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Tailoring a Treatment Fidelity Framework for an Intensive Care Unit Clinical Trial

Chlan, Linda L.; Guttormson, Jill L.; Savik, Kay

doi: 10.1097/NNR.0b013e31822cc0cf

Background: Treatment fidelity (TF) refers to methodological strategies and practices used to monitor and enhance the reliability and validity of behavioral interventions. Treatment fidelity monitoring enhances internal and external validity and is needed for study replication and generalizability.

Objectives: The aim of this study was to describe the implementation, monitoring, and impact of TF in an intensive-care-unit-based clinical trial testing music for anxiety self-management with mechanically ventilated patients.

Method: Development of the criteria was based on the Five-Component Treatment Fidelity Framework from the Treatment Fidelity Workgroup. Descriptive statistics were used to evaluate adherence rates to the key TF criteria and the reasons criteria were unmet. Descriptive and nonparametric statistics were used to evaluate the impact of TF on participants' use of the assigned intervention.

Results: The Treatment Fidelity Framework was adapted easily to fit the study interventions. After the initial implementation phase of monitoring, adherence to key criteria was maintained at the targeted level of 80%. The majority of barriers to adherence affected the research nurses' opportunity to interact with the participant and encourage use of the intervention. There was a trend toward increased use of equipment associated with the assigned condition after the initiation of TF; however, this difference was not statistically significant.

Discussion: Treatment fidelity monitoring is an iterative process that requires ongoing vigilance. Identification of barriers and the implementation of methods to enhance protocol adherence are needed to enhance the reliability, validity, and generalizability of clinical trials in the dynamic and challenging research environment of the intensive care unit.

Linda L. Chlan, PhD, RN, is Associate Professor; Jill L. Guttormson, MS, RN, is Project Coordinator and PhD Candidate; and Kay Savik, MS, is Biostatistician, School of Nursing, University of Minnesota, Minneapolis.

Accepted for publication July 6, 2011.

The project described in this article was supported by a grant (R01NR009295) from the National Institute of Nursing Research.

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Nursing Research or the National Institutes of Health.

The authors have no conflicts of interest to disclose.

Corresponding author: Linda L. Chlan, PhD, RN, School of Nursing, University of Minnesota, 5-160 Weaver-Densford Hall, 308 Harvard St., SE Minneapolis, MN 55455 (e-mail:

© 2011 Lippincott Williams & Wilkins, Inc.