hcv-related services in substance abuse treatment settings: the nida clinical trials network
DESCRIPTION
HCV-Related Services in Substance Abuse Treatment Settings: The NIDA Clinical Trials Network. Lawrence S. Brown Jr., MD, MPH, FASAM Addiction Research and Treatment Corporation, Brooklyn, NY; and Weill Medical College, Cornell University, New York, NY. - PowerPoint PPT PresentationTRANSCRIPT
HCV-Related Services in HCV-Related Services in Substance Abuse Treatment Substance Abuse Treatment
Settings: Settings: The NIDA Clinical Trials The NIDA Clinical Trials
NetworkNetwork
Lawrence S. Brown Jr., MD, MPH, FASAMLawrence S. Brown Jr., MD, MPH, FASAM
Addiction Research and Treatment Corporation, Brooklyn, Addiction Research and Treatment Corporation, Brooklyn, NY; and NY; and
Weill Medical College, Cornell University, New York, NYWeill Medical College, Cornell University, New York, NY
Oral Presentation at the American Association for the Treatment of Opioid DependenceAtlanta, GA - April 25, 2006
ACKNOWLEDGEMENACKNOWLEDGEMENTSTSPATIENTS AND STAFF PATIENTS AND STAFF
OF THE ADDICTION OF THE ADDICTION RESEARCH AND RESEARCH AND TREATMENT TREATMENT CORPORATION, A CORPORATION, A COMMUNITY-BASED COMMUNITY-BASED SUBSTANCE ABUSE SUBSTANCE ABUSE SERVICE AGENCYSERVICE AGENCY
ACKNOWLEDGEMENTSACKNOWLEDGEMENTS• Research Supported by National Institute on Research Supported by National Institute on
Drug Abuse (NIDA) as part of a Cooperative Drug Abuse (NIDA) as part of a Cooperative Agreement (1U10DA013046)Agreement (1U10DA013046) with the NIDA with the NIDA CTN and Protocol Team members consisting CTN and Protocol Team members consisting of:of:– Steven Kritz, MD; John Rotrosen, MD; Jim Steven Kritz, MD; John Rotrosen, MD; Jim
Robinson, MEd; Edmund Bini, MD, MPH; Jeff Robinson, MEd; Edmund Bini, MD, MPH; Jeff Goldsmith, MD; Dennis McCarty, PhD; Donald Goldsmith, MD; Dennis McCarty, PhD; Donald Calsyn, PhD; Patrick McAuliffe, MBA, LADC; Karen Calsyn, PhD; Patrick McAuliffe, MBA, LADC; Karen Reese, CAC-ADReese, CAC-AD
– Shirley Irons; Sherryl Baker, PhD; Shirley Irons; Sherryl Baker, PhD; Kathlene Tracy, Kathlene Tracy, PhD PhD
STUDY SITESSTUDY SITES• New York Node:New York Node: New York University, New York, NYNew York University, New York, NY• South Carolina Node:South Carolina Node: Medical University of South Carolina, Medical University of South Carolina,
Charleston, SCCharleston, SC• Florida Node:Florida Node: University of Miami, Coral Gables, FLUniversity of Miami, Coral Gables, FL• Great Lakes Node:Great Lakes Node: Wayne State University, Detroit, MIWayne State University, Detroit, MI• Ohio Valley Node:Ohio Valley Node: University of Cincinnati, Cincinnati, OHUniversity of Cincinnati, Cincinnati, OH• Rocky Mountain Node:Rocky Mountain Node: University of CO Health Sciences Center, University of CO Health Sciences Center,
Denver, CODenver, CO• New England Node:New England Node: Yale University, New Haven, CTYale University, New Haven, CT• Delaware Valley Node:Delaware Valley Node: University of Pennsylvania, Philadelphia, PAUniversity of Pennsylvania, Philadelphia, PA• Mid-Atlantic Node:Mid-Atlantic Node: Johns Hopkins Univ., Baltimore, MD; Medical Johns Hopkins Univ., Baltimore, MD; Medical
College College of Virginia, Richmondof Virginia, Richmond• Pacific Region Node:Pacific Region Node: University of California at Los Angeles, CAUniversity of California at Los Angeles, CA• Oregon Node:Oregon Node: Oregon Health Sciences University, Portland, OROregon Health Sciences University, Portland, OR• Washington Node:Washington Node: University of Washington, Seattle, WAUniversity of Washington, Seattle, WA• Long Island Node:Long Island Node: NY State Psychiatric Institute, New York, NYNY State Psychiatric Institute, New York, NY• North Carolina Node:North Carolina Node: Duke University, Raleigh/Durham, NCDuke University, Raleigh/Durham, NC• Southwest Node:Southwest Node: University of New Mexico, Albuquerque, NMUniversity of New Mexico, Albuquerque, NM• Northern New England Node:Northern New England Node: McLean Hospital, Belmont, MAMcLean Hospital, Belmont, MA• California-Arizona Node:California-Arizona Node: University of California at San Francisco, CAUniversity of California at San Francisco, CA
Drug Abuse Treatment Clinical Trials Network
Philadelphia
Portland
Los Angeles
Charleston
Miami
Cincinnati
Denver
CTN Sites
Seattle
Raleigh/Durham
Long Island
Boston
San Francisco (CA/AZ Node)
New York City
Detroit
Albuquerque
Baltimore/Richmond
New Haven
17 Nodes with 116 Community Treatment 17 Nodes with 116 Community Treatment Agencies Reaching into 26 States!Agencies Reaching into 26 States!
STUDY RATIONALESTUDY RATIONALE
• HCV: the major cause of hepatic failure HCV: the major cause of hepatic failure requiring liver transplantation in the US requiring liver transplantation in the US
• Substance use: a major vehicle for HCV Substance use: a major vehicle for HCV transmission transmission
• Scope of, and challenges to identifying, Scope of, and challenges to identifying, counseling and treating persons with counseling and treating persons with HCV in substance abuse treatment will HCV in substance abuse treatment will assist in developing effective assist in developing effective interventionsinterventions
PREVIOUS RESEARCHPREVIOUS RESEARCH
• Focused on a single treatment Focused on a single treatment program or a local group of programsprogram or a local group of programs
• The 2 national multi-site assessments The 2 national multi-site assessments did not include associations to state did not include associations to state policies, guidelines of regulations or policies, guidelines of regulations or information from cliniciansinformation from clinicians
IMPORTANT IMPORTANT ABREVIATIONSABREVIATIONS
• HCV = Hepatitis C VirusHCV = Hepatitis C Virus
• CTP = Community Treatment ProgramCTP = Community Treatment Program
• CTN = Clinical Trials NetworkCTN = Clinical Trials Network
• SOP = Standard Operating ProceduresSOP = Standard Operating Procedures
• IRB = Institutional (Human Subject) Review IRB = Institutional (Human Subject) Review BoardBoard
IMPORTANT DEFINITIONSIMPORTANT DEFINITIONS
•Community Treatment Programs =
•Substance Abuse Treatment Agencies
Treatment Program= Modalities
Treatment Program= Modalities
Treatment Program= Modalities
Service AService AService A
Service E
Service BService CService D
IMPORTANT TERMSIMPORTANT TERMS
• Treatment Program vs. NIDA CTN CTPTreatment Program vs. NIDA CTN CTP
• Services AssessedServices Assessed– Provider EducationProvider Education
– Patient EducationPatient Education
– Patient Risk AssessmentPatient Risk Assessment
– Patient CounselingPatient Counseling
– Patient Medical History & Physical ExamPatient Medical History & Physical Exam
– Patient Biological TestingPatient Biological Testing
– Patient TreatmentPatient Treatment
– Patient MonitoringPatient Monitoring
PRIMARY OBJECTIVESPRIMARY OBJECTIVES• TO DESCRIBE:TO DESCRIBE:
– Range of HCV-Related Services AvailableRange of HCV-Related Services Available– CTP Characteristics (funding, staffing)CTP Characteristics (funding, staffing)– Perceived Barriers to Providing HCV-Related Perceived Barriers to Providing HCV-Related
ServicesServices– State Policies, Regulations, or GuidelinesState Policies, Regulations, or Guidelines
• TO EXAMINE ASSOCIATIONS TO EXAMINE ASSOCIATIONS BETWEEN: BETWEEN: – CTPs’ Availability of Selected HCV-Related CTPs’ Availability of Selected HCV-Related
Services and State Policies, Guidelines, Services and State Policies, Guidelines, RegulationsRegulations
DESIGN AND DESIGN AND POPULATIONPOPULATION
•STUDY DESIGNSTUDY DESIGN– 2 2 Cross-sectional Surveys Cross-sectional Surveys – Descriptive & ExploratoryDescriptive & Exploratory
•STUDY POPULATIONSTUDY POPULATION– CTP AdministratorsCTP Administrators– Administrators of State Health Administrators of State Health
Departments and State Substance Departments and State Substance Abuse AgenciesAbuse Agencies
ETHICAL, REGULATORY ETHICAL, REGULATORY & ADMINISTRATIVE & ADMINISTRATIVE
CONSIDERATIONSCONSIDERATIONS
• Expedited IRB Approval Expedited IRB Approval
• Waiver of Informed ConsentWaiver of Informed Consent
• Training for Node Protocol Training for Node Protocol ManagersManagers
STUDY PROCEDURESSTUDY PROCEDURES
• Node Protocol Managers Node Protocol Managers
• Information Sheet In Lieu of Informed Information Sheet In Lieu of Informed ConsentConsent
• Survey AdministrationSurvey Administration– Paper or ElectronicPaper or Electronic– Central data acquisitionCentral data acquisition
Administrator SurveysContact CTP Directors for Treatment Program and Administrator contact information
Survey materials mailed to Administrators
Ensure IRBapproval
Administrator completes survey online or mails to Data Center; Administrator enters contact information for Clinicians
Node Protocol Manager contacts Administrators that have not responded within two weeks
Data Center contacts Administratorsthat have not completed the survey or Clinician contact information within 30 days
Data Center contactsAdministratorsto resolve any data queries
After four weekly attempts, Administrators flagged as non-responders by the Data Center
Node Protocol Managers contact non-responderAdministrators 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
State Surveys
Data Center mails survey material to State Administrators
Project Manager enters State Administrator contact information into the Data Center system
State Administrator completes the survey online or mails to Data Center
Project Manager contacts State Administratorsthat have not completed surveywithin 30 days
After four weekly attempts to contact State Administrators, the Project Manager flags them as non-responders
Project Manager contacts State Administrators to resolve data queries
Data Center reviews data and communicates any issues to Project Manager
RESULTSRESULTS• 269 administrators responded 269 administrators responded (84%)(84%) out out
of 319 substance abuse program of 319 substance abuse program administrators surveyed, from 95 CTPs in administrators surveyed, from 95 CTPs in the NIDA CTN, covering 26 states & DCthe NIDA CTN, covering 26 states & DC
• 1723 clinicians of 2210 targeted 1723 clinicians of 2210 targeted (78%)(78%)
• At least one substance abuse or health At least one substance abuse or health department administrator from 48 states department administrator from 48 states and the District of Columbia and the District of Columbia (96%)(96%)
Characteristics of Treatment Programs Characteristic Number of Surveys with
Valid ResponsesNumber (%) of
Treatment Programs*
Corporate structure Private not-for-profit Private for profit Government Other
268212 (78.5)15 (5.6)
36 (13.4)6 (2.2)
Largest source of revenueCounty/local grants State funds Medicaid Federal grants VA Benefits Medicare Private contracts/insurance Self-pay Other Unknown
26945 (16.7)103 (38.1)46 (17.0)33 (12.2)
5 (1.9)4 (1.5)9 (3.3)
15 (5.6)3 (1.1)7 (2.6)
**Percentages do not total 100% due to rounding and non-respondentsPercentages do not total 100% due to rounding and non-respondents
Characteristics of Treatment Programs
Patient census ≤500 500 – 1000 >1000
250145 (53.9)52 (19.3)53 (19.7)
Addiction Services Offered #
Inpatient or residential services Outpatient pharmacotherapy Other outpatient services Outreach & support services
256242257259
148 (55.0)89 (33.1)
206 (76.6)227 (84.4)
Medical Staff 01
2-34-78+
55 (20.4)31 (11.5)64 (23.8)54 (20.1)57 (21.2)
Non-Medical Staff 0-78-11
12-1718+
79 (29.4)59 (21.9)59 (21.9)64 (23.8)
Characteristic Number of Surveys with Valid Responses
Number (%) of Treatment Programs*
**Percentages do not total 100% due to rounding and non-respondentsPercentages do not total 100% due to rounding and non-respondents## Responses were not mutually exclusive for this item Responses were not mutually exclusive for this item
HCV-RELATED SERVICES IN SUBSTANCE HCV-RELATED SERVICES IN SUBSTANCE ABUSEABUSETREATMENT PROGRAMS: NIDA CTN TREATMENT PROGRAMS: NIDA CTN ADMINISTRATOR RESPONSES (N=269)ADMINISTRATOR RESPONSES (N=269)
Service OfferedService Offered
n (%)n (%)Risk AssessmentRisk Assessment 194 (77)194 (77)
Patient EducationPatient Education 200 (74)200 (74)
Patient CounselingPatient Counseling 159 (59)159 (59)
History & Physical ExaminationHistory & Physical Examination 135 (50)135 (50)
Biological AssessmentsBiological Assessments 93 (34)93 (34)
Pharmacotherapies Pharmacotherapies Administered/ PrescribedAdministered/ Prescribed
78 (29)78 (29)
Clinical MonitoringClinical Monitoring 95 (35)95 (35)
PRELIMINARY RESULTSPRELIMINARY RESULTS: TREATMENT : TREATMENT PROGRAM CHARACTERISTICS BY PROGRAM CHARACTERISTICS BY HCV-RELATED PATIENT COUNSELING HCV-RELATED PATIENT COUNSELING SERVICESSERVICES
TREATMENT PROGRAM TREATMENT PROGRAM CHARACTERISTICSCHARACTERISTICS
For-For-ProfitProfit
Non-Non-ProfitProfit
ResidentiResidentialal
Drug Drug FreeFree
OpiateOpiate
Agonist Agonist RxRx
Offer HCV Offer HCV Patient Patient CounselinCounselingg
n (%)n (%)
13 13 (87)(87)
114 114 (57)(57)
48 (66)48 (66) 92 (63)92 (63) 65 (87)65 (87)
PRELIMINARY RESULTS:PRELIMINARY RESULTS: Relationship Between State Relationship Between State Policy & TP HCV Patient Risk Policy & TP HCV Patient Risk AssessmentAssessment• State Administrator RespondentsState Administrator Respondents
– 53%53% Reported Guidelines/Regulations/Policies Reported Guidelines/Regulations/Policies
• TP Administrator RespondentsTP Administrator Respondents– In States With Guidelines/Regulations/Policies: In States With Guidelines/Regulations/Policies:
79%79% of Programs Provide the Service of Programs Provide the Service– In States Without Guidelines/Regulations/Policies: In States Without Guidelines/Regulations/Policies:
65%65% of Programs Provide the Service of Programs Provide the Service
PRELIMINARY RESULTS:PRELIMINARY RESULTS: Relationship Between State Policy Relationship Between State Policy & Treatment Program (TP) HCV & Treatment Program (TP) HCV Biological TestingBiological Testing• State Administrator RespondentsState Administrator Respondents
– 26%26% Reported Guidelines/Regulations/Policies Reported Guidelines/Regulations/Policies
• TP Administrator RespondentsTP Administrator Respondents– In States With Guidelines/Regulations/Policies: In States With Guidelines/Regulations/Policies:
43%43% Provide the Service Provide the Service– In States Without Guidelines/Regulations/Policies: In States Without Guidelines/Regulations/Policies:
32%32% Provide the Service Provide the Service
RELATIONSHIP BETWEEN STATE POLICIES, RELATIONSHIP BETWEEN STATE POLICIES, GUIDELINES, & REGULATIONS AND HCV-GUIDELINES, & REGULATIONS AND HCV-
RELATED SERVICES IN SUBSTANCE ABUSE RELATED SERVICES IN SUBSTANCE ABUSE TREATMENT PROGRAMS TREATMENT PROGRAMS
State Policies/Guidelines/RegsState Policies/Guidelines/Regs
ServicesServices YESYES NONOProvider EducationProvider Education 113 (69)113 (69) 57 (65)57 (65)
Patient EducationPatient Education 140 (80)140 (80) 58 (75)58 (75)
Risk AssessmentRisk Assessment 147 (79)147 (79) 45 (65)45 (65)
History & Physical History & Physical ExaminationExamination
62 (57)62 (57) 54 (50)54 (50)
Biological TestingBiological Testing 48 (43)48 (43) 45 (32)45 (32)
CounselingCounseling 93 (73)93 (73) 65 (52)65 (52)
TreatmentTreatment 38 (56)38 (56) 40 (25)40 (25)
MonitoringMonitoring 38 (69)38 (69) 57 (29)57 (29)
STUDY STUDY LIMITATIONSLIMITATIONS
• Generalizability of ResultsGeneralizability of Results
– Consistent with 2 previous published Consistent with 2 previous published assessmentsassessments
• Does not include utilization, cost, Does not include utilization, cost, efficiency, or effectiveness of HCV-efficiency, or effectiveness of HCV-related servicesrelated services
– Hypothesis generatingHypothesis generating
SUMMARYSUMMARY• Most HCV-related services are Most HCV-related services are
offered by:offered by:– a substantial proportion of private not-a substantial proportion of private not-
for-profit, for-profit, and public agenciesfor-profit, for-profit, and public agencies– a substantial proportion of substance a substantial proportion of substance
abuse treatment programs of all sizesabuse treatment programs of all sizes
• Staffing patterns (medical and non-Staffing patterns (medical and non-medical) are quite variedmedical) are quite varied
SUMMARYSUMMARY• There is substantial variation in the There is substantial variation in the
availability of HCV-related services in availability of HCV-related services in CTN treatment programsCTN treatment programs
• The availability of most services The availability of most services appeared to be unrelated to state appeared to be unrelated to state policies, guidelines, or regulations.policies, guidelines, or regulations.
• The availability of counseling, The availability of counseling, treatment and monitoring appeared to treatment and monitoring appeared to be associated with the presence state be associated with the presence state guidelines, policies and mandatesguidelines, policies and mandates
BOTTOM LINEBOTTOM LINE• Many treatment programs offer an array of Many treatment programs offer an array of
HCV-related servicesHCV-related services
• A significant number of programs offer no A significant number of programs offer no HCV-related services.HCV-related services.
• State guidance appears to have some State guidance appears to have some influence on the availability of HCV-related influence on the availability of HCV-related servicesservices
• A number of hypotheses & opportunities A number of hypotheses & opportunities remain to be proposed, pursued, and remain to be proposed, pursued, and answeredanswered
• These are These are preliminarypreliminary results of a larger study results of a larger study
BOTTOM LINEBOTTOM LINE• Significant opportunities exist to explore Significant opportunities exist to explore
other associations between the HCV-other associations between the HCV-related services offered andrelated services offered and– Other Substance Abuse Treatment Program Other Substance Abuse Treatment Program
CharacteristicsCharacteristics– CTP Characteristics (funding, staffing)CTP Characteristics (funding, staffing)– Clinician Characteristics (training, knowledge, Clinician Characteristics (training, knowledge,
behavior)behavior)– OpinionsOpinions– Perceived Barriers to Providing Infection-Perceived Barriers to Providing Infection-
Related ServicesRelated Services
FOR MORE FOR MORE INFORMATION ABOUT THIS INFORMATION ABOUT THIS
STUDYSTUDY• AT THIS MEETINGAT THIS MEETING
– Poster- P4-Poster- P4-
• AT OTHER PROFESSIONAL MEETINGSAT OTHER PROFESSIONAL MEETINGS– American Society on Addiction Medicine, San Diego, CA American Society on Addiction Medicine, San Diego, CA
20062006– College on Problems of Drug Dependence, Scottsdale, College on Problems of Drug Dependence, Scottsdale,
AZ, 2006AZ, 2006
• PEER-REVIEWED PUBLICATIONSPEER-REVIEWED PUBLICATIONS– Accepted by Journal of Substance Abuse TreatmentAccepted by Journal of Substance Abuse Treatment
• CONTACTING STUDY PERSONNELCONTACTING STUDY PERSONNEL– Dr. Brown, the Principal Investigator: Dr. Brown, the Principal Investigator: [email protected]@artcny.org– Steven Kritz, MD – the Project Director: Steven Kritz, MD – the Project Director: [email protected]@artcny.org