programs focus on phone calls post-discharge without considering a more complete view of the patient's situation. To address this issue, this pilot is implementing more complex interventions such as additional educational materials, a focus on the patient's readmission risk during interdisciplinary medical team huddles/care transition rounds, and multiple home healthcare programs that cover a broad spectrum of potential interventions. The expectation is that by accurately identifying the higher risk patients and having a broader view of the patients' situation with multiple interventions, we can reduce the 30-day unplanned readmission rate. 2. STUDY OBJECTIVES Offering more complex interventions that are higher intensity than those currently universally provided at UM CRMC. By targeting patients who are at a higher risk of readmission using a novel AI-based risk score, the RecuR Score, resources can be best allocated to those who need them most. These more intense interventions include additional educational materials, emphasis on a patient's readmission risk during their multidisciplinary team huddle, and home health services. For the study, we will only be targeting patients with a high readmission risk (based on the patient's RecuR Score), to test the efficacy of the standardized use of these resources.

The first primary hypothesis for this study is that using a novel UMMS algorithm (RecuR Score) to identify patients at a higher risk of unplanned hospital readmission combined with enhanced pre-discharge and follow-up care interventions including, additional educational material about their health, a focus on their readmission risk during interdisciplinary team huddles, and home health care, can reduce 30-day unplanned hospital readmissions in this high-risk group by 30%. The second primary hypothesis in this fallback design trial, is that using the aforementioned enhanced interventions, there will be a 30% reduction of unplanned hospital readmission risk in patients determined to be a medium-high risk of readmission (RecuR Score level 2 or 3). 3. METHODS This is a parallel-group, two-arm, prospective, randomized, non-blinded, fallback design, controlled superiority study of the impact of a new transitional care model for patients determined to be at higher risk of 30-day unplanned hospital readmission conducted at UM CRMC. UM CRMC is an approximately 100-bed community hospital located in Charles County, Maryland and is part of the University of Maryland Medical System. Patients will be 1:1 (equally) randomized to Arm 1 or Arm 2 using a stratified randomization method with stratification by RecuR Score.

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
None

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

  • •Patient is in Observation (and is expected to be admitted) or is admitted as an Inpatient Encounter. Consider eligible patients in any unit except Emergency Department.
  • •Patient has RecuR Score available 24 hours after start of data collection in EHR.
  • •Patient is at least 18 years of age.
  • •Participant is willing and able to provide informed consent for the trial.
  • •Participant has a RecuR Score greater than or equal to 3; OR Participant has a RecuR Score greater than or equal to 2 and length of stay greater than 10 days; OR Participant has a RecuR Score greater than or equal to 2 with admitting diagnosis of COPD, CHF, Diabetes with elevated HbA1c, Hypertension, or pneumonia; OR Participant has any RecuR Score AND current admission is a readmission where participant was not enrolled during any prior admission.

排除标准

  • •Patients who were enrolled in the pilot during an earlier inpatient hospital encounter.
  • •Patients with encounters having length of stay less than 48 hours or greater than 30 days.
  • •Patients who are not expected to be discharged to "home", e.g., patients who were admitted from skilled nursing facility (SNF) and are expected to be discharged to SNF. Use Admission Source (or disposition field) as an indicator of who may not be discharged home.
  • •Patients with an admission diagnosis of Septicemia.
  • •Patients who lack capacity to sign the consent and participate in the study.
  • •Patients who are not fluent English.
  • •Patients who are already receiving home health care.
  • •Patients who the nursing team believes will require home health care post- hospitalization.
  • •Post-Hoc Exclusion Criteria
  • •Patients who leave against medical advice.

研究组 & 干预措施

Arm 1: Intervention A

Active Comparator
  • Diagnosis education includes verbal 1:1 patient education by the Transitional Nurse Navigator (TNN) and a folder with Epic printed education and other handouts specific to that disease process.
  • Follow-up appointment scheduling assistance, including transportation to the follow-up appointment. The Community Health Worker (CHW) or TNN will schedule the appointments for the PCP and other specialists within 1 week when available.
  • Offer resources in the community post the 1:1 meeting with the patient to meet specific access to care challenges identified for that patient by the TNN or CHW.
  • Provide weekly follow-up calls for one month by TNN or delegate.
  • Social Determinants of Health (SDOH) assessment. Screenings by CHW regarding patients' SDOH and documentation in the EHR (Epic) of this SDOH assessment. If a patient demonstrates a need, a CHW will help identify and offer opportunities for the patient.

干预措施: Standard of Care (Other)

Arm 2: Receives Intervention "A" and Intervention "B"

Experimental
  • Additional educational training using iPads. Education using iPad and/or teach-back components to reinforce the individualized disease and medication specific education. iPads are programmed with patient education from "The Patient Channel." This visit will be completed by a TNN.
  • Focus on readmission risk during Care Transition Rounds. Multi-disciplinary team conducts daily rounds to discuss patient. TNNs share the risk scores for the patients and discuss coordination of the patient receiving interventions and other resources suggested by team members.
  • Home health care from Home Health Services (HHS), Mobile Integrated Healthcare (MIH) or Resources, Education and Access to Community Health (REACH). Involves home visits to the patient, environmental assessments, and medication reconciliation from a home health nurse. Duration and specifications of home health care depend on the patient's needs. Participants will be assigned based on program eligibility and availability.

干预措施: Standard of Care (Other)

Arm 2: Receives Intervention "A" and Intervention "B"

Experimental
  • Additional educational training using iPads. Education using iPad and/or teach-back components to reinforce the individualized disease and medication specific education. iPads are programmed with patient education from "The Patient Channel." This visit will be completed by a TNN.
  • Focus on readmission risk during Care Transition Rounds. Multi-disciplinary team conducts daily rounds to discuss patient. TNNs share the risk scores for the patients and discuss coordination of the patient receiving interventions and other resources suggested by team members.
  • Home health care from Home Health Services (HHS), Mobile Integrated Healthcare (MIH) or Resources, Education and Access to Community Health (REACH). Involves home visits to the patient, environmental assessments, and medication reconciliation from a home health nurse. Duration and specifications of home health care depend on the patient's needs. Participants will be assigned based on program eligibility and availability.

干预措施: Enhanced Care (Other)

结局指标

主要结局

Number of moderate-high risk participants with 30-day post-discharge hospital readmission

时间窗: 30 days post-hospital discharge

This is the second primary endpoint of this fallback design study. It measures the number of moderate-high risk participants, those having a RecuR Score of 2 or 3, with a hospital readmission in the 30 days post-hospital discharge.

Number of overall participants with 30-day post-discharge hospital readmission

时间窗: 30 days post-hospital discharge

This is the first primary endpoint of this fallback design study. It measures the number of participants with a hospital readmission in the 30 days post-hospital discharge in the overall study population.

次要结局

  • 90-day post-discharge emergency department usage(90 days post-hospital discharge)
  • 30 day post-discharge mortality(30 days post-hospital discharge)
  • 30 day post-discharge unplanned hospital readmission(30 days post-hospital discharge)
  • 90-day post-discharge unplanned hospital readmission(90 days post-hospital discharge)
  • 30-day post-discharge emergency department usage(30 days post-hospital discharge)

研究者

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

Stephen N. Davis, MBBS

Professor, Theodore E. Woodward Chair of Medicine, Chair, Department of Medicine; Director, General Clinical Research Center; Director, Institute for Clinical and Translational Research; Vice President Vice President of Clinical Translational Science

University of Maryland, Baltimore

研究点 (1)

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