UM CRMC RecuR Score Pilot

NCT05765903 | Withdrawn

• 1 other identifier: HP-00104036
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Patient Readmission; Pulmonary Disease, Chronic Obstructive; Heart Failure; Diabetes Mellitus Poor Control; Hypertension; Pneumonia

Keywords

patient; unplanned; hospital; readmissions

Outcome Measures

Primary Outcomes (2)

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

  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.

  30 days post-hospital discharge

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

  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.

  30 days post-hospital discharge

Secondary Outcomes (5)

• 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

• 90-day post-discharge emergency department usage

  90 days post-hospital discharge

Study Arms (2)

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.

Other: Standard of Care

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.

Other: Standard of Care; Other: Enhanced Care

Interventions

Standard of Care OTHER

* Diagnosis education. * Follow-appointment scheduling assistance. * Offer resources in the community. * Offer weekly follow-up calls for one month. * Social Determinants of Health (SDoH) assessment.

Also known as: University of Maryland Medical System (UMMS) Charles Regional Medical Center (CRMC) Appendix A.1. Transitional Care/Nurse Navigator Program, Policy Number: 9770-001

Arm 1: Intervention A; Arm 2: Receives Intervention "A" and Intervention "B"

Enhanced Care OTHER

* Additional educational training using computer tablet devices, such as iPads. * Focus on readmission risk. * Set-up Home Health Services (HHS), Mobile Integrated Healthcare (MIH) or Resources, Education and Access to Community Health (REACH).

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patients who leave against medical advice.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Charles Regional Medical Center

La Plata, Maryland, 20646, United States

Location

Related Publications (12)

• Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.

  PMID: 3558716 BACKGROUND

• Damery S, Combes G. Evaluating the predictive strength of the LACE index in identifying patients at high risk of hospital readmission following an inpatient episode: a retrospective cohort study. BMJ Open. 2017 Jul 13;7(7):e016921. doi: 10.1136/bmjopen-2017-016921.

  PMID: 28710226 BACKGROUND

• Dhalla IA, O'Brien T, Morra D, Thorpe KE, Wong BM, Mehta R, Frost DW, Abrams H, Ko F, Van Rooyen P, Bell CM, Gruneir A, Lewis GH, Daub S, Anderson GM, Hawker GA, Rochon PA, Laupacis A. Effect of a postdischarge virtual ward on readmission or death for high-risk patients: a randomized clinical trial. JAMA. 2014 Oct 1;312(13):1305-12. doi: 10.1001/jama.2014.11492.

  PMID: 25268437 BACKGROUND

• Donze JD, Williams MV, Robinson EJ, Zimlichman E, Aujesky D, Vasilevskis EE, Kripalani S, Metlay JP, Wallington T, Fletcher GS, Auerbach AD, Schnipper JL. International Validity of the HOSPITAL Score to Predict 30-Day Potentially Avoidable Hospital Readmissions. JAMA Intern Med. 2016 Apr;176(4):496-502. doi: 10.1001/jamainternmed.2015.8462.

  PMID: 26954698 BACKGROUND

• Hansen LO, Young RS, Hinami K, Leung A, Williams MV. Interventions to reduce 30-day rehospitalization: a systematic review. Ann Intern Med. 2011 Oct 18;155(8):520-8. doi: 10.7326/0003-4819-155-8-201110180-00008.

  PMID: 22007045 BACKGROUND

• Jenq GY, Doyle MM, Belton BM, Herrin J, Horwitz LI. Quasi-Experimental Evaluation of the Effectiveness of a Large-Scale Readmission Reduction Program. JAMA Intern Med. 2016 May 1;176(5):681-90. doi: 10.1001/jamainternmed.2016.0833.

  PMID: 27065180 BACKGROUND

• Kripalani S, Chen G, Ciampa P, Theobald C, Cao A, McBride M, Dittus RS, Speroff T. A transition care coordinator model reduces hospital readmissions and costs. Contemp Clin Trials. 2019 Jun;81:55-61. doi: 10.1016/j.cct.2019.04.014. Epub 2019 Apr 25.

  PMID: 31029692 BACKGROUND

• Leppin AL, Gionfriddo MR, Kessler M, Brito JP, Mair FS, Gallacher K, Wang Z, Erwin PJ, Sylvester T, Boehmer K, Ting HH, Murad MH, Shippee ND, Montori VM. Preventing 30-day hospital readmissions: a systematic review and meta-analysis of randomized trials. JAMA Intern Med. 2014 Jul;174(7):1095-107. doi: 10.1001/jamainternmed.2014.1608.

  PMID: 24820131 BACKGROUND

• Marafino BJ, Escobar GJ, Baiocchi MT, Liu VX, Plimier CC, Schuler A. Evaluation of an intervention targeted with predictive analytics to prevent readmissions in an integrated health system: observational study. BMJ. 2021 Aug 11;374:n1747. doi: 10.1136/bmj.n1747.

  PMID: 34380667 BACKGROUND

• McWilliams A, Roberge J, Anderson WE, Moore CG, Rossman W, Murphy S, McCall S, Brown R, Carpenter S, Rissmiller S, Furney S. Aiming to Improve Readmissions Through InteGrated Hospital Transitions (AIRTIGHT): a Pragmatic Randomized Controlled Trial. J Gen Intern Med. 2019 Jan;34(1):58-64. doi: 10.1007/s11606-018-4617-1. Epub 2018 Aug 14.

  PMID: 30109585 BACKGROUND

• van Walraven C, Dhalla IA, Bell C, Etchells E, Stiell IG, Zarnke K, Austin PC, Forster AJ. Derivation and validation of an index to predict early death or unplanned readmission after discharge from hospital to the community. CMAJ. 2010 Apr 6;182(6):551-7. doi: 10.1503/cmaj.091117. Epub 2010 Mar 1.

  PMID: 20194559 BACKGROUND

• Wang H, Robinson RD, Johnson C, Zenarosa NR, Jayswal RD, Keithley J, Delaney KA. Using the LACE index to predict hospital readmissions in congestive heart failure patients. BMC Cardiovasc Disord. 2014 Aug 7;14:97. doi: 10.1186/1471-2261-14-97.

  PMID: 25099997 BACKGROUND

Related Links

• Community-based Care Transitions Program \| CMS Innovation Center
• Overview of U.S. Hospital Stays in 2016: Variation by Geographic Region
• Hospital Readmissions Reduction Program (HRRP)
• National Inpatient Hospital Costs: The Most Expensive Conditions by Payer, 2017
• Overview of Clinical Conditions With Frequent and Costly Hospital Readmissions by Payer, 2018

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Heart Failure; Hypertension; Pneumonia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Infections; Infections

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Stephen N Davis, MBBS

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Model Details: This is a two-arm interventional study where participants will be randomized to receive either the Standard of Care or Enhanced Care treatment. Participants in the Standard of Care arm will receive the Transitional Care protocol most commonly used for patients at the University of Maryland Charles Regional Medical Center (UM CRMC). Participants in the Enhanced Care arm will receive the interventions in the Standard of Care arm plus the additional protocols unique to Enhanced Care arm (Social Determinants of Health Wheel assessment in the University of Maryland Medical System electronic medical record, coordination of home health services, and additional diagnosis education). These arms are designed to ensure that participants receive the same high quality of care that they would have received before the study while also focusing on some added interventions from the enhanced care arm to help determine if these additional interventions help improve patient outcomes.

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 13, 2023
• Study Start: March 31, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 15, 2024

Record last verified: 2024-02

Locations

US (1)