Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2011 Sep;37(5):434-9.
doi: 10.3109/00952990.2011.596969.

Standardized patient walkthroughs in the National Drug Abuse Treatment Clinical Trials Network: common challenges to protocol implementation

Holly E Fussell  1 , Lynn E Kunkel, Dennis McCarty, Colleen S Lewy
Affiliations

Standardized patient walkthroughs in the National Drug Abuse Treatment Clinical Trials Network: common challenges to protocol implementation

Holly E Fussell et al. Am J Drug Alcohol Abuse. 2011 Sep.

Abstract

Background: Training research staff to implement clinical trials occurring in community-based addiction treatment programs presents unique challenges. Standardized patient walkthroughs of study procedures may enhance training and protocol implementation.

Objectives: Examine and discuss cross-site and cross-study challenges of participant screening and data collection procedures identified during standardized patient walkthroughs of multi-site clinical trials.

Method: Actors portrayed clients and "walked through" study procedures with protocol research staff. The study completed 57 walkthroughs during implementation of 4 clinical trials.

Results: Observers and walkthrough participants identified three areas of concern (consent procedures, screening and assessment processes, and protocol implementation) and made suggestions for resolving the concerns.

Conclusions and scientific significance: Standardized patient walkthroughs capture issues with study procedures previously unidentified with didactic training or unscripted rehearsals. Clinical trials within the National Drug Abuse Treatment Clinical Trials Network are conducted in addiction treatment centers that vary on multiple dimensions. Based on walkthrough observations, the national protocol team and local site leadership modify standardized operating procedures and resolve cross-site problems prior to recruiting study participants. The standardized patient walkthrough improves consistency across study sites and reduces potential site variation in study outcomes.

PubMed Disclaimer

References

    1. Tai B, Straus MM, Liu D, Sparenborg S, Jackson RT, McCarty D. The first decade of the national drug abuse treatment clinical trials network: Bridging the gap between research and practice to improve drug abuse treatment. J Subst Abuse Treat. 2010;38(Suppl):S4–S13. - PMC - PubMed
    1. Colliver JA, Swartz MH. Assessing clinical performance with standardized patients. JAMA-J Am Med Assoc. 1997;278:790–791. - PubMed
    1. Swartz MH, Colliver JA. Using standardized patients for assessing clinical performance: An overview. Mt Sinai J Med. 1996;63:241–249. - PubMed
    1. Hazelkorn HM, Robins L. Actors play patients: Using surrogate patients to look into private practice. Public Health Rep. 1996;111:129–132. - PMC - PubMed
    1. Marchiondo K, Kipp C. Establishing a standardized patient education program. Crit Care Nurs. 1987;7:58–66. - PubMed

Publication types