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

Treatment Programs Treatment Programs

L.S. Brown, MD, MPH; S. Kritz, MD; J. Rotrosen, L.S. Brown, MD, MPH; S. Kritz, MD; J. Rotrosen, MD; R.J. Goldsmith, MD; E. Bini, MD, MPH; J. MD; R.J. Goldsmith, MD; E. Bini, MD, MPH; J. Robinson, MEd, D. Alderson, MS and the NIDA Robinson, MEd, D. Alderson, MS and the NIDA Clinical Trials Network Infections Study (CTN-Clinical Trials Network Infections Study (CTN-0012) Team0012) Team

Addiction Research & Treatment Corp, Brooklyn, Addiction Research & Treatment Corp, Brooklyn, NY; NYU School of Medicine and VA Hospital, NY, NY; NYU School of Medicine and VA Hospital, NY, NY; University of Cincinnati Medical Center, NY; University of Cincinnati Medical Center, Cincinnati, OH; Nathan Kline Institute, Cincinnati, OH; Nathan Kline Institute, Orangeburg, NY; and NYS Psychiatric Institute, Orangeburg, NY; and NYS Psychiatric Institute, NY, NYNY, NY

ABSTRACTABSTRACTBackground:Background: The Infections and Substance Abuse Study (NIDA CTN-0012) examined associations 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 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 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 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 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 viewed by clinicians, and the availability of eight infection-related services for all three disease groups.groups.

Methods:Methods: Data for this report was derived from three surveys: one for state health and substance 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 abuse department administrators, and one each for substance abuse treatment program clinicians and administrators. The surveys included questions dealing with eight infection-related services: and administrators. The surveys included questions dealing with eight infection-related services: provider education, patient education, risk assessment, counseling, medical history and physical provider education, patient education, risk assessment, counseling, medical history and physical exam, biological testing, treatment and monitoring. exam, biological testing, treatment and monitoring.

Results:Results: Administrators of state substance abuse and/or health departments from 48 states and 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 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 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 (7%) and 831 non-medical non-experts (48%). Completed surveys were obtained from 269 of 319

administrators (84%). administrators (84%). With few exceptions, clinician assessment of clarity of state policies, 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 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, 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 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.substantially higher percentage of sites where there were state policies, regulations or guidelines.

Discussion:Discussion: This information suggests that state policies, regulations or guidelines are often not 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 clearly understood by clinicians, and even where they exist, they are not sufficient to assure "best practices" in treating these epidemic infections.practices" in treating these epidemic infections.

ACKNOWLEDGEMENTSACKNOWLEDGEMENTS• Research Supported by the National Research Supported by the National

Institute on Drug Abuse (NIDA) as part of a Institute on Drug Abuse (NIDA) as part of a Cooperative Agreement (1U10DA013046) Cooperative Agreement (1U10DA013046) with the NIDA CTN; and other Protocol Team with the NIDA CTN; and other Protocol Team members consisting of:members consisting of:– Randy Seewald, MD; Cheryl Smith, MD; Frank Randy Seewald, MD; Cheryl Smith, MD; Frank

McCorry, PhD; Dennis McCarty, PhD; Donald McCorry, PhD; Dennis McCarty, PhD; Donald Calsyn, PhD; Leonard Handelsman, MD; Steve Calsyn, PhD; Leonard Handelsman, MD; Steve Kipnis, MD Kipnis, MD

– Patrick McAuliffe, MBA, LADC; Al Hassen, MSW; Patrick McAuliffe, MBA, LADC; Al Hassen, MSW; Karen Reese, CAC-AD; Sherryl Baker, PhDKaren Reese, CAC-AD; Sherryl Baker, PhD

– Shirley Irons; Shirley Irons; Kathlene Tracy, PhD Kathlene Tracy, PhD

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!

STUDYSTUDY SITESSITES• 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, Charleston, Medical University of South Carolina, Charleston,

SCSC• 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

STUDY RATIONALESTUDY RATIONALE

• HIV/HCV/STI: major causes of excess HIV/HCV/STI: major causes of excess morbidity and mortality in the USmorbidity and mortality in the US

• Substance abuse: a major vehicle for Substance abuse: a major vehicle for the transmission of infectionthe transmission of infection

• Scope of, and challenges to Scope of, and challenges to identifying, counseling, and treating identifying, counseling, and treating persons with these infections in persons with these infections in substance abuse treatment will assist substance abuse treatment will assist in developing effective interventionsin developing effective interventions

IMPORTANT IMPORTANT ABREVIATIONSABREVIATIONS• HIV = Human Immunodeficiency VirusHIV = Human Immunodeficiency Virus

• AIDS = Acquired Immunodeficiency SyndromeAIDS = Acquired Immunodeficiency Syndrome

• HCV = Hepatitis C VirusHCV = Hepatitis C Virus

• STI = Sexually Transmitted InfectionsSTI = Sexually Transmitted Infections

• 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 IMPORTANT DEFINITIONSDEFINITIONS• 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

• Medical vs. Non-Medical Clinical StaffMedical vs. Non-Medical Clinical Staff

• ‘‘Expert’ vs. ‘Non-expert’ Clinical StaffExpert’ vs. ‘Non-expert’ Clinical Staff

PRIMARY OBJECTIVESPRIMARY OBJECTIVES

• TO DESCRIBE:TO DESCRIBE: – Range of Infection-Related Services AvailableRange of Infection-Related Services Available– Clinician Characteristics (training, knowledge, Clinician Characteristics (training, knowledge,

behavior)behavior)– OpinionsOpinions– Perceived Barriers to Providing Infection-Perceived Barriers to Providing Infection-

Related ServicesRelated Services

• TO EXAMINE ASSOCIATIONS BETWEEN: TO EXAMINE ASSOCIATIONS BETWEEN: – CTPs’ Availability of Selected Infection ServicesCTPs’ Availability of Selected Infection Services– Other Constructs Listed AboveOther Constructs Listed Above

DESIGN AND POPULATIONDESIGN AND POPULATION

• STUDY DESIGNSTUDY DESIGN– Cross-sectional Survey Cross-sectional Survey – Descriptive & ExploratoryDescriptive & Exploratory

• STUDY POPULATIONSTUDY POPULATION– Administrators of State Health Departments Administrators of State Health Departments

and State Substance Abuse Agenciesand State Substance Abuse Agencies– Treatment Program CliniciansTreatment Program Clinicians– Treatment Program AdministratorsTreatment Program Administrators

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 STUDY PROCEDURESPROCEDURES

• 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

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

Clinician SurveysStatistician selects Clinicians from Treatment Programs based on contact information provided by Administrators

Clinician surveys mailed

Gathering sessions held for Clinicians to complete surveys

Clinician completessurvey online or mails to Data Center

Completed surveys mailed to Data CenterData Center

contacts non-responders after 30 days; flagged as non-responders after four weekly failed attempts

If non-responder isa randomly selected Clinician, the next eligible Clinician on the selection list is sent a survey

Data Center monitors the data entry of Clinicians

Data Center contacts Clinicians to resolve any data queries

Randomization

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

MEASUREMENTS & MEASUREMENTS & ANALYTICAL METHODSANALYTICAL METHODS

• SAMPLING METHODOLOGY:SAMPLING METHODOLOGY:At Each Treatment Program …At Each Treatment Program …– All ‘Expert’ Clinicians Designated by the CTPAll ‘Expert’ Clinicians Designated by the CTP– 10 randomly sampled ‘Non-Expert’ Clinicians,10 randomly sampled ‘Non-Expert’ Clinicians, in a ratio of Medical:Non-Medical reflecting in a ratio of Medical:Non-Medical reflecting

that of that of the CTP’s clinical staffthe CTP’s clinical staff– All Treatment Program AdministratorsAll Treatment Program Administrators

• ANALYTIC METHODOLOGIESANALYTIC METHODOLOGIES– ‘‘Experts’ will be analyzed separatelyExperts’ will be analyzed separately– Clinicians may decline; next randomly Clinicians may decline; next randomly selected person will be asked to participateselected person will be asked to participate

STATISTICAL STATISTICAL ELEMENTSELEMENTS

• Sample Size and Precision of the Sample Size and Precision of the Estimated MeanEstimated Mean

• Analytic PlanAnalytic Plan– Descriptive stats for survey variablesDescriptive stats for survey variables– Principal Component or Cluster or Factor Principal Component or Cluster or Factor

Analysis to group and reduce the Analysis to group and reduce the number of variablesnumber of variables

– Structural Equation Models to test for Structural Equation Models to test for associationsassociations

RESULTSRESULTS

• Surveys obtained from at least one Surveys obtained from at least one substance abuse or health department substance abuse or health department administrator from 48 states and the administrator from 48 states and the District of Columbia District of Columbia (96%).(96%).

• Surveys Obtained from 1719 Clinicians of Surveys Obtained from 1719 Clinicians of 2207 Targeted 2207 Targeted (78%)(78%)– 831 Non-Medical Non-Experts831 Non-Medical Non-Experts (48%) (48%)– 115 Medical Non-Experts115 Medical Non-Experts (7%) (7%)– 522 Non-Medical Experts522 Non-Medical Experts (30%) (30%)– 251 Medical Experts251 Medical Experts (15%) (15%)

• Surveys Obtained from 269 Administrators Surveys Obtained from 269 Administrators of 319 Targeted of 319 Targeted (84%)(84%)

CLARITY OF HIV GUIDELINES: % OF CLARITY OF HIV GUIDELINES: % OF CLINICIANS SCORING GUIDELINES AS CLINICIANS SCORING GUIDELINES AS

CLEARCLEAR

NON -NON - EXPERT EXPERT EXP EXP

ERTERT

SERVICSERVICEE

Non-Non-MedMed

MedicalMedical Non-MedNon-Med MedicalMedical OVERALLOVERALL

Provider Provider EducationEducation

50%50% 55%55% 56%56% 49%49% 52%52%

Patient Patient EducationEducation

57%57% 60%60% 66%66% 54%54% 60%60%

Risk Risk AssessmentAssessment

57%57% 54%54% 65%65% 59%59% 60%60%

History & History & Physical Physical ExamExam

56%56% 66%66% 53%53% 76%76% 58%58%

TestingTesting 35%35% 47%47% 42%42% 59%59% 41%41%CounselingCounseling 49%49% 52%52% 54%54% 58%58% 52%52%TreatmentTreatment 43%43% 55%55% 46%46% 55%55% 47% 47% MonitoringMonitoring 39%39% 42%42% 38%38% 51%51% 41%41%

CLARITY OF HCV GUIDELINES: % OF CLARITY OF HCV GUIDELINES: % OF CLINICIANS SCORING GUIDELINES AS CLINICIANS SCORING GUIDELINES AS

CLEARCLEAR

NON -NON - EXPERT EXPERT EXP EXP

ERTERT

SERVICSERVICEE

Non-Non-MedMed

MedicalMedical Non-MedNon-Med MedicalMedical OVERALLOVERALL

Provider Provider EducationEducation

42%42% 53%53% 43%43% 45%45% 43%43%

Patient Patient EducationEducation

48%48% 54%54% 51%51% 48%48% 49%49%

Risk Risk AssessmentAssessment

48%48% 50%50% 54%54% 54%54% 51%51%

History & History & Physical Physical ExamExam

53%53% 64%64% 50%50% 74%74% 56%56%

TestingTesting 32%32% 44%44% 37%37% 54%54% 37%37%CounselingCounseling 41%41% 47%47% 45%45% 51%51% 44%44%TreatmentTreatment 39%39% 52%52% 40%40% 48%48% 41% 41% MonitoringMonitoring 35%35% 42%42% 32%32% 43%43% 36%36%

CLARITY OF STI GUIDELINES: % OF CLARITY OF STI GUIDELINES: % OF CLINICIANS SCORING GUIDELINES AS CLINICIANS SCORING GUIDELINES AS

CLEARCLEAR

NON -NON - EXPERT EXPERT EXP EXP

ERTERT

SERVICSERVICEE

Non-Non-MedMed

MedicalMedical Non-MedNon-Med MedicalMedical OVERALLOVERALL

Provider Provider EducationEducation

40%40% 50%50% 41%41% 40%40% 41%41%

Patient Patient EducationEducation

47%47% 51%51% 50%50% 41%41% 47%47%

Risk Risk AssessmentAssessment

46%46% 48%48% 51%51% 46%46% 48%48%

History & History & Physical Physical ExamExam

49%49% 64%64% 49%49% 73%73% 53%53%

TestingTesting 28%28% 42%42% 35%35% 50%50% 35%35%CounselingCounseling 39%39% 45%45% 44%44% 44%44% 41%41%TreatmentTreatment 37%37% 53%53% 40%40% 51%51% 41% 41% MonitoringMonitoring 32%32% 42%42% 31%31% 43%43% 34%34%

HIV/AIDS, HCV & STI-RELATED SERVICES INHIV/AIDS, HCV & STI-RELATED SERVICES INSUBSTANCE ABUSE TREATMENT PROGRAMS: NIDA SUBSTANCE ABUSE TREATMENT PROGRAMS: NIDA

CTN ADMINISTRATOR RESPONSES (N=269)CTN ADMINISTRATOR RESPONSES (N=269)

HIV/AIDSHIV/AIDS HCVHCV STIsSTIs

SERVICESERVICE n (%)n (%) n (%)n (%) n (%)n (%)Provider EducationProvider Education 186 (69)186 (69) 171 (63)171 (63) 155 (57)155 (57)

Patient EducationPatient Education 226 (84)226 (84) 200 (74)200 (74) 205 (76)205 (76)

Risk AssessmentRisk Assessment 224 (89)224 (89) 194 (77)194 (77) 195 (77)195 (77)

History & Physical History & Physical ExaminationExamination

150 (56)150 (56) 135 (50)135 (50) 133 (49)133 (49)

TestingTesting 131 (49)131 (49) 93 (34)93 (34) 109 (40)109 (40)

CounselingCounseling 178 (66)178 (66) 159 (59)159 (59) 163 (60)163 (60)

TreatmentTreatment 103 (38)103 (38) 78 (29)78 (29) 92 (34)92 (34)

MonitoringMonitoring 117 (43)117 (43) 95 (35)95 (35) 105 (39)105 (39)

SUMMARY SUMMARY

• Clarity of guidelines for the 8 targeted Clarity of guidelines for the 8 targeted services is generally about 50% or less services is generally about 50% or less for all three infection groups, with the for all three infection groups, with the following exceptions:following exceptions:– History & Physical Exam (medical experts History & Physical Exam (medical experts

and non-experts) for all three infection and non-experts) for all three infection groupsgroups

– Patient Education and Risk Assessment Patient Education and Risk Assessment (non-medical experts) for HIV(non-medical experts) for HIV

SUMMARYSUMMARY

• There is… There is… – substantial variation in the % of substantial variation in the % of

programs offering the various services programs offering the various services for a particular infection groupfor a particular infection group

– consistency in the % of programs consistency in the % of programs offering a particular service for all three offering a particular service for all three infection groupsinfection groups

SUMMARYSUMMARY• Significant opportunities exist to Significant opportunities exist to

explore other associations between explore other associations between the HIV/AIDS, HCV & STI-related the HIV/AIDS, HCV & STI-related services offered and…services offered and…– Clinician Characteristics (training, Clinician Characteristics (training,

knowledge, behavior)knowledge, behavior)– OpinionsOpinions– Perceived Barriers to Providing Infection-Perceived Barriers to Providing Infection-

Related ServicesRelated Services