UT Clinical Safety amp Effectiveness Conference San Antonio TX October 2728 2011 Amy Fowler MD Alexis Kennedy CPNP Naomi Winick MD The Team Team Members CSampE Participants Amy Fowler MD Project Leader ID: 734655
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Provider Adherence to Oral Chemotherapy Dose Adjustment Guidelines
UT Clinical Safety & Effectiveness ConferenceSan Antonio, TXOctober 27-28, 2011Amy Fowler, MDAlexis Kennedy, CPNPNaomi Winick, MDSlide2
The Team
Team MembersCS&E Participants Amy Fowler, MD, Project LeaderAlexis Kennedy, CPNP, Project ChampionTeam Members Naomi Winick, MD, Physician ChampionGretchen Hirschey, RN, Nursing Champion
Jessica Rajian, RN, EPIC ChampionChristian Tellinghuisen, Database support
All the pediatric hematology/oncology fellowsFacilitator - Pat Griffith, BS, MT, MBA Slide3
Childhood Acute Lymphoblastic Leukemia (ALL)
Most common malignancy of childhood50-60 new cases annually in DallasAbout 150 children treated for ALL at any given timeCurrent survival rates vastly improvedOral chemotherapy Important component of therapy 6-mercaptopurine (6MP) and methotrexate (MTX)Given daily, at home, for ~ 2-3 yearsDosed based on degree of bone marrow suppressionPublished dosing guidelines for providers
Specific rules for when to hold doses or dose escalateTarget absolute neutrophil count (ANC): 500 – 1,500/μ
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Clinical importance of dosing guidelines
Degree of bone marrow suppressionLower ANC Improved survivalDose intensity of oral chemotherapyGreater dose intensity Improved survivalProblem with excessive neutropenia (ANC <500)Risk of serious infections increasesResults in held doses (chemo interruptions)Decreases dose intensity due to breaks in therapyDose interruptionsGreater dose interruptions Inferior survivalProvider adherence impacts all of the aboveSlide5
Dose Adjustment GuidelinesDose Escalations
Dose escalation when current dose is ≥ 100%When ANC > 1,500 on3 CBC over 6 weeks OR 2 successive monthly CBCs Alternate 6MP/MTX, and increase by 25% each timeDose escalation when current dose is <100%When ANC remains > 750 and platelets > 75KIncrease doses by 25% every 2-4 weeksMay increase both drugs simultaneouslySlide6
Dose Adjustment GuidelinesHolding for Neutropenia
When ANC < 500 or platelets < 50KHold doses of both 6MP & MTXRestart both 6MP & MTX After 1st dropResume when ANC > 500 and platelets > 50KRestart at 100% prior doseAfter ≥ 2nd dropResume when ANC >750 and platelets >75KRestart at 50% most recent dose 6Slide7
Background Data
Overall ANC results from retrospective review 2006-20107Target
ANC
Average ANCSlide8
Background Data Percentage of time providers adherent to indicated dose increases
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Aim Statement
Improve percentage of time that providers modify chemotherapy doses as indicated by protocol guidelines in children with ALL from 39% to over 75% From January 1, 2011 to May 31, 2011. Slide10
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Measures of SuccessProvider adherence Proportion of times dose escalation made when indicated by the guidelines.Followed specific rules based on guidelinesUsed consistent and trained set of providers to make decision on appropriateness of dose escalationsGoal to minimize variation in interpretationGoal to improve from 39% to >75%Slide11
Pareto Chart - Provider Survey Results
Most common reason why providers neglect indicated dose escalationsSlide12
Targets for Intervention
Provider and nursing educationAwareness of the clinical importanceReview of guideline contentCreated flow-sheet Easy access to pertinent labs and dosingPosters with guidelines placed in provider work areasChange in process of clinic flowTiming of lab drawsResults return prior to patient leaving clinicSlide13Slide14
Flow chart of clinic flowSlide15
Quality ImprovementTimelineSlide16
Percent adherence per month compared to pre-interventionSlide17
Absolute neutrophil count
Episodes of neutropenia per patient per month Slide18
Conclusions
Exceeded goal with 90% adherence Increased bone marrow suppression (ANC) No change in frequency of neutropenic episodes May increase length of dose interruptions Longer dose interruptions Theoretical risk of negative influence on survival rates Must weigh risks and benefits of improved adherenceUniversal buy-in Nursing staff
Families Administration Providers (Mid-level and physician)Slide19
ChallengesData collection
Very labor and time intensiveComplex spreadsheetsClinical expertise needed for data evaluationCommitment from providers “set in their ways”Guidelines leaving room for interpretationDifficult to put $$ value on resultsSlide20
Next Steps
Clinic to continue the interventions Continued monitoring Quarterly chart audits Introduce into EMR systemBuild reminders and flow sheets electronically Large scale, multi-institution collaborativeNeed to look at effect on survival rates Publish results Influence the Children’s Oncology Group, organization creating new versions of guidelinesSlide21