Clarity of State Guidance on InfectionRelated Health Services in Substance Abuse Treatment Programs

1
Clarity of State Guidance on
Infection-Related Health
Services in Substance Abuse Treatment
Programs

• L.S. Brown, MD, MPH S. Kritz, MD J. Rotrosen,
  MD R.J. Goldsmith, MD E. Bini, MD,
  MPH J. Robinson, MEd, D. Alderson, MS and the
  NIDA Clinical Trials Network Infections Study
  (CTN-0012) Team
• Addiction Research Treatment Corp, Brooklyn,
  NY NYU School of Medicine and VA Hospital, NY,
  NY University of Cincinnati Medical Center,
  Cincinnati, OH Nathan Kline Institute,
  Orangeburg, NY and NYS Psychiatric Institute,
  NY, NY

2
ABSTRACT
Background The Infections and Substance Abuse
Study (NIDA CTN-0012) examined associations
between services provided for HIV/AIDS, hepatitis
C viral infection (HCV), and sexually transmitted
infection (STI) at substance abuse treatment
programs in the National Drug Abuse Treatment
Clinical Trials Network (NIDA CTN), and the
states within which they are located. This
report specifically looks at the relationships
between clarity of state policy, regulations and
guidelines as viewed by clinicians, and the
availability of eight infection-related services
for all three disease groups.Methods Data for
this report was derived from three surveys one
for state health and substance abuse department
administrators, and one each for substance abuse
treatment program clinicians and administrators.
The surveys included questions dealing with eight
infection-related services provider education,
patient education, risk assessment, counseling,
medical history and physical exam, biological
testing, treatment and monitoring. Results
Administrators of state substance abuse and/or
health departments from 48 states and the
District of Columbia participated. Surveys were
also obtained from 1723 clinicians (78) within
the NIDA CTN 251 medical experts (15), 522
non-medical experts (30), 115 medical
non-experts (7) and 831 non-medical non-experts
(48). Completed surveys were obtained from 269
of 319 administrators (84). With few
exceptions, clinician assessment of clarity of
state policies, regulations and guidelines for
the eight targeted services was generally about
50 or less for all three infection groups. Six
of eight services were provided by a similar
percentage of programs, regardless of state
mandates. Two services (treatment and
monitoring) were provided by a substantially
higher percentage of sites where there were state
policies, regulations or guidelines.Discussion
This information suggests that state policies,
regulations or guidelines are often not clearly
understood by clinicians, and even where they
exist, they are not sufficient to assure "best
practices" in treating these epidemic infections.
3
ACKNOWLEDGEMENTS

• Research Supported by the National Institute on
  Drug Abuse (NIDA) as part of a Cooperative
  Agreement (1U10DA013046) with the NIDA CTN and
  other Protocol Team members consisting of
• Randy Seewald, MD Cheryl Smith, MD Frank
  McCorry, PhD Dennis McCarty, PhD Donald Calsyn,
  PhD Leonard Handelsman, MD Steve Kipnis, MD
• Patrick McAuliffe, MBA, LADC Al Hassen, MSW
  Karen Reese, CAC-AD Sherryl Baker, PhD
• Shirley Irons Kathlene Tracy, PhD

4
17 Nodes with 116 Community Treatment Agencies
Reaching into 26 States!
Drug Abuse Treatment Clinical Trials Network
Seattle
Portland
New York City
Detroit
Boston
New Haven
Denver
Long Island
Philadelphia
Cincinnati
San Francisco (CA/AZ Node)
Baltimore/Richmond
Raleigh/ Durham
Albuquerque
Los Angeles
Charleston
Miami
CTN Sites
5
STUDY SITES

• New York Node New York University, New York, NY
• South Carolina Node Medical University of South
  Carolina, Charleston, SC
• Florida Node University of Miami, Coral Gables,
  FL
• Great Lakes Node Wayne State University,
  Detroit, MI
• Ohio Valley Node University of Cincinnati,
  Cincinnati, OH
• Rocky Mountain Node University of CO Health
  Sciences Center, Denver, CO
• New England Node Yale University, New Haven, CT
• Delaware Valley Node University of Pennsylvania,
  Philadelphia, PA
• Mid-Atlantic Node Johns Hopkins Univ.,
  Baltimore, MD Medical College
• of
  Virginia, Richmond
• Pacific Region Node University of California at
  Los Angeles, CA
• Oregon Node Oregon Health Sciences University,
  Portland, OR
• Washington Node University of Washington,
  Seattle, WA
• Long Island Node NY State Psychiatric Institute,
  New York, NY
• North Carolina Node Duke University,
  Raleigh/Durham, NC
• Southwest Node University of New Mexico,
  Albuquerque, NM
• Northern New England Node McLean Hospital,
  Belmont, MA
• California-Arizona Node University of California
  at San Francisco, CA

6
STUDY RATIONALE

• HIV/HCV/STI major causes of excess morbidity and
  mortality in the US
• Substance abuse a major vehicle for the
  transmission of infection
• Scope of, and challenges to identifying,
  counseling, and treating persons with these
  infections in substance abuse treatment will
  assist in developing effective interventions

7
IMPORTANT ABREVIATIONS

• HIV Human Immunodeficiency Virus
• AIDS Acquired Immunodeficiency Syndrome
• HCV Hepatitis C Virus
• STI Sexually Transmitted Infections
• CTP Community Treatment Program
• CTN Clinical Trials Network
• SOP Standard Operating Procedures
• IRB Institutional (Human Subject) Review Board

8
IMPORTANT DEFINITIONS

• Treatment Program vs. NIDA CTN CTP
• Services Assessed
• Provider Education
• Patient Education
• Patient Risk Assessment
• Patient Counseling
• Patient Medical History Physical Exam
• Patient Biological Testing
• Patient Treatment
• Patient Monitoring
• Medical vs. Non-Medical Clinical Staff
• Expert vs. Non-expert Clinical Staff

9
PRIMARY OBJECTIVES

• TO DESCRIBE
• Range of Infection-Related Services Available
• Clinician Characteristics (training, knowledge,
  behavior)
• Opinions
• Perceived Barriers to Providing Infection-Related
  Services
• TO EXAMINE ASSOCIATIONS BETWEEN
• CTPs Availability of Selected Infection Services
• Other Constructs Listed Above

10
DESIGN AND POPULATION

• STUDY DESIGN
• Cross-sectional Survey
• Descriptive Exploratory
• STUDY POPULATION
• Administrators of State Health Departments and
  State Substance Abuse Agencies
• Treatment Program Clinicians
• Treatment Program Administrators

11
ETHICAL, REGULATORY ADMINISTRATIVE
CONSIDERATIONS

• Expedited IRB Approval
• Waiver of Informed Consent
• Training for Node Protocol Managers

12
STUDY PROCEDURES

• Node Protocol Managers
• Information Sheet In Lieu of Informed Consent
• Survey Administration
• Paper or Electronic
• Central data acquisition

13
State Surveys
Project Manager enters State Administrator
contact information into the Data Center system
Data Center mails survey material to State
Administrators
State Administrator completes the survey online
or mails to Data Center
Project Manager contacts State Administrators that
have not completed survey within 30 days
After four weekly attempts to contact State
Administrators, the Project Manager flags them as
non-responders
Data Center reviews data and communicates any
issues to Project Manager
Project Manager contacts State Administrators to
resolve data queries
14
Clinician Surveys
Statistician selects Clinicians from Treatment
Programs based on contact information provided by
Administrators
Clinician surveys mailed
Randomization
Clinician completes survey online or mails to
Data Center
Gathering sessions held for Clinicians to
complete surveys
Completed surveys mailed to Data Center
If non-responder is a randomly selected
Clinician, the next eligible Clinician on the
selection list is sent a survey
Data Center contacts non-responders after 30
days flagged as non-responders after four weekly
failed attempts
Data Center contacts Clinicians to resolve any
data queries

Data Center monitors the data entry of Clinicians
15
Administrator Surveys
Administrator completes survey online or mails to
Data Center Administrator enters contact
information for Clinicians
Contact CTP Directors for Treatment Program and
Administrator contact information
Ensure IRB approval
Survey materials mailed to Administrators
Data Center contacts Administrators that have not
completed the survey or Clinician contact
information within 30 days

Node Protocol Manager contacts Administrators
that have not responded within two weeks
Data Center contacts Administrators to resolve
any data queries
After four weekly attempts, Administrators
flagged as non-responders by the Data Center

Node Protocol Managers contact non-responder Admin
istrators weekly
For Administrators that refuse to participate or
still have not responded after two additional
weeks, the Node Protocol Manager alerts the Node
Principal Investigator

16
MEASUREMENTS ANALYTICAL METHODS

• SAMPLING METHODOLOGYAt Each Treatment Program
• All Expert Clinicians Designated by the CTP
• 10 randomly sampled Non-Expert Clinicians,
• in a ratio of MedicalNon-Medical reflecting
  that of
• the CTPs clinical staff
• All Treatment Program Administrators
• ANALYTIC METHODOLOGIES
• Experts will be analyzed separately
• Clinicians may decline next randomly
• selected person will be asked to participate

17
STATISTICAL ELEMENTS

• Sample Size and Precision of the Estimated Mean
• Analytic Plan
• Descriptive stats for survey variables
• Principal Component or Cluster or Factor Analysis
  to group and reduce the number of variables
• Structural Equation Models to test for
  associations

18
RESULTS

• Surveys obtained from at least one substance
  abuse or health department administrator from 48
  states and the District of Columbia (96).
• Surveys Obtained from 1719 Clinicians of 2207
  Targeted (78)
• 831 Non-Medical Non-Experts (48)
• 115 Medical Non-Experts (7)
• 522 Non-Medical Experts (30)
• 251 Medical Experts (15)
• Surveys Obtained from 269 Administrators of 319
  Targeted (84)

19
CLARITY OF HIV GUIDELINES OF CLINICIANS
SCORING GUIDELINES AS CLEAR
20
CLARITY OF HCV GUIDELINES OF CLINICIANS
SCORING GUIDELINES AS CLEAR
21
CLARITY OF STI GUIDELINES OF CLINICIANS
SCORING GUIDELINES AS CLEAR
22
HIV/AIDS, HCV STI-RELATED SERVICES INSUBSTANCE
ABUSE TREATMENT PROGRAMS NIDA CTN ADMINISTRATOR
RESPONSES (N269)
23
SUMMARY

• Clarity of guidelines for the 8 targeted services
  is generally about 50 or less for all three
  infection groups, with the following exceptions
• History Physical Exam (medical experts and
  non-experts) for all three infection groups
• Patient Education and Risk Assessment
  (non-medical experts) for HIV

24
SUMMARY

• There is
• substantial variation in the of programs
  offering the various services for a particular
  infection group
• consistency in the of programs offering a
  particular service for all three infection groups

25
SUMMARY

• Significant opportunities exist to explore other
  associations between the HIV/AIDS, HCV
  STI-related services offered and
• Clinician Characteristics (training, knowledge,
  behavior)
• Opinions
• Perceived Barriers to Providing Infection-Related
  Services