De-implementation of expensive blood saving measures in hip and knee arthroplasties: study protocol for the LISBOA-II cluster randomized trial

Implementation Science

Leti van Bodegom-Vos⁵  Thea PMM Vliet Vlieland³  Rob GHH Nelissen³  Albert Dahan¹  Ankie WMM Koopman-van Gemert⁶  M Elske van den Akker-van Marle⁵  Anja van der Hout⁵  Ad A Kaptein²  Cynthia So-Osman⁴  Perla J Marang-van de Mheen⁵  Veronique MA Voorn⁵ 

[1] Department of Anesthesiology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands;Department of Medical Psychology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands;Department of Orthopaedics, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands;Jon J van Rood, Netherlands Center for Clinical Transfusion Research, Sanquin Research, Plesmanlaan 1-A, 2333 BZ, Leiden, The Netherlands;Department of Medical Decision Making, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands;Department of Anesthesiology, Albert Schweitzer Hospital, Albert Schweitzerplaats 25, 3318 AT, Dordrecht, The Netherlands

关键词: De-implementation;    Blood saving measures;    Patient blood management;    Blood transfusion;    Hip/knee arthroplasties;   

Others  :  803890
DOI  :  10.1186/1748-5908-9-48

 received in 2014-03-14, accepted in 2014-04-08,  发布年份 2014

【 摘 要 】

Background

Despite evidence that erythropoietin and intra- and postoperative blood salvage are expensive techniques considered to be non-cost-effective in primary elective total hip and knee arthroplasties in the Netherlands, Dutch medical professionals use them frequently to prevent the need for allogeneic transfusion. To actually change physicians’ practice, a tailored strategy aimed at barriers that hinder physicians in abandoning the use of erythropoietin and perioperative blood salvage was systematically developed. The study aims to examine the effectiveness, feasibility and costs of this tailored de-implementation strategy compared to a control strategy.

Methods/Design

A cluster randomized controlled trial including an effect, process and economic evaluation will be conducted in a minimum of 20 Dutch hospitals. Randomisation takes place at hospital level. The hospitals in the intervention group will receive a tailored de-implementation strategy that consists of four components: interactive education, feedback in educational outreach visits, electronically sent reports on hospital performance (all aimed at orthopedic surgeons and anesthesiologists), and information letters or emails aimed at other involved professionals within the intervention hospital (transfusion committee, OR-personnel, pharmacists). The hospitals in the control group will receive a control strategy (i.e., passive dissemination of available evidence). Outcomes will be measured at patient level, using retrospective medical record review. This will be done in all hospitals at baseline and after completion of the intervention period. The primary outcome of the effect evaluation is the percentage of patients undergoing primary elective total hip or knee arthroplasty in which erythropoietin or perioperative blood salvage is applied. The actual exposure to the tailored strategy and users’ experiences will be assessed in the process evaluation. In the economic evaluation, the costs of the tailored strategy and the control strategy in relation to the difference in their effectiveness will be compared.

Discussion

This study will show whether a systematically developed tailored strategy is more effective for de-implementation of non-cost-effective blood saving measures than the control strategy. This knowledge can be used in national and international initiatives to make healthcare more efficient. It also provides more generalized knowledge regarding de-implementation strategies.

Trial registration

This trial is registered at the Dutch Trial Register NTR4044.

【 授权许可】

   
2014 Voorn et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

【 参考文献 】

• [1]Spahn DR: Anemia and patient blood management in hip and knee surgery: a systematic review of the literature. Anesthesiology 2010, 113:482-495.
• [2]Treloar CJ, Hewitson PJ, Henderson KM, Harris G, Henry DA, McGrath KM: Factors influencing the uptake of technologies to minimize perioperative allogeneic blood transfusion: an interview study of national and institutional stakeholders. Intern Med J 2001, 31:230-236.
• [3]Squires JE: Risks of transfusion. South Med J 2011, 104:762-769.
• [4]Munoz M, Garcia-Erce JA, Villar I, Thomas D: Blood conservation strategies in major orthopaedic surgery: efficacy, safety and European regulations. Vox Sang 2009, 96:1-13.
• [5]Alsaleh K, Alotaibi GS, Almodaimegh HS, Aleem AA, Kouroukis CT: The use of preoperative erythropoiesis-stimulating agents (ESAs) in patients who underwent knee or hip arthroplasty: a meta-analysis of randomized clinical trials. J Arthroplasty 2013, 28:1463-1472.
• [6]Sharma R, Farrokhyar F, McKnight LL, Bhandari M, Poolman RW, Adili A: Quality of assessment of randomized controlled trials in blood conservation after joint arthroplasty. J Arthroplasty 2011, 26:909-913.
• [7]Alshryda S, Sarda P, Sukeik M, Nargol A, Blenkinsopp J, Mason JM: Tranexamic acid in total knee replacement: a systematic review and meta-analysis. J Bone Joint Surg Br 2011, 93:1577-1585.
• [8]Carless PA, Henry DA, Moxey AJ, O'Connell D, Brown T, Fergusson DA: Cell salvage for minimising perioperative allogeneic blood transfusion. Cochrane Database Syst Rev 2010, 4:CD001888.
• [9]Haien Z, Yong J, Baoan M, Mingjun G, Qingyu F: Post-operative auto-transfusion in total hip or knee arthroplasty: a meta-analysis of randomized controlled trials. PLoS One 2013, 8:e55073.
• [10]Markar SR, Jones GG, Karthikesalingam A, Segaren N, Patel RV: Transfusion drains versus suction drains in total knee replacement: meta-analysis. Knee Surg Sports Traumatol Arthrosc 2012, 20:1766-1772.
• [11]Otten N: Economic Evaluation of Erythropoietin Use in Surgery. 1998. Ottawa: Canadian coordinating office for health technology assessment (CCOHTA); 1998.
• [12]Davies L, Brown TJ, Haynes S, Payne K, Elliott RA, McCollum C: Cost-effectiveness of cell salvage and alternative methods of minimising perioperative allogeneic blood transfusion: a systematic review and economic model. Health Technol Assess 2006, 10:iii-iv. ix-x, 1-210
• [13]Coyle D, Lee KM, Fergusson DA, Laupacis A: Economic analysis of erythropoietin use in orthopaedic surgery. Transfus Med 1999, 9:21-30.
• [14]Green WS, Toy P, Bozic KJ: Cost minimization analysis of preoperative erythropoietin vs autologous and allogeneic blood donation in total joint arthroplasty. J Arthroplasty 2010, 25:93-96.
• [15]Fergusson DA, Hebert P: The health(y) cost of erythropoietin in orthopedic surgery. Can J Anaesth 2005, 52:347-351.
• [16]Waters JH, Dyga RM, Waters JF, Yazer MH: The volume of returned red blood cells in a large blood salvage program: where does it all go? Transfusion 2011, 51:2126-2132.
• [17]Waters JR, Meier HH, Waters JH: An economic analysis of costs associated with development of a cell salvage program. Anesth Analg 2007, 104:869-875.
• [18]So-Osman C, Nelissen RG, Koopman-van Gemert AW, Kluyver E, Poll RG, Onstenk R, van Hilten JA, Jansen-Werkhoven TM, van den Hout WB, Brand R, Brand A: Patient blood management in elective total hip- and knee-replacement surgery (part 1): a randomized controlled trial on erythropoietin and blood salvage as transfusion alternatives using a restrictive transfusion policy in erythropoietin-eligible patients. Anesthesiology 2014, 120(4):839-851.
• [19]So-Osman C, Nelissen RG, Koopman-van Gemert AW, Kluyver E, Poll RG, Onstenk R, van Hilten JA, Jansen-Werkhoven TM, van den Hout WB, Brand R, Brand A: Patient blood management in elective total hip- and knee-replacement surgery (part 2): a randomized controlled trial on blood salvage as transfusion alternative using a restrictive transfusion policy in patients with a preoperative hemoglobin above 13 g/dl. Anesthesiology 2014, 120(4):852-860.
• [20]Dutton T, De-Souza R, Parsons N, Costa ML: The timing of tourniquet release and 'retransfusion' drains in total knee arthroplasty: a stratified randomised pilot investigation. Knee 2012, 19:190-192.
• [21]Thomassen BJ, Pilot P, Scholtes VA, Grohs JG, Holen K, Bisbe E, Poolman RW: Limit allogeneic blood use with routine re-use of patient's own blood: a prospective, randomized, controlled trial in total hip surgery. PLoS One 2012, 7:e44503.
• [22]Cheung G, Carmont MR, Bing AJ, Kuiper JH, Alcock RJ, Graham NM: No drain, autologous transfusion drain or suction drain? A randomised prospective study in total hip replacement surgery of 168 patients. Acta Orthop Belg 2010, 76:619-627.
• [23]Cip J, Widemschek M, Benesch T, Waibel R, Martin A: Does single use of an autologous transfusion system in TKA reduce the need for allogenic blood?: a prospective randomized trial. Clin Orthop Relat Res 2013, 471:1319-1325.
• [24]Horstmann WG, Kuipers BM, Slappendel R, Castelein RM, Kollen BJ, Verheyen CC: Postoperative autologous blood transfusion drain or no drain in primary total hip arthroplasty? A randomised controlled trial. Int Orthop 2012, 36:2033-2039.
• [25]Voorn VM, de Mheen PJ M-v, Wentink MM, So-Osman C, Vliet Vlieland TP, Koopman-van Gemert AW, Nelissen RG, van Bodegom-Vos L, for the LISBOA study group: Frequent use of blood-saving measures in elective orthopaedic surgery: a 2012 Dutch blood management survey. BMC Musculoskelet Disord 2013, 14:230. BioMed Central Full Text
• [26]Prasad V, Cifu A, Ioannidis JP: Reversals of established medical practices: evidence to abandon ship. JAMA 2012, 307:37-38.
• [27]Prasad V, Ioannidis JP: Evidence-based de-implementation for contradicted, unproven, and aspiring healthcare practices. Implement Sci 2014, 9:1. BioMed Central Full Text
• [28]Baker R, Camosso-Stefinovic J, Gillies C, Shaw EJ, Cheater F, Flottorp S, Robertson N: Tailored interventions to overcome identified barriers to change: effects on professional practice and health care outcomes. Cochrane Database Syst Rev 2010, 3:CD005470.
• [29]Grol R: Personal paper. Beliefs and evidence in changing clinical practice. BMJ 1997, 315:418-421.
• [30]Voorn VMA, de Mheen PJ M-v, So-Osman C, Vliet Vlieland TPM, Koopman-van Gemert AWMM, Nelissen RGHH, van Bodegom-Vos L, for the LISBOA study group: Designing a strategy to implement cost-effective blood transfusion management in elective hip and knee artroplasties: a study protocol. Implement Sci 2012, 7:58. BioMed Central Full Text
• [31]Grol R, Grimshaw J: From best evidence to best practice: effective implementation of change in patients' care. Lancet 2003, 362:1225-1230.
• [32]Grimshaw JM, Thomas RE, MacLennan G, Fraser C, Ramsay CR, Vale L, Whitty P, Eccles MP, Matowe L, Shirran L, Wensing M, Dijkstra R, Donaldson C: Effectiveness and efficiency of guideline dissemination and implementation strategies. Health Technol Assess 2004, 8:1-72.
• [33]Prior M, Guerin M, Grimmer-Somers K: The effectiveness of clinical guideline implementation strategies–a synthesis of systematic review findings. J Eval Clin Pract 2008, 14:888-897.
• [34]Voorn VMA, de Mheen PJ M-v, Wentink MW, Kaptein AA, Koopman-van Gemert AWMM, So-Osman C, Vliet Vlieland TPM, Nelissen RGHH, van Bodegom-Vos L, for the LISBOA study group: Perceived barriers among physicians for stopping non cost-effective blood saving measures in total hip and total knee arthroplasties. Transfusion 2014. (accepted for publication)
• [35]Michie S, Johnston M, Abraham C, Lawton R, Parker D, Walker A: Making psychological theory useful for implementing evidence based practice: a consensus approach. Qual Saf Health Care 2005, 14:26-33.
• [36]Francis JJ, Tinmouth A, Stanworth SJ, Grimshaw JM, Johnston M, Hyde C, Stockton C, Brehaut JC, Fergusson D, Eccles MP: Using theories of behaviour to understand transfusion prescribing in three clinical contexts in two countries: development work for an implementation trial. Implement Sci 2009, 4:70. BioMed Central Full Text
• [37]Michie S, Johnston M, Francis JJ, Hardeman W, Eccles M: From theory to intervention: mapping theoretically derived behavioural determinants to behaviour change techniques. Appl Psychol Int Rev 2008, 57:660-680.
• [38]Hulscher ME, Laurant MG, Grol RP: Process evaluation on quality improvement interventions. Qual Saf Health Care 2003, 12:40-46.
• [39]Severens JL: Value for money of changing healthcare services? Economic evaluation of quality improvement. Qual Saf Health Care 2003, 12(5):366-371.
• [40]Hakkaart-van Roijen L, Tan SS, Bouwmans CAM: Handleiding voor kostenonderzoek, methoden en standaard kostprijzen voor economische evaluaties in de gezondheidszorg. College voor zorgverzekeringen 2010.
• [41]WMA general Assembly: WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. Fortaleza; 2013.