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Implement Sci. 2015 Jan 13;10:8. doi: 10.1186/s13012-014-0190-0.

A cluster randomized trial of a multifaceted quality improvement intervention in Brazilian intensive care units: study protocol.

Collaborators (344)

Pinho SC, Dultra L, Hizumi LO, Calvete JO, Renner L, Vieira SR, Parolo E, Prado K, Lisboa NG, Esmeraldo ML, Benício RB, Pereira LA, Dias MD, Drumond FS, Diziola AD, da Silva DV, Li HY, Siniscalchi G, Nunes LB, Randi B, Malbouisson LM, Caltabeloti FP, Bassi E, Ferreira CB, Cagnon RG, Rodrigues AC, Begni Vdos S, Alves FR, Marchetti RO, de Oliveira Junior AA, Lannes R, Ludovico Ada S, Michel VN, Gonçalves SP, Gargioni RR, Faria SZ, Duarte RZ, Fonseca AL, da Silva MA, Coutinho MM, Pereira RS, dos Santos VO, de Gois AF, Ping KT, Borges Mde C, Lovato WJ, Gomes TM, Cerantola RB, Santos TM, Franci D, Bernardes KA, Rossi SB, Ferreira TE, de Freitas WV, Santos AP, de Freitas NA, Bezerra IS, Ferreira VL, Teixeira C, Maccari JG, Grion CM, Dias AO, Maier Gde S, Torres PR, Torres MM, Gomes RV, Toscano ML, Mattos MA, Nascimento VC, Jardim AM, Maciel AC, Westphal GA, Sperotto G, Fernandes JF, Ferreira RL, de Stefano LM, Gut AL, de Stefano GM, Ferreira DM, Gonçalves FA, Martins RH, de França LE, de Carvalho FB, Moreira GC, Cechinatti ED, Passos AC, Thompson MM, Pinheiro EP, Sodré Ade O, Ferreira LR, Bergo RR, Campo FT, Ribeiro GR, Matoso DC, Toneto MA, de Oliveira KR, Bandeira JA, Mesquita CC, Arcaro G, Wolff C, Betônico GN, Maroto RP, Menegon LF, Plantier GM, da Silveira PJ, de Queiroga Oliveira GE, da Rocha ML, Leao MA, de Assis J, Dal Pizzol F, Tomasi CD, Guimarães MR, Bastos LC, Gomes LM, Vale Éde L, Fernando A, da Silva DA, de Souza RL, Takashiba KS, Guerreiro MO, Bainy MP, Hardt Pde A, Urbano HC, de Souza CA, Japiassú AM, Medeiros DM, da Silva MB, Lisboa TC, Hädric M, Piras C, Néspoli LV, Taliule AS, Rabello LS, de Siqueira CR, de Souza RV, Cuadra JL, Spanholi J, Alta C, Viecili PR, de Almeida SD, de Oliveira CD, Moreira AG, de Moura MR, Soares PM, Silva LC, Barreto Júnior FF, Cruz EM, Costa Cda S, da Silva GA, Moreira R, Sebold M, Curvelo SL Jr, Passos JT, Pires P, de Souza Bouzaga Furlani D, de Oliveira NR, Deborssan Sde P, Fortaleza SC, Porfirio ML, Colares MM, Nunes LB, Neto SG, Miranda EV, de Oliveira Lopes Lima LK, Yamada SS, Germano A, Antunes F, Silva SR, Oliveira Tde A, Campos MT, Paranhos JE, Fraga AR, de Souza Júnior NJ, Nunes Jde S, Monteiro Rde S, Gorios ST, de Morais JP, Zambelli DM, Pereira MV, Lapa LN, da Silva R, Conceição MC, Carvalho LF, de Araujo Campos L, Soboslai P, Oliveira MA, de Souza LV, da Silva JN, Fragoso LV, Barros DA, Moreno G, Segundo DN, Dias MS, Santana MX, Mendes CL, Gottardo PC, Neto JM, Maia Fde S, Gusmao-Flores D, Araujo TL, Mota RS, Paranhos JL, Galati M, Meireles Ade C, de Souza HC, Vassallo PF, de Lima MH, Loureiro WL, Borghardt AT, Tavares Rda C, Gonçalves MR, Sá S, Vianna IA, Anabuki NT, Magalhães LM, Seabra NP, de Oliveira PC, Oliva RL, Asturi G, de Souza RM, de Paiva EC, Ribeiro AG, Nunes Neto PA, Cortes SA, Fernandes CA, Luchesi CÁ, Vaz SM, Merch JM, Oliveira JM, Laviola MB, de Sá NR, Rodrigues RA, Radespiel LS, Iorio VL, Bhering D, Linhares VR, de Brito Sobrinho E, Reis HJ, Santos SM, Rebelo MS, da Silva AR, dos Santos L, de Godoy MM, Sobral PD, Campelo Júnior Ede B, da Silva RS, Vasconcelos M, de Souza F, Martins MA, Muller RB, Stringari FB, Recalcatti MC, Rosenfeld RS, Rosenfeld VA, Santos GA, Japiassú L, Ribeiro AS, Giovanini CC, Carvalho ET, Antognetti MR, Fernandes LC, Rocha DM, Moreira VT, de Freitas CM, de Almeida R, Couto KA, Toffolo IM, de Oliveira AL, Prado LF, Martins FC, Feijó J, Maia MA, Lima VF, Nogueira EM, Gomes AC, Lima MA, Milagres LM, D'ávila VG, Schiavetto PM, dos Santos PA, Del Pintor LA, Raimundo Fde M, de Melo CL, Gondim R, Farias G, de Carvalho AA, de Santana CF, Nasrala ML, Pinheiro EK, Leite JA, Santos MR, Macedo SK, Furlani Dde S, Áglio E, da Silva EP, da Silva MG, de Lima EM, Mangini C, Resende AL, de Araujo LP, Cavalcante Lde O, Oliveira Filho W, Rodrigues J, de Pinho MC, Quintana D, dos Santos KT, Guimaraes AC, Diniz MD, Ferreira PH, Cordeiro RM, Mendes MO, Batista CC, Neumann T, Leite RO, Dias ÂR, Lacerda Fde M, Santos JR, Duque UH, Liparizi AE, Lana PV, Hirata F, Barreto AC, Gomes KR, Francisco VV, de Carvalho DS, Campos AN, Silva Maia I, Rassele T, Zanzi C, Sousa MF, Vial AA, Souza MM, Correia PC, Almeida LL, de Moura MR, Ferreira BE, Martins LF, Oliveira MH, Ferreira AK, Gurgel GT, Vasconcelos VA, de Lima SO, Bezerra S, da Silva AB.

Author information

1
Research Institute - Hospital do Coração (IEP- HCor), Rua Abílio Soares 250, 12th floor, CEP: 04005-000 - São Paulo, SP, Brazil. abiasi@hcor.com.br.

Abstract

BACKGROUND:

The uptake of evidence-based therapies in the intensive care environment is suboptimal, particularly in limited-resource countries. Checklists, daily goal assessments, and clinician prompts may improve compliance with best practice processes of care and, in turn, improve clinical outcomes. However, the available evidence on the effectiveness of checklists is unreliable and inconclusive, and the mechanisms are poorly understood. We aim to evaluate whether the use of a multifaceted quality improvement intervention, including the use of a checklist and the definition of daily care goals during multidisciplinary daily rounds and clinician prompts, can improve the in-hospital mortality of patients admitted to intensive care units (ICUs). Our secondary objectives are to assess the effects of the study intervention on specific processes of care, clinical outcomes, and the safety culture and to determine which factors (the processes of care and/or safety culture) mediate the effect of the study intervention on mortality.

METHODS/DESIGN:

This is a cluster randomized trial involving 118 ICUs in Brazil conducted in two phases. In the observational preparatory phase, we collect baseline data on processes of care and clinical outcomes from 60 consecutive patients with lengths of ICU stay longer than 48 h and apply the Safety Attitudes Questionnaire (SAQ) to 75% or more of the health care staff in each ICU. In the randomized phase, we assign ICUs to the experimental or control arm and repeat data collection. Experimental arm ICUs receive the multifaceted quality improvement intervention, including a checklist and definition of daily care goals during daily multidisciplinary rounds, clinician prompting, and feedback on rates of adherence to selected care processes. Control arm ICUs maintain usual care. The primary outcome is in-hospital mortality, truncated at 60 days. Secondary outcomes include the rates of adherence to appropriate care processes, rates of other clinical outcomes, and scores on the SAQ domains. Analysis follows the intention-to-treat principle, and the primary outcome is analyzed using mixed effects logistic regression.

DISCUSSION:

This is a large scale, pragmatic cluster-randomized trial evaluating whether a multifaceted quality improvement intervention, including checklists applied during the multidisciplinary daily rounds and clinician prompting, can improve the adoption of proven therapies and decrease the mortality of critically ill patients. If this study finds that the intervention reduces mortality, it may be widely adopted in intensive care units, even those in limited-resource settings.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01785966.

PMID:
25928627
PMCID:
PMC4342101
DOI:
10.1186/s13012-014-0190-0
[Indexed for MEDLINE]
Free PMC Article

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