A feasibility study of a randomised controlled trial to examine the impact of the ABCDE bundle on quality of life in ICU survivors

Pilot and Feasibility Studies

Volumn 4, Issue 1, 2018, Pages

  Sosnowski, Kellie ^a,b   Mitchell, Marion L ^b,c   White, Hayden ^a,b   Morrison, Lynette ^a   Sutton, Joanne ^a   Sharratt, Jessica ^a   Lin, Frances ^b  

^a Logan Hospital   (Australia)

^b GRIFFITH UNIVERSITY   (Australia)

^c PRINCESS ALEXANDRA HOSPITAL   (Australia)

Author keywords

ABCDE bundle; Critical illness; Delirium; Intensive care; Muscle weakness; Quality of life; Rehabilitation

Indexed keywords

ADULT; ADVERSE EVENT; AGITATION; ARTICLE; AUSTRALIA; CARE BUNDLE; CLINICAL ARTICLE; CLINICAL PRACTICE; CONTROLLED STUDY; CRITICALLY ILL PATIENT; DELIRIUM; FEASIBILITY STUDY; FEMALE; FUNCTIONAL INDEPENDENCE MEASURE; HUMAN; INTENSIVE CARE UNIT; MALE; OUTCOME ASSESSMENT; PAIN; PRIORITY JOURNAL; PROSPECTIVE STUDY; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); SURVIVOR; VENTILATED PATIENT;

EID: 85046749201     PISSN: None     EISSN: 20555784     Source Type: Journal    
DOI: 10.1186/s40814-017-0224-x     Document Type: Article

References (46)

1. Reade MC, Finfer S. Sedation and delirium in the intensive care unit. N Engl J Med. 2014;370(5):444-54.
2. Schweickert WD, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook CL, Spears L, Miller M, Franczyk M, Deprizio D, et al. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet. 2009;373(9678):1874-82.
3. Herridge MS, Tansey CM, Matté A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, et al. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011;364(14):1293-304.
4. Barr J, Fraser GL, Puntillo K, Ely EW, Gelinas C, Dasta JF, Davidson JE, Devlin JW, Kress JP, Joffe AM, et al. Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit. Crit Care Med. 2013;41(1):263-306.
5. Trogrlic Z, van der Jagt M, Bakker J, Balas MC, Ely EW, van der Voort PH, Ista E. A systematic review of implementation strategies for assessment, prevention, and management of ICU delirium and their effect on clinical outcomes. Crit Care. 2015;19:157.
6. Brummel NE, Jackson JC, Pandharipande PP, Thompson JL, Shintani AK, Dittus RS, Gill TM, Bernard GR, Ely EW, Girard TD. Delirium in the intensive care unit and subsequent long-term disability among survivors of mechanical ventilation. Crit Care Med. 2014;42(2):369-77.
7. Balas MC, Vasilevskis EE, Burke WJ, Boehm L, Pun BT, Olsen KM, Peitz GJ, Ely EW. Critical care nurses' role in implementing the "ABCDE bundle" into practice. Crit Care Nurse. 2012;32(2):35-8. 40-37; quiz 48
8. Harper S. Implementation plan for the ABCDE bundle. USA: The University of Arizona; 2015.
9. Barnes-Daly A, Phillips M, Ely G, Wesley E: ICU liberation: Using the ABCDEF bundle to improve outcomes in 7 California community ICUs In: Critical Care Congress. vol. Volume 43 Orlando, Florida: Critical Care Medicine:; 2015: 11.
10. Balas MC, Vasilevskis EE, Olsen KM, Schmid KK, Shostrom V, Cohen MZ, Peitz G, Gannon DE, Sisson J, Sullivan J, et al. Effectiveness and safety of the awakening and breathing coordination, delirium monitoring/management, and early exercise/mobility bundle. Crit Care Med. 2014;42(5):1024-36.
11. Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot Feasibility Stud. 2016;2:64.
12. Zealand. CoICMoAaN: Minimum standards for intensive care units. 2011, IC-01.
13. Levati S, Campbell P, Frost R, Dougall N, Wells M, Donaldson C, Hagen S. Optimisation of complex health interventions prior to a randomised controlled trial: a scoping review of strategies used. Pilot Feasibility Studies. 2016;2(1):1-17.
14. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655.
15. Sosnowski K, Lin F, Mitchell ML, White H. Early rehabilitation in the intensive care unit: an integrative literature review. Aust Crit Care. 2015;28(4):216-25.
16. Dobkin B. Progressive staging of pilot studies to improve phase III trials for motor interventions. Neurorehab Neural Repair. 2009;23:197-206.
17. Plow M, Moore S, Kirwan J, Frost F, Katzan I, Jaeger S, Alberts J. Randomized controlled pilot study of a SystemCHANGETM weight management intervention in stroke survivors: rationale and protocol. Trials. 2013;14(1):130.
18. Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, Altman DG, Barbour V, Macdonald H, Johnston M, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687.
19. Ely EW, Margolin R, Francis J, May L, Truman B, Dittus R, Speroff T, Gautam S, Bernard GR, Inouye SK. Evaluation of delirium in critically ill patients: validation of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Crit Care Med. 2001;29(7):1370-9.
20. Ely EW, Truman B, Shintani A, Thomason JW, Wheeler AP, Gordon S, Francis J, Speroff T, Gautam S, Margolin R, et al. Monitoring sedation status over time in ICU patients: reliability and validity of the Richmond Agitation-Sedation Scale (RASS). JAMA. 2003;289(22):2983-91.
21. Schweickert WD, Gehlbach BK, Pohlman AS, Hall JB, Kress JP. Daily interruption of sedative infusions and complications of critical illness in mechanically ventilated patients. Crit Care Med. 2004;32(6):1272-6.
22. Zanni JM, Korupolu R, Fan E, Pradhan P, Janjua K, Palmer JB, Brower RG, Needham DM. Rehabilitation therapy and outcomes in acute respiratory failure: an observational pilot project. J Crit Care. 2010;25(2):254-62.
23. Ottenbacher KJ, Hsu Y, Granger CV, Fiedler RC. The reliability of the functional independence measure: a quantitative review. Arch Phys Med Rehabil. 1996;77(12):1226-32.
24. Denehy L, de Morton NA, Skinner EH, Edbrooke L, Haines K, Warrillow S, Berney S. A physical function test for use in the intensive care unit: validity, responsiveness, and predictive utility of the physical function ICU test (scored). Phys Ther. 2013;93(12):1636-45.
25. Nordon-Craft A, Schenkman M, Edbrooke L, Malone DJ, Moss M, Denehy L. The physical function intensive care test: implementation in survivors of critical illness. Phys Ther. 2014;94(10):1499-507.
26. Brazier JE, Harper R, Jones NM, O'Cathain A, Thomas KJ, Usherwood T, Westlake L. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ. 1992;305(6846):160-4.
27. Hofhuis JG, Spronk PE, van Stel HF, Schrijvers GJ, Rommes JH, Bakker J. The impact of critical illness on perceived health-related quality of life during ICU treatment, hospital stay, and after hospital discharge: a long-term follow-up study. Chest. 2008;133(2):377-85.
28. Hofhuis JG, Hautvast JL, Schrijvers AJ, Bakker J. Quality of life on admission to the intensive care: can we query the relatives? Intensive Care Med. 2003;29(6):974-9.
29. Hofhuis JG, van Stel HF, Schrijvers AJ, Rommes JH, Spronk PE. ICU survivors show no decline in health-related quality of life after 5 years. Intensive Care Med. 2015;41(3):495-504.
30. Shanyinde M, Pickering RM, Weatherall M. Questions asked and answered in pilot and feasibility randomized controlled trials. BMC Med Res Methodol. 2011;11:117.
31. Bugge C, Williams B, Hagen S, Logan J, Glazener C, Pringle S, Sinclair L. A process for Decision-making after Pilot and feasibility Trials (ADePT): development following a feasibility study of a complex intervention for pelvic organ prolapse. Trials. 2013;14:353.
32. Bailey P, Thomsen GE, Spuhler VJ, Blair R, Jewkes J, Bezdjian L, Veale K, Rodriquez L, Hopkins RO. Early activity is feasible and safe in respiratory failure patients. Crit Care Med. 2007;35(1):139-45.
33. Berney S, Haines K, Skinner EH, Denehy L. Safety and feasibility of an exercise prescription approach to rehabilitation across the continuum of care for survivors of critical illness. Phys Ther. 2012;92(12):1524-35.
34. Burtin C, Clerckx B, Robbeets C, Ferdinande P, Langer D, Troosters T, Hermans G, Decramer M, Gosselink R. Early exercise in critically ill patients enhances short-term functional recovery. Crit Care Med. 2009;37(9):2499-505.
35. Chen YH, Lin HL, Hsiao HF, Chou LT, Kao KC, Huang CC, Tsai YH. Effects of exercise training on pulmonary mechanics and functional status in patients with prolonged mechanical ventilation. Respir Care. 2012;57(5):727-34.
36. Davis J, Crawford K, Wierman H, Osgood W, Cavanaugh J, Smith KA, Mette S, Orff S. Mobilization of ventilated older adults. J Geriatr Phys Ther. 2013;36(4):162-8.
37. Parker A, Sricharoenchai T, Needham DM. Early rehabilitation in the intensive care unit: preventing physical and mental health impairments. Curr Phys Med Rehabil Rep. 2013;1(4):307-14.
38. Fan E, Dowdy DW, Colantuoni E, Mendez-Tellez PA, Sevransky JE, Shanholtz C, Dennison Himmelfarb CR, Desai SV, Ciesla N, Herridge MS, et al. Physical complications in acute lung injury survivors: a two-year longitudinal prospective study. Crit Care Med. 2014;42(4):849-59.
39. Abresch RT, Han JJ, Carter GT. Rehabilitation management of neuromuscular disease: the role of exercise training. J Clin Neuromuscul Dis. 2009;11(1):7-21.
40. Dias L, Schoenfeld E, Thomas J, Baldwin C, McLeod J, Smith J, Owens R, Hyman L. Reasons for high retention in pediatric clinical trials: comparison of participant and staff responses in the Correction of Myopia Evaluation Trial. Clin Trials. 2005;2(5):443-52.
41. Bounds M, Kram S, Speroni KG, Brice K, Luschinski MA, Harte S, Daniel MG. Effect of ABCDE bundle implementation on prevalence of delirium in intensive care unit patients. Am J Crit Care. 2016;25(6):535-44.
42. Truog RD, Campbell ML, Curtis JR, Haas CE, Luce JM, Rubenfeld GD, Rushton CH, Kaufman DC. Recommendations for end-of-life care in the intensive care unit: a consensus statement by the American College [corrected] of Critical Care Medicine. Crit Care Med. 2008;36(3):953-63.
43. Balas MC, Barnes-Daly A, Byrum D, Pun BT, Ely W: Helping critically ill patients and families thrive through an ABCDEF approach. In: Critical Connections. vol. August; 2015.
44. Arain M, Campbell MJ, Cooper CL, Lancaster GA. What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Med Res Methodol. 2010;10:67.
45. Parry SM, Denehy L, Beach LJ, Berney S, Williamson HC, Granger CL. Functional Outcomes in ICU - What should we be using? An observational study. Crit Care. 2015;19:127.
46. Leon AC, Davis LL, Kraemer HC. The role and interpretation of pilot studies in clinical research. J Psychiatr Res. 2011;45(5):626-9.