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

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

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

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: 1.Initial 4-week treatment with taper 2.12-week stabilization program plus 4-week taper

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

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

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

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

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

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

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

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!

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 – –10 datasets currently available –More to follow as completed