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

Integrating Services Research into CTN Clinical Trials: The 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. Why Do HSR in CTN?.

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

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  1. Integrating Services Research into CTN Clinical Trials:The 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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!

  13. 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

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