Evaluating the association between unmet healthcare needs and subsequent clinical outcomes: protocol for the Addressing Post-Intensive Care Syndrome-01 (APICS-01) multicentre cohort study

Narjes Akhlaghi, Dale M Needham, Somnath Bose, Valerie M Banner-Goodspeed, Sarah J Beesley, Victor D Dinglas, Danielle Groat, Tom Greene, Ramona O Hopkins, James Jackson, Mustafa Mir-Kasimov, Carla M Sevin, Emily Wilson, Samuel M Brown, Narjes Akhlaghi, Dale M Needham, Somnath Bose, Valerie M Banner-Goodspeed, Sarah J Beesley, Victor D Dinglas, Danielle Groat, Tom Greene, Ramona O Hopkins, James Jackson, Mustafa Mir-Kasimov, Carla M Sevin, Emily Wilson, Samuel M Brown

Abstract

Introduction: As short-term mortality declines for critically ill patients, a growing number of survivors face long-term physical, cognitive and/or mental health impairments. After hospital discharge, many critical illness survivors require an in-depth plan to address their healthcare needs. Early after hospital discharge, numerous survivors experience inadequate care or a mismatch between their healthcare needs and what is provided. Many patients are readmitted to the hospital, have substantial healthcare resource use and experience long-lasting morbidity. The objective of this study is to investigate the gap in healthcare needs occurring immediately after hospital discharge and its association with hospital readmissions or death for survivors of acute respiratory failure (ARF).

Methods and analysis: In this multicentre prospective cohort study, we will enrol 200 survivors of ARF in the intensive care unit (ICU) who are discharged directly home from their acute care hospital stay. Unmet healthcare needs, the primary exposure of interest, will be evaluated as soon as possible within 1 to 4 weeks after hospital discharge, via a standardised telephone assessment. The primary outcome, death or hospital readmission, will be measured at 3 months after discharge. Secondary outcomes (eg, quality of life, cognitive impairment, depression, anxiety and post-traumatic stress disorder) will be measured as part of 3-month and 6-month telephone-based follow-up assessments. Descriptive statistics will be reported for the exposure and outcome variables along with a propensity score analysis, using inverse probability weighting for the primary exposure, to evaluate the relationship between the primary exposure and outcome.

Ethics and dissemination: The study received ethics approval from Vanderbilt University Medical Center Institutional Review Board (IRB) and the University of Utah IRB (for the Veterans Affairs site). These results will inform both clinical practice and future interventional trials in the field. We plan to disseminate the results in peer-reviewed journals, and via national and international conferences.

Trial registration details: ClinicalTrials.gov (NCT03738774). Registered before enrollment of the first patient.

Keywords: Adult intensive & critical care; REHABILITATION MEDICINE; RESPIRATORY MEDICINE (see Thoracic Medicine).

Conflict of interest statement

Competing interests: Samuel M. Brown reports grants from National Institutes of Health, Department of Defense, Intermountain Research and Medical Foundation, and Janssen and consulting fees paid to his employer from Faron and Sedana, outside the submitted work. He also reports payments for DSMB service from Hamilton, outside the submitted work.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Phases of acute lung injury and its aftermath.
Figure 2
Figure 2
Flow chart depicting patient identification, enrolment and follow-up.

References

    1. Zimmerman JE, Kramer AA, Knaus WA. Changes in hospital mortality for United States intensive care unit admissions from 1988 to 2012. Crit Care 2013;17:R81. 10.1186/cc12695
    1. Phua J, Badia JR, Adhikari NKJ, et al. . Has mortality from acute respiratory distress syndrome decreased over time?: a systematic review. Am J Respir Crit Care Med 2009;179:220–7. 10.1164/rccm.200805-722OC
    1. Zambon M, Vincent J-L. Mortality rates for patients with acute lung injury/ARDS have decreased over time. Chest 2008;133:1120–7. 10.1378/chest.07-2134
    1. Erickson SE, Martin GS, Davis JL, et al. . Recent trends in acute lung injury mortality: 1996-2005. Crit Care Med 2009;37:1574–9. 10.1097/CCM.0b013e31819fefdf
    1. Spragg RG, Bernard GR, Checkley W, et al. . Beyond mortality: future clinical research in acute lung injury. Am J Respir Crit Care Med 2010;181:1121–7. 10.1164/rccm.201001-0024WS
    1. Hopkins RO, Weaver LK, Pope D, et al. . Neuropsychological sequelae and impaired health status in survivors of severe acute respiratory distress syndrome. Am J Respir Crit Care Med 1999;160:50–6. 10.1164/ajrccm.160.1.9708059
    1. Hopkins RO, Herridge MS. Quality of life, emotional abnormalities, and cognitive dysfunction in survivors of acute lung injury/acute respiratory distress syndrome. Clin Chest Med 2006;27:679–89. 10.1016/j.ccm.2006.06.003
    1. Needham DM, Dinglas VD, Bienvenu OJ, et al. . One year outcomes in patients with acute lung injury randomised to initial trophic or full enteral feeding: prospective follow-up of EDEN randomised trial. BMJ 2013;346:f1532. 10.1136/bmj.f1532
    1. Needham DM, Dinglas VD, Morris PE, et al. . Physical and cognitive performance of patients with acute lung injury 1 year after initial trophic versus full enteral feeding. EDEN trial follow-up. Am J Respir Crit Care Med 2013;188:567–76. 10.1164/rccm.201304-0651OC
    1. Dowdy DW, Eid MP, Dennison CR, et al. . Quality of life after acute respiratory distress syndrome: a meta-analysis. Intensive Care Med 2006;32:1115–24. 10.1007/s00134-006-0217-3
    1. Hopkins RO, Weaver LK, Collingridge D, et al. . Two-Year cognitive, emotional, and quality-of-life outcomes in acute respiratory distress syndrome. Am J Respir Crit Care Med 2005;171:340–7. 10.1164/rccm.200406-763OC
    1. Heyland DK, Groll D, Caeser M. Survivors of acute respiratory distress syndrome: relationship between pulmonary dysfunction and long-term health-related quality of life. Crit Care Med 2005;33:1549–56. 10.1097/01.CCM.0000168609.98847.50
    1. Hopkins RO, Weaver LK, Chan KJ, et al. . Quality of life, emotional, and cognitive function following acute respiratory distress syndrome. J Int Neuropsychol Soc 2004;10:1005–17. 10.1017/S135561770410711X
    1. Schelling G, Stoll C, Vogelmeier C, et al. . Pulmonary function and health-related quality of life in a sample of long-term survivors of the acute respiratory distress syndrome. Intensive Care Med 2000;26:1304–11. 10.1007/s001340051342
    1. Pandharipande PP, Girard TD, Jackson JC, et al. . Long-Term cognitive impairment after critical illness. N Engl J Med 2013;369:1306–16. 10.1056/NEJMoa1301372
    1. Kamdar BB, Sepulveda KA, Chong A, et al. . Return to work and lost earnings after acute respiratory distress syndrome: a 5-year prospective, longitudinal study of long-term survivors. Thorax 2018;73:125–33. 10.1136/thoraxjnl-2017-210217
    1. Kamdar BB, Huang M, Dinglas VD, et al. . Joblessness and lost earnings after acute respiratory distress syndrome in a 1-year national multicenter study. Am J Respir Crit Care Med 2017;196:1012–20. 10.1164/rccm.201611-2327OC
    1. Kamdar BB, Suri R, Suchyta MR, et al. . Return to work after critical illness: a systematic review and meta-analysis. Thorax 2019.
    1. Taylor SP, Chou S-H, Figueroa Sierra M, et al. . Association between adherence to recommended care and outcomes for adult survivors of sepsis. Ann Am Thorac Soc 2019.
    1. Prescott HC, Langa KM, Liu V, et al. . Increased 1-year healthcare use in survivors of severe sepsis. Am J Respir Crit Care Med 2014;190:62–9. 10.1164/rccm.201403-0471OC
    1. Prescott HC, Langa KM, Iwashyna TJ. Readmission diagnoses after hospitalization for severe sepsis and other acute medical conditions. JAMA 2015;313:1055–7. 10.1001/jama.2015.1410
    1. Liu V, Lei X, Prescott HC, et al. . Hospital readmission and healthcare utilization following sepsis in community settings. J. Hosp. Med. 2014;9:502–7. 10.1002/jhm.2197
    1. Ruhl AP, Huang M, Colantuoni E, et al. . Healthcare resource use and costs in long-term survivors of acute respiratory distress syndrome: a 5-year longitudinal cohort study. Crit Care Med 2017;45:196–204.
    1. Deb P, Murtaugh CM, Bowles KH, et al. . Does early follow-up improve the outcomes of sepsis survivors discharged to home health care? Med Care 2019;57:633–40. 10.1097/MLR.0000000000001152
    1. Bienvenu OJ, Colantuoni E, Mendez-Tellez PA, et al. . Depressive symptoms and impaired physical function after acute lung injury. Am J Respir Crit Care Med 2012;185:517–24. 10.1164/rccm.201103-0503OC
    1. Brown LM, Calfee CS, Matthay MA, et al. . A simple classification model for hospital mortality in patients with acute lung injury managed with lung protective ventilation*. Crit Care Med 2011;39:2645–51. 10.1097/CCM.0b013e3182266779
    1. Nuckton TJ, Alonso JA, Kallet RH, et al. . Pulmonary dead-space fraction as a risk factor for death in the acute respiratory distress syndrome. N Engl J Med Overseas Ed 2002;346:1281–6. 10.1056/NEJMoa012835
    1. Gajic O, Afessa B, Thompson BT, et al. . Prediction of death and prolonged mechanical ventilation in acute lung injury. Crit Care 2007;11:R53 10.1186/cc5909
    1. Patrawalla P, Kazeros A, Rogers L, et al. . Application of the asthma phenotype algorithm from the severe asthma research program to an urban population. PLoS One 2012;7:e44540 10.1371/journal.pone.0044540
    1. Mikkelsen ME, Christie JD, Lanken PN, et al. . The adult respiratory distress syndrome cognitive outcomes study: long-term neuropsychological function in survivors of acute lung injury. Am J Respir Crit Care Med 2012;185:1307–15.
    1. Stevenson JE, Colantuoni E, Bienvenu OJ, et al. . General anxiety symptoms after acute lung injury: predictors and correlates. J Psychosom Res 2013;75:287–93. 10.1016/j.jpsychores.2013.06.002
    1. Chelluri L, Im KA, Belle SH, et al. . Long-Term mortality and quality of life after prolonged mechanical ventilation*. Crit Care Med 2004;32:61–9. 10.1097/01.CCM.0000098029.65347.F9
    1. Rattray JE, Johnston M, Wildsmith JAW. Predictors of emotional outcomes of intensive care. Anaesthesia 2005;60:1085–92. 10.1111/j.1365-2044.2005.04336.x
    1. Hopkins RO, Key CW, Suchyta MR, et al. . Risk factors for depression and anxiety in survivors of acute respiratory distress syndrome. Gen Hosp Psychiatry 2010;32:147–55. 10.1016/j.genhosppsych.2009.11.003
    1. Brown SM, Wilson E, Presson AP, et al. . Predictors of 6-month health utility outcomes in survivors of acute respiratory distress syndrome. Thorax 2017;72:311–7. 10.1136/thoraxjnl-2016-208560
    1. Huang M, Parker AM, Bienvenu OJ, et al. . Psychiatric symptoms in acute respiratory distress syndrome survivors: a 1-year national multicenter study. Crit Care Med 2016;44:954–65.
    1. Brown SM, Bose S, Banner-Goodspeed V, et al. . Approaches to addressing Post–Intensive care syndrome among intensive care unit survivors. A narrative review. Ann Am Thorac Soc 2019;16:947–56. 10.1513/AnnalsATS.201812-913FR
    1. Jorm AF. A short form of the informant questionnaire on cognitive decline in the elderly (IQCODE): development and cross-validation. Psychol Med 1994;24:145–53. 10.1017/S003329170002691X
    1. Lin JS, O’Connor E, Rossom RC, et al. . Screening for cognitive impairment in older adults: a systematic review for the U. S. Preventive Services Task Force. Ann Intern Med 2013;159:601–12.
    1. Sevin CM, Bloom SL, Jackson JC, et al. . Comprehensive care of ICU survivors: development and implementation of an ICU recovery center. J Crit Care 2018;46:141–8. 10.1016/j.jcrc.2018.02.011
    1. Dettling-Ihnenfeldt DS, De Graaff AE, Nollet F, et al. . Feasibility of Post-Intensive care unit clinics: an observational cohort study of two different approaches. Minerva Anestesiol 2015;81:865–75.
    1. Morandi A, Vasilevskis E, Pandharipande PP, et al. . Inappropriate medication prescriptions in elderly adults surviving an intensive care unit hospitalization. J Am Geriatr Soc 2013;61:1128–34. 10.1111/jgs.12329
    1. Stollings JL, Bloom SL, Wang L, et al. . Critical care pharmacists and medication management in an ICU recovery center. Ann Pharmacother 2018;52:713–23. 10.1177/1060028018759343
    1. Robinson KA, Dinglas VD, Sukrithan V, et al. . Updated systematic review identifies substantial number of retention strategies: using more strategies retains more study participants. J Clin Epidemiol 2015;68:1481–7. 10.1016/j.jclinepi.2015.04.013
    1. Dinglas VD, Huang M, Sepulveda KA, et al. . Personalized contact strategies and predictors of time to survey completion: analysis of two sequential randomized trials. BMC Med Res Methodol 2015;15:5 10.1186/1471-2288-15-5
    1. Robinson KA, Dennison CR, Wayman DM, et al. . Systematic review identifies number of strategies important for retaining study participants. J Clin Epidemiol 2007;60:757.e1–65. 10.1016/j.jclinepi.2006.11.023
    1. Haines KJ, Berney S, Warrillow S, et al. . Long-Term recovery following critical illness in an Australian cohort. j intensive care 2018;6:8 10.1186/s40560-018-0276-x
    1. Tansey CM, Matté AL, Needham D, et al. . Review of retention strategies in longitudinal studies and application to follow-up of ICU survivors. Intensive Care Med 2007;33:2051–7. 10.1007/s00134-007-0817-6
    1. Coday M, Boutin-Foster C, Goldman Sher T, et al. . Strategies for retaining study participants in behavioral intervention trials: retention experiences of the NIH behavior change Consortium. Ann Behav Med 2005;29:55–65. 10.1207/s15324796abm2902s_9
    1. Imai K, Ratkovic M. Covariate balancing propensity score. J. R. Stat. Soc. B 2014;76:243–63. 10.1111/rssb.12027
    1. Ards definition Task force, Ranieri Vm, Rubenfeld Gd, Thompson Bt, Ferguson Nd, Caldwell E, et al. acute respiratory distress syndrome: the Berlin definition. JAMA 2012;307:2526–33.
    1. Ridgeway G, McCaffrey D, Morral A, et al. . Toolkit for weighting and analysis of nonequivalent groups: a tutorial for the twang package. Santa Monica, CA: RAND Corporation, 2006.
    1. Abshire M, Dinglas VD, Cajita MIA, et al. . Participant retention practices in longitudinal clinical research studies with high retention rates. BMC Med Res Methodol 2017;20;17:30.
    1. Heins SE, Wozniak AW, Colantuoni E, et al. . Factors associated with missed assessments in a 2-year longitudinal study of acute respiratory distress syndrome survivors. BMC Med Res Methodol 2018;15;18:55.
    1. Fong C, Hazlett C, Imai K. Covariate balancing propensity score for a continuous treatment: application to the efficacy of political advertisements. Ann Appl Stat 2018;12:156–77. 10.1214/17-AOAS1101
    1. Bloom SL, Stollings JL, Kirkpatrick O, et al. . Randomized clinical trial of an ICU recovery pilot program for survivors of critical Illness*. Crit Care Med 2019;47:1337–45. 10.1097/CCM.0000000000003909
    1. Needham DM, Davidson J, Cohen H, et al. . Improving long-term outcomes after discharge from intensive care unit: report from a stakeholders’ conference. Crit Care Med 2012;40:502–9.
    1. Haines KJ, Sevin CM, Hibbert E, et al. . Key mechanisms by which post-ICU activities can improve in-ICU care: results of the International thrive collaboratives. Intensive Care Med 2019;45:939–47. 10.1007/s00134-019-05647-5
    1. Elliott D, McKinley S, Alison J, et al. . Health-Related quality of life and physical recovery after a critical illness: a multi-centre randomised controlled trial of a home-based physical rehabilitation program. Crit Care 2011;15:R142 10.1186/cc10265
    1. Cuthbertson BH, Rattray J, Campbell MK, et al. . The practical study of nurse led, intensive care follow-up programmes for improving long term outcomes from critical illness: a pragmatic randomised controlled trial. BMJ 2009;339:b3723 10.1136/bmj.b3723
    1. Jensen JF, Egerod I, Bestle MH, et al. . A recovery program to improve quality of life, sense of coherence and psychological health in ICU survivors: a multicenter randomized controlled trial, the RAPIT study. Intensive Care Med 2016;42:1733–43. 10.1007/s00134-016-4522-1
    1. Feltner C, Jones CD, Cené CW, et al. . Transitional care interventions to prevent readmissions for persons with heart failure: a systematic review and meta-analysis. Ann Intern Med 2014;160:774–84.
    1. Krumholz HM, Amatruda J, Smith GL, et al. . Randomized trial of an education and support intervention to preventreadmission of patients with heart failure. J Am Coll Cardiol 2002;39:83–9. 10.1016/S0735-1097(01)01699-0
    1. Ruhl AP, Lord RK, Panek JA, et al. . Health care resource use and costs of two-year survivors of acute lung injury. An observational cohort study. Ann Am Thorac Soc 2015;12:392–401. 10.1513/AnnalsATS.201409-422OC
    1. Ruhl AP, Huang M, Colantuoni E, et al. . Healthcare utilization and costs in ARDS survivors: a 1-year longitudinal national US multicenter study. Intensive Care Med 2017;43:980–91. 10.1007/s00134-017-4827-8

Source: PubMed

Sponsorit ja yhteistyökumppanit

Sairaudet

Huumeiden interventiot

3
Tilaa