Integrating Services Research into CTN Clinical Trials: The Devil is in the Details

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Integrating Services Research into CTN Clinical
TrialsThe Devil is in the Details
Synergy

• Harold I Perl, PhD
• Center for the Clinical Trials Network
• National Institute on Drug Abuse

Addiction Health Services Research
Conference October 16, 2007 Athens, GA
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Why Do HSR in CTN?

• CTN blends skill and experience of two key groups
  of experts
• community-based treatment providers
• academic researchers
• Diverse and extensive network interested in
  developing and participating in research on
  critical public health issues
• Incorporating HSR into existing clinical trials
  can be resource-efficient

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Why Do HSR in CTN Now?

• Blue Ribbon Task Force on HSR in NIDA
• Recommended closer collaboration with CTN
• DESPR/SRB enthusiastic to support
• Supplements to collect baseline/pilot data for
  future R01 applications
• Current cadre of CCTN staff with expertise,
  experience, and interest in HSR
• Opportunities to participate as new clinical
  trials are planned and conducted

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Bringing HSR into a Clinical Trial Already
In-the-Field

• POATS Prescription Opioid Addiction Treatment
  Study
• 2 medication management models of varying length,
  complexity, and expense
• Twice-weekly individual drug counseling added to
  standard medical management
• 2-Phase design
• Initial 4-week treatment with taper
• 12-week stabilization program plus 4-week taper

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POATS - CE

• Collect data to calculate the incremental
  cost-effectiveness ratio of enhanced treatment
  compared with standard
• Cost estimates comprehensive in scope including
• Facility/program level
• Treatment staff level
• Participant level
• Follow-on R01 application expected

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POATS - CE

• Protocol lead team very interested in cost
  effectiveness
• Key part of recent competing continuation
  application for Node
• NIDA protocol coordinator also interested in cost
  effectiveness
• Existing relationship between protocol lead team
  and Brandeis team

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POATS - CE

• Expertise and enthusiasm of key players essential
  to making this work
• Created liaisons at staff level as well as study
  managers
• Desired assessment package cut down to fit
  reality
• Approached CTPs already recruiting participants
  and those about to start
• Small supplement budget required innovative ways
  provide incentives to CTPs
• Involved CTN data and clinical coordinating
  centers
• Shared vision did not guarantee shared
  understanding between teams -- needed flexibility
  and realistic expectations from all

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Bringing HSR into a Clinical Trial During Early
Planning

• HIV/AIDS Rapid Testing protocol
• Studying impact of on-site rapid testing,
  HIV-status counseling, or referral to off-site
  testing in drug treatment programs
• Development team sees it as promising vehicle for
  cost-effectiveness analyses
• Protocol design still in initial phases
• Actual integration of HSR as yet unclear

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Bringing HSR into a Clinical Trial in Advanced
Development

• STAGE-12
• Combined group/individual treatment for stimulant
  abusers to facilitate engagement in 12-step
  groups
• Protocol lead team approached by members of CTN
  HSR Special Interest Group
• STAGE-12 leaders interested in questions of
  implementation and sustainability
• NIDA protocol coordinator HSR-experienced

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STAGE-12 - HSR

• Existing relationship among key players
• HSR team already part of CTN family
• HSR investigators invited to participate in
  weekly protocol development calls
• Direct negotiations with CTN Data and Clinical
  Coordinating Centers
• Contributed to design of main study as well as
  HSR component

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STAGE-12 - HSR

• Examining organizational and counselor variables
  that may affect implementation
• Monitoring impact on sustainability in CTPs
  following clinical trial completion
• Collecting baseline data prior to STAGE-12 trial
  initiation
• Developing future R01 application to
• conduct secondary analyses
• evaluate implementation and fidelity of
  STAGE-12 intervention during and after trial

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STAGE-12 - HSR

• Integrating HSR into main STAGE-12 trial
• Extensive participation of HSR team in planning
  process
• Overlap of assessment packages allowed
  streamlining in data collection process
• Alignment of informed consent across studies
• HSR team collecting counselor-level data to be
  used by main trial
• STAGE-12 trial providing treatment tapes to HSR
  team for fidelity analyses
• Full integration and enthusiastic cooperation
  does not guarantee smooth implementation!

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How You Can Join the Fun

• Contact SRB staff to discuss options for
  collaborating with current or future CTN trial
• Apply for RPG funding under existing FOA
• Health Services Research on Practice Improvement
  Utilizing Community Treatment Programs within the
  National Drug Abuse Clinical Trials Network (CTN)
• Dissemination and Implementation Research in
  Health
• Download and analyze public use datasets from CTN
  data share website
• www.ctndatashare.org
• 10 datasets currently available
• More to follow as completed