Development and iterative testing of a computerized decision support system to improve opioid prescribing for chronic pain

Jodie Trafton, Ph.D.

VA Center for Health Care Evaluation

Opioids are highly prescribed
        - Based on number of US prescriptions dispensed in 2005: 
        - Hydrocodone #3, Tramadol #5, Vicodin #6, Oxycodone #8, Percocet #12
        - From 1996-2002, opioid prescribing increased 309% in Medicaid programs
        - Biggest increase in oxycodone and methadone

Opioid prescribing may be associated with a variety of problems
        - Misuse/Abuse/Addiction
        - Lack of Effectiveness
        - Side-effects
        - Lethal
        - Troublesome
        - Legal problems
        - For patients
        - For physicians

Opioids activate reward circuits and thus, like all rewards, will shape behaviors.  Depending on the context and pattern of use, these behaviors may be helpful or harmful to emotional well-being and life functioning.  When harmful behaviors are learned, opioid use can result in problems with misuse, abuse or addiction.

Opioids may or may not provide reductions in pain and improvements in functioning over the long-term.  There is little research testing the long-term (beyond 4 weeks) effectiveness of opiods for treatment of chronic pain, and there is evidence that at least some patients develop tolerance or opioid-induced hyperalgesia and show improvements in pain and functioning when opioid treatment is discontinued.  

Additionally, even when opioids do help, they reduce but do not eliminate pain.  A 30% reduction in pain is a good response. Patients and providers may have unrealistic expectations for treatment outcome with opioid medications.

All medications have side-effects.  Opioid medications produce respiratory depression, especially in opioid naïve patients, and may be lethal if overdosed.  They also may produce sedation, constipation, nausea, itching, and problematic psychotic effects in some patients.

Opioid prescriptions may have legal consequences for patients and providers.  Patients may choose to illegally sell or share their prescriptions.  Providers have been prosecuted for overexuberant prescribing, poor documentation of opioid prescribing, and elder abuse.

Misuse/Abuse/Addiction
        - Improper use of medications
        - e.g. Hoarding, using others Rx, taking more than prescribed
        - Aberrant behaviors around opioid prescriptions
        - e.g. MD shopping, early refills, ER visits
        - Diversion
        - Medication addiction
        - Need to differentiate dependence and pseudoaddiction

A percentage of patients will show problematic behaviors related to their opioid prescriptions.  Estimated rates of such behaviors range wildly (3-50%) depending on the patient population studied and the definitions used.  

There is not complete consensus on what constitutes problem behavior, but research on opioid misuse is intensifying. 

Currently researchers and clinicians have delineated a number of behaviors that may indicate that the patient is having trouble using their medication properly and may have and addition.  These include hoarding medication, using other people’s prescriptions, taking more than prescribed, getting prescriptions from multiple doctors, asking for early refills for lost or stolen medication, frequent ER visits, preference for a single opioid or route of administration, buying medication off the street or internet, lying about medication.  These behaviors range from relatively common to infrequent and obviously range in intensity.  For example, having 25 doctors is much more worrisome than 2.  

Diversion is a relatively straightforward problem, not necessarily to detect, but to respond to, but may not be related to addiction.

Identifying addiction is additionally complicated in chronic pain patients where effective analgesics will be sought solely for their their pain relieving effects.  To illustrate, in animal self-administration models, a healthy rodent will not self-administer NSAIDS, however, an animal with an induced inflammatory injury will self-administer NSAIDS.  Analgesic-seeking behaviors that occur only in search of pain relief are considered normal.  Although they may mimic addictive behaviors, they are considered a “pseudoaddiciton”.  Some argue that in order to truly diagnosis opioid medication addiction in the presense of chronic pain, one must determine if the behavior persists when the pain is effectively relieved.

Effectiveness
        - Lack of research evidence for long-term effectiveness
        - Effect on pain experience versus functioning
        - Need to define goals and expectations
        - Tolerance and dose escalation
        - Opioid-induced hyperalgesia

Side-effects
        - Accidental overdose
        - Rates have been increasing markedly as opioid prescribing rates have increased.  A CDC report found: 
        - Between 1999 and 2002, the number of opioid analgesic overdoses on death certificates increased 91.2%.
        - Among opioid analgesic overdoses in 2002, 54% were from semi-synthetic opioids such as oxycodone and hydrocodone, 32% were from methadone, and 13% were from other synthetic opioids such as fentanyl. 
        - Psychological effects
        - Sedation
        - Accidents
        - Mental impairment
        - Constipation

Legal Problems
        - Diversion
        - According to the NSDUH, 4.8% of people age 12 or older used a prescription opioid non-medically in the last  year (2005)
        - Improper prescribing
        - Elder abuse

Physicians desire help with opioid prescribing and chronic pain management
        - Lack training in pain management
        - Communication difficulties
        - Between clinicians
        - Between patient and provider
        - Lack of clear research data to guide decisions
        - Apparently conflicting goals
        - Reduce pain/Prevent negative consequence of medication use
        - Legal community: limit use/Medical community: increase use of opioids
        - Want to be told what to do

Clinical Practice Guidelines are available
        - Predominantly consensus based
        - Not strictly operationalized
        - Not clear how to implement guideline in practice 
        - Not well followed in practice

Complex problem
        - Not something that can be fixed with a simple reminder or warning
        - Many concerns that need to be balanced
        - Many medication options with subtle differences in indications, dosing strategies, and risks
        - Simple medical informatics tools are not likely to help substantially

Decision Support
        - With the support of the SUD QUERI, we decided to develop a computerized decision support system to provide primary care providers with recommendations for individual patients to guide use of opioid therapy for chronic pain based upon the VA/DOD 2003 clinical practice guideline.

Used ATHENA-DSS structure
        - Integrated with CPRS to fit within clinical workflow
        - Extracts data from electronic medical record
        - Data is run through a complex algorithm to generate patient specific warnings and recommendations for care
        - Recommendations and tools are provided in a graphical user interface
        - Limited information can be written back to the electronic medical record

Sbm- highlight that it is set up to fit in the provider’s clinical workflow. For example, the provider gets our Advisory as a pop up window when he/she selects the patient in CPRS (quasi-integration with CPRS). Provider does not need to activate the program.

What the Clinician Sees...

The ATHENA system

Goals
        - Improve analgesia and functioning
        - Reduce use, or improve monitoring of effectiveness and negative consequences, in contraindicated patients
        - Improve screening for and decrease abberrant behaviors (e.g. MD shopping, multiple Rxers, use of ER)
        - Improve documentation of opioid therapy and chronic pain management plan
        - Facilitate patient/provider communication and monitoring of chronic pain
        - Provide clinicians with detailed prescribing information and algorithms to save time and cost

Add improve analgesia/activities of daily living?

Provide for informational needs of clinicians when managing chronic pain (conversion calculator, etc.)

Challenge 1
        - Operationalizing clinical guideline
        - More of a guide for good practice strategy than an algorithm for determining correct clinical choices
        - Limited to information we could reliably extract from the patient medical record
        - Imperfect consensus on best practice even among experts

Our response
        - Design graphical user interface and tools to foster good practice strategies
        - Clinician behavior checklist
        - Written back into patient notes
        - Provides reminders to complete what can be uncomfortable or time-consuming procedures
        - Highlight potentially concerning patient characteristics or medical history for consideration
        - Standardized assessment and education tools

Our response cont.
        - Scenarios versus recommended strategy
        - Focus on providing information that should contribute to management plan 
        - Present detailed information on how to implement opioid therapy once a broad decision (e.g. initiate treatment, increase dose, switch medication, discontinue medication) has been made

Challenge 2
        - Designing a system that is useful despite variation in clinicians’ pattern of EMR use
        - Use system before visit
        - Use system in visit alone
        - Use system in visit with patient
        - Use system after visit

Our Response
        - Use relatively simple, concise language
        - Not insulting to provider but understandable by a patient
        - Present information in an order and format that follows clinical process
        - Warnings and data tables help before decision
        - Dosing instructions help during decision
        - Education and treatment agreements help following decision
        - Documentation tools help after visit
        - Checklists provide either guide for care or review of practice

Current choices for System

Tool bars
        - Assessment
        - Pain assessment and pain reassessment template
        - Write back structured notes to VISTA
        - Orders
        - Opioid conversion calculator
        - Guide to interpreting UDS results
        - Drug tables and adjunctive medication algorithm
        - Education/Agreements
        - Pain management agreement (opioid contract)
        - Patient education documents (e.g. Side effect management)
        - Information on referrals within and outside VA

Opioid conversion calculator

Testing Process
        - Validation that rules matched guideline
        - Guideline author assessment
        - Accuracy assessment
        - Clinician validation of recommendations
        - Usability testing
        - Laboratory testing by clinicians
        - In-clinic observation of system use
        - Pilot testing
        - Implementation in primary care clinic
        - Assess changes in clinical practice
        - Assess changes in patient health care use patterns
        - Iterative up-dating 

Guideline rules validation
        - Rules of the algorithm were written in plain English
        - These were sent to 3 authors of the VA/DOD clinical practice guideline for opioid therapy
        - Each rule was assessed and guideline authors indicated whether they agreed or disagreed with the guideline or needed elaboration/clarification
        - The rules document was revised based upon author comments and re-reviewed iteratively

Example Identified problems
        - Over generalization of guideline concepts (e.g. although the guideline does not apply to treatment of cancer pain, the guideline may apply to patients with cancer diagnoses, only some personality disorders may be cause for concern)
        - Miscoding of concepts (e.g. substance abuse diagnosis is not equivalent to diversion)
        - Concerns about coding in medical record (e.g. medical record diagnoses of substance dependence/abuse may not be accurate, allergies may not really be allergies)
        - Concerns about need for confirmatory labs (e.g. if UDS is positive)

Accuracy Assessment
        - System recommendations for sample patient cases were reviewed by experts in pain management and clinicians
        - System errors or inappropriate recommendations were identified and sent to the knowledge modeling team for correction. 
        - This testing also occurs iteratively and is on-going, as the system must be re-tested every time changes are made.

Sample Identified Problems 
        - Errors in data extract
        - Errors in categorization of concepts (e.g. diagnoses or lab values)
        - Poor wording of recommendation
        - Missing recommendations and warnings
        - Unanticipated “special cases” (e.g. methadone clinic patient receiving dosing from inpatient program)

Usability Assessment
        - Volunteer clinicians were asked to use the system while evaluating 3 patient cases.  They were asked to verbally walk through their thought process as they used the system.
        - Clinicians shared their impressions, likes and dislikes of the system, recommendations for improvements and barriers to use in clinical practice, and satisfaction with the system
        - Conducted Round 1 with 4 clinicians, and are revising system based upon comments
        - Will repeat when redesigned system is complete

Usability results
        - Too many recommendations
        - Recommendations too wordy and disorganized
        - System will be helpful but will not save time
        - Generally satisfied with system and would like to use it
        - Some graphical elements not intuitive
        - Write-back is highly desirable

Pilot testing
        - 12 primary care physicians recruited to use system in their practice for 6 months
        - Project manager will observe their use of the system in clinic, and contact them monthly by phone.  Clinicians also may enter comments or requests for changes while using the system at any time. 
        - Log system use

Outcomes
        - System use: What screens and elements were used?
        - Provider behaviors: 
        - Use of UDS
        - Referral for evaluation of co-morbid conditions (e.g. SUD or mental health care)
        - Referral for behavioral health (e.g. exercise therapy, behavioral health consult)
        - Better assessment, documentation, and education
        - Reduced use of combined short-acting opioids with NSAIDS/acetominophen
        - Better adherence to cost algorithm in opioid choice
        - Better initiation and titration doses (i.e. dose increases within guideline recommended range)
        - Reduced prescribing to patients with contraindicated diagnoses

Research needed
        - Validation of algorithms to detect risk of negative consequences
        - Underway, focus on misuse/abuse/addiction
        - Evidence to guide initiation, titration, switch, discontinuation choices
        - Optimizing patient-clinician communication
        - Larger scale implementation to test impact on patient outcomes

Thank You!
        - VA HSR&D TRX 04-402
        - SUD QUERI
        - The ATHENA-OT and ATHENA-Hypertension teams 
        - Mary Goldstein, Denise Daniels, Samson Tu, Susana Martins, Dan Wang, Martha Michel, Bob Coleman, Naquell Johnson, John Finney, Steve Balt
        - The VA Palo Alto Primary Care and Chronic Pain Clinics
        - Lars Osterberg, Jan Elliott, Dave Clark
        - Mike Clark, Charlie Sintek, Jack Rosenberg
        - Stanford Medical Informatics