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Trials
Published in: Trials 1/2019

Open Access 01-12-2019 | Septicemia | Study protocol

Structured, proactive care coordination versus usual care for Improving Morbidity during Post-Acute Care Transitions for Sepsis (IMPACTS): a pragmatic, randomized controlled trial

Authors: Marc Kowalkowski, Shih-Hsiung Chou, Andrew McWilliams, Cathryn Lashley, Stephanie Murphy, Whitney Rossman, Alfred Papali, Alan Heffner, Mark Russo, Larry Burke, Michael Gibbs, Stephanie P. Taylor, On behalf of Atrium Health ACORN Investigators

Published in: Trials | Issue 1/2019

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Abstracts

Background

Hospital mortality for patients with sepsis has recently declined, but sepsis survivors still suffer from significant long-term mortality and morbidity. There are limited data that support effective strategies to address post-discharge management of patients hospitalized with sepsis.

Methods

The Improving Morbidity during Post-Acute Care Transitions for Sepsis (IMPACTS) study is a pragmatic, randomized controlled trial at three hospitals within a single healthcare delivery system comparing clinical outcomes between sepsis survivors who receive usual care versus care delivered through the Sepsis Transition and Recovery (STAR) program. The STAR program includes a centrally located nurse navigator using telephone counseling and electronic health record-based support to facilitate best-practice post-sepsis care strategies for patients during hospitalization and the 30 days after hospital discharge, including post-discharge review of medications, evaluation for new impairments or symptoms, monitoring existing comorbidities, and palliative care referral when appropriate. Adults admitted through the Emergency Department with suspected infection (i.e., antibiotics initiated, bacterial cultures drawn) and deemed, by previously developed risk-stratification models, high risk for readmission or death are included. Eligible patients are randomly allocated 1:1 to either Arm 1, usual care or Arm 2, STAR. Planned enrollment is 708 patients during a 6-month period. The primary outcome is the composite of all-cause hospital readmissions and mortality assessed 30 days post discharge. Secondary outcomes include 30- and 90-day hospital readmissions, mortality, emergency department visits, acute care-free days alive, and acute care and total costs.

Discussion

This pragmatic evaluation provides the most comprehensive assessment to date of a strategy to improve delivery of recommended post-sepsis care.

Trial registration

ClinicalTrials.gov, NCT03865602. Registered retrospectively on 6 March 2019.
Appendix
Available only for authorised users
Literature
1.
Fleischmann C, Scherag A, Adhikari NK, et al. Assessment of global incidence and mortality of hospital-treated sepsis. Current estimates and limitations. Am J Respir Crit Care Med. 2016;193(3):259–72.PubMedCrossRef
2.
Rhodes A, Evans LE, Alhazzani W, et al. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017;43(3):304–77.PubMedCrossRef
3.
Kaukonen KM, Bailey M, Suzuki S, Pilcher D, Bellomo R. Mortality related to severe sepsis and septic shock among critically ill patients in Australia and New Zealand, 2000–2012. JAMA. 2014;311(13):1308–16.PubMedCrossRef
4.
Iwashyna TJ, Ely EW, Smith DM, Langa KM. Long-term cognitive impairment and functional disability among survivors of severe sepsis. JAMA. 2010;304(16):1787–94.PubMedPubMedCentralCrossRef
5.
Shah FA, Pike F, Alvarez K, et al. Bidirectional relationship between cognitive function and pneumonia. Am J Respir Crit Care Med. 2013;188(5):586–92.PubMedPubMedCentralCrossRef
6.
7.
Borges RC, Carvalho CR, Colombo AS, da Silva Borges MP, Soriano FG. Physical activity, muscle strength, and exercise capacity 3 months after severe sepsis and septic shock. Intensive Care Med. 2015;41(8):1433–44.PubMedCrossRef
8.
9.
Jackson JC, Hopkins RO, Miller RR, Gordon SM, Wheeler AP, Ely EW. Acute respiratory distress syndrome, sepsis, and cognitive decline: a review and case study. South Med J. 2009;102(11):1150–7.PubMedPubMedCentralCrossRef
10.
Prescott HC, Langa KM, Iwashyna TJ. Readmission diagnoses after hospitalization for severe sepsis and other acute medical conditions. JAMA. 2015;313(10):1055–7.PubMedPubMedCentralCrossRef
11.
Huang C, Daniels R, Lembo A, et al. Sepsis survivors’ satisfaction with support services during and after their hospitalization. Crit Care Med. 2016;44(12):425.CrossRef
12.
13.
Winters BD, Eberlein M, Leung J, Needham DM, Pronovost PJ, Sevransky JE. Long-term mortality and quality of life in sepsis: a systematic review. Crit Care Med. 2010;38(5):1276–83.PubMedCrossRef
14.
Nesseler N, Defontaine A, Launey Y, Morcet J, Malledant Y, Seguin P. Long-term mortality and quality of life after septic shock: a follow-up observational study. Intensive Care Med. 2013;39(5):881–8.PubMedCrossRef
15.
16.
Goodwin AJ, Rice DA, Simpson KN, Ford DW. Frequency, cost, and risk factors of readmissions among severe sepsis survivors. Crit Care Med. 2015;43(4):738–46.PubMedPubMedCentralCrossRef
17.
Prescott HC, Langa KM, Liu V, Escobar GJ, Iwashyna TJ. Increased 1-year healthcare use in survivors of severe sepsis. Am J Respir Crit Care Med. 2014;190(1):62–9.PubMedPubMedCentralCrossRef
18.
Liu V, Lei X, Prescott HC, Kipnis P, Iwashyna TJ, Escobar GJ. Hospital readmission and healthcare utilization following sepsis in community settings. J Hosp Med. 2014;9(8):502–7.PubMedCrossRef
19.
20.
21.
Taylor S, Figueroa-Sierra M, Shuman T, et al. Post-sepsis care recommendations are associated with improved patient outcomes but adherence is low [abstract]. Crit Care Med. 2019;47(1):636.CrossRef
22.
Brownson RC, Allen P, Duggan K, Stamatakis KA, Erwin PC. Fostering more-effective public health by identifying administrative evidence-based practices: a review of the literature. Am J Prev Med. 2012;43(3):309–19.PubMedPubMedCentralCrossRef
23.
Bodenheimer T. Coordinating care—a perilous journey through the health care system. N Engl J Med. 2008;358(10):1064–71.PubMedCrossRef
24.
Coleman EA, Berenson RA. Lost in transition: challenges and opportunities for improving the quality of transitional care. Ann Intern Med. 2004;141(7):533–6.PubMedCrossRef
25.
Kim CS, Flanders SA. In the clinic. Transitions of care. Ann Intern Med. 2013;158(5 Pt 1):ITC3-1.PubMed
26.
Tschudy MM, Raphael JL, Nehal US, et al. Barriers to Care Coordination and Medical Home Implementation. Pediatrics. 2016;138(3):e20153458.PubMedCrossRef
27.
Wagner EH. Chronic disease management: what will it take to improve care for chronic illness? Eff Clin Pract. 1998;1(1):2–4.PubMed
28.
Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7.PubMedPubMedCentralCrossRef
29.
Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 2015;350:h2147.PubMedCrossRef
30.
Seymour CW, Liu VX, Iwashyna TJ, et al. Assessment of clinical criteria for sepsis: for the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016;315(8):762–74.PubMedPubMedCentralCrossRef
31.
32.
McWilliams A, Roberge J, Moore CG, et al. Aiming to Improve Readmissions Through InteGrated Hospital Transitions (AIRTIGHT): study protocol for a randomized controlled trial. Trials. 2016;17(1):603.PubMedPubMedCentralCrossRef
33.
McWilliams A, Roberge J, Anderson WE, et al. Aiming to Improve Readmissions Through InteGrated Hospital Transitions (AIRTIGHT): a pragmatic randomized controlled trial. J Gen Intern Med. 2019;34(1):58–64.PubMedCrossRefPubMedCentral
34.
Kroenke K, Spitzer RL, Williams JB. The Patient Health Questionnaire-2: validity of a two-item depression screener. Med Care. 2003;41(11):1284–92.PubMedCrossRef
35.
Serafim R, Gomes JA, Salluh J, Povoa P. A comparison of the Quick-SOFA and systemic inflammatory response syndrome criteria for the diagnosis of sepsis and prediction of mortality: a systematic review and meta-analysis. Chest. 2018;153(3):646–55.PubMedCrossRef
36.
Fernando SM, Tran A, Taljaard M, et al. Prognostic accuracy of the Quick Sequential Organ Failure Assessment for mortality in patients with suspected infection: a systematic review and meta-analysis. Ann Intern Med. 2018;168(4):266–75.PubMedCrossRef
37.
Weissman DE, Meier DE. Identifying patients in need of a palliative care assessment in the hospital setting: a consensus report from the Center to Advance Palliative Care. J Palliat Med. 2011;14(1):17–23.PubMedCrossRef
38.
Yende S, Linde-Zwirble W, Mayr F, Weissfeld LA, Reis S, Angus DC. Risk of cardiovascular events in survivors of severe sepsis. Am J Respir Crit Care Med. 2014;189(9):1065–74.PubMedPubMedCentralCrossRef
39.
Ou SM, Chu H, Chao PW, et al. Long-term mortality and major adverse cardiovascular events in sepsis survivors. A nationwide population-based study. Am J Respir Crit Care Med. 2016;194(2):209–17.PubMedCrossRef
40.
Shen HN, Lu CL, Yang HH. Risk of recurrence after surviving severe sepsis: a matched cohort study. Crit Care Med. 2016;44(10):1833–41.PubMedCrossRef
41.
Berger VW, Ivanova A, Knoll MD. Minimizing predictability while retaining balance through the use of less restrictive randomization procedures. Stat Med. 2003;22(19):3017–28.PubMedCrossRef
42.
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)—a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–81.CrossRefPubMed
43.
Gaudry S, Messika J, Ricard JD, et al. Patient-important outcomes in randomized controlled trials in critically ill patients: a systematic review. Ann Intensive Care. 2017;7(1):28.PubMedPubMedCentralCrossRef
44.
Liu V, Escobar GJ, Greene JD, et al. Hospital deaths in patients with sepsis from 2 independent cohorts. JAMA. 2014;312(1):90–2.PubMedCrossRef
45.
Mayr FB, Talisa VB, Balakumar V, Chang CH, Fine M, Yende S. Proportion and cost of unplanned 30-day readmissions after sepsis compared with other medical conditions. JAMA. 2017;317(5):530–1.PubMedCrossRef
46.
Zuckerman RB, Sheingold SH, Epstein AM. The Hospital Readmissions Reduction Program. N Engl J Med. 2016;375(5):494.PubMedCrossRef
47.
Gupta A, Allen LA, Bhatt DL, et al. Association of the Hospital Readmissions Reduction Program implementation with readmission and mortality outcomes in heart failure. JAMA Cardiol. 2018;3(1):44–53.PubMedCrossRef
48.
Foster SO, Schubauer-Berigan MK, Waters KM. The specificity of the National Death Index and Social Security Administration Death Master File when information on Social Security Number is lacking. Am J Epi. 2000;151(11):S43.
49.
Hoyer EH, Needham DM, Atanelov L, Knox B, Friedman M, Brotman DJ. Association of impaired functional status at hospital discharge and subsequent rehospitalization. J Hosp Med. 2014;9(5):277–82.PubMedCrossRef
50.
Greysen SR, Stijacic Cenzer I, Auerbach AD, Covinsky KE. Functional impairment and hospital readmission in Medicare seniors. JAMA Intern Med. 2015;175(4):559–65.PubMedPubMedCentralCrossRef
51.
Pederson JL, Warkentin LM, Majumdar SR, McAlister FA. Depressive symptoms are associated with higher rates of readmission or mortality after medical hospitalization: a systematic review and meta-analysis. J Hosp Med. 2016;11(5):373–80.PubMedCrossRef
52.
Rogers AT, Bai G, Lavin RA, Anderson GF. Higher hospital spending on occupational therapy Is associated with lower readmission rates. Med Care Res Rev. 2017;74(6):668–86.PubMedCrossRef
53.
Freburger JK, Li D, Fraher EP. Community use of physical and occupational therapy after stroke and risk of hospital readmission. Arch Phys Med Rehabil. 2018;99(1):26–34 e25.PubMedCrossRef
54.
Bruce ML, Lohman MC, Greenberg RL, Bao Y, Raue PJ. Integrating depression care management into Medicare home health reduces risk of 30- and 60-day hospitalization: the Depression Care for Patients at Home cluster-randomized trial. J Am Geriatr Soc. 2016;64(11):2196–203.PubMedPubMedCentralCrossRef
55.
Chen J, Novak P, Barath D, Goldman H, Mortensen K. Local health departments’ promotion of mental health care and reductions in 30-day all-cause readmission rates in Maryland. Med Care. 2018;56(2):153–61.PubMedCrossRef
56.
Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009;360(14):1418–28.PubMedCrossRef
57.
Hernandez AF, Greiner MA, Fonarow GC, et al. Relationship between early physician follow-up and 30-day readmission among Medicare beneficiaries hospitalized for heart failure. JAMA. 2010;303(17):1716–22.PubMedCrossRef
58.
Sharma G, Kuo YF, Freeman JL, Zhang DD, Goodwin JS. Outpatient follow-up visit and 30-day emergency department visit and readmission in patients hospitalized for chronic obstructive pulmonary disease. Arch Intern Med. 2010;170(18):1664–70.PubMedPubMedCentralCrossRef
59.
Field TS, Ogarek J, Garber L, Reed G, Gurwitz JH. Association of early post-discharge follow-up by a primary care physician and 30-day rehospitalization among older adults. J Gen Intern Med. 2015;30(5):565–71.PubMedCrossRef
60.
Shen E, Koyama SY, Huynh DN, et al. Association of a dedicated post-hospital discharge follow-up visit and 30-day readmission risk in a Medicare Advantage population. JAMA Intern Med. 2017;177(1):132–5.PubMedCrossRef
61.
Mueller SK, Sponsler KC, Kripalani S, Schnipper JL. Hospital-based medication reconciliation practices: a systematic review. Arch Intern Med. 2012;172(14):1057–69.PubMedPubMedCentralCrossRef
62.
Christensen M, Lundh A. Medication review in hospitalised patients to reduce morbidity and mortality. Cochrane Database Syst Rev. 2016;2:CD008986.PubMed
63.
64.
Rowe TA, McKoy JM. Sepsis in older adults. Infect Dis Clin N Am. 2017;31(4):731–42.CrossRef
65.
Kadri SS, Rhee C, Strich JR, et al. Estimating ten-year trends in septic shock incidence and mortality in United States academic medical centers using clinical data. Chest. 2017;151(2):278–85.PubMedCrossRef
66.
Shankar-Hari M, Phillips GS, Levy ML, et al. Developing a new definition and assessing new clinical criteria for septic shock: for the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016;315(8):775–87.PubMedPubMedCentralCrossRef
Metadata
Title
Structured, proactive care coordination versus usual care for Improving Morbidity during Post-Acute Care Transitions for Sepsis (IMPACTS): a pragmatic, randomized controlled trial
Authors
Marc Kowalkowski
Shih-Hsiung Chou
Andrew McWilliams
Cathryn Lashley
Stephanie Murphy
Whitney Rossman
Alfred Papali
Alan Heffner
Mark Russo
Larry Burke
Michael Gibbs
Stephanie P. Taylor
On behalf of Atrium Health ACORN Investigators
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3792-7

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