1. ARV MANAGEMENT: Is Anybody Home? HIVQUAL Workshop BRUCE AGINS MD MPH October 15th, 2003

2. The ARV Indicator ARV Data The Letter The Responses Next Steps

3. The ARV Indicator What’s an Unstable Patient Anyways?

4. Stable Patient: Definition Viral load is undetectable, or Viral load has dropped by at least one log since last 4-month review period, or Viral load has increased by less than 3X from the lowest value in last 12 months on that regimen and A note in the patient record by the treating physician states that the patient is stable despite detectable viral load

5. Stable Patient: Considerations for the Reviewer Viral load is dropping (but not yet undetectable) or VL has increased by less than 3X from the lowest value in last 12 months, or A note in the patient record by the treating physician states that the patient is stable despite detectable viral load

6. Stable Patient: Appropriate Management Monitoring of viral load every 4 months

7. Unstable Patient: Definition Viral load is increasing by more than 1 log and absolute value is over 1,000; or CD4 is dropping by 50% since last 4-month review period or Patient deemed unstable by physician or OI in the last four month review period (new or recurrent); or

8. Unstable Patient: Appropriate Management Three Options: –Regimen was changed and viral load assay performed within 8 weeks of decision –Justification provided not to change therapy intercurrent illness, recent vaccination, adherence intervention documented, viral load reordered, resistance testing ordered, other and viral load assay performed within 8 weeks of decision –Decision made to discontinue therapy and clinical follow-up plan noted in record

9. Unstable Patient: Appropriate Management Ultimately, the decision about whether the patient is stable or unstable is made by the clinician

10. The Data

11. Data: AIDS Institute Response Review of data raises concerns about appropriateness of care about management of ARV in unstable patients Staff review medical records to assess validity of indicator and discover causes of poor performance Review confirms that the data are accurate Concern raised to Advisory Committee which recommends that we send letter to facilities to raise awareness

12. Data: Advisory Committee Suggestions Send letters asking for explanation & to review systems of care for ARV management Arrange individual meetings to discuss low scores Highlight below average results in reports Develop tracking forms with prompts to address abnormal results Develop best practices to improve ARV performance

13. Data: Advisory Committee Suggestions Think about systems problems –Delays in lab results –Panic Value Systems –Direct transmission of results to medical directors Correlate with HIV Specialist data Provider education focusing on management of patients with high viral loads receiving antiretroviral therapy

14. Data: Mailing Non-HIVQUAL sites: –2001 data mailed to facilities HIVQUAL sites: –Data entered and can be produced by facility

15. The Letter

16. Sent to facilities with performance of 70% or lower Mailing date of January 8, 2003 Results in red and boxed Copies sent to Program Medical Director and Program Administrator Asks facilities to review management of ARV in their clinic as part of their HIV Quality Management Program focusing on systems Respond to me via phone or email to discuss findings by early March, 2003

17. The Responses

18. Responses: Individual Factors Physician not managing patients appropriately Documentation poor by specific physicians

19. Responses: Indicator Issues For patients with high viral loads, when the decision is made not to change therapy, VL does not need to be rechecked in 8 weeks Inappropriate management for not ordering a resistance test? Only one value is below threshold for ARV [should have been appropriate if documentation was provided since therapy was not offered] Won’t pick up special case – no need for action or change [intercurrent illness diverting attention from ARV management and documentation]

20. Changes: Flow Sheets Comprehensive flow sheets with key components of HIV care –HIV issues included now in routine visit sheet Standardized forms covering the following areas: - CD4 and Viral load monitoring + trends -Triggers for VL>1000 -Adherence referrals -Defined follow-up intervals -Specific ARV management parameters -New medical visits Add HIV elements to standard medical visit sheet Medication flow sheet with documentation about adherence

21. Changes: Provider Education Review of guidelines and indicator definitions –Discuss concepts of stability/instability at physician meeting, including management of ARV Integrate ARV management into routine provider meetings Specific education about ARV management to frontline clinician staff Documentation requirements, including f/u of VL Adherence tools Meetings with HIV Specialist Preceptorships Increase number of HIV Specialists Attendance at IAS conferences Offer CME credits for HIV training

22. Changes: Provider Education (2) Discuss when ARV should not be given Tighten resident supervision Train case workers about ARV management and importance of routine monitoring Updates in HIV care at monthly provider meetings Weekly clinical conference for providers to discuss complicated ARV decisions Attending review of fellows management decisions Grand Rounds Case Presentations and seminars by HIV experts

23. Changes: Medical Director Involvement Feedback to frontline practitioners Letter sent by medical director to medical staff about guidelines for unstable patients Assign medical director as backup for complex cases Designate clinician lead at each site Monitoring of clinical decisions by medical director with random chart review Medical Director follow up on findings from chart audits

24. Changes: Reminder Strategies Follow-up calls by case manager or nurse Letters to no-shows Call no-shows Enhance outreach program Call before appointment Tickler file to send cards out for appointments Comprehensive no-show program – including patient input into process for follow-up & checking in after visit - Montefiore

25. Changes: Self-Management Patient Education/Empowerment Treatment readiness program, including importance of keeping appts. Side effects education Information system with new appointment system to easily track appointments Automated reminder system Database to track followup appointments and outcomes Incentives Patient diary to track labs, treatment, provide tips about adherence and other educational materials Enhance role of CAB in reviewing data

26. Changes: Home Visits COBRA Nursing staff VNS Adherence - ?DOT

27. Changes: Information Systems Tracking databases QA database showing multiple parameters Automated appointment tracking Scheduling database Use EMR data to monitor care

28. Changes: Tracking Systems Logbooks Facilitate contact of no-shows Complete baseline assessments Create list of unstable patients, update and use for tracking, referrals to multidisciplinary team Routine updating of list of visits and missed appointments with direct feedback to medical providers

29. Changes: Documentation Emphasize importance & general improvements Adherence counseling CM interventions included in record Reorganize medical records Clearly state in record whether patient is stable or unstable Documentation of side-effects Incorporate pharmacy provider into adherence form (Interfaith) Improve documentation of decision process about ARV Hasten return of information and results to chart Information about no-shows

30. Changes: Documentation (2) Stamp for progress note that includes criteria and stable/unstable status for use at every encounter (LICH) Modify medical history and physical forms to improve documentation about ARV management Patients sign that they are choosing not to take ARV (can reverse decision) [ENY] Progress note developed to document & prompt providers at each visit to address & review CD4, VL, treatment plans, with prompt to document rationale for decisions & issuesleading to unstable status

31. Changes: QI Plans Specific ARV QI Plan (Elmhurst, Scruggs) Unstable Patients Plan: (Middletown) -Review case with clinical coordinator -Contact case manager -use adherence information form -flag for resistance test or repeat VL -case conference Unstable Patients Plan -MD review -Team review -Tracking -Increase HIV Specialist involvement -Focused plans to facilitate adherence, expedite & enhance access to multidisciplinary team services Monitor timeliness of viral loads

32. Changes: Lab Issues Simplify review of results Shorten turnaround time for results Posting of results to computerized lab system, including resistance testing Coordinate blood drawing with visit Staff drawing blood will ensure f/u clinic visit scheduled in two weeks Loosen lab restrictions for processing specimens Lab Error Plan (see next slide)

33. Responses: Lab Issues Lab Error Plan (Scruggs) –Identify when blood not drawn or not picked up –Flag missing results for follow up –Nurse communicates routinely with lab staff –Lab log to track when labs were completed for checking results within 14 d of draw –Immediate rescheduling if labs not obtained –CM and outreach staff to bring patient for labs –Coordinate with lab staff/address IS issues –Ongoing performance measurement

34. Changes: Case Conferencing Focus on difficult cases Routine quarterly adherence discussions Include as part of monthly provider meeting in clinic

35. Changes: Adherence Promote enrollment into adherence program Comprehensive treatment adherence services Increase referrals by physicians to adherence counselors Increase appointment-keeping for labs Routine monitoring quarterly by case manager Pts who miss appts. meet with Medical Director or administrator and may be referred elsewhere

36. Changes: Performance Measurement Routine medical record reviews: monthly, quarterly, Random ARV management reviews Independent reviewer Specific reviews of patients >1000 copies to determine if unstable, and if so flag for special review Review of charts by medical director Modify indicators to incorporate indicators from guidelines Develop new indicators to measure care of unstable patients on ARV Review all unstable patients QA Database: shows values which can be flagged QOC review teams – multidisciplinary (Narco)

37. Changes: Staff & Visits Hire new case managers Special medication visit for unstable patients

38. Changes: Pharmacy Involvement Delivery of medications onsite to ensure pickup whenever refills are due Pharmacist onsite in clinic to discuss changes in regimen Integrate pharmacy into adherence form

39. Responses: Systems Issues Community Resources –Referral processes to CBOs documented

40. Other Responses Patients who are non-adherent substance users and shouldn’t be counted in the sample Patients don’t return for their lab tests or visits (“no shows”)

41. Results Improvements have already been measured

42. Next Steps and Some Preliminary Observations

43. What Have We Learned So Far Where’s the Data? Routine monitoring and QI that focuses on ARV management is not occurring Minor tinkering with the indicator is indicated Many providers pay attention to letters flagging poor result

44. What Have We Learned So Far Difficult issues to resolve include “no-shows” and complicated patients –Challenges of documentation –Complexity of management –Some innovative strategies!

45. Conclusions Most people are home Lots of interesting innovations Some full-scale QI plans and programs Some are still stuck A handful are still not home

46. Next Steps Responders –Encouragement –Ongoing follow-up –Some still need to provide QI information! –Follow up: compare subsequent results –Letter Compilation of Best Practices and Innovative Solutions