NSQIP and Enhanced Recovery After Surgery (ERAS) for Colon Surgery. July252014

Transcription

1 NSQIP and Enhanced Recovery After Surgery (ERAS) for Colon Surgery July252014

2 Outline for the Day Introduction to ERAS overview of ERAS putting a team together importance of education Preoperative and Intraoperative Elements: the evidence preoperative fasting and CHO mechanical bowel preparation prevention of PONV open or laparoscopic fluid management tubes and drains Postoperative elements: the evidence prevention of ileus multimodal analgesia nutrition and early mobilization the important of audit Introduction to ERIN (Enhanced Recovery In NSQIP) information about pilot program

3 Enhanced Recovery After Surgery: What s it all about? Liane Feldman MD FACS FRCS Professor of Surgery Director, DivisionofGeneralSurgery McGill University Health Centre July ERIN symposium

4 Outline What is an enhanced recovery pathway (ERP)? What can it achieve? Our experience

5 What s the issue? Despite significant innovations in surgical care: A significant proportion of patients do not derive maximal benefit from surgery Complications Prolonged recovery There is significant variability in care processes, outcomes and cost

6 Prioritizing Quality Improvementin GeneralSurgery Schilling PL, Dimick JB, Birkmeyer JD. JACS 2008 Conclusion: A relatively small number of procedures account for a disproportionate share of the morbidity, mortality and excess hospital days in general surgery.

7 Variability in Processes of Care: Responses (%) to questionnaire on perioperative care in colonic resection in 5 northern European countries Lassen K, BMJ, 2005 Response Scotland Netherlands Sweden Norway Denmark Range NG is removed in OR 75% 22% 83% 82% 85% % Epidural analgesia is used routinely on ward Clear fluids day of surgery 11% 38% 83% 58% 93% 71% 89% 82% 96% 96% % % Oral intake at will by POD1 27% 46% 44% 53% 85% %

8 Variability in long length of stay afteruncomplicated colorectal surgery in NSQIP hospitals 87% had no complications: 6.1(3.8) days, median 5 days 13% had complications: 16.1(14.2) days, median 12 days Cohen ME Ann Surg 2009

9 Achieving high value for patients must become the over arching goal of health care delivery

10 Improving value for patients Value = health outcomes achieved thatmatterto patients relativetothecost ofachieving those outcomes no single outcome captures results of care cost refers to full cycle of care for a medical condition To improve value improve outcomes without raising costs lower costs without compromising outcomes Not: accept worse outcomes because cost is less* Michael Porter * bad outcomes often cost more anyway

11 What if surgery could be done without: Catabolic stress response Pain GI dysfunction Complications Fatigue

12 What if surgery could be done without: Catabolic stress response Pain GI dysfunction Complications Fatigue If so, then length of stay and costs will decrease too

13 Why Minimally Invasive Surgery?

14 Why Minimally Invasive Surgery?

15 Why Minimally Invasive Surgery?

16 Recovery takes longer than we think: >1month torecover high intensity physical activities after out-patientlap cholecystectomy 40 higher intensity lower intensity kcal.kg-1.wk Baseline 1 week 1 month p=0.68 p<0.05 Feldman et al, Surgery 2009 Median (25 th -75 th percentile)

17 Approaches to reduce surgical stress and improving surgical recovery Kehlet and Wilmore, Ann Surg 2008

18 Perioperative care in elective digestive surgery: no lack of evidence 20 elements preop, intraop, postop Most are Strong recommendations Multiple stakeholders: surgery, anesthesia, nursing, patient Only a few involve the surgical procedure itself Several challenge traditions Howcan we get this into practice to benefit our patients?

19 Evidence is not enough Example: Preoperative Fasting to Prevent Complications The Rationale: NPO after midnight to prevent aspiration The Downside: Long period without hydration and nutrition The Evidence: Cochrane review of 22 RCTs (2009) Can reduce period of fasting to 2 hours for clear fluids without increasing risk

20 Fasting Guidelines from National Anesthesia Societies Ljungqvist O et al. BJS 2003;90(4): Clear fluids = water, coffee, tea (no milk), some juice 2h before anesthesia and surgery Exclusions: Emergency surgery; upper GI surgery; slow gastric empyting

21 Benefits of feeding patients prior to surgery! T h i rst! A nxiety! PONV! Postoperative insulin resistance! Postoperative nitrogen and protein losses Maintained lean body mass Nygren et al.1998;17:65-71 Nygren et al Am J Endocrinol Metab E Hausel et al. Anesth Analg 2001;93: Crowe et al. Br J Surg 1984;71; " M u s cle strength Better anabolic state to benefit from early postoperative nutrition! Postoperative hyperglycemia Anabolic effect of epidural blockade requires substrate Can give oral CHO Faith Can et al.nutrition 2009;25:72-77 Hendry et al. Colorectal Dis. 2008;10(9): Yuill et al. Clin Nutr 2005;24, Schricker et al 2002;97:943-51

22 Cole Thompson "Three Silos- Central Colorado- 2007"

23 Turning knowledge into action Perioperative management relies greatly on tradition and personal experience Management may not be beneficial or may even be harmful Even when there is evidence, not widely translated into clinical care The good news we can change this!

24 Crossing the Divide Quality problems occur typically not because of failure of goodwill, knowledge, effort or resources devoted to health care, but because of fundamental shortcomings in the ways care is organized HA Pincus MD AHRQ's Annual Research Conference Panel Session. September 16,

25 What is an integrated care pathway? A complex intervention for organization of care processes for a well-defined group of patients during a well-defined period www. e-p-a.org

26 What is an ERP? ERP = Enhanced Recovery After Surgery Pathway Evidence-based, multimodal, integrated consensus on perioperative care to: Improve outcomes Improve efficiencies Decrease unwanted variability Increase value of surgery

27 ERPs: Integration of Care Patients journey C li n i c Preop Surgery Ward Home Anesthesia Recovery Audit compliance & outcomes

28 Key elements to include in ERPs (evidence-based, procedure-specific) Kehlet 2011 (Rev) Preoperative Intraoperative Postoperative Preoperative risk assessment & optimization of organ dysfunction Patient education Exercise/Prehabilitation Alcohol/smoking abstinence Avoid routine bowel preparation Modern fasting guidelines Avoid fluid excess/ goal-directed fluid Regional anesthesia (when evidence based) Minimally invasive surgery Short-acting opioids Multimodal, opioid sparing analgesia (evidence based, procedure specific) Anti-emetic and anti-ileus prophylaxis (evidence based) Examine use of drains, tubes, catheters, monitoring (evidence-based) Early nutrition and ambulation Daily care maps, well defined discharge criteria Postdischarge rehabilitation plan (evidence based)

29 Challenging Our Traditions in GI Surgery Surgeon No routine bowel prep No NGs No drains Food after surgery No foley or out POD1 Criteria--based early discharge Anesthesiologist No routine fasting Carbohydrate drink Epidural analgesia or blocks Goal directed fluids Active warming Narcotic sparing anesthesia and analgesia All evidence-based Nursing Care Eat POD 0 Remove IV Daily mobilization goals Daily nutrition goals Criteria--based early discharge

30 McGill Bowel Surgery Pathway Patient Education with booklet Selective mechanical bowel prep No prolonged fasting Carbohydrate drinks Heplock IV day of OR Early feeding (Fluids+supplement day of OR, solids + supplement POD 1) Remove Foley POD1 Standard antibiotic ordering Preoperative Postoperative ERAS DVT prophylaxis Intraoperative Midthoracic epidural for open or rectal PCA for lap colon Glycemic monitoring Normothermic control Avoidance of fluid overload (6cc/kg/hr) Mobilization POD0 Stimulation of gut motility (gum chewing and MOM) Multimodal oral analgesia Epidural analgesia (if used) x48h Urinary retention protocol GI dysfunction protocol Discharge criteria target POD 3-4 PONV prophylaxis

31 Outline What is an enhanced recovery pathway (ERP)? Whatcan itachieve? Our experience

32 Ann Surg 2000

33 Ann Surg patients (74 yo) Open colon resection + postop care program Epidural, early feeding and mobilization Median LOS 2 days (avg 3 days) 15% readmissions

34 DisColRec, 2013 Systematic review- 13 RCTs (with 7 ERP elements) Included 8 new trials compared to last meta--analysis from 2011 (NB. There have been 8 published systematic reviews of colorectal ERP vs Traditional care)

35 13 RCTs of colorectal surgery with 7 ERAS elements documented Number Age ASA ERAS# rectal Anderson 2003 (UK) Open Gatt 2005 (UK) Open yes Khoo 2007 (UK) Open yes Ionescu 2009 (Romania) Open Muller 2009 (Switzerland) Open Serclova 2009(Czech Rep) Open yes Bree 2011 (Belgium) Lap Garcia--Botello 2011(Spain) Mix yes Vlug 2011 (Netherlands) Lap Ren 2012 (China) Open yes Wang G 2012 (China) Lap Wang Q 2012 (China) Lap Yang 2012(China) Open

36 Meta-analysis (Colorectal) 13 RCTs (with 7 ERP elements) ERP: shorter length of stay by 2.4 days (range 0-6 d) No differences in readmission rates Zhuang et al. discol rec 2013

37 Meta-analysis (Colorectal) 13 RCTs (with 7 ERP elements) ERP: shorter length of stay by 2.4 days (range 0-6 d) No differences in readmission rates What s driving the earlier discharge? Zhuang et al. discol rec 2013

38 Meta--analysis (Colorectal) ERP: 30% reduction in general complications No difference in surgical complications Zhuang et al.dis Colon Rectum2013

39 Meta--analysis (Colorectal) ERP: faster return of bowel function (1 day) Zhuang et al.dis Colon Rectum2013

40 Satisfactionwith hospitalstayand dischargeday(erasrcts) Even though LOS shorter: Similar happiness to be discharged from hospital and satisfaction with hospital stay(delaney 2003) Same number of patients who felt they would have benefitted from longer stays (Khoo 2007) No difference in QOL at discharge (Wang 2010)

41 TABLE 2. Cost Data Reported in Included Studies Lee, Ann Surg, 2013 Study ID Quality (/19) Costs ERP cc p/95% CI Statistical Method Archibald et al 21 6 Total hospital costs US$ 11662* US$ 21037* p < sample hypothesis tests (direct + overhead) Bosio et al 24 0 Hospital direct costs US$ 4993* US$ 11383* p < Not reported Folkerson et al Direct medical costs DKK DKK21340 N/A Sensitivity analysis (results not shown in this table) Indirect costs DKK DKK24l34 Jurowich et al 26 4 Total costs DKK DKK45474 P = t test for independent samples Hospital direct costs for the first 5 postoperative days Kariv et al 22 8 Direct hospital costs US$ 5692t US$ 6672t P = Wilcoxon signed rank test King et al:j: Total costs * * 95% Cl: Bootstrap estimates (l0,000 to iterations) with Cis taken at 2.5% and 97.5% percentiles Indirect costs * 1,061.50* 95% Cl: to Ren et al 8 4 Total costs of the CNY 15997* CNY 17763* p < "independent-sample t-test" Sammour et al 10 8 procedure Postoperative costs Total hospital costs development (incl. protocol and research fellow's salary) Stephen et al 27 8 Total hospital costs (excluding Vlug et al 7 9 surgeon's fees) Direct hospital costs CNY 3594* NZ$ 16052* CNY 5268* NZ$ 22939* p < Not reported None performed US$ 7070* US$ 9310* P = l-tailed t test (lap)t (lap)t P = 0.56 Kruskal-Wallis/Mann (ooiversity (open)t (open)t -Whitney Utests hospitals) Direct hospital costs 5768 (lap)t 6228 (lap)t p = 0.41 (teaching 5497 (open)t 5650 (open)t hospitals) *Mean cost. tmedian cost. t in this study, the confidence intervals in the published manuscript were erroneous, and the author was contacted to provide the corrected Cis. CI indicates confidence interval; Lap, laparoscopic. US$ = US dollars; DKK = Danish Krone; CNY = Chinese Yuan Renminbi; NZ$ = New Zealand dollars. I DKK = US$; I = US$ in 20 I0, US$ in 20 II; I = US$; I CNY = USD; I NZD = USD; currency exchange rates at date of publication from

42 Lee, Ann Surg, 2013 Cost savings for colorectal ERAS USA studies (4/4) European studies (2/4) 8/10 studies But: Only 1 study included implementation costs No studies reported QALYs

43 Gastrectomy for cancer RCTs population LOS complications other Liu 2010 Open gastrectomy, n=63 Wang 2010 Open gastrectomy n=92 Kim 2012 Hu,2012 Laparoscopic distal gastrectomy, n=44 Lap distal gastrectomy, n=41 ERP: 6.2(2) Trad: 9.8(2.8)* ERP: 6(6--7) Trad: 7(7--8)* ERP: 5.4(1.5) Trad: 8(0.65)* ERP:7( ) Trad: 7.5(6--11) No differences --faster bowel function --body composition better preserved No differences --faster bowel function --less stress response --lower costs No differences --better pain control --less nausea --some QOL domains No differences --faster return of bowel function --lower cost Hu2012 Open distal gastrectomy n=42 Feng 2013 Radical total gastrectomy, N=119 ERP:7(6--11) Trad: 8.75(7--14)* ERP:5.7(1.2) Trad: 7(2)* No differences --faster return of bowel function --lower cost 10% vs 28%* --faster return of bowel function

44 Gastrectomy for cancer RCTs population LOS complications other Liu 2010 Open gastrectomy, n=63 ERP: 6.2(2) Trad: 9.8(2.8)* No differences --faster bowel function -body composition better preserved Wang 2010 Open gastrectomy ERP: 6(6-7) No differences --faster bowe l function n=92 Trad: 7(7-8)* -less stress response -lower costs Kim 2012 Hu, 2012 No NGs! Early feeding! Complications not increased Shorter duration of ileus 5 out of 6 studies: LOS with ERP Lower costs Lapa roscopic distal ERP: 5.4(1.5) No differences --better pain control gast rectomy, n=44 Trad: 8(0.65)* -less nausea -some QOL domains Lap distal gastrectomy, ERP:7(5.5-10) n=41 Trad: 7.5(6-11) No differences --faster retur n ofbowel function --lower cost Hu 2012 Open distal gastrectomy n=42 Feng 2013 Radical total gastrectomy, N=119 ERP:7(6-11) Trad: 8.75(7-14)* ERP:5.7(1.2) Trad: 7(2)* No differences --faster return of bowel function --lower cost 10% vs 28%* --faster return of bowel function

45 BJS 2013 RCT 91 patients Time to medically fit for discharge: 3 (3--4)vs 6 (6--7)days* Actual LOS: 4(3--5) vs 7(6--8) days* Fewer medical complications: 7%vs 27%* Faster return of bowel function, faster time to independent mobility Better QOL over 28days

46 JonesBr JSurg2013

47 What was the difference? Patient education CHO drink 2h preop Goal directed fluid management Urinary catheter 1-2 d Oral nutritional supplements Physiotherapy for mobilization bid JonesBr JSurg2013

48 ERPcompliance: Lengthofstay&Readmissions 11 Colorectal cancer Mean LOS (days) Readmissions (%) 2.8 n = 953 p < <50 C % ompliance >7 w 0% ith ERP pr > o 8 to 0 c % ol elemen > ts 90% Gustafsson et al, Arch Surg 2011

49 ERPcompliance: Complications&Symptoms Per cent patients affected Colorectal cancer Symtoms Complicauons n = 953 p < <5 C 0 o % mpliance > w 70 it % h ERP pro > t 8 o 0 c % ol elements 0% Gustafsson et al, Arch Surg, 2011

50 Association with LOS in patients without complications(461/524 patients) All laparoscopic with other elements of ERP also in place % mean LOS mean LOS p Preop Gabapentin + Celecoxib 87% 3.3(1.4) 3.3(1.4) Intraop Intrathecal analgesia 84% 3.2(1.3) 3.7(1.6) Postop NSAID use 88% 3.2(1.3) 3.8(1.7) Diet within 4 hrs 90% 3.1(1.3) 4.4(1.9) <0.001 IVF stopped 8 am POD1 86% 3.1(1.3) 4.2(1.7) <0.001 Larson DW, BJS 2014

51 Outline What is an enhanced recovery pathway (ERP)? What can it achieve? Our experience

52 Objective: create and implement multidisciplinary perioperative care pathways across department of surgery Debbie Watson

53 Step 1: get a logo Objective: create and implement multidisciplinary perioperative care pathways across department of surgery Debbie Watson

54 Step 1: get a logo Objective: create and implement multidisciplinary perioperative care pathways across department of surgery Pathways would be standard of care Debbie Watson

55 Step 1: get a logo Objective: create and implement multidisciplinary perioperative care pathways across department of surgery Pathways would be standard of care Target prevalent in-patient procedures Debbie Watson

56 Step 1: get a logo Objective: create and implement multidisciplinary perioperative care pathways across department of surgery Pathways would be standard of care Target prevalent in-patient procedures Originated with clinicians with support of administration (=full-time coordinator) Debbie Watson

57 Step 1: get a logo Objective: create and implement multidisciplinary perioperative care pathways across department of surgery Pathways would be standard of care Target prevalent in-patient procedures Originated with clinicians with support of administration (=full-time coordinator) Pilot project, MGH October 2008 (permanent 2010) Debbie Watson

58 Step 1: get a logo Objective: create and implement multidisciplinary perioperative care pathways across department of surgery Pathways would be standard of care Target prevalent in-patient procedures Originated with clinicians with support of administration (=full-time coordinator) Pilot project, MGH October 2008 (permanent 2010) Permanent multidisciplinary team (~weekly meeting) Debbie Watson

59 Step 1: get a logo Objective: create and implement multidisciplinary perioperative care pathways across department of surgery Pathways would be standard of care Target prevalent in-patient procedures Originated with clinicians with support of administration (=full-time coordinator) Pilot project, MGH October 2008 (permanent 2010) Permanent multidisciplinary team (~weekly meeting) Work with clinical experts for each pathway Debbie Watson

60 ERP Working Group Clinical care pathway coordinator (Debbie Watson) 2surgeons 2 anesthesiologists Nurse manager surgery ward Clinical nurse specialist-pain Physiotherapist Nutritionist Pharmacist Librarian PLUS Clinical Experts for each pathway surgical lead, anesthesia, nursing

61 Development of an ERP Pathway creation Literature review- guidelines, discharge target Perioperative medical and pharmaceutical orders ADL flowsheets and nursing documentation External prescriptions New Perioperative Pathway MUHC Committees Reviews and Approvals Surgeons &nurses: Standard orders Patient: Education booklet Personnel Training Audit and Revision Surgical Recovery team Review Committee Nursing Clinical Practice Review Committee (NCPRC) Pharmacy and Therapeutics (P&T) Committee Form Committee (medical archives) MUHC Patient Education Network Committee Nurses: preoperative clinic and the recovery room Surgeon staff and Surgical Residents Launch date- everyone starts the pathway

62 Key elements to include in ERPs (procedure-specific) Kehlet 2011 Preoperative Preoperative risk assessment & optimization of organ dysfunction Patient education Exercise/Prehabilitation Alcohol/smoking abstinence Avoid routine bowel preparation Intraoperative Modern fasting guidelines Avoid fluid excess/ goal--directed fluid Regional anesthesia (when evidence based) Minimally invasive surgery Short--acting opioids Postoperative Multimodal, opioid sparing analgesia (evidence based, procedure specific) Anti--emetic and anti--ileus prophylaxis (evidence based) Examine use of drains, tubes, catheters, monitoring (evidence--based) Early nutrition and ambulation Daily care maps, well defined discharge criteria Postdischarge rehabilitation plan (evidence based)

63 Key elements to include in ERPs (procedure-specific) Preoperative Preoperative risk assessment & optimization of organ dysfunction Patient education Exercise/Prehabilitation Colorectal Alcohol/smoking abstinence Esophagectomy Avoid routine bowel preparation Prostatectomy Modern fasting guidelines Pulmonary resection Intraoperative Avoid fluid excess/ goal-directed fluid Knee arthroplasty Regional anesthesia (when evidence based) Thyroidectomy Minimally invasive surgery Laparoscopic cholecystectomy Postoperative Short-acting opioids Inguinal hernia Multimodal, opioid sparing analgesia (evidence based, pr ocedure specific) Nephrectomy Hepatectomy Spine Cystectomy Bariatric Anti-emetic and anti-ileus prophylaxis (evidence based) Examine use of drains, tubes, catheters, monitoring (evid Early nutrition and ambulation Daily care maps, well defined discharge criteria Postdischarge rehabilitation plan (evidence based) ence-based) Kehlet 2011

64 Postoperative Management Median days to mobilization > 2h/day, days [IQR] Median days to discontinuation of IV fluids, days [IQR] Median days passage of first flatus, days [IQR] Median days to receiving oral fluids, days [IQR] Median days to toleration of solid diet, days [IQR] Median days to removal of bladder catheter, days [IQR] Conventional Care (n=95) Enhanced Recovery (n=95) 2[1--2] 1[1--2] < [2--5] 1[1--1] < [2--3] 1[1--2] < [1--3.5] 0[0--0] < [3--5] 1[1--2] < [1--3] 1[1--1] <0.001 Median Total hospital stay, days [IQR] 7[5--9] 4[3--7] <0.001 p LeeL, et al (Submitted)

65 Lee L, et al (Submitted) Conventional Care (n=95) Enhanced Recovery (n=95) p-value Clinical outcomes Mean total hospitalization, days (SD) 9.8 (12.2) 6.5 (6.0) day emergency room visits 17 (18%) 19 (20%) day readmissions 10(11%) 12 (13%) day complications 41 (43%) 38 (40%) Mean complication severity, (SD) 10.7 (174) 10.2 (14.3) Post-discharge outcomes Returned to work by eight-weeks 29 (58%) 30 (71%) Mean lost days from work, days (SD) 34.8 (19.7) 25.8 (17.8) Mean postoperative days requirin 14.7 (17.3) 14.9 (12.1) help with activities of daily living, days (SD) Mean caregiver lost days from work, 5.0 (12.0) 1.3 (2.6) days (SD) Mean postoperative community health 3.7 (8.7) 1.4(4.6) service centre visits, visits (SD) Mean postoperative surgeon followup 1.1 (0.5) 1.0 (0.4) visits, visits (SD) Mean postoperative specialist or family medicine visits, visits (SD) 1.2 (1.6) 0.9 (1.4) 0.099

66 Conclusions ERPs: Help get evidence into practice Foster interdisciplinary discussions and teamwork Increase attention on patient s role Decrease unwanted variability in care processes Decrease length of stay without increasing complications or readmissions Improve recover after colorectal surgery Costs decreased or unchanged = increase value for surgical care

67 Multimodal perioperative care pathways have not been widely adopted: Barriers Requires substantial resources and sustained effort Numerous stakeholders, need to reach consensus, resistance to change Not available off the shelf need to review evidence and create in light of local context Levels of bureaucracy to implement Challenges in auditing and updating

68 Why reinvent the wheel?

69 Lots of opportunities to learn more prensqip meeting course & pilot project July 2014 ACS postgraduate course in Oct 2014 ERAS Canada/SAGES course Nov 2014

70