Faculty Collaboration Database

Tailoring a treatment fidelity framework for an intensive care unit clinical trial. Nurs Res 2011;60(5):348-53

Date

09/01/2011

Pubmed ID

21878797

Pubmed Central ID

PMC3164965

DOI

10.1097/NNR.0b013e31822cc0cf

Scopus ID

2-s2.0-80052468932 (requires institutional sign-in at Scopus site)   7 Citations

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.

Author List

Chlan LL, Guttormson JL, Savik K

Author

Jill Guttormson BSN,MS,PhD Assistant Professor in the College of Nursing department at Marquette University

MESH terms used to index this publication - Major topics in bold

Adult
Aged
Behavior Therapy
Efficiency, Organizational
Female
Guideline Adherence
Humans
Intensive Care Units
Male
Middle Aged
Music Therapy
Nursing Methodology Research
Respiration, Artificial