QI vs Research Models of Improvement: Experience in an ITB program

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1 QI vs Research Models of Improvement: Experience in an ITB program Michael D Partington MD Sam A Roiko PHD Emily E Partington OTD Gillette Children s Specialty Healthcare St Paul MN

2 No financial disclosures or conflicts to report

3 Overview Quality improvement (QI) processes and clinical research efforts can both be utilized to improve clinical operations In this talk, an example of each approach was used in a pediatric intrathecal baclofen (ITB) program

4 What is QI? systematic, data-guided activities designed to bring about immediate improvements in health delivery in particular settings (Hastings Center) Key words: Systematic Data-guided Immediate improvements

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6 What is research? A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. May or may not be integrated into an ongoing clinical process Short or long time-course

7 What is outcomes research? That s a whole separate talk.

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9 ITB program: background Gillette Children s Specialty Healthcare (GCSH) provides focused care for children and young adults with childhood onset disability Majority (>90%) of ITB patients have spasticity related to cerebral palsy, mainly GMFCS 4-5 Over 750 patients with pumps running at present Co-morbidities are high: Infection risk is high Frequent need for multiple procedures

10 Initial implants at GCSH in mid-1990s Infection rates were high, ranging from 10-20% An initial review established that highest risk population were patients in the lowest height-weight (or BMI) percentiles. The introduction of a minimum weight of 15kg pre-implant was introduced, with only modest impact on infection rates

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12 Plan The majority of infections were noted to be caused by Staphylococcal species Could baseline carrier states predict risk of infection?

13 Do Surveillance cultures for Staph aureus were obtained on all patients undergoing non-emergency surgery Cultures were obtained from nares, ostomies (when present) and rectum Patients who were Staph aureus carriers received topical mupirocin (Bactroban) BID for 5 days before surgery Perioperative antibiotics were vancomycin IV for (+) carriers (24h coverage), surgeons choice (usually cefazolin) for non-carriers

14 Study Short-term results were an overall reduction in frequency of infection (5-10% per quarter) However, an increase in the number of Gram negative infections was identified (this may be a second PDSA cycle)

15 Act Antibiotic protocol adjusted: All patients receive pre-operative mupirocin All patients receive pre-operative vancomycin Pre-operative gentamicin added for patients at risk of Gram negative carrier states (tracheostomy, gastrostomy, ACE or diapered) New literature later showed that only one pre-operative dose of mupirocin was needed for carrier conversion, so total duration was shortened

16 Result Long-term infection rate has remained in the range of 3-8% using this approach Per-operative cultures are no longer obtained

17 If you had to identify, in one word, the reason why the human race has not achieved, and never will achieve, its full potential, that word would be meetings. Dave Barry

18 Can research help in an established care model? In the first example, an existing care model was studied and adjusted. In this example, care was adjusted based on the results of a retrospective study. Not all studies are prospective..

19 Does additional surgery increased the risk of infection in drug pump implant surgery? Michael D Partington, MD Linda E Krach MD Emily E Partington OTD Samuel A Roiko PhD

20 Introduction and rationale Recent publications have added to the understanding of developmental risks of anesthetics in childhood This trend, combined with family preferences towards the convenience of scheduling single procedures whenever possible, has resulted in increased risks for combining implant surgery with other procedures when possible However, not all surgeons are comfortable with combined procedures because of a perceived increased risk of ITB pump infection

21 Study intent and design This study was designed to address the question of whether pump surgery was more likely to be complicated by infection if it was combined with another procedure Retrospective study All pump surgery performed at GCSH over a 5 year period, with minimum of 1 year follow-up Procedures grouped according to presence/absence of second procedure Infection rates established for each group

22 Antibiotic prophylaxis Institutional protocol based on earlier study on carrier states All patients received Vancomycin mg/kg IV (pre-op and 24h post) Mupirocin both nares (pre-op and 4d post) Amingoglycoside (24h total) added for certain patients: Surgical ostomies Diapers

23 Results IRB approval obtained All records reviewed for patients undergoing any pump surgery in a 5 year period ( ) with a minimum of one year post-operative follow up Pump explant surgery was excluded Patients with a combined procedure were identified and analyzed separately

24 Results (continued) Additional procedures included: Injection therapy (Botox, phenol) Orthopaedic surgery (non-spine) Spine surgery No surgeon allowed for pump surgery in combination with a contaminated procedure or procedure with anticipated risk of bacteremia

25 Numbers of procedures Pump surgery alone 422 With extremity surgery 34 With spine surgery 29 With injection therapy 19

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28 Infections Pump only: 16/422 (3.79%) Staph aureus 5 Staph unspecified 3 Staph epidermitis 1 Proteus mirabili 1 Serratia 1 E. coli/pseudomonas 1 Other/unidentified 4

29 Infections Extremity 2/34 (5.9%) Staph epi 1 Staph aureus 1 Both cases were combined with plate removal Spine 3/29 (10.3%) Staph species 1 Klebsiella 1 Unknown 1 Two primary fusions with catheter dislodgment, one repair of pseudoarthrosis

30 Infections Injection therapy 1/19 (5.3%) Staph species Botox injection

31 Analysis of infection rates Pump surgery alone: 16/422 (3.79%) All combined procedures: 6/82 (7.31%) (No significant difference by Fischer s exact, p=0.148)

32 Analysis by subgroup No significant differences in any group versus pump only surgery Caveat is that subgroups are small (<5 infections in each group limits validity of test)

33 Conclusion The addition of injection therapy or clean orthopaedic surgery does not significantly increase the risk of pump infection Spine surgery appears to have a trend towards higher rates of pump infection, but Not significant Other risk factors: long surgery, exposed Silastic, unplanned procedure

34 Individual surgeon s and family s preference still respected, but number of combined procedures has increased

35 Overall conclusions Two small examples of how a surgical care process can be improved have been presented In both, a significant impact on different outcomes measures was achieved (morbidity reduction in one, access and process efficiency in the other) Surgeons appreciate data and objective results, particularly if they do not disrupt ongoing care while they are being developed