Hypertension Clinical Trial
Official title:
Readmission Risk Score (RecuR Score) Pilot at The University of Maryland Charles Regional Medical Center (UM CRMC)
Verified date | February 2024 |
Source | University of Maryland, Baltimore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 2026 |
Est. primary completion date | September 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria - 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. Exclusion Criteria - 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Maryland Charles Regional Medical Center | La Plata | Maryland |
Lead Sponsor | Collaborator |
---|---|
University of Maryland, Baltimore | University of Maryland Medical System |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 30 day post-discharge mortality | Number of participants with 30 day post-discharge mortality | 30 days post-hospital discharge | |
Secondary | 30 day post-discharge unplanned hospital readmission | Number of participants with 30 day post-discharge unplanned hospital readmission | 30 days post-hospital discharge | |
Secondary | 90-day post-discharge unplanned hospital readmission | Number of participants with 90 day post-discharge unplanned hospital readmission | 90 days post-hospital discharge | |
Secondary | 30-day post-discharge emergency department usage | Number of participants with 30 day post-discharge emergency department usage | 30 days post-hospital discharge | |
Secondary | 90-day post-discharge emergency department usage | Number of participants with 90 day post-discharge emergency department usage | 90 days post-hospital discharge |
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