Introduction                       

A possible solution to our current national health care crisis is for providers, payers and policymakers to create and utilize transparent, consumer-driven care. If medicine is returned to its optimal focus - enabling health and providing effective care1 - then health care will improve for all stakeholders. A new quality and safety initiative created and deployed at the Good Samaritan Hospital (GSH) Orthopaedic Center of Excellence (OCE) is offered as an example of optimal focus in the conditions and care cycles of reconstructive surgery for patients with disabling arthritis of the hip and knee. This initiative is entitled “Zero in on Zero” (Zero).

Ten of the most crippling and expensive adverse events (AE) known to occur in patients with hip and knee arthroplasty were selected as targets for a zero rate of occurrence. Clinical practice guidelines (CPG) and best practice proposals (BPP) were discerned using best evidence literature.2,3 Each target was analyzed mirroring Root Cause Analysis (RCA)4,5 so that factors occurring before, during and after the adverse event(s) associated with hip and knee arthroplasty care cycles, could be thoroughly analyzed for future correction with CPG and BPPs. Essential to the success of the overall Zero initiative was collaboration of all stakeholders in the care cycles.

Reducing the rate of blood transfusions during and after total joint reconstruction of the hip and knee is offered as a stellar example of the initiative’s potential benefit. Prior to employing this particular BPP, the 17 surgeon rate was greater than 20%. After six months of the Zero initiative deployment, the rate was less than 2%. Similar reductions in AE rate were experienced in surgical site infections, poor pain management, patient dissatisfaction, poor discharge handoff, and venous thromboembolism (VTE). A total joint registry was created in order to track and measure care cycle details, including AEs.

Patient access will be a proxy for success in the Zero initiative because patients desire outcome transparency in health care; and their satisfaction with care will drive their selection of services. Additionally, patients acknowledge the quality of life benefits of hip and knee arthroplasty when they are encouraged by providers to select this type of care. They are also more likely to select total joint arthroplasty when they can be assured of optimal recovery and low rates of AE. The GSH OCE Zero initiative is an optimal solution to reduce AEs and increase patient access to total hip and knee arthroplasty.

Preparing         for         Excellence                  

The future of heath care around the world is threatened by variable patient access and poorly managed health care costs. Government mandates to control costs by severely reducing

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payments to hospitals and providers will never effectively provide robust access to health care, nor will it successfully manage costs in any society burdened by aging and unhealthy populations. However, a vigorous reduction in adverse events, as in care cycles like total hip and knee arthroplasty, holds great promise to benefit all stakeholders in health care. Patient satisfaction is inexorably linked to value, safety, and consumer-driven strategies like: transparency,6 consumer-friendly providers, consumer-friendly payers, and consumer-friendly policy makers.7 Avoidance of adverse events will help protect patients and leveraged societal resources.8,9 Patient safety works for everyone in health care, and it is cost effective! Physician leadership is critical to success in the future of health care. Enabling health and providing effective treatment are the principles goals worthy of pursuit. The principles strategies to achieve these goals are: providing value for patients, organizing care around conditions and care cycles, and risk-adjusted results and costs.1 In our efforts to build and succeed with the Zero initiative for total hip and knee arthroplasty, we postulated that value for patients could be rapidly assisted by radically reducing adverse events and patient dissatisfaction. The conditions of disabling arthritis of the hip and knee and correction with total joint arthroplasty serve as ideal organizational models since results are rapidly achieved and most significant AEs occur relatively early in the care cycle. A total joint registry is one of the best ways to measure results and track costs, if set up with appropriate data fields

integrated with hospital data systems.10

 

Total Hip Arthroplasty

 

Zero in on Zero: A Step in the Right Direction

 

A year after our institution began the quest to achieve Joint Commission certification as a center of excellence in total hip and knee arthroplasty, we proposed the Zero initiative. Since clinical care is a process addressing disease before, during and after its assault on human health, it seemed appropriate to organize the Zero initiative around ten known costly and potentially crippling adverse events and processes in total hip and knee arthroplasty (Flow chart 43.1). We expected, and later realized, that the Joint Commission would recognize the nationally significant nature of our AE reduction initiative. See the Zero chart for the full listing of AE reduction targets and improvement strategies.

The next step was to review our institutional data for occurrence rates in the ten Zero areas. Where that data was not known, such is often the case in health care without clinical registries, national rates were listed [e.g., Medicare population rates for periprosthetic joint infection (PJI)]. The occurrence rate targets were then set with an ultimate goal of zero per

 

Flow chart 43.1: Zero in on zero clinical focus

 

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cent. It is clear that a zero rate of AE occurrence will never be consistently achieved, but any movement in that direction will produce benefits for all stakeholders in health care. Finally, available clinical practice guidelines (CPG) were acknowledged, and best practice proposals (BPP) were developed using best evidence literature.

Zero in on Zero

 

Since physician leadership is so critical to success in health care and institutional performance, we early appreciated that BPP deployment would require physician development and continuous review. We also supported the responsibility of every physician to pre-empt BPPs if a given patient situation required different strategies. Deployment strategies were listed in order to transparently engage center of excellence physicians, as well as challenge us all to collaborate in the beginning and throughout the years of ever improving total hip and knee reconstructive care.

 

DEPLOYMENT STRATEGIES

1. Simple three step process: contributing factors before, during, and after total hip and knee arthroplasty.

2. Research and analyze EBM literature, where available, emphasizing the highest level of evidence found in randomized clinical trials, controlled clinical trials, meta-analyses, and Cochrane reviews.

3. Assign the literature to one or more of the three step process. Draw from the references included in the “Zero...” chart.

4. Propose simple protocols to improve outcomes in each of the ten “Zero...” categories.

5. Collaborate and achieve consensus with the total joint docs starting first with the Orthopaedic Service Council (OSC) and Orthopaedic Center of Excellence (OCE) groups. Also achieve multidisciplinary consensus.

6. Publish and provide simple protocols to all stakeholders.

7. Present protocols to Section for approval.

8. Obtain administrative support when costs of deployment are significant.

9. When needed, design and execute a formal CQI process.

10. Use the registry for essential data collection and cost analysis.

11. Report data up the institutional leadership levels as soon as valid.

The first AE reduction target we pursued was reducing allogeneic transfusions. These are associated with increased rates of PJI, all-cause death, and 30-day readmissions. Our institution had also embarked on a system wide effort to reduce all blood transfusions. See charts B and C for the methods we employed to define the RCA process, embed literature, and then formalize the BPP. We were pleased to observe a greater than 90% reduction in the rate of allogeneic transfusion within six months of deploying this particular BPP. For some surgeons (author) the rate is less than 0.5% for all hip and knee reconstructive surgeries. Key strategies were detecting all patients with a pre-operative hemoglobin of less an 13 gm and correcting with erythropoietin, the use of pre-operative tranexamic acid, avoidance of deep wound drains when feasible, and modified transfusion triggers. The GSH institution highly regards how orthopaedic surgeons from various unrelated practices, hospital administrators and staff, and patients and their families collaborated to achieve such rapid

 

 

Flow chart 43.2:

 

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Total Hip Arthroplasty

 

Flow chart 43.3:

 

success. Additionally, transfusion cost reductions exceeded 50 percent in the first six months after deployment. As of this publication, similar successes are documented in avoidance of PJI, high patient satisfaction, avoidance of VTE deaths in during and 30 days after hospitalization, optimal discharge handoff, and effective post-operative pain management. Zero really works!

 

Table 43.1: The zero chart

 

Topic for improvement target	Trihealth data	FLR and national benchmarks	Goals achievable	Best practice proposals
Infected primary	Exceeds 1% >3% in	Medicare TKA rate	0% rate and no	All patients pre-op 2%
THA and TKA	some months See recent IPC PPT cardiac	1.55%1 Financial burden near $50,000 per case2	MRSA cases	chlorhexidine3-6 body wipe and possibly nasal mupirocin7 Full SCIP compliance acticoatTM
	sternotomy infection			cover8,9 closure ATB dose? ATB
	rate <0.1%			cement10,11 Pre-op health
				optimization, esp DM12
				Handwashing
In hospital and 30 day	<0.1% for TJA cases	2008 ACCP13	0% rate	Multimodal with LMWH or
post-op death from VTE		recommendations ACCP > AAOS14		Fondaparinux or Coumadin SCDs FWB post-op? future factor Xa
		Existing triggers		inhibitors
				Clinical suspicion
Primary THA early	6% rate15	Large diameter	0% rate for	Use of maximum head diameter
prosthetic dislocation	MAS rate <0.5%	heads16	uncomplicated primary	where feasible
		Direct anterior17	cases	Either DA or capsule repair with
		Mini posterior with capsule repair18		other approaches

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Contd...

 

Topic for improvement Trihealth data FLR and national Goals achievable Best practice proposals target benchmarks

 

Poorly controlled In the absence of AOA/OREF survey data 0% rate of patients MMPM with pre-emptive

Zero in on Zero

 

	blocks, post-op TJA pain control is often poor	Pain concerns23,24	MMPM	Peri-op COX-225 and neuroleptics26 Wound injection Regional block
Allogenic transfusions	Variable but high rate MAS 8%	Special strategies for pre-op anemia	0% rate in primary THA and TKA <10%	Multimodal. Erythropoiten in selected patients30
		Prevent auto waste!27	in bilateral TKA and	Decreased drain use
		2010 AAOS consensus	rev TJA	Reinfusion system Bipolar use31
		Risk of allogeneic		Revised transfusion triggers
		transfusion27-29		(7 gm)32
				Pre-op Tranexamic 15 mg/kg IV 15 min before incision33-36
30 day readmission	<2%	5.5% US TKA rate37	0% rate of VTE,	Resolve med issues prior to D/C
		VTE, sepsis, dislocation	dislocation and	Use best practice proposals
		Med issues37 SNF>home	infected TJR 0%
		D/C38 Suboptimal
		discharge program39
Orthopedic unit falls	?>5%	Cochrane review 2001	0% rate	Prevention strategies align with
		verifies risk reduction40		risk data
		Greater risk at night and		Peri-op balance training (Yoga?)
		BR41		Family education FN blocks over
		Balance efforts pre-op		catheters
		might help40		Decrease confusion by limiting
		Related to blocks		narcotics42
		Patient confusion
Patient dissatisfaction	<5%	Pre-op risks: Patient factors43,44	0% rate	Pre-op documentation of psychosocial state
		Pain catastrophizing45		Pain control
		Missing patient		Complication prevention
		expectations46-48		Awareness of expectations
		Poor pain control		Patient education
		TKA pain relief greater than full function48-49
		Complications49
Poor discharge handoff	<5%	Improper documen-	0% rate	TJA Guidelines 100% use
		tation at discharge50		Updated Choudhury D/C forms
		Excessive ECF use		Family/friends support
		Lack of TJA guidelines		continuously developed
		use Poor grasp of patients’		Optimize home-based rehabilitation52?
		specific need51		Extra day(s) in hospital
		Poor patient/ family		Follow Consensus Standards50
		compliance with
		pre-op discharge
		recommendations
Cather associated UTI	<5%	Premature foley Pre-op UTI	0%	Follow established practice guidelines53
		Foley > 24 hours		GSH protocol
		Female pts at risk		ISC up to 4 times
		Frequent coding errors54		Pre-op GU consult
		Failure to restrict foley to proven needs55		Pre-op U/A and culture if indicated RX UTI pre-op

 

post-op pain MMPM or regional FLR19-22 not treated with anesthesia

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Concluding                    Remarks                   

By 2016, the United States will likely experience total joint surgical shortfalls of between

18.6 to 69.4 percent.11 This will result from ever increasing end-stage hip and knee arthritis disease burden, and from a flat growth rate of surgeons capable of and committed to performing total hip and knee arthroplasty. There is no reason to believe to that delaying the timing of necessary total hip and knee arthroplasty will support optimal patient outcomes. In fact, just the opposite decline in benefit has already been observed.12

We predict a crisis in access to total hip and knee arthroplasty, and to revision arthroplasty. There will be three principle driving forces to limit access. First, patients themselves limit access by assuming that joint pain and decreased function are the natural results of aging.13 Second, primary care physicians who provide first contact care infrequently recommend total joint reconstruction. Patients are negatively influenced by this like of timely referral.14 Finally, patients choose to avoid access if they are fearful of difficult recovery, AEs, and burdensome costs.15

We recommend the Zero initiative as part of a regional, if not national solution to future patient access crises. It can provide stellar safety and quality for patients, providers, and policymakers—a “win-win” for all. Physician leadership is critical to create and sustain patient-centered solutions for adverse event and related cost challenges in hip and knee reconstructive surgery.

 

Total Hip Arthroplasty

 

References      for      Zero      Chart                 

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2. Lavernia C, et al. The increasing financial burden of knee revision in the United States. Clin Orthop 2006;446:221.

3. Parvizi J, et al. Periprosthetic joint infection. The economic impact of methicillin-resistant infections. J Arthroplasty 2010;25(6, Suppl 1):103-7.

4. Zwiel M, et al. Pre-admission Chlorhexidine Preparation Reduces the Incidence of Surgical Site Infections in TKA. AAOS 2010, Poster 159.

5. Eiselt D. Presurgical skin preparation with a novel 2% chlrohexidine gluconate cloth reduces rates of surgical site infection in orthopaedic surgical patients. Orthop Nurs 2009;28:141.

6. Evans HL, et al. Effect of chlorhexidine whole-body bathing on hospital-acquired infections among trauma patients. Arch Surg 2010;145:240.

7. Ruschulte H, et al. Prevention of central venous catheter related infections with chlorhexidine gluconate impregnated wound dressings: a randomized controlled trial. Ann Hematol 2009;88:267.

8. Patel JB, et al. Mupirocin resistance. Clin Infect Dis 2009;49:935 .

9. Brett DW. A discussion of silver as an antimicrobial agent: alleviating the confusion. Ostomy Wound Manage 2006;52:34.

10. Castellano JJ, et al. Comparative evaluation of silver-containing antimicrobial dressings and drugs. Int Wound J 2007;4:114.

11. Jamsen E, et al. Risk factors for infection after knee arthroplasty. A register-based analysis of 43,149 cases. J Bone Joint Surg Am 2009;91:38.

12. Cummins JS, et al. Cost-effectiveness of antibiotic-impregnated bone cement used in primary total hip arthroplasty. J Bone Joint Surg Am 2009;91:634.

13. Marchant MH, et al. The impact of glycemic control and diabetes mellitus on perioperative outcomes after total joint arthroplasty. J Bone Joint Surg Am 2009;91:1621.

14. Geerts WH, et al. Prevention of venous thromboembolism: American College of Chest Physicians evidence-Based Clinical Practice Guidelines (8th Ed). Chest 2008;133(6 Suppl):381S.

15. Woller et al. Comparison of ACCP Guidelines to AAOS Guidelines for the prevention of PE among TJR patients. AAOS 2010, Poster 77.

16. Masonis JL, Bourne RB. Surgical approach, abductor function, and total hip arthroplasty dislocation. Clin Orthop 2002;405:46.

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17. Cuckler JM, et al. Large versus small femoral heads in metal-on-metal total hip arthroplasty. J Arthroplasty 2004;19(8 Suppl 3):41.

18. Masonis J, et al. safe and accurate: learning the direct anterior total hip arthroplasty. Orthopedics 2008;31(12 Suppl 2).

19. Kwon MS, et al. Does surgical approach affect total hip arthroplasty dislocation rates? Clin Orthop 2006;447:34.

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20. Malkani AL, et al. Early-and Late-Term Dislocation Risk After Primary Total Hip Arthroplasty in the Medicare Population. Dorr Award. J Arthroplasty 2010:25(6, Suppl 1):21-25.

21. Busch CA, et al. Efficacy of a periarticular multimodal drug injection in total knee arthroplasty. A randomized trial. J Bone Joint Surg Am 2006;88:959.

22. Peters CL, et al. The effect of a new multimodal perioperative anesthetic regimen on postoperative pain, side effects, rehabilitation, and length of hospital stay after total joint arthroplasty. J Arthroplasty 2006;21(6 Supple 2):132.

23. Hebl JR, et al. A pre-emptive multimodal pathway featuring peripheral nerve block improves perioperative outcomes after major orthopedic surgery. Reg Anesth Pain Med 2008;33:510.

24. Duncan CM, et al. The economic implications of a multimodal analgesic regimen for patients undergoing major orthopedic surgery: a comparative study of direct costs. Reg Anesth Pain Med 2009;34:301.

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26. Riddle DL, et al. Preoperative pain catastrophizing predicts pain outcome after knee arthroplasty. 2010;468:798.

27. Franklin PD, et al. Reduction in Narcotic Use After Primary Total Knee Arthroplasty and Association with Patient Pain Relief and Satisfaction. J Arthroplasty 2010;25(6, Suppl 1):12-16.

28. Meunier A, et al. Effects of celecoxib on blood loss, pain, and recovery of function after total knee replacement; a randomized placebo-controlled trial. Acta Orthop 2007;78:661.

29. Schroeder WC, et al. Six-Week Postoerative COX-2 Inhibitor Use Improves TKA Recovery: A Double-Blind, Placebo-Controlled Study. Symposium lll: TKA Perioperative Management. The Knee Society 2011 Annual Meeting at AAOS. Feb 19, 2011. San Diego, California.

30. Tiippana EM, et al. Do surgical patients benefit from perioperative gabapentin/pregabalin? A systematic review of efficacy and safety. Anesth Analg 2007:104:1545.

31. Salida JA, et al. Preoperative hemoglobin levels and the need for transfusion after prosthetic hip and knee surgery: predictive factors. JBJS 2002 84:216.

32. Bong MR, et al. Risks associated with blood transfusion after total knee arthroplasty. J Arthroplasty 2004;19:281.

33. Bierbaum BE, et al. An analysis of blood management in patients having a total hip or knee arthroplasty. J Bone Joint Surg Am 1999;81:2.

34. Rosencher, N. Orthopedic Surgery Transfusion Hemoglobin European Overview (OSTHEO) study: blood management in elective knee and hip arthroplasty in Europe. Transfusion 2003;43(4):459.

35. Pierson JL, et al. A blood-conservation algorithm to reduce blood transfusions after total hip and knee arthroplasty. J Bone Joint Surg 2004 86:1512.

36. Keating EM, et al. A randomized, parallel-group, open-label trail of recombinant erythropoietin vs preoperative autologous donation in primary total joint arthroplasty: effect on postoperative vigor and handgrip strength. J Arthroplasty 2007; 22:325.

37. Li C, et al. No Clear Advantage to Use of Wound Drains After Unilateral Total Knee Arthroplasty: a prospective randomized, controlled trial. J Arthroplasty 2010 Jul 13 (Epub ahead of publication).

38. Marulanda GA, et al. Reductions in blood loss with a bipolar sealer in total hip arthroplasty: a prospective, blinded, randomized study. Expert Rev Med Devices 2008;5(2):125.

39. Arrington TL, et al. Evaluate Simple Guidelines for Reducing Blood transfusion in Total Joint Replacement Patients. AAOS 2008, Podium 579.

40. Eubanks JD. Antifibrinolytics in major orthopaedic surgery. J Am Acad Orthop Surg 2010;18(3):132.

41. MacGillivray RG, Tarabichi SB, Hawari MF, Raoof NT. Tranexamic Acid to Reduce Blood Loss After Bilateral Total Knee Arthroplasty. A prospective randomized double blind study. J Arthroplasty 2011;26(1):24-28.

42. Henry DA. Anti-fibrinolytic use for minimizing perioperative allogenic blood transfusions. Cochrane Database Syst Rev 2007 17;(4):CD001886.

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43. Orpen NM, et al. Tranexamic acid reduces early post-operative blood loss after total knee arthroplasty: a prospective randomized controlled trail of 29 patients. Knee 2006;13:106.

44. Ho KM, Ismail H. Use of intravenous tranexamic acid to reduce allogeneic blood transfusion in total hip and knee arthroplasty: a meta-analysis. Anaesth Intensive care 2003;31:529.

45. Huddleston JI, et al. Adverse events after total knee arthroplasty: a national Medicare study. J Arthroplasty 2009;24(6 Suppl):95.

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46. Herndon JH, et al. Readmission and Length of Stay After THA in a National Medicare sample 2002-2007. Podium No. 718, 2011 Annual AAOS, San Diego, CA.

47. Barsoum WK, et al. Predicting Patient Discharge Disposition After Total Joint Arthroplasty in the United States. J Arthroplasty 2010;25(6, Suppl 1);885-92.

48. Bini SA, et al. Does discharge disposition after primary total joint arthroplasty affect readmission rates? J Arthroplasty 2010;25:114.

49. Jack BW,et al. A reengineered hospital discharge program to decrease rehospitalization: a randomized trial. Ann Intern Med 2009;150:178.

50. Gillespie LD, et al. Interventions for preventing falls in elderly people. Cochrane Database Syst Rev 2001;(3):CD000340.

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6. Zogby Poll, “Americans Favor Transparency in Medicare, Physician Changes,” May 2, 2006, www.zogby.com

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