(CONCERN) Clinical Decision Support (CDS) System

NCT03911687 | Completed Results

• 2 other identifiers: AAAR1389R01NR016941
• Study Type: interventional
• Target: 60,893
• Locations: 1 country
• Sites: 4

Brief Summary

There are patients who die or have a bad outcome in the hospital and this could be prevented. Data in the nurses' notes could be used by computers to tell the rest of the care team that a patient is not doing well and that they should act more quickly. This project will build and evaluate a computer system that makes it easier for the care team to see and understand that data and act quickly to save patients. The aims of this study is to answer the questions, what is the level of provider use of the CONCERN CDS notification system (called CONCERN SMARTapp) and resulting impact on selected patient outcomes? Specifically, the study has 1) validated desired thresholds for the CONCERN CDS system and 2) integrated the CONCERN CDS system for early warning of risky patient states within CDS tools. In this portion of the study (aim 3), the investigator will implement and evaluate the CONCERN CDS system on primary outcomes of in-hospital mortality and length of stay and secondary outcomes of cardiac arrest, unanticipated transfers to the intensive care unit, and 30-day hospital readmission rates.

Conditions

Hospital Acquired Condition

Keywords

Early warning system; Clinical decision support; Predictive analysis; Failure to rescue; Inter-professional situational awareness; Nursing surveillance; Healthcare process models of clinical concern (HPM-CC)

Outcome Measures

Primary Outcomes (2)

• In-hospital Mortalities

  Number of patient deaths occurring in the hospital.

  Up to 24 months

• Average Length of Hospital Stay

  The number of days that a patient was in the hospital

  Up to 24 months

Secondary Outcomes (4)

• Number of Cardiac Arrests

  Up to 24 months

• Number of Hospital Acquired Sepsis

  Up to 24 months

• Number of Unanticipated Transfers to ICU

  Up to 24 months

• Number of Hospital Readmissions

  Up to 24 months

Study Arms (2)

Control Group

NO INTERVENTION

Control data will be collected in the CONCERN CDS system that will be "live" in the EHR, but in silent release mode (e.g., not providing notification to clinicians).

Intervention Group

EXPERIMENTAL

Experimental data will be collected in the CONCERN CDS system that will be "live" in the EHR in "active" release mode (e.g., providing CONCERN CDS system notification to clinicians).

Behavioral: CONCERN CDS system notification

Interventions

CONCERN CDS system notification BEHAVIORAL

The CONCERN CDS will trigger based on analytics of nursing documentation that indicates recognition and concern of patient changes. The CONCERN CDS will alert the care team of the patients "risky state" to increase team-based situational awareness (i.e., shared understanding of the patient situation) of patients predicted to be at risk for patient decompensating in need of rapid intervention to prevent mortality and associated harm. Version 1: Burn in phase to evaluate adoption and adaptation to the algorithm being studied. Expected time frame - 3 months Version 2: Version 2 refined based on continuous monitoring of data. Expected time frame - 3 months Version 3: Version 3 refined based on continuous monitoring of data. Expected time frame - 3 months

Also known as: CONCERN SMARTapp notification, CONCERN Clinical Decision Support (CDS) system notification

Intervention Group

Eligibility Criteria

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

You may qualify if:

• Inpatients with a stay of at least 24 hours on one of our study units

You may not qualify if:

• Inpatients with less than 24 hours on one of our study units
• Patients less than 18 years of age
• Hospice patients
• Did not have a hospital encounter, patients not on one of our study units.
• Definition of Study Units:
• A clinical unit is considered a CONCERN Study unit if it meets the following criteria:
• A general medical or surgical acute care or critical care unit
• The following clinical units are NOT considered CONCERN Study units:
• Pediatric or Neonatal units
• Hospice units
• Emergency Department
• Oncology units
• Obstetrician (OB)/labor and delivery units
• Behavioral/psych units
• Observational units

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Nursing Research (NINR): collaborator
• Brigham and Women's Hospital: collaborator

Study Sites (4)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Newton-Wellesley Hospital

Newton, Massachusetts, 02462, United States

Location

New York Presbyterian Columbia University Medical Center

New York, New York, 10032, United States

Location

New York Presbyterian Allen Hospital

New York, New York, 10034, United States

Location

Related Publications (95)

• Hripcsak G, Zhou L, Parsons S, Das AK, Johnson SB. Modeling electronic discharge summaries as a simple temporal constraint satisfaction problem. J Am Med Inform Assoc. 2005 Jan-Feb;12(1):55-63. doi: 10.1197/jamia.M1623. Epub 2004 Oct 18.

  PMID: 15492038 BACKGROUND

• Zhou L, Parsons S, Hripcsak G. The evaluation of a temporal reasoning system in processing clinical discharge summaries. J Am Med Inform Assoc. 2008 Jan-Feb;15(1):99-106. doi: 10.1197/jamia.M2467. Epub 2007 Oct 18.

  PMID: 17947618 BACKGROUND

• Sittig DF, Wright A, Osheroff JA, Middleton B, Teich JM, Ash JS, Campbell E, Bates DW. Grand challenges in clinical decision support. J Biomed Inform. 2008 Apr;41(2):387-92. doi: 10.1016/j.jbi.2007.09.003. Epub 2007 Sep 21.

  PMID: 18029232 BACKGROUND

• Hripcsak G, Elhadad N, Chen YH, Zhou L, Morrison FP. Using empiric semantic correlation to interpret temporal assertions in clinical texts. J Am Med Inform Assoc. 2009 Mar-Apr;16(2):220-7. doi: 10.1197/jamia.M3007. Epub 2008 Dec 11.

  PMID: 19074297 BACKGROUND

• Muller-Engelmann M, Krones T, Keller H, Donner-Banzhoff N. Decision making preferences in the medical encounter--a factorial survey design. BMC Health Serv Res. 2008 Dec 17;8:260. doi: 10.1186/1472-6963-8-260.

  PMID: 19091091 BACKGROUND

• Murphy SN, Weber G, Mendis M, Gainer V, Chueh HC, Churchill S, Kohane I. Serving the enterprise and beyond with informatics for integrating biology and the bedside (i2b2). J Am Med Inform Assoc. 2010 Mar-Apr;17(2):124-30. doi: 10.1136/jamia.2009.000893.

  PMID: 20190053 BACKGROUND

• Albers DJ, Hripcsak G. A statistical dynamics approach to the study of human health data: resolving population scale diurnal variation in laboratory data. Phys Lett A. 2010 Feb 15;374(9):1159-1164. doi: 10.1016/j.physleta.2009.12.067.

  PMID: 20544004 BACKGROUND

• Collins SA, Bakken S, Vawdrey DK, Coiera E, Currie L. Model development for EHR interdisciplinary information exchange of ICU common goals. Int J Med Inform. 2011 Aug;80(8):e141-9. doi: 10.1016/j.ijmedinf.2010.09.009. Epub 2010 Oct 25.

  PMID: 20974549 BACKGROUND

• Collins SA, Bakken S, Vawdrey DK, Coiera E, Currie LM. Agreement between common goals discussed and documented in the ICU. J Am Med Inform Assoc. 2011 Jan-Feb;18(1):45-50. doi: 10.1136/jamia.2010.006437. Epub 2010 Nov 27.

  PMID: 21113075 BACKGROUND

• Hripcsak G, Vawdrey DK, Fred MR, Bostwick SB. Use of electronic clinical documentation: time spent and team interactions. J Am Med Inform Assoc. 2011 Mar-Apr;18(2):112-7. doi: 10.1136/jamia.2010.008441. Epub 2011 Feb 2.

  PMID: 21292706 BACKGROUND

• Senathirajah Y, Bakken S. Visual clustering analysis of CIS logs to inform creation of a user-configurable Web CIS interface. Methods Inf Med. 2011;50(4):337-48. doi: 10.3414/ME09-01-0087. Epub 2011 Jun 21.

  PMID: 21691676 BACKGROUND

• Merchant RM, Yang L, Becker LB, Berg RA, Nadkarni V, Nichol G, Carr BG, Mitra N, Bradley SM, Abella BS, Groeneveld PW; American Heart Association Get With The Guidelines-Resuscitation Investigators. Incidence of treated cardiac arrest in hospitalized patients in the United States. Crit Care Med. 2011 Nov;39(11):2401-6. doi: 10.1097/CCM.0b013e3182257459.

  PMID: 21705896 BACKGROUND

• Collins SA, Vawdrey DK. "Reading between the lines" of flow sheet data: nurses' optional documentation associated with cardiac arrest outcomes. Appl Nurs Res. 2012 Nov;25(4):251-7. doi: 10.1016/j.apnr.2011.06.002. Epub 2011 Nov 12.

  PMID: 22079746 BACKGROUND

• Hripcsak G, Albers DJ, Perotte A. Exploiting time in electronic health record correlations. J Am Med Inform Assoc. 2011 Dec;18 Suppl 1(Suppl 1):i109-15. doi: 10.1136/amiajnl-2011-000463. Epub 2011 Nov 23.

  PMID: 22116643 BACKGROUND

• Mandl KD, Mandel JC, Murphy SN, Bernstam EV, Ramoni RL, Kreda DA, McCoy JM, Adida B, Kohane IS. The SMART Platform: early experience enabling substitutable applications for electronic health records. J Am Med Inform Assoc. 2012 Jul-Aug;19(4):597-603. doi: 10.1136/amiajnl-2011-000622. Epub 2012 Mar 17.

  PMID: 22427539 BACKGROUND

• Vawdrey DK, Wilcox LG, Collins S, Feiner S, Mamykina O, Stein DM, Bakken S, Fred MR, Stetson PD. Awareness of the Care Team in Electronic Health Records. Appl Clin Inform. 2011;2(4):395-405. doi: 10.4338/ACI-2011-05-RA-0034.

  PMID: 22574103 BACKGROUND

• Rothman MJ, Solinger AB, Rothman SI, Finlay GD. Clinical implications and validity of nursing assessments: a longitudinal measure of patient condition from analysis of the Electronic Medical Record. BMJ Open. 2012 Aug 8;2(4):e000646. doi: 10.1136/bmjopen-2012-000849. Print 2012.

  PMID: 22874626 BACKGROUND

• Zhou L, Karipineni N, Lewis J, Maviglia SM, Fairbanks A, Hongsermeier T, Middleton B, Rocha RA. A study of diverse clinical decision support rule authoring environments and requirements for integration. BMC Med Inform Decis Mak. 2012 Nov 12;12:128. doi: 10.1186/1472-6947-12-128.

  PMID: 23145874 BACKGROUND

• Brady PW, Muething S, Kotagal U, Ashby M, Gallagher R, Hall D, Goodfriend M, White C, Bracke TM, DeCastro V, Geiser M, Simon J, Tucker KM, Olivea J, Conway PH, Wheeler DS. Improving situation awareness to reduce unrecognized clinical deterioration and serious safety events. Pediatrics. 2013 Jan;131(1):e298-308. doi: 10.1542/peds.2012-1364. Epub 2012 Dec 10.

  PMID: 23230078 BACKGROUND

• Albers DJ, Hripcsak G, Schmidt M. Population physiology: leveraging electronic health record data to understand human endocrine dynamics. PLoS One. 2012;7(12):e48058. doi: 10.1371/journal.pone.0048058. Epub 2012 Dec 14.

  PMID: 23272040 BACKGROUND

• Fukui S, Salyers MP, Matthias MS, Collins L, Thompson J, Coffman M, Torrey WC. Predictors of shared decision making and level of agreement between consumers and providers in psychiatric care. Community Ment Health J. 2014 May;50(4):375-82. doi: 10.1007/s10597-012-9584-0. Epub 2013 Jan 9.

  PMID: 23299226 BACKGROUND

• Middleton B, Bloomrosen M, Dente MA, Hashmat B, Koppel R, Overhage JM, Payne TH, Rosenbloom ST, Weaver C, Zhang J; American Medical Informatics Association. Enhancing patient safety and quality of care by improving the usability of electronic health record systems: recommendations from AMIA. J Am Med Inform Assoc. 2013 Jun;20(e1):e2-8. doi: 10.1136/amiajnl-2012-001458. Epub 2013 Jan 25.

  PMID: 23355463 BACKGROUND

• Smith SW, Koppel R. Healthcare information technology's relativity problems: a typology of how patients' physical reality, clinicians' mental models, and healthcare information technology differ. J Am Med Inform Assoc. 2014 Jan-Feb;21(1):117-31. doi: 10.1136/amiajnl-2012-001419. Epub 2013 Jun 25.

  PMID: 23800960 BACKGROUND

• Finlay GD, Rothman MJ, Smith RA. Measuring the modified early warning score and the Rothman index: advantages of utilizing the electronic medical record in an early warning system. J Hosp Med. 2014 Feb;9(2):116-9. doi: 10.1002/jhm.2132. Epub 2013 Dec 19.

  PMID: 24357519 BACKGROUND

• Cato K, Hyun S, Bakken S. Response to a mobile health decision-support system for screening and management of tobacco use. Oncol Nurs Forum. 2014 Mar 1;41(2):145-52. doi: 10.1188/14.ONF.145-152.

  PMID: 24578074 BACKGROUND

• Mandl KD, Kohane IS, McFadden D, Weber GM, Natter M, Mandel J, Schneeweiss S, Weiler S, Klann JG, Bickel J, Adams WG, Ge Y, Zhou X, Perkins J, Marsolo K, Bernstam E, Showalter J, Quarshie A, Ofili E, Hripcsak G, Murphy SN. Scalable Collaborative Infrastructure for a Learning Healthcare System (SCILHS): architecture. J Am Med Inform Assoc. 2014 Jul-Aug;21(4):615-20. doi: 10.1136/amiajnl-2014-002727. Epub 2014 May 12.

  PMID: 24821734 BACKGROUND

• Albers DJ, Elhadad N, Tabak E, Perotte A, Hripcsak G. Dynamical phenotyping: using temporal analysis of clinically collected physiologic data to stratify populations. PLoS One. 2014 Jun 16;9(6):e96443. doi: 10.1371/journal.pone.0096443. eCollection 2014.

  PMID: 24933368 BACKGROUND

• Zhou L, Lu Y, Vitale CJ, Mar PL, Chang F, Dhopeshwarkar N, Rocha RA. Representation of information about family relatives as structured data in electronic health records. Appl Clin Inform. 2014 Apr 9;5(2):349-67. doi: 10.4338/ACI-2013-10-RA-0080. eCollection 2014.

  PMID: 25024754 BACKGROUND

• Hum RS, Cato K, Sheehan B, Patel S, Duchon J, DeLaMora P, Ferng YH, Graham P, Vawdrey DK, Perlman J, Larson E, Saiman L. Developing clinical decision support within a commercial electronic health record system to improve antimicrobial prescribing in the neonatal ICU. Appl Clin Inform. 2014 Apr 9;5(2):368-87. doi: 10.4338/ACI-2013-09-RA-0069. eCollection 2014.

  PMID: 25024755 BACKGROUND

• Senathirajah Y, Bakken S, Kaufman D. The clinician in the Driver's Seat: part 1 - a drag/drop user-composable electronic health record platform. J Biomed Inform. 2014 Dec;52:165-76. doi: 10.1016/j.jbi.2014.09.002. Epub 2014 Sep 18.

  PMID: 25240253 BACKGROUND

• Yakusheva O, Lindrooth R, Weiss M. Nurse value-added and patient outcomes in acute care. Health Serv Res. 2014 Dec;49(6):1767-86. doi: 10.1111/1475-6773.12236. Epub 2014 Sep 25.

  PMID: 25256089 BACKGROUND

• Drew BJ, Harris P, Zegre-Hemsey JK, Mammone T, Schindler D, Salas-Boni R, Bai Y, Tinoco A, Ding Q, Hu X. Insights into the problem of alarm fatigue with physiologic monitor devices: a comprehensive observational study of consecutive intensive care unit patients. PLoS One. 2014 Oct 22;9(10):e110274. doi: 10.1371/journal.pone.0110274. eCollection 2014.

  PMID: 25338067 BACKGROUND

• Klann JG, Mendis M, Phillips LC, Goodson AP, Rocha BH, Goldberg HS, Wattanasin N, Murphy SN. Taking advantage of continuity of care documents to populate a research repository. J Am Med Inform Assoc. 2015 Mar;22(2):370-9. doi: 10.1136/amiajnl-2014-003040. Epub 2014 Oct 28.

  PMID: 25352566 BACKGROUND

• Senathirajah Y, Kaufman D, Bakken S. The clinician in the driver's seat: part 2 - intelligent uses of space in a drag/drop user-composable electronic health record. J Biomed Inform. 2014 Dec;52:177-88. doi: 10.1016/j.jbi.2014.09.008. Epub 2014 Oct 24.

  PMID: 25445921 BACKGROUND

• Hripcsak G, Albers DJ, Perotte A. Parameterizing time in electronic health record studies. J Am Med Inform Assoc. 2015 Jul;22(4):794-804. doi: 10.1093/jamia/ocu051. Epub 2015 Feb 26.

  PMID: 25725004 BACKGROUND

• Adler L, Yi D, Li M, McBroom B, Hauck L, Sammer C, Jones C, Shaw T, Classen D. Impact of Inpatient Harms on Hospital Finances and Patient Clinical Outcomes. J Patient Saf. 2018 Jun;14(2):67-73. doi: 10.1097/PTS.0000000000000171.

  PMID: 25803176 BACKGROUND

• Payne TH, Corley S, Cullen TA, Gandhi TK, Harrington L, Kuperman GJ, Mattison JE, McCallie DP, McDonald CJ, Tang PC, Tierney WM, Weaver C, Weir CR, Zaroukian MH. Report of the AMIA EHR-2020 Task Force on the status and future direction of EHRs. J Am Med Inform Assoc. 2015 Sep;22(5):1102-10. doi: 10.1093/jamia/ocv066. Epub 2015 May 28. No abstract available.

  PMID: 26024883 BACKGROUND

• Cato KD, Cohen B, Larson E. Data elements and validation methods used for electronic surveillance of health care-associated infections: a systematic review. Am J Infect Control. 2015 Jun;43(6):600-5. doi: 10.1016/j.ajic.2015.02.006.

  PMID: 26042848 BACKGROUND

• Schulz CM, Krautheim V, Hackemann A, Kreuzer M, Kochs EF, Wagner KJ. Situation awareness errors in anesthesia and critical care in 200 cases of a critical incident reporting system. BMC Anesthesiol. 2016 Jan 16;16:4. doi: 10.1186/s12871-016-0172-7.

  PMID: 26772179 BACKGROUND

• Liu V, Escobar GJ, Greene JD, Soule J, Whippy A, Angus DC, Iwashyna TJ. Hospital deaths in patients with sepsis from 2 independent cohorts. JAMA. 2014 Jul 2;312(1):90-2. doi: 10.1001/jama.2014.5804. No abstract available.

  PMID: 24838355 BACKGROUND

• Sharek PJ, Parast LM, Leong K, Coombs J, Earnest K, Sullivan J, Frankel LR, Roth SJ. Effect of a rapid response team on hospital-wide mortality and code rates outside the ICU in a Children's Hospital. JAMA. 2007 Nov 21;298(19):2267-74. doi: 10.1001/jama.298.19.2267.

  PMID: 18029830 BACKGROUND

• Hiissa M, Pahikkala T, Suominen H, Lehtikunnas T, Back B, Karsten H, Salantera S, Salakoski T. Towards automated classification of intensive care nursing narratives. Int J Med Inform. 2007 Dec;76 Suppl 3:S362-8. doi: 10.1016/j.ijmedinf.2007.03.003. Epub 2007 May 21.

  PMID: 17513166 BACKGROUND

• Goodwin L, VanDyne M, Lin S, Talbert S. Data mining issues and opportunities for building nursing knowledge. J Biomed Inform. 2003 Aug-Oct;36(4-5):379-88. doi: 10.1016/j.jbi.2003.09.020.

  PMID: 14643734 BACKGROUND

• Zhou L, Hripcsak G. Temporal reasoning with medical data--a review with emphasis on medical natural language processing. J Biomed Inform. 2007 Apr;40(2):183-202. doi: 10.1016/j.jbi.2006.12.009. Epub 2007 Jan 11.

  PMID: 17317332 BACKGROUND

• Hazlehurst B, McMullen CK, Gorman PN. Distributed cognition in the heart room: how situation awareness arises from coordinated communications during cardiac surgery. J Biomed Inform. 2007 Oct;40(5):539-51. doi: 10.1016/j.jbi.2007.02.001. Epub 2007 Feb 8.

  PMID: 17368112 BACKGROUND

• Zhou L, Plasek JM, Mahoney LM, Chang FY, DiMaggio D, Rocha RA. Mapping Partners Master Drug Dictionary to RxNorm using an NLP-based approach. J Biomed Inform. 2012 Aug;45(4):626-33. doi: 10.1016/j.jbi.2011.11.006. Epub 2011 Nov 28.

  PMID: 22142948 BACKGROUND

• Lai KH, Topaz M, Goss FR, Zhou L. Automated misspelling detection and correction in clinical free-text records. J Biomed Inform. 2015 Jun;55:188-95. doi: 10.1016/j.jbi.2015.04.008. Epub 2015 Apr 24.

  PMID: 25917057 BACKGROUND

• McNeill G, Bryden D. Do either early warning systems or emergency response teams improve hospital patient survival? A systematic review. Resuscitation. 2013 Dec;84(12):1652-67. doi: 10.1016/j.resuscitation.2013.08.006. Epub 2013 Aug 17.

  PMID: 23962485 BACKGROUND

• Alam N, Hobbelink EL, van Tienhoven AJ, van de Ven PM, Jansma EP, Nanayakkara PW. The impact of the use of the Early Warning Score (EWS) on patient outcomes: a systematic review. Resuscitation. 2014 May;85(5):587-94. doi: 10.1016/j.resuscitation.2014.01.013. Epub 2014 Jan 25.

  PMID: 24467882 BACKGROUND

• Wahl WL, Talsma A, Dawson C, Dickinson S, Pennington K, Wilson D, Arbabi S, Taheri PA. Use of computerized ICU documentation to capture ICU core measures. Surgery. 2006 Oct;140(4):684-9; discussion 690. doi: 10.1016/j.surg.2006.06.017. Epub 2006 Sep 6.

  PMID: 17011917 BACKGROUND

• Rittenhouse DR, Shortell SM, Fisher ES. Primary care and accountable care--two essential elements of delivery-system reform. N Engl J Med. 2009 Dec 10;361(24):2301-3. doi: 10.1056/NEJMp0909327. No abstract available.

  PMID: 19864649 BACKGROUND

• Berwick DM. Launching accountable care organizations--the proposed rule for the Medicare Shared Savings Program. N Engl J Med. 2011 Apr 21;364(16):e32. doi: 10.1056/NEJMp1103602. Epub 2011 Mar 31. No abstract available.

  PMID: 21452999 BACKGROUND

• Cioffi J. Recognition of patients who require emergency assistance: a descriptive study. Heart Lung. 2000 Jul-Aug;29(4):262-8. doi: 10.1067/mhl.2000.108327.

  PMID: 10900063 BACKGROUND

• Dellit TH, Owens RC, McGowan JE Jr, Gerding DN, Weinstein RA, Burke JP, Huskins WC, Paterson DL, Fishman NO, Carpenter CF, Brennan PJ, Billeter M, Hooton TM; Infectious Diseases Society of America; Society for Healthcare Epidemiology of America. Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America guidelines for developing an institutional program to enhance antimicrobial stewardship. Clin Infect Dis. 2007 Jan 15;44(2):159-77. doi: 10.1086/510393. Epub 2006 Dec 13. No abstract available.

  PMID: 17173212 BACKGROUND

• Alterovitz G, Warner J, Zhang P, Chen Y, Ullman-Cullere M, Kreda D, Kohane IS. SMART on FHIR Genomics: facilitating standardized clinico-genomic apps. J Am Med Inform Assoc. 2015 Nov;22(6):1173-8. doi: 10.1093/jamia/ocv045. Epub 2015 Jul 21.

  PMID: 26198304 BACKGROUND

• Devita MA, Bellomo R, Hillman K, Kellum J, Rotondi A, Teres D, Auerbach A, Chen WJ, Duncan K, Kenward G, Bell M, Buist M, Chen J, Bion J, Kirby A, Lighthall G, Ovreveit J, Braithwaite RS, Gosbee J, Milbrandt E, Peberdy M, Savitz L, Young L, Harvey M, Galhotra S. Findings of the first consensus conference on medical emergency teams. Crit Care Med. 2006 Sep;34(9):2463-78. doi: 10.1097/01.CCM.0000235743.38172.6E.

  PMID: 16878033 BACKGROUND

• Schulz CM, Endsley MR, Kochs EF, Gelb AW, Wagner KJ. Situation awareness in anesthesia: concept and research. Anesthesiology. 2013 Mar;118(3):729-42. doi: 10.1097/ALN.0b013e318280a40f.

  PMID: 23291626 BACKGROUND

• Matney S, Brewster PJ, Sward KA, Cloyes KG, Staggers N. Philosophical approaches to the nursing informatics data-information-knowledge-wisdom framework. ANS Adv Nurs Sci. 2011 Jan-Mar;34(1):6-18. doi: 10.1097/ANS.0b013e3182071813.

  PMID: 21150551 BACKGROUND

• Hermanides J, Vriesendorp TM, Bosman RJ, Zandstra DF, Hoekstra JB, Devries JH. Glucose variability is associated with intensive care unit mortality. Crit Care Med. 2010 Mar;38(3):838-42. doi: 10.1097/CCM.0b013e3181cc4be9.

  PMID: 20035218 BACKGROUND

• Egi M, Bellomo R, Stachowski E, French CJ, Hart GK, Taori G, Hegarty C, Bailey M. The interaction of chronic and acute glycemia with mortality in critically ill patients with diabetes. Crit Care Med. 2011 Jan;39(1):105-11. doi: 10.1097/CCM.0b013e3181feb5ea.

  PMID: 20975552 BACKGROUND

• Watson A, Skipper C, Steury R, Walsh H, Levin A. Inpatient nursing care and early warning scores: a workflow mismatch. J Nurs Care Qual. 2014 Jul-Sep;29(3):215-22. doi: 10.1097/NCQ.0000000000000058.

  PMID: 24569518 BACKGROUND

• James JT. A new, evidence-based estimate of patient harms associated with hospital care. J Patient Saf. 2013 Sep;9(3):122-8. doi: 10.1097/PTS.0b013e3182948a69.

  PMID: 23860193 BACKGROUND

• Albers DJ, Sprott JC, Crutchfield JP. Persistent chaos in high dimensions. Phys Rev E Stat Nonlin Soft Matter Phys. 2006 Nov;74(5 Pt 2):057201. doi: 10.1103/PhysRevE.74.057201. Epub 2006 Nov 2.

  PMID: 17280024 BACKGROUND

• Nakamura A, Osonoi T, Terauchi Y. Relationship between urinary sodium excretion and pioglitazone-induced edema. J Diabetes Investig. 2010 Oct 19;1(5):208-11. doi: 10.1111/j.2040-1124.2010.00046.x.

  PMID: 24843434 BACKGROUND

• Jones L, King L, Wilson C. A literature review: factors that impact on nurses' effective use of the Medical Emergency Team (MET). J Clin Nurs. 2009 Dec;18(24):3379-90. doi: 10.1111/j.1365-2702.2009.02944.x.

  PMID: 20487489 BACKGROUND

• Bates DW, Saria S, Ohno-Machado L, Shah A, Escobar G. Big data in health care: using analytics to identify and manage high-risk and high-cost patients. Health Aff (Millwood). 2014 Jul;33(7):1123-31. doi: 10.1377/hlthaff.2014.0041.

  PMID: 25006137 BACKGROUND

• Churpek MM, Yuen TC, Park SY, Gibbons R, Edelson DP. Using electronic health record data to develop and validate a prediction model for adverse outcomes in the wards*. Crit Care Med. 2014 Apr;42(4):841-8. doi: 10.1097/CCM.0000000000000038.

  PMID: 24247472 BACKGROUND

• Zhang AL, Chen RX, Kang MF, Fan HL, Wang WL. Study of the regulatory effect of acupuncture on rotation-induced gastric dysrhythmia in rabbits. World J Gastroenterol. 1997 Mar 15;3(1):54-5. doi: 10.3748/wjg.v3.i1.54.

  PMID: 27006588 BACKGROUND

• Collins S, Bakken S, Vawdrey D, Coiera E, Currie LM. Discuss now, document later: CIS/CPOE perceived to be a 'shift behind' in the ICU. Stud Health Technol Inform. 2010;160(Pt 1):178-82.

  PMID: 20841673 BACKGROUND

• Zhou L, Hongsermeier T, Boxwala A, Lewis J, Kawamoto K, Maviglia S, Gentile D, Teich JM, Rocha R, Bell D, Middleton B. Structured representation for core elements of common clinical decision support interventions to facilitate knowledge sharing. Stud Health Technol Inform. 2013;192:195-9.

  PMID: 23920543 BACKGROUND

• Zhou L, Friedman C, Parsons S, Hripcsak G. System architecture for temporal information extraction, representation and reasoning in clinical narrative reports. AMIA Annu Symp Proc. 2005;2005:869-73.

  PMID: 16779164 BACKGROUND

• Collins SA, Cato K, Albers D, Scott K, Stetson PD, Bakken S, Vawdrey DK. Relationship between nursing documentation and patients' mortality. Am J Crit Care. 2013 Jul;22(4):306-13. doi: 10.4037/ajcc2013426.

  PMID: 23817819 BACKGROUND

• Collins SA, Fred M, Wilcox L, Vawdrey DK. Workarounds used by nurses to overcome design constraints of electronic health records. NI 2012 (2012). 2012 Jun 23;2012:93. eCollection 2012.

  PMID: 24199061 BACKGROUND

• Collins SA, Currie LM. Interdisciplinary communication in the ICU. Stud Health Technol Inform. 2009;146:362-6.

  PMID: 19592866 BACKGROUND

• Collins S, Hurley AC, Chang FY, Illa AR, Benoit A, Laperle S, Dykes PC. Content and functional specifications for a standards-based multidisciplinary rounding tool to maintain continuity across acute and critical care. J Am Med Inform Assoc. 2014 May-Jun;21(3):438-47. doi: 10.1136/amiajnl-2013-001949. Epub 2013 Sep 30.

  PMID: 24081019 BACKGROUND

• Collins SA, Gazarian P, Stade D, McNally K, Morrison C, Ohashi K, Lehmann L, Dalal A, Bates DW, Dykes PC. Clinical Workflow Observations to Identify Opportunities for Nurse, Physicians and Patients to Share a Patient-centered Plan of Care. AMIA Annu Symp Proc. 2014 Nov 14;2014:414-23. eCollection 2014.

  PMID: 25954345 BACKGROUND

• Ferguson TB Jr. The Institute of Medicine committee report "best care at lower cost: the path to continuously learning health care". Circ Cardiovasc Qual Outcomes. 2012 Nov;5(6):e93-4. doi: 10.1161/CIRCOUTCOMES.112.968768. No abstract available.

  PMID: 23170008 BACKGROUND

• Albers DJ, Hripcsak G. Using time-delayed mutual information to discover and interpret temporal correlation structure in complex populations. Chaos. 2012 Mar;22(1):013111. doi: 10.1063/1.3675621.

  PMID: 22462987 BACKGROUND

• Hyun S, Bakken S. Toward the creation of an ontology for nursing document sections: mapping section names to the LOINC semantic model. AMIA Annu Symp Proc. 2006;2006:364-8.

  PMID: 17238364 BACKGROUND

• Aiken LH, Clarke SP, Sloane DM. Hospital staffing, organization, and quality of care: Cross-national findings. Nurs Outlook. 2002 Sep-Oct;50(5):187-94. doi: 10.1067/mno.2002.126696.

  PMID: 12386653 BACKGROUND

• Moss J, Andison M, Sobko H. An analysis of narrative nursing documentation in an otherwise structured intensive care clinical information system. AMIA Annu Symp Proc. 2007 Oct 11;2007:543-7.

  PMID: 18693895 BACKGROUND

• Bequette BW. Algorithms for a closed-loop artificial pancreas: the case for model predictive control. J Diabetes Sci Technol. 2013 Nov 1;7(6):1632-43. doi: 10.1177/193229681300700624.

  PMID: 24351190 BACKGROUND

• Zhou L, Plasek JM, Mahoney LM, Karipineni N, Chang F, Yan X, Chang F, Dimaggio D, Goldman DS, Rocha RA. Using Medical Text Extraction, Reasoning and Mapping System (MTERMS) to process medication information in outpatient clinical notes. AMIA Annu Symp Proc. 2011;2011:1639-48. Epub 2011 Oct 22.

  PMID: 22195230 BACKGROUND

• Stein-Parbury J, Liaschenko J. Understanding collaboration between nurses and physicians as knowledge at work. Am J Crit Care. 2007 Sep;16(5):470-7; quiz 478.

  PMID: 17724244 BACKGROUND

• Collins S, Bakken S, Cimino JJ, Currie LM. Identifying logical clinical context clusters in nursing orders for the purpose of information retrieval. AMIA Annu Symp Proc. 2008 Nov 6;2008:131-5.

  PMID: 18999260 BACKGROUND

• Senathirajah Y, Kaufman D, Bakken S. Essential questions: accuracy, errors and user perceptions in a drag/drop user-composable electronic health record. Stud Health Technol Inform. 2013;194:181-7.

  PMID: 23941953 BACKGROUND

• Currie L, Sheehan B, Graham PL 3rd, Stetson P, Cato K, Wilcox A. Sociotechnical analysis of a neonatal ICU. Stud Health Technol Inform. 2009;146:258-62.

  PMID: 19592845 BACKGROUND

• Cato KD, Bakken S. What am I giving tonight? Information needs of nurses related to patient medications administration while using a clinical information system. NI 2012 (2012). 2012 Jun 23;2012:65. eCollection 2012.

  PMID: 24199053 BACKGROUND

• Topaz M, Seger DL, Lai K, Wickner PG, Goss F, Dhopeshwarkar N, Chang F, Bates DW, Zhou L. High Override Rate for Opioid Drug-allergy Interaction Alerts: Current Trends and Recommendations for Future. Stud Health Technol Inform. 2015;216:242-6.

  PMID: 26262047 BACKGROUND

• Klann JG, Phillips LC, Herrick C, Joss MAH, Wagholikar KB, Murphy SN. Web services for data warehouses: OMOP and PCORnet on i2b2. J Am Med Inform Assoc. 2018 Oct 1;25(10):1331-1338. doi: 10.1093/jamia/ocy093.

  PMID: 30085008 BACKGROUND

• Sedigh-Sarvestani M, Albers DJ, Gluckman BJ. Data assimilation of glucose dynamics for use in the intensive care unit. Annu Int Conf IEEE Eng Med Biol Soc. 2012;2012:5437-40. doi: 10.1109/EMBC.2012.6347224.

  PMID: 23367159 BACKGROUND

• Ludwick R, Zeller RA. The factorial survey: an experimental method to replicate real world problems. Nurs Res. 2001 Mar-Apr;50(2):129-33. doi: 10.1097/00006199-200103000-00009.

  PMID: 11302293 BACKGROUND

• Rossetti SC, Dykes PC, Knaplund C, Cho S, Withall J, Lowenthal G, Albers D, Lee RY, Jia H, Bakken S, Kang MJ, Chang FY, Zhou L, Bates DW, Daramola T, Liu F, Schwartz-Dillard J, Tran M, Bokhari SMA, Thate J, Cato KD. Real-time surveillance system for patient deterioration: a pragmatic cluster-randomized controlled trial. Nat Med. 2025 Jun;31(6):1895-1902. doi: 10.1038/s41591-025-03609-7. Epub 2025 Apr 2.

  PMID: 40175738 DERIVED

• Rossetti SC, Dykes PC, Knaplund C, Cho S, Withall J, Lowenthal G, Albers D, Lee R, Jia H, Bakken S, Kang MJ, Chang FY, Zhou L, Bates DW, Daramola T, Liu F, Schwartz-Dillard J, Tran M, Abbas Bokhari SM, Thate J, Cato KD. Multisite Pragmatic Cluster-Randomized Controlled Trial of the CONCERN Early Warning System. medRxiv [Preprint]. 2024 Jun 4:2024.06.04.24308436. doi: 10.1101/2024.06.04.24308436.

  PMID: 38883706 DERIVED

• Rossetti SC, Dykes PC, Knaplund C, Kang MJ, Schnock K, Garcia JP Jr, Fu LH, Chang F, Thai T, Fred M, Korach TZ, Zhou L, Klann JG, Albers D, Schwartz J, Lowenthal G, Jia H, Liu F, Cato K. The Communicating Narrative Concerns Entered by Registered Nurses (CONCERN) Clinical Decision Support Early Warning System: Protocol for a Cluster Randomized Pragmatic Clinical Trial. JMIR Res Protoc. 2021 Dec 10;10(12):e30238. doi: 10.2196/30238.

  PMID: 34889766 DERIVED

MeSH Terms

Conditions

Iatrogenic Disease

Interventions

Compact Disks

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Videodisc Recording; Optical Storage Devices; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Results Point of Contact

• Title: Sarah Collins Rossetti, PhD
• Organization: Columbia University

sac2125@cumc.columbia.edu

2123056605

Study Officials

• Patricia Dykes, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Sarah Collins Rossetti, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Kenrick Cato, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Biomedical Informatics and Nursing

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: April 11, 2019
• Study Start: July 21, 2020
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: May 9, 2025
• Results First Posted: May 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)