Bustani Ri Conference Cas Evaluation Oct 3 2007
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Bustani Ri Conference Cas Evaluation Oct 3 2007

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Selecting An Intervention In A Complex Adaptive Health Care System & Evaluating Its Impact

Selecting An Intervention In A Complex Adaptive Health Care System & Evaluating Its Impact

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Bustani Ri Conference Cas Evaluation Oct 3 2007 Bustani Ri Conference Cas Evaluation Oct 3 2007 Presentation Transcript

  • Selecting An Intervention In A Complex Adaptive Health Care System & Evaluating Its Impact Malaz Boustani, MD, MPH Indianapolis Discovery Network for Dementia Indiana University center for Aging Research Regenstrief Institute, Inc www.indydiscoverynetwork.com
  • The US Health Care System Report Card
    • Sub-optimal quality
      • Dementia recognition:< 40%
      • FDA approved Trx: < 10%
      • Inappropriate Trx: > 25%
    • Compromised safety
      • 90,000 death / yr
      • 1,000,000 injury / yr
    • Waste
      • 30% - 40% health expenditure (overuse, underuse, misuse, duplication)
    • Discovery to Delivery:
      • 17 yrs
      • $800 millions
    • Generalizability of Research Findings:
      • < 1% of real world patients enrolled in AD studies
    Boustani, 2007; IOM, 2001, Westfall, 2007; Faison et al, 2003;
  • Independent Agent E Other Local CASs Stress Feedback Independent Agent D Independent Agent C Independent Agent B Independent Agent A Changing Environment Connection The health care CAS Emergent Performance
  • Complex Adaptive Health Care System
    • An open, dynamic, flexible, adaptive, and complex network
    • Complex due to
      • Numerous interconnected, semi-autonomous, competing, and collaborating members
    • Adaptive due to
      • Its capability of learning from its prior experience
      • Its flexibility to change its members connecting patterns to fit better with its surrounding environment
    Holden, 2005; Litaker et al. 2006 Feb.
  • Complex Adaptive Health Care System
    • Emergent behaviors
      • NOT predetermined ones
    • Self-organized controls
      • NOT central controls
    Holden, 2005; Litaker et al. 2006 Feb.
  • The Paradox of CAS
    • Each CAS is unique in its
      • Members diversity
      • Members interactions
      • Surrounding environment
      • Previous history
      • Evolving and learning process.
    • Health care research centers generate scientific data from group-based studies
      • Then regulators/guideline developers ask each unique CAS to implement the findings.
    Holden, 2005; Litaker et al. 2006 Feb; Stoebel et al, 2005.
  • The Paradox of CAS
    • The performance of a CAS fluctuates over time
    • The connecting patterns of its members are dynamic and change over time in respond to the stress or the fitness requirements of its surrounding environment.
    Holden, 2005; Litaker et al. 2006 Feb; Stoebel et al, 2005.
  • How Can I Assess CAUSALITY? Can I Predict?
    • How can I identify or determine that a system is a CAS?
    • How can a system with no bosses, no mandates and no plans produce repeatedly complicated structures and perform difficult tasks?
    • Can I build a complex adaptive system model to study? What can I do with a simulator?
    • What data do I have & how can I analyze data in CAS?
    • How can I manage the problems of uncertainty, variability, and variable interdependency in a CAS?
    • Is replication essential in science?
    • How can I select a change in a CAS?
    • How can I evaluate the success or the impact of my proposed intervention or change in a CAS?
    • How are experiments performed in a complex adaptive system?
    • Is a randomized controlled trial the best accurate study design to evaluate an intervention in a CAHS?
    How Can I Assess CAUSALITY? Can I Predict?
  • Selecting an Intervention
  • The 9 Principles of Selecting a Change in a Complex Health Care System
    • View your system through the lens of complexity.
    • Build a good enough vision with minimum specifications
    • Lead from the edge by balancing data and intuition, planning and acting, safety and risk.
    • Foster the &quot;right&quot; degree of information flow, diversity and difference, connection among agents, power differential, and anxiety.
    • Uncover and work with paradox and tension.
    Paul E Plsek. 1997.
  • The 9 Principles of Selecting a Change in a Complex Health Care System
    • Go for multiple actions at the fringes, let direction arise.
    • Listen to the informal relationships, gossip, rumor, and hallway conversations that contribute significantly to the individuals’ perceptions about their surrounding environment and their subsequent actions.
    • Allow complex systems to emerge out of the links among simple systems that work well and are capable of operating independently.
    • Build a community of members who collaborate, create, learn and compete
    Paul E Plsek. 1997.
  • Reflective Adaptive Process
    • Build a local “Think-Tank: the RAP Team” responsible of introducing an acceptable, locally matched, flexible and effective change in its CAS.
    • External or internal facilitators who encourage the RAP Team to select, adopt or create local processes to
      • solve the CAS problem
      • enhance the CAS performance
      • guide the CAS respond to its surrounding environment
    • RAP is the second generation of CQI
    Stroebel et al.2005.
  • The RAP Principles
    • Vision, mission, and shared values are fundamental in guiding ongoing change processes in a CAS
    • Creating time and space for learning and reflection is necessary for a CAS to adapt to and plan change
    • Tension and discomfort are essential and normal during CAS change
    • Improvement teams should include a variety of system’s agents with different perspectives of the system and its environment
    • System change requires supportive leadership that is actively involved in the change process, ensuring full participation from all members and protecting time for reflection
    McDaniel et al, 2003; Stroebel et al.2005; Boustani et al 2007.
  • Evaluation of Interventions in CAS
    • Selecting the content and the delivery of the intervention
      • A- The content based on SER of past research or guidelines
      • B- Develop a RAP team to
        • Localize the content
        • Localize / Invent the delivery process
        • Monitor the delivery process
        • Monitor the agents interactions
        • Detect emergent behaviors
  • Evaluating the Impact of the Selected Interventions
  • Methodological Quality “ Extent to which a study’s design, conduct, and analysis has minimized selection, measurement , and confounding biases” West et al, 2002
  • The “Safeguards” Evidence
    • Random assignment against
      • both unconscious and deliberate human influence on the assignment of subjects to different groups
      • unknown confounders
    • Blind outcome assessment ensures
      • treatment and analysis of outcomes are not colored by prejudice
    Guyatt et al, 1993; West et al, 2002
  • The Hierarchical Strength of Evidence in Treatment Decisions
    • N-of-1 RCT
    • SER of RCT
    • Single RCT
    • SER of observational studies
    • Single observational study
    • Physiologic studies
    • Unsystematic clinical observations
    Guyatt et al, 1993; West et al, 2002
    • Design:
      • N-OF-1 RCT
    • System outcomes
      • Overall Cost
      • Overall Safety
      • Overall Quality
      • Overall Patient Satisfaction
      • Overall Staff Satisfaction
    • Intervention specific outcomes
    Proposed Evaluation Process
  • Applying N-OF-1 RCT in CAS
    • A CAS receives pairs of evaluation periods
      • Each pair including one period of active intervention and another of usual care in random order.
    • CAS members are kept masked to allocation
    • Outcomes are monitored blindly and continuously
  • N-OF-1 RCT in CAS 0----------1------------2-----------3-----------4----------5-----------6------------7-----------8-------------9-----------10------------11------------12 Time Outcome Data Outcome Data Outcome Data Outcome Data Outcome Data Outcome Data Outcome Data R to Int R to Int R to Int R to UC R to UC R to UC
  • Issues of –OF-1 RCT
    • Selecting the Intervention:
      • Is there enough data to suggest the efficacy of the intervention?
      • Did the RAP team modify the intervention delivery and content to match the local resources?
    • Determining the rapidity of onset of the intervention effect:
      • How quickly does the intervention begin to act and cease acting?
    • Optimizing dose:
      • What is the best dose?
      • Does it differ between systems?
    Guyatt et al, 1986; Price & Evans, 2002
  • Issues of –OF-1 RCT
    • 4. Selecting the outcomes:
      • the overall common system outcomes not related specifically to the intervention.
      • the outcomes that the intervention effect directly.
      • the process that mediates the effect of the interventions such as the relationship and the new connection between the CAS members.
    • 5. Interpreting the Results of N-of-1 RCTs:
      • What a priori criteria should be established for classifying a trial as definitely negative or indefinite?
    Guyatt et al, 1986; Price & Evans, 2002
  • The Requirement for N-of-1 RCT:
    • The problem that requires intervention needs to be chronic.
    • The problem that requires intervention needs to be stable.
    • The effect of the new intervention begins to acts within days to weeks at most.
    • The effect of the new change ceases acting after discontinuing within days to weeks at most.
    Guyatt et al, 1986; Price & Evans, 2002
  • The Science of CAS
    • “ A general feeling of unease when contemplating complex systems dynamics. Its devotees are practicing fact-free science. A fact for them is, at best, the outcome of a computer simulation; it is rarely a fact about the world.”
            • (Smith 1995, p. 30).
  • The Science of CAS
    • “ Prediction is our best means of distinguishing science from pseudo-science”
            • Karl Popper
    • “ The history of 20th-century science should also give complexologists pause. Complexity is simply the latest in a long line of highly mathematical ‘theories of almost everything’ that have gripped the imaginations of scientists in this century”
            • (Horgan 1995, p. 104).