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ARV MANAGEMENT: Is Anybody Home?
HIVQUAL Workshop
BRUCE AGINS MD MPH
October 15th, 2003
The ARV Indicator
ARV Data
The Letter
The Responses
Next Steps
The ARV Indicator
What’s an Unstable Patient Anyways?
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
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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
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Stable Patient: Appropriate Management
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Monitoring of viral load every 4 months
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
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Unstable Patient: Appropriate Management
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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
Unstable Patient: Appropriate Management
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Ultimately, the decision about whether the
patient is stable or unstable is made by the
clinician
The Data
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
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Data: Advisory Committee Suggestions
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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
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
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Data: Mailing
Non-HIVQUAL sites:
– 2001 data mailed to facilities
 HIVQUAL sites:
– Data entered and can be produced by
facility
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The Letter
The Letter
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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
The Responses
Responses: Individual Factors
Physician not managing patients
appropriately
 Documentation poor by specific physicians
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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
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[should have been appropriate if documentation was provided since
therapy was not offered]
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Won’t pick up special case – no need for
action or change [intercurrent illness diverting attention from
ARV management and documentation]
Changes: Flow Sheets
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Comprehensive flow sheets with key components of HIV
care
– HIV issues included now in routine visit sheet
Standardized forms covering the following areas:
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-CD4 and Viral load monitoring + trends
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-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
Changes: Provider Education
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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
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Changes: Provider Education (2)
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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
Changes: Medical Director Involvement
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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
Changes: Reminder Strategies
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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
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
Changes: Home Visits
COBRA
 Nursing staff
 VNS
 Adherence - ?DOT
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Changes: Information Systems
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Tracking databases
QA database showing multiple parameters
Automated appointment tracking
Scheduling database
Use EMR data to monitor care
Changes: Tracking Systems
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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
Changes: Documentation
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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
Changes: Documentation (2)
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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 & issues leading to unstable status
Changes: QI Plans
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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
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)
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Responses: Lab Issues
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Lab Error Plan (Scruggs)
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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
Changes: Case Conferencing
Focus on difficult cases
 Routine quarterly adherence discussions
 Include as part of monthly provider meeting
in clinic
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Changes: Adherence
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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
Changes: Performance Measurement
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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)
Changes: Staff & Visits
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Hire new case managers
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Special medication visit for unstable patients
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
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Responses: Systems Issues
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Community Resources
– Referral processes to CBOs documented
Other Responses
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Patients who are non-adherent substance
users and shouldn’t be counted in the sample
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Patients don’t return for their lab tests or
visits (“no shows”)
Results
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Improvements have already been measured
Next Steps and
Some Preliminary Observations
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
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What Have We Learned So Far
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Difficult issues to resolve include “no-shows”
and complicated patients
– Challenges of documentation
– Complexity of management
– Some innovative strategies!
Conclusions
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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
Next Steps
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Responders
– Encouragement
– Ongoing follow-up
– Some still need to provide QI information!
– Follow up: compare subsequent results
– Letter
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Compilation of Best Practices and Innovative
Solutions