Tailoring a treatment fidelity framework for an intensive care unit clinical trial

Linda Chlan, Jill L. Guttormson, Kay Savik

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)348-353
Number of pages6
JournalNursing research
Volume60
Issue number5
DOIs
StatePublished - Sep 1 2011
Externally publishedYes

Fingerprint

Intensive Care Units
Clinical Trials
Therapeutics
Reproducibility of Results
Music
Self Care
Nonparametric Statistics
Research
Anxiety
Nurses
Equipment and Supplies

Keywords

  • clinical trial
  • intensive care
  • intervention studies
  • research design

ASJC Scopus subject areas

  • Nursing(all)

Cite this

Tailoring a treatment fidelity framework for an intensive care unit clinical trial. / Chlan, Linda; Guttormson, Jill L.; Savik, Kay.

In: Nursing research, Vol. 60, No. 5, 01.09.2011, p. 348-353.

Research output: Contribution to journalArticle

Chlan, Linda ; Guttormson, Jill L. ; Savik, Kay. / Tailoring a treatment fidelity framework for an intensive care unit clinical trial. In: Nursing research. 2011 ; Vol. 60, No. 5. pp. 348-353.
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