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Clinical Decision Support and Knowledge Management Roberto A. Rocha, MD, PhD Sr. Corporate Manager Clinical Knowledge Management and Decision Support, Clinical Informa@cs Research and Development, Partners Healthcare System Lecturer in Medicine Division of General Internal Medicine and Primary Care, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School Biomedical Informa/cs Course Marine Biological Laboratory in Woods Hole, MA June, 2010

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Page 1: RRocha - Clinical Decision Support and Knowledge ... · Informaonexplosion?’ 0 100,000 200,000 300,000 400,000 500,000 600,000 700,000 800,000 1988 1989 1990 1991 1992 1993 1994

Clinical  Decision  Support  and  Knowledge  Management    

Roberto  A.  Rocha,  MD,  PhD  Sr.  Corporate  Manager  

Clinical  Knowledge  Management  and  Decision  Support,  Clinical  Informa@cs  Research  and  Development,  Partners  Healthcare  System  

Lecturer  in  Medicine  Division  of  General  Internal  Medicine  and  Primary  Care,  Department  of  Medicine,  Brigham  and  Women’s  Hospital,  Harvard  Medical  School  

Biomedical  Informa/cs  Course  Marine  Biological  Laboratory  in  Woods  Hole,  MA  

-­‐  June,  2010  -­‐    

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Objec:ves  

•  Outline  the  main  factors  that  jus@fy  the  need  for  computerized  Clinical  Decision  Support  (CDS)  and  Clinical  Knowledge  Management  (CKM)  

•  Describe  the  history  and  benefits  of  CDS  systems  

•  Describe  the  main  components  of  a  CDS  system  

•  Describe  the  different  modali@es  of  CDS  and  their  associated  requirements  –  Provide  examples  of  CDS  modali@es  integrated  with  EHRs  

•  Describe  the  CKM  processes  required  to  create,  deploy,  disseminate,  and  maintain  CDS  interven@ons  

•  Describe  the  main  components  of  a  CKM  system  –  Provide  examples  of  CKM  tools  

•  Outline  challenges  and  opportuni@es  related  to  CDS  &  CKM  

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Expected  Results  

•  As  a  result  of  par@cipa@ng  in  this  ac@vity,  learners  will  be  able  to:  –  Explain  uses  and  benefits  of  Clinical  Decision  Support  (CDS)  and  Clinical  Knowledge  Management  (CKM)  

– Describe  the  main  components  of  a  CDS  system  

– Describe  the  different  modali@es  of  CDS  – Describe  CKM  processes  and  associated  tools  – Outline  important  challenges  and  opportuni@es  related  to  CDS  and  CKM  

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Outline  

1.   Background  –  Mo@va@on  –  History  &  Benefits  

2.   Clinical  Decision  Support  (CDS)  –  CDS  modali@es  (examples)  and  standards  

–  Components  of  a  CDS  system  

3.   Clinical  Knowledge  Management  (CKM)  –  Mo@va@on  for  CKM  

–  CKM  Program:  processes,  people,  and  infrastructure  

4.   Challenges  and  opportuni:es  

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Background  

Mo@va@on  

History  of  CDS  Demonstrated  benefits  

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Informa:on  needs  

•  Informa@on  needs  –  47  physicians  (self-­‐reported)  

  269  ques@ons  raised  during  409  visits  »  2  ques@ons  for  every  3  pa@ents  seen  

  Answers  not  pursued  70%  of  the  @me  

•  Frequent  barriers  –  Pursued  answers  only  55%  

  Doubt  that  an  answer  existed  –  lack  of  usable  informa@on  

–  Sources:  human  (informa@on  consulta@on)  and/or  textbook  (63%),  electronic  resource  (16%)    Unable  to  find  answer  in  28%  

Covell  DG,  Uman  GC,  Manning  PR.  Informa@on  needs  in  office  prac@ce:  are  they  being  met?  Ann  

Intern  Med.  1985  Oct;103(4):596-­‐9.  

Ely  JW,  Osheroff  JA,  Chambliss  ML,  Ebell  MH,  Rosenbaum  ME.  Answering  physicians'  clinical  ques@ons:  obstacles  and  poten@al  solu@ons.  J  Am  Med  Inform  Assoc.  2005  Mar-­‐Apr;12(2):217-­‐24.  

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Informa:on  explosion?  

0  

100,000  

200,000  

300,000  

400,000  

500,000  

600,000  

700,000  

800,000  

1988   1989   1990   1991   1992   1993   1994   1995   1996   1997   1998   1999   2000   2001   2002   2003   2004   2005   2006   2007   2008  

MEDLINE®/PubMed®  Baseline  Yearly  Cita:on  Count  Totals  

Sta@s@cal  Reports  on  MEDLINE®/PubMed®  Baseline  Data  

Over  18  million  cita@ons  total  50%  since  1991    

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Survival  of  Systema:c  Reviews  

Shojania  KG,  Sampson  M,  Ansari  MT,  Ji  J,  Douceoe  S,  Moher  D.  How  quickly  do  systema@c  reviews  go  out  of  date?  A  survival  

analysis.  Ann  Intern  Med.  2007  Aug  21;147(4):224-­‐33.  

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Cri:cal  diges:on  of  informa:on  

•  “…  the  expanding  of  informa@on  into  dimensions  greater  than  can  be  traversed  rapidly  and  efficiently  is  raising  needs  for  synop@c  and  cri@cal  diges@on  of  needed  informa@on.  Such  diges@on  and  synopsis  is  costly  in  intellectual  effort  that  is  not  well  rewarded  academically  or  commercially.”  

Huth  EJ.  The  informa@on  explosion.  Bull  N  Y  Acad  Med.  1989  Jul-­‐Aug;65(6):647-­‐61.  

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Defini:ons  (1)  

• Medical/Clinical  Decision  Support  System  –  “a  computer  program  that  provides  reminders,  advice  or  interpreta@on  specific  to  a  given  pa@ent  at  a  par@cular  @me”  

–  “computer  systems  that  provide  the  correct  amount  of  relevant  knowledge  at  the  appropriate  @me  and  context,  ul@mately  contribu@ng  to  improved  clinical  care  and  outcomes.”  

Wyao  JC.  Decision  Support  Systems.  J  R  Soc  Med  2000;  93:629-­‐33  

Osheroff  JA,  Teich  JM,  Middleton  B,  Steen  EB,  Wright  A,  Detmer  DE.  A  roadmap  for  na@onal  ac@on  on  clinical  decision  support.  J  Am  Med  Inform  Assoc.  2007  Mar-­‐Apr;14(2):141-­‐5.  

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Defini:ons  (2)  

•  Medical  Decision  Analysis  (decision-­‐making)  –  Assist  with  the  uncertain  nature  of  medical  informa@on  –  Fundamental  concepts  include  probability,  u@lity,  and  expected  value  decision  making  

–  Make  clinicians  beoer  decision  makers  –  Pa@ents  need  to  be  directly  involved  (u@lity/value)  

•  Typical  ques@ons  –  How  should  I  interpret  new  diagnos@c  informa@on?  

–  How  do  I  select  the  appropriate  diagnos@c  test?  –  How  do  I  choose  among  several  risky  treatments?  

H.C.  Sox,  M.A.  Blao,  M.C.  Higgins,  K.I.  Marton.  Medical  Decision  Making.  Buoerworth-­‐Heinemann,  Stoneham,  MA,  1988.  

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Evolu:on:  1960s  and  1970s  

•  1960s  –  Early  explora@ons  using  digital  computers,  probabilis@c  (sta@s@cal)  

models  (Bayes’  theorem),  good  diagnos@c  accuracy,  need  for  reliable  and  contextualized  data  sources;  

–  Medical  decision  making  methods,  u@lity  theory  

•  1970s  –  Symbolic  and  heuris@c  reasoning  methods,  medical  Ar@ficial  

Intelligence  (AI),  need  for  knowledge  engineering,  expert  systems  

–  Inadequacy  of  expert  judgment,  enhance  data  collec@on  (large  databases),  superior  diagnos@c  accuracy  when  compared  to  experts  

–  Complexity  of  decision-­‐analy@c  models,  teaching  principles  to  physicians  and  health  workers  

Shortliffe  EH.  Medical  Knowledge  and  Decision  Making.  Methods  in  InformaEon  in  Medicine.  1988  27,  209-­‐218.  

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Evolu:on:  1980s  and  1990s  

•  1980s  –  Combina@on  of  symbolic  and  probabilis@c  models,  theory  of  fuzzy  

sets,  importance  of  explana@ons,  cri@quing  instead  of  diagnosing  (decision  support)  

–  Personal  computers,  rapid  dissemina@on  and  faster  processing,  graphical  user  interfaces,  knowledge  authoring  tools,  knowledge  acquisi@on,  importance  of  proper  evalua@on  

•  1990s  –  Demise  of  stand-­‐along  consulta@on  model  (expert  system),  integra@on  

with  data  management  systems  (clinical  informa@on  systems),    

–  Sosware  cer@fica@on  and  legal  liability,  ownership  and  maintenance  of  knowledge  bases,  standard  formats  for  knowledge  encoding  and  exchange,  clinical  and  IT  governance  (“poli@cal  challenges”)  

Shortliffe  EH.  Medical  Knowledge  and  Decision  Making.  Methods  in  InformaEon  in  Medicine.  1988  27,  209-­‐218.  

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Evolu:on  of  CDS  

•  1960  -­‐  1985  –  Enthusiasm  for  CDS  (and  AI),  research  and  new  ideas  

•  1985  -­‐  1998  –  Successful  CDS  implementa@ons,  evalua@ons  showing  benefit,  but  limited  dissemina@on  

•  1998  -­‐  –  Na@onal  agendas  (call  to  ac@on),  safety  and  quality  (errors,  ADEs),  roll  out  of  

Electronic  Health  Records  (EHRs),  Computer-­‐base  Provider  Order  Entry  (CPOE),  Electronic  Prescribing  (eRx),  and  Personal  Health  Records  (PHRs)  

•  2005  -­‐  –  Recognizing  knowledge  management  as  enabling  CDS  at  scale  

  Federal  Health  IT  Strategic  Plan  (ONC):  2008-­‐2012    Rector,  1986  (“Defaults,  excepEons  and  ambiguity  in  a  medical  knowledge  representaEon  

system”  Med  Inform  (Lond).  Oct-­‐Dec;11(4):295-­‐306.)  

•  2010  -­‐  –  Government  incen@ves  to  implement  EHR  systems  with  CDS  

Shortliffe  EH.  Medical  Knowledge  and  Decision  Making.  Methods  in  

InformaEon  in  Medicine.  1988  27,  209-­‐218.  

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Regenstrief  Medical  Record  System  (RMRS)  

Clement  McDonald,  Marc  Overhage,  William  Tierney,  Paul  Biondich,  et  al.  

Greenes  RA,  editor.  Clinical  decision  support:  the  road  ahead.  Academic  Press,  2006.  Chapter  4:  Regenstrief  Medical  Informa@cs  

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RMRS:  Timeline  (1)  

•  1972:  management  of  outpa@ent  diabetes  care  

•  1976:  results  of  the  first  randomized  controlled  studies  –  300-­‐400  rules;  posi@ve  effect  of  reminders  (as  paper  reports);  no  “training  

effect”  –  “non-­‐perfectability  of  man”  (NEJM)  

•  Late  1970s:  evolu@on  to  a  hospital  system;  rela@onal  database;  language  for  rule  (“CARE”)  

•  1980:  larger  study  (reminders  +  literature)  –  410  protocols;  confirming  results;  no  interest  in  the  suppor@ng  literature  (no  

@me,  already  knew)  

•  1984:  results  of  a  2-­‐year  RCT  –  130  providers,  14,000  pa@ents,  +50,000  visits;  +140,000  paper  reminders  generated  –  1,490  rules;  confirming  results;  greatest  effect  on  preven@ve  interven@ons;  

only  40-­‐50%  responded  to  reminders  (did  not  see,  inappropriate  reminders  due  largely  to  missing  data)  

Greenes  RA,  editor.  Clinical  decision  support:  the  road  ahead.  Academic  Press,  2006.  Chapter  4:  Regenstrief  Medical  Informa@cs  

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RMRS:  Timeline  (2)  

•  Mid  1980s:  “Medical  Gopher”  –  order  entry;  outpa@ent  and  inpa@ent  –  CDS  Lab  test  ordering:  previous  results,  test  cost,  likelihood  of  posi@ve  result    –  CDS  Medica@on  ordering:  charge  for  med,  allergy  warnings,  drug-­‐drug,  and  

drug-­‐diagnosis  interac@ons;  corollary  orders  

•  1990s:  Extensions  to  handle  prac@ce  guidelines  –  Problems  with  guidelines:  vague  terminology,  omit  branch  points,  data  is  not  

available,  no  considera@on  for  concurrent  therapy  and  comorbidi@es  

–  Physicians  ignored  most  reminders  about  chronic  disease  management:  intrusive,  cost  control  emphasis,  logic  is  too  complex  for  discrete  rules  

•  2000s:    Indianapolis  Network  for  Pa@ent  Care  (INPC)  –  Leveraging  commitment  to  standards  (HL7  and  LOINC)  

–  Ongoing  studies  at  a  larger  scale,  involving  mul@ple  ins@tu@ons  

Greenes  RA,  editor.  Clinical  decision  support:  the  road  ahead.  Academic  Press,  2006.  Chapter  4:  Regenstrief  Medical  Informa@cs  

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Brigham  Integrated  Compu:ng  System  (BICS)  

David  Bates,  Jonathan  Teich,  Gilad  Kuperman,  John  Glaser,  et  al.  

Greenes  RA,  editor.  Clinical  decision  support:  the  road  ahead.  Academic  Press,  2006.  Chapter  5:  CDS  at  Brigham  and  Women’s  Hospital  

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BICS:  Timeline  

•  1984:  decision  to  develop  clinical  system;  emphasis  on  decision  support;  complete  hospital  informa@on  system  (clinical,  financial,  and  administra@ve  func@ons)  –  derived  from  systems  developed  at  Beth  Israel  Hospital  (Slack  &  Bleich  

–  MIIS  system);  implemented  in  MUMPS;  independent  since  1988  

•  1989:  outpa@ent  electronic  medical  record  system  (Miniamb);  free  text  notes  (dicta@on)  

•  1993:  computerized  physician  order  entry  (CPOE  –  Glaser  &  Teich);  embedded  with  real-­‐@me  decision  support;  front-­‐end  

•  1997:  longitudinal  medical  record  (LMR);  now  Web-­‐based    

Teich  JM,  Glaser  JP  et  al.  The  Brigham  integrated  compu@ng  system  (BICS):  advanced  clinical  systems  in  an  academic  hospital  environment.  Int  J  Med  Inform.  1999  Jun;54(3):197-­‐208.  

Greenes  RA,  editor.  Clinical  decision  support:  the  road  ahead.  Academic  Press,  2006.  Chapter  5:  CDS  at  Brigham  and  Women’s  Hospital  

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BICS:  Studies  

•  1995:  Adverse  drug  events  (Leape  et  al.  &  Bates  et  al.)  –  common  (6.5/100  admissions);  osen  preventable  (28%);  osen  serious  (43%)  

•  1997:  Costs  of  ADEs  (Bates  et  al.)  –  $2,600  (2.2  days)  per  ADE  or  $5.6M/year  at  BWH;  $4,700  (4.6  days)  per  

preventable  ADE  or  $2.8M/year  at  BWH  

•  ADEs  major  mo@va@on  for  CPOE  –  Wrong  dose,  wrong  choice,  known  allergy,  wrong  frequency,  drug-­‐drug  

interac@on,  etc.  

–  CPOE  reduced  serious  medica@on  error  rate  by  55%  (Bates  et  al.  1998)  –  Overall  medica@on  error  rate  fell  83%  with  CPOE  (Bates  et  al.  1999)  

•  Display  of  lab  test  charges,  redundant  lab  tests,  corollary  orders,  radiology  ordering,  follow-­‐up  of  abnormal  results,  among  others  

•  Many  opportuni@es  remain:  what  best  to  deliver  and  how  to  deliver  it  

Greenes  RA,  editor.  Clinical  decision  support:  the  road  ahead.  Academic  Press,  2006.  Chapter  5:  CDS  at  Brigham  and  Women’s  Hospital  

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Health  Evalua:on  through  Logical  Processing  (HELP)  

Homer  Warner,  T.  Allan  Pryor,  Reed  Gardner,  R.  Scoo  Evans,  

Peter  Haug,  et  al.  

Greenes  RA,  editor.  Clinical  decision  support:  the  road  ahead.  Academic  Press,  2006.  Chapter  6:  CDS  at  LDS  Hospital  

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HELP:  Timeline  (1)  

•  1966-­‐72:  design  and  implementa@on  of  the  HELP  system;  designed  from  the  outset  as  a  clinical  system  –  clinical  data  stored  in  a  common  database;  most  data  stored  in  a  coded  

format  

–  knowledge  base  organized  as  “medical  logic  modules”  (MLMs);  ranging  simple  rules  to  complex  logic  using  data  from  mul@ple  sources  

–  ability  to  data-­‐  and  @me-­‐drive  the  knowledge  base;  all  data  is  inspected  by  the  decision  engine  

•  1976:  pharmacy  applica@on;  adverse  drug  events:  drug-­‐drug,  allergy,  laboratory,  disease,  dose,  diet,  and  interval;  alerts  displayed  to  pharmacists  (not  a  CPOE)  –  MDs  changed  therapy  for  77%  of  the  alerts  (Hulse  et  al.)  

•  1975:  interpreta@on  of  blood  gas  results  

•  1980s:  bedside  char@ng  by  nurses;  installa@on  of  bedside  computers  

Greenes  RA,  editor.  Clinical  decision  support:  the  road  ahead.  Academic  Press,  2006.  Chapter  6:  CDS  at  LDS  Hospital  

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HELP:  Timeline  (2)  

•  1985:  infec@ous  disease  monitoring;  hospital-­‐acquired  infec@ons,  reportable  diseases,  an@bio@c-­‐resistant  pathogens,  infec@ons  in  sterile  body  sites;  hospital-­‐wide  surveillance  

•  1990:  therapeu@c  an@bio@c  monitor;  appropriate  an@bio@c  based  on  culture  and  suscep@bility  results    

•  1989:  preopera@ve  an@bio@cs  2-­‐hours  prior  to  incision;  surgery  schedule  –  improvement  from  40%  to  96%;  decreased  wound  infec@on  (Classen  et  al)        

•  1989:  iden@fica@on  of  high-­‐risk  for  hospital-­‐acquired  infec@ons  (diagnosis)  •  1990:  computerized  laboratory  aler@ng  system;  life-­‐threatening  

condi@ons;  flashing  yellow  lights;  paging  nurses  –  67%  @me  unaware  of  cri@cal  result  (Tate  el  al.)  

•  1990:  blood  ordering  applica@on    

Greenes  RA,  editor.  Clinical  decision  support:  the  road  ahead.  Academic  Press,  2006.  Chapter  6:  CDS  at  LDS  Hospital  

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HELP:  Timeline  (3)  

•  1990-­‐1:  ven@lator  protocols;  treatment  of  acute  respiratory  distress  syndrome  (ARDS);  distributed  to  other  hospitals  –  survival  with  computer  protocol  was  67%,  compared  to  33%  (East  et  al.)  

•  1991:  adverse  drug  event  monitor;  sen@nel  events  (lab  results,  serum  drug  levels,  treatment  of  ADEs,  physiologic  signs)  –  increased  annual  number  of  ADEs  from  10  to  over  500  (Classen  &  Evans  et  al.)  

•  1992:  dura@on  of  an@bio@c  therapy;  prophylac@c  an@bio@cs  longer  that  48  hours;  significant  cost  savings  

•  1994:  an@-­‐infec@ve  agent  assistance;  logis@c  regression  models  using  accumulated  data;  suggest  proper  an@bio@c  prior  to  culture  results  –  reduced  inappropriate  an@-­‐infec@ve  use,  excessive  dosages,  number  of  ADEs  

caused  by  an@-­‐infec@ve,  reduced  cost  (Evans  et  al.)  

Greenes  RA,  editor.  Clinical  decision  support:  the  road  ahead.  Academic  Press,  2006.  Chapter  6:  CDS  at  LDS  Hospital  

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CDS:  addi:onal  evidence  

•  Systema@c  review  of  70  studies  (RCTs),  up  to  2003  –  Evalua@ng  the  ability  of  CDS  to  improve  clinical  prac@ce  –  Focus  on  15  CDS  features  (derived  from  literature)  

•  CDS  improved  prac@ce  in  68%  of  trials  –  Key  features  (independent  predictors)  

  CDS  as  part  of  clinician  workflow    Recommenda@ons  rather  than  just  assessments  

  CDS  at  the  @me  and  loca@on  of  decision  making  

  CDS  triggered  by  computerized  data  analysis  

Kawamoto  K,  Houlihan  CA,  Balas  EA,  Lobach  DF.  Improving  clinical  prac@ce  using  clinical  decision  support  systems:  a  systema@c  review  of  trials  to  iden@fy  features  cri@cal  to  success.  BMJ.  2005;330(7494):765  

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CDS:  value  &  impact  

•  Most  profound  impact  of  ambulatory  CPOE  arises  with  sophis@cated  CDS  

•  Advanced  CPOE  systems  cost  5  @mes  as  much  as  basic  CPOE,  but  were  projected  to  generate  12  @mes  greater  financial  return    

•  Model  projected  reduc@on  of  more  than  2  million  adverse  drug  events  (ADEs)  annually  with  na@onwide  implementa@on  of  ambulatory  CPOE  

•  Annual  savings  of  approximately  $44  billion  from  reduced  medica@on,  radiology,  laboratory,  and  ADE-­‐related  expenses    

Johnston  D,  Pan  E,  Middleton  B,  Walker  J,  Bates  D.  The  Value  of  Computerized  Provider  Order  Entry  in  Ambulatory  SeSngs.  Center  for  Informa@on  Technology  Leadership  (CITL),  2003.  

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Clinical  Decision  Support  (CDS)  

CDS  modali@es  

Examples:  content  +  process  

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CDS:  modali:es  

1.   Reference  knowledge  selec:on  and  retrieval  –  e.g.,  infobuoons,  crawlers  

2.   Informa:on  aggrega:on  and  presenta:on  –  e.g.,  summaries,  reports,  dashboards  

3.   Data  entry  assistance  –  e.g.,  forcing  func@ons,  calcula@ons,  evidence-­‐based  templates  for  

ordering  and  documenta@on  

4.   Event  monitors  –  e.g.,  alerts,  reminders,  alarms  

5.   Care  workflow  assistance  –  e.g.,  protocols,  care  pathways,  prac@ce  guidelines  

6.   Descrip:ve  or  predic:ve  modeling  –  e.g.,  diagnosis,  prognosis,  treatment  planning,  treatment  outcomes  

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Knowledge  Lifecycle  

Generate  

Acquire  

Represent  Deploy  

Maintain  

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CDS  Modali:es:  example  1  

Health  Maintenance  Reminders  

Acquire  

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Reminders:  overview  

•  Extensive  literature  about  reminders  – Mul@ple  studies  indica@ng  posi@ve  results  

•  Specific  example:  – Method  that  facilitates  the  authoring,  discussion,  review,  and  approval  of  reminders  by  prac@cing  clinicians  (expert  panels)   Promotes  ‘fingerprin@ng’  and  collabora@on  

 Virtual  sessions  are  recorded  (retrievable)  

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Reminders  

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Structure  of  rules  

IF      {Pa@ent  in  risk  group}  AND  

   {Pa@ent  has  triggering  condi:on}  AND  

   {NOT  previously  suppressed  by  user}  AND      {NOT  suppressed  by  another  reminder}  AND      {Ac:ve  at  specific  prac@ce}  

THEN      {Reminder  message  and/or  ac@ons}  

Risk  Group  

State  

Display  

Trigger  

Regier R, Gurjar R, Rocha RA. A clinical rule editor in an electronic medical record setting: development, design, and implementation. AMIA Annu Symp Proc. 2009 Nov 14;2009:537-41.

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Narra:ve  specifica:on  

Risk  Group  

Triggers  

Display  

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New  &  exis@ng  reminders  

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Focused  ques@ons  with  hyperlinks  to  suppor@ng  evidence  

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Opinions  and  opportuni@es  for  

discussion  

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Logic  of  each  Reminder  is  made  available  through  the  KM  Portal  

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Example  1:  Reminders  

•  Emphasis  on  acquisi:on  &  review  – Virtual  collabora@on  spaces  – Overcome  tradi@onal  knowledge  acquisi@on  and  elucida@on  boolenecks  

•  Stakeholder  involvement  during  different  lifecycle  phases    effec@ve  adop@on  and  use  – Direct  involvement  of  domain  experts  (panels)  

•  Knowledge  content  accessible  and  maintained  with  a  detailed  audit  trail  – Access  to  knowledge  assets  using  open  portal  

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CDS  Modali:es:  example  2  

Problem  List  Infobudons  

Represent  

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Infobudons:  overview  

•  Extensive  literature  about  infobuoons  –  Successfully  balloted  HL7  dras  standard  

•  Specific  example:  – Method  that  facilitates  the  retrieval  and  naviga@on  of  common  prac@ce  guidelines  by  physicians  at  the  point  of  care    “Infobuoons”  linked  to  problems  in  an  EHR  

  Each  infobuoon  displays  a  list  of  common  ques@ons  that  can  be  answered  by  the  guideline  

Poon SK, Rocha RA, De Fiol G. Rapid Answer Retrieval from Clinical Practice Guidelines at the Point of Care. 19th IEEE International Symposium on Computer-Based Medical Systems, 2006. pages 143-150

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Problem  List    Infobuoons  

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‘Ques@on-­‐driven’  Infobuoons  

Poon SK, Rocha RA, De Fiol G. Rapid Answer Retrieval from Clinical Practice Guidelines at the Point of Care. 19th IEEE International Symposium on Computer-Based Medical Systems, 2006. pages 143-150

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Infobudons:  knowledge  model  

Poon SK, Rocha RA, De Fiol G. Rapid Answer Retrieval from Clinical Practice Guidelines at the Point of Care. 19th IEEE International Symposium on Computer-Based Medical Systems, 2006. pages 143-150

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Infobudons:  requirements  

•  EHR  with  coded  Problem  List    Problem  List  concepts:  terminology  or  classifica@on  

  Problem  List  records:  structured  observa@ons  

• Models  – Ques@ons  (previous  slide)  

 Ques@ons,  ranking,  classes,  answer  sources  – Guideline  metadata  

  Indexed  with  same  codes  used  by  EHR  Problem  List  

– Guideline  ‘tagging’    Tagged  with  same  codes  used  by  Ques@ons  

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Example  2:  Infobudons  

•  Emphasis  on  Modeling  &  Representa@on  –  Enhanced  informa@on  retrieval  based  on  a  ques@on-­‐answer  paradigm  

–  Avoid  knowledge  modeling  and  data  availability  ‘roadblocks’  related  to  ac@onable/executable  CDS  

•  Leverage  widespread  availability  of  authorita@ve  reference  content  (guidelines)  –  Maximize  the  usefulness  of  these  documents  

•  Provides  a  ‘passive’  alterna@ve  to  CDS,  without  interfering  with  clinician  workflow  

•  Rela@vely  simple  to  implement  (infobuVon  manager)  –  Cumbersome  ‘tagging’  of  reference  documents  

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CDS  Modali:es:  example  3  

CPOE  Inpa@ent  Order  sets  

Maintain  

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Order  Sets:  overview  

•  Extensive  literature  about  order  sets  –  Cri@cal  for  CPOE  success,  but  cumbersome  to  create  and  maintain  

•  Specific  example:  – Method  that  enables  con@nuous  refinement  of  order  sets  using  u@liza@on  tracking  data    Interac@ons  of  prescribers  with  order  sets  are  recorded   U@liza@on  data  is  analyzed  and  presented  back  to  order  set  authors  

Hulse NC, Del Fiol G, Bradshaw RL, Roemer LK, Rocha RA. Towards an on-demand peer feedback system for a clinical knowledge base: a case study with order sets. J Biomed Inform. 2008 Feb;41(1):152-64.

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Run-­‐@me  changes  to  order  sets  

Check  or  Uncheck  

Select  values  

Add  new  orders  

Enter  values  

Hulse NC, Del Fiol G, Bradshaw RL, Roemer LK, Rocha RA. Towards an on-demand peer feedback system for a clinical knowledge base: a case study with order sets. J Biomed Inform. 2008 Feb;41(1):152-64.

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Hulse NC, Del Fiol G, Bradshaw RL, Roemer LK, Rocha RA. Towards an on-demand peer feedback system for a clinical knowledge base: a case study with order sets. J Biomed Inform. 2008 Feb;41(1):152-64.

Report  u@liza@on  using  authoring  tool  and/or  CPOE  UI  

Items  from  a  pull-­‐down  menu  (sequence)  

Mutually  exclusive  orders  (pre-­‐selec@on)  

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Hulse NC, Del Fiol G, Bradshaw RL, Roemer LK, Rocha RA. Towards an on-demand peer feedback system for a clinical knowledge base: a case study with order sets. J Biomed Inform. 2008 Feb;41(1):152-64.

Comprehensive  sugges@ons  to  

improve  order  set  

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Example  3:  Order  sets  

•  Emphasis  on  maintenance  (CQI)  –  Detailed  u@liza@on  tracking  providing  aggregated  end-­‐user  feedback  (constantly  updated)  

–  Refinements  based  on  how  knowledge  is  used  

•  Reduce  the  cost  and  increase  efficiency  of  knowledge  maintenance  –  Enable  (passive)  end-­‐user  involvement  

–  Avoid  poten@al  liability  due  to  lack  of  coverage  or  update  •  Iden@fy  opportuni@es  for  educa@on  (interven@on)  

–  Monitor  quality,  safety,  and  opera@ng  business  drivers  –  S@ll  requires  oversight  provided  by  expert  panels  

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CDS  Modali:es:  example  4  

Disease  Management:  Care  Pathway  

Deploy  

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Care  Pathway:  overview  

•  Extensive  literature  about  guidelines/pathways  –  Cri@cal  for  disease  management,  but  very  difficult  to  computerize  (research  prototypes)  

•  Specific  example:  – Method  that  implements  EHR  “Smart  Forms”  to  integrate  mul@ple  modali@es  of  CDS   Data  visualiza@on,  documenta@on,  and  interpreta@on   Ordering  guidance  and  tracking  

Schnipper JL, Linder JA, Palchuk MB, Einbinder JS, Li Q, Postilnik A, Middleton B. "Smart Forms" in an Electronic Medical Record: documentation-based clinical decision support to improve disease management. J Am Med Inform Assoc. 2008 Jul-Aug;15(4):513-23.

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View:  Data  Display  

Assessment,  Orders,  and  Plan  

Assessment  and  recommenda@ons  generated  from  rules  engine  

Documenta:on  

•  Lipids  •  An@-­‐platelet  therapy  •  Blood  pressure  •  Glucose  control  • Microalbuminuria  •  Immuniza@ons  •  Smoking    • Weight  •  Eye  and  foot  examina@ons  

Smart  Forms  (1)  

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Smart  Forms  (2)  

Medica:on  Orders  

Lab  Orders  

Referrals  

Handouts/Educa:on  

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Example  4:  CDS-­‐enabled  workflow  

•  Detailed  structured  and  coded  data  •  Intui@ve  authoring  and  maintenance  of  protocols  and  workflows  (complex  knowledge)  

•  Able  to  merge  overlapping  protocols  and  workflows  –  mul@ple  diseases,  various  user  roles,  transi@ons  of  care,  …  

•  Able  to  rollback  triggered  ac@ons  and  revise  context,  including  ‘pa@ent’  and  ‘protocol’  states  

•  Proper  handling  of  errors  and  uncertainty  affec@ng  data  and  workflow  defini@on  –  Detect  unexpected  condi@ons  and  ‘fail  gracefully’  

•  Performance  (online/real-­‐@me  execu@on)  

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CDS:  implementa:on  strategies  

CDS  modality   Implementa:on  Strategies  1.  Reference  

knowledge  selec@on  and  retrieval  

Reference  2.  Informa@on  

aggrega@on  and  presenta@on   Ac:onable  3.  Data  entry  

assistance  

4.  Event  monitors  

Executable  5.  Care  workflow  

assistance  

6.  Descrip@ve  or  predic@ve  modeling  

Cost  

Availability  

Complexity  

Maintaina

bility  

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Clinical  Decision  Support  (CDS)  

Components  of  a  CDS  system  

CDS  standards  

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Clinical  Data!  

•  Data  are  the  ‘diamonds’  of  medical  informa@cs  –  Computer  systems  come  and  go    –  Data  is  forever  

  Or  at  least  it  should  be  –  The  data  you  have  constrains  what  you  can  do  with  decision  support    Be  very  conscious  of  these  limits  

–  Do  not  assume  you  can  capture  data  that  you  don’t  have  

Slide from Clem McDonald, MD

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Haug  PJ,  Rocha  BH,  Evans  RS.  Decision  support  in  medicine:  lessons  from  the  HELP  system.  Int  J  Med  

Inform.  2003  Mar;69(2-­‐3):273-­‐84.  

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Basic  model  

Knowledge  Base  

Inference  Engine  

Interface  

User  

Pa:ent  database  

Editor  

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CDS  Rules  Manager  (‘Event  Monitor’)  

Rocha R.A,Bradshaw R.L., Hulse N.C., and Rocha B.H.S.C. The clinical knowledge management infrastructure of Intermountain Healthcare. In: Clinical Decision Support: The road ahead, RA. Greenes (ed.). Academic Press, Boston, 2007, pp. 469–502.

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CDS:  standard  representa:on  formats  

CDS  modality   Standard  Formats  1.  Reference  

knowledge  selec@on  and  retrieval  

Guideline  Elements  Model  (GEM):  ASTM  Context-­‐aware  Info  Retrieval  (Infobuoon):  HL7  (dras)  

2.  Informa@on  aggrega@on  and  

presenta@on  Clinical  Document  Architecture  (CDA):  HL7  Quality  Measures  (eMeasure):  HL7  (dras)  

Order  sets:  HL7  (in  progress)  3.  Data  entry  assistance  

4.  Event  monitors  Arden  Syntax  for  Medical  Logic  Systems:  HL7  GELLO  -­‐  A  Common  Expression  Language:  HL7  

Decision  Support  Services:  HL7  (dras)  Virtual  Medical  Record:  HL7  (in  progress)  

5.  Care  workflow  assistance  

6.  Descrip@ve  or  predic@ve  modeling  

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Clinical  Knowledge  Management  (CKM)  

Mo@va@on  for  CKM  

CKM  Program  characteris@cs  

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Implica:ons  of  CDS  strategy  

Development  of  CDS  content  

CDS  content  available  for  EHR  use  

Standard  CDS  content  formats  

Implement  EHRs  with  

CDS  capabili@es  

Knowledge  Management  

Acquisi:on   Representa:on   Dissemina:on   Deployment  

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Desirable  CDS  Features    CKM  

  Knowledge  is  based  on  the  best  evidence  available  

  Knowledge  covers  problem  in  detail  –  allow  sophis@cated  problem  solving,  advice,  explana@ons  

  Knowledge  can  be  readily  updated  by  a  clinician  without  unexpected  effects  

  Knowledge  base  provides  links  to  related  local  and  Internet  material  –  lifelong  learning  

•  Most  pa@ent  data  drawn  from  exis@ng  sources  –  ease  of  use  

  System  (knowledge)  performance  is  validated  against  suitable  gold  standard  

  Demonstrated  prac@ce  or  outcomes  improvements  in  rigorous  study  

  Clinician  always  in  control  –  Receive  advice,  browse  the  

knowledge  base,  get  help  and  explana@ons,  try  out  ‘what-­‐if’  scenarios,  and  obtain  a  cri@que  of  the  pa@ent  management  plan  

•  System  is  easy  to  access  –  for  example  via  the  Web  

Modified from Wyatt JC. Decision Support Systems. J R Soc Med 2000;93:629-633

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CKM:  mo:va:on  

•  Quan@ty  of  knowledge  (explosion)  –  Evolu@on  towards  stra@fied/personalized  clinical  prac@ce  –  Complex  decision  making  process  demanding  computerized  support  

•  Distributed  care  delivery  processes  (fragmented)  –  Extensive  knowledge  is  needed  beyond  organiza@onal  boundaries  –  Learning  opportuni@es  leading  to  op@mal  care  and  stewardship  

•  Global  trends  towards  knowledge  socializa@on  –  Consumers  (pa@ent)  constantly  seeking  knowledge  (empowerment)  

–  Shared  responsibility  only  possible  with  proper  understanding  •  Knowledge  content  maintainability  (long-­‐term)  

–  Content  diversity  and  quan@ty  makes  tradi@onal  cura@on  unrealis@c  

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Engineering  vs.  Deployment  

Knowledge  Engineering  

Knowledge  Deployment  

Crea:on/Revision  

Review/Approval  

Configura:on/Tes:ng  

Deployment/Valida:on  

Evalua:on/Monitoring  

CDS  consumers  

CDS  developers  

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CKM:  deployment  models  

Import

Configure

EHR with CDS

Update

Integrate

Configure EHR with CDS

Knowledge  Content  only  

Knowledge  Services  +  Content  

Both  require  content  localiza:on  (configura:on)  

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CKM:  concurrent  lifecycles  Generate

Acquire

Represent Deploy

Maintain

Rules  

Generate

Acquire

Represent Deploy

Maintain

Order  Sets  

Generate

Acquire

Represent Deploy

Maintain

Dic:onaries  

Generate

Acquire

Represent Deploy

Maintain

Protocols  

Generate

Acquire

Represent Deploy

Maintain

Workflows  Generate

Acquire

Represent Deploy

Maintain

Reports  

Generate

Acquire

Represent Deploy

Maintain

Templates  

Import

Configure

EHR with CDS

Update

Integrate

Configure EHR with CDS Dic:onaries  Rules  

Import

Configure

EHR with CDS

Update Monographs  

Integrate

Configure EHR with CDS

Guidelines  

Import

Configure

EHR with CDS

Update Templates  

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Strategic  Goals  @  Partners  

•  Enable  all  knowledge  content  to  be  accessible,  updatable,  and  maintained  with  an  audit  trail  

•  Reduce  the  cost  and  increase  efficiency  of  both  design  and  implementa@on  maintenance  

•  Enable  stakeholder  involvement  in  the  design  process  to  support  effec@ve  adop@on  and  use  

•  Ensure  alignment  with  quality,  safety,  and  opera@ng  business  drivers  (HPM,  Joint  Commission,  etc.)  

•  Avoid  poten@al  liability  of  making  incorrect  or  incomplete  recommenda@ons  due  to  lack  of  coverage  or  update  

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CKM:  program  components  

Personnel  

Domain  Experts  

Knowledge  Engineers  

Informa:on  Modelers  

Terminology  Engineers  

Framework  

Lifecycle  Processes  

Governance  Processes  

Sonware  Plaoorm  

Assets  Knowledge  Repositories  

Logical  Data  Templates  

Concept  Dic:onaries  

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Clinical  Content  Commidee    Priori@zes  and  Sponsors  Opera@onal  Stewardship  of  Content  

Safety  

CAD/CHF,  Diabetes,    Heme-­‐Onc,  Asthma,    ID/HIV,  Nephrology,    

Psych  

Disease  Areas  

Adult,  Geriatrics,  Pediatrics,    

Women’s  Health  

Primary  Care  

PCHI  P&T  

Pharmacotherapy  

Quality   Disease  Management   Trend  Management  

SME  Groups  

Medica:on  Knowledge  Commidee  

BWH  Precipio  

Imaging  Studies  

MGH  ROE  

Knowledge  Repositories  

Knowledge  Engineers    

Tools    

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CKM:  staffing  challenges  

•  Recrui@ng  is  a  lengthy  process  –  Technology  professionals  with  clinical  training  (exposure)  –  Partnerships  with  local  academic  programs  

•  Training  is  quite  intense  and  takes  @me  (6-­‐18  months)  –  Processes,  domains,  mul@tude  of  systems,  KM  Framework  

–  Informa@cs  Principles:  external  courses  and  internal  mentoring  

•  Reten@on  can  be  problema@c  –  Uncommon  skills  (differen@a@on)  

–  Compe@@on  with  similar  organiza@ons  (and  EHR  vendors)  

•  Crea@on  of  specific  job  families  (interrelated)  –  Knowledge  and  Terminology  Engineers  

–  Clinical  Subject  Maoer  Experts  

–  Informa@cians  

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CKM:  sonware  plaoorm  requirements  

•  Enable  consistent  lifecycle  and  configura@on  •  Proper  handling  of  dependencies  

–  Preserva@on  of  reference  sources  (with  control)  •  Enable  collabora@ve  authoring  and  localiza@on  

–  Promote  modularity  and  reuse  

•  Extensible  and  “intelligent”  –  Maintain  assets  with  “meta-­‐knowledge”  –  Leveraging  seman@c  technologies  

•  Built-­‐in  u@liza@on  monitoring    •  Built-­‐in  analy@cal  capabili@es  (CQI/Discovery)  

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CKM:  sonware  infrastructure  

View   Analyze  

Concept  Dic:onaries  

Logical  Data  Templates  

Knowledge  Repositories  

Lifecycle  Management  

Collabora/on  Management  

Edit   Publish  

Store   Archive  Import   Map  

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Challenges  &  Opportuni:es  

CDS  and  CKM  

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  User  is  right;  data  gaps  -­‐  override  alerts  and  reminders  

  Workflow  

•  CDS  can  become  overwhelming  

  Con@nuous  user  input,  collabora@on,  and  feedback  

  Prospec@ve  evalua:on  studies  

o  Importance  of  standards:  interoperability  

o  Speed  is  everything  

  An@cipate  user  needs    Workflow  o  Details  are  important  

o  Stopping  vs.  changing  direc@on  

  Simple  interven:ons  

  Data  is  expensive    Prospec@ve  evalua:on  

studies    Knowledge  must  be  

managed  and  maintained  

  Data  is  cri@cal    Knowledge  is  a  team  

effort    Workflow  

o  Proper  tes:ng  before  

  Simple  interven:ons  

•  Evidence-­‐based  and  matching  local  prac@ces  

  Knowledge  has  to  be  periodically  reviewed  

•  Ease  of  use    Evalua:on  is  difficult  

  Cost-­‐effec:ve  to  implement  and  maintain  

RMRS   BICS   HELP  

CDS:  important  lessons  compared  

Greenes  RA,  editor.  Clinical  decision  support:  the  road  ahead.  Academic  Press,  2006.  Chapters  4  (RMRS),  5  (BICS),  and  6  (HELP)  

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Healthcare  IT:  Meaningful  Use  

2009 2011 2013 2015

HIT-Enabled Health Reform

Mea

ning

ful U

se C

riter

ia

HITECH Policies 2011 Meaningful

Use Criteria (Capture/share

data) 2013 Meaningful

Use Criteria (Advanced care processes with

decision support)

2015 Meaningful Use Criteria (Improved Outcomes)

Diagram from: Tang & Mostashari (chairs) et al., Meaningful Use Workgroup Presentation. HIT Policy Committee, June 16, 2009.

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Quality  improvement  with  EHR  use  

•  Study  looked  at  the  quality  of  care  delivered  in  ambulatory  prac@ces  and  dura@on  of  EHR  use:  –  Survey  of  physicians’  adop@on/use  of  EHR  (Massachuseos)  

  137  physicians  using  an  EHR;  average  of  4.8  years  –  Claims  data  reflec@ng  quality  of  care  as  indicated  by  widely  used  quality  measures    Healthcare  Effec@veness  Data  &  Informa@on  Set  (HEDIS):  Breast  cancer  screening,  HbA1c  tes@ng,  LDL  screening,  Well-­‐child  visits,  …  

•  No  associa@on  between  dura@on  of  using  an  EHR  and  performance  with  respect  to  quality  of  care  –  “Intensifying  the  use  of  key  EHR  features,  such  as  clinical  decision  support,  may  be  needed  to  realize  quality  improvement  from  EHRs”  

Zhou et al. The relationship between Electronic Health Record Use and Quality of Care. J Am Med Inform Assoc. 2009;16:457-64.

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CPOE  with  advanced  CDS  

Metzger J, Welebob E, Bates DW, Lipsitz S, Classen DC. Mixed results in the safety performance of computerized physician order entry. Health Aff (Millwood). 2010 Apr;29(4):655-63.

62  hospitals  volunteered  to  assess  

CDS  applied  to  medica@on  ordering  –  simulated  test  orders  likely  to  cause  serious  harm  entered  in  local  CPOE  (8  vendors)  

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CKM:  implementa:on  challenges  (1)  

•  Clinical  governance  and  stewardship  is  poorly  defined  –  Clinical  strategy  does  not  drive  KM  ac@vi@es  nor  is  informed  by  KM  principles  

–  Opportuni@es  for  strategic  interven@ons  not  proac@vely  iden@fied  or  planned  •  Projects  and  resources  defined  in  compe@@on  with  other  ac@vi@es  

–  IT  efforts  not  aligned  with  clinical  quality  and  safety  ini@a@ves  –  Inadequate  defini@on  and  priori@za@on  of  KM  strategic  ac@vi@es  –  Cost  of  not  having  ‘knowledge’  is  not  frequently  considered  

•  Deployment  of  knowledge  assets  is  underes@mated  and  inconsistent  –  Domain  experts  (clinicians)  frequently  unavailable;  limited  commitment  

–  Processes  for  configuring  and  ve|ng  knowledge  are  not  explicitly  defined  

–  Lack  of  a  systemic  view  promotes  overlapping  efforts  (varia@on)  

Modified from Tonya Hongsermeier, MD, MBA – Partners/CIRD

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CKM:  implementa:on  challenges  (2)  

•  Sosware  tools  to  create  and  maintain  knowledge  are  inadequate  –  Knowledge  once  deployed  for  use  is  not  easily  accessible  (‘locked’)  –  Tools  frequently  ignore  content  dependencies  and  lifecycle  

requirements  (subsequent  updates)  

•  Maintenance  of  knowledge  assets  is  an  aserthought  –  Long-­‐term  commitment  to  content  maintenance  is  underes@mated  

–  Liability  resul@ng  from  outdated  or  incorrect  recommenda@ons  not  recognized  

•  Analy@c  data  regarding  impact  on  clinical  processes  and  outcomes  is  generally  not  available  

Modified from Tonya Hongsermeier, MD, MBA – Partners/CIRD

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Personalized  Medicine  

•  Greatly  expanded  diagnos@c  space  –  1920s:  1  leukemia  &  1  lymphoma  

–  1940s:  3  leukemia  &  2  lymphoma  –  Today:  38  leukemia  &  51  lymphoma  (outdated?)  

•  Greatly  reduced  (targeted)  therapeu@c  space  –  “Blockbusters”  (e.g.,  atorvasta@n,  sildenafil)  –  “Niche  busters”  (e.g.,  ima@nib  –  “magic  bullet”  to  cure  cancer)  –  “Orphans”  (e.g.,  imiglucerase  –  Gaucher’s  disease)  

Modified from Michael G. Kahn MD, PhD – University of Colorado

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Test  for  gene:c  differences  

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Knowledge  Sharing  

•  Clinical  Decision  Support  Consor:um  –  “Goal  of  the  CDS  Consor@um  is  to  assess,  define,  demonstrate,  and  evaluate  best  prac@ces  for  knowledge  management  and  clinical  decision  support  in  healthcare  informa@on  technology  at  scale  –  across  mul@ple  ambulatory  care  se|ngs  and  EHR  technology  pla}orms.”   hop://www.partners.org/cird/cdsc/  

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CDSC  Portal  

hdp://cdsportal.partners.org  

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Acknowledgements  

Blackford  Middleton  Tonya  Hongsermeier  

Saverio  Maviglia  

Beatriz  Rocha  

CIRD/KM  Team  at  Partners  

Stanley  Huff  

David  Burton  

KB  Team  at  Intermountain  

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Addi:onal  readings  

•  Book  “Clinical  decision  support:  the  road  ahead”  –  Greenes  RA,  editor.  Academic  Press,  2006.  

•  Paper  “Ten  commandments  for  effec@ve  clinical  decision  support:  making  the  prac@ce  of  evidence-­‐based  medicine  a  reality.”  –  Bates  DW,  Kuperman  GJ,  Wang  S,  Gandhi  T,  Kioler  A,  Volk  L,  Spurr  C,  Khorasani  R,  Tanasijevic  M,  

Middleton  B.  J  Am  Med  Inform  Assoc.  2003  Nov-­‐Dec;10(6):523-­‐30.  (PMID:  12925543)  

•  Paper  “A  roadmap  for  na@onal  ac@on  on  clinical  decision  support.”  –  Osheroff  JA,  Teich  JM,  Middleton  B,  Steen  EB,  Wright  A,  Detmer  DE.  J  Am  Med  Inform  Assoc.  2006  

Jul-­‐Aug;13(4):369-­‐71.  (PMID:  17213487)  

•  Paper  “Just-­‐in-­‐@me  delivery  comes  to  knowledge  management.”  –  Davenport  TH,  Glaser  J.  Harv  Bus  Rev.  2002  Jul;80(7):107-­‐11,  126.  (PMID:  12140850)  

•  Paper  “Using  commercial  knowledge  bases  for  clinical  decision  support:  opportuni@es,  hurdles,  and  recommenda@ons.”  –  Kuperman  GJ,  Reichley  RM,  Bailey  TC.  J  Am  Med  Inform  Assoc.  2007  Mar-­‐Apr;14(2):141-­‐5.  (PMID:  

16622160)  

•  Paper  “Predic@ve    data  mining  in  clinical  medicine:  current  issues  and  guidelines.”  –  Bellazzi  R,  Zupan  B.  Int  J  Med  Inform.  2008  Feb;77(2):81-­‐97  (PMID:  17188928)  

•  Web  site  “Open  Clinical”  (UK):  hop://www.openclinical.org/  

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Thank  you!  

Roberto A. Rocha, MD, [email protected] !