Assessing Treatment Fidelity in Clinical Trials: An Example from a Nurse-Practitioner, Community-based Cognitive -Behavioral Intervention for Pain (CBT)

2.50
Hdl Handle:
http://hdl.handle.net/10755/163381
Category:
Abstract
Type:
Presentation
Title:
Assessing Treatment Fidelity in Clinical Trials: An Example from a Nurse-Practitioner, Community-based Cognitive -Behavioral Intervention for Pain (CBT)
Author(s):
Bruckenthal, Patricia; Broderick, Joan E.; Keefe, Francis J.
Author Details:
Patricia Bruckenthal, PhD, RN, ANP, Clinical Associate Professor, Stony Brook University Adult Health Nursing, Stony Brook, New York, USA, email: patricia.bruckenthal@stonybrook.edu; Joan E. Broderick, PhD; Francis J. Keefe, PhD
Abstract:
Purpose: To demonstrate the value of assessing treatment fidelity in the context of clinical trials Theoretical Framework: A key element to interpreting behavior change research is measurement of actual treatment dosing. Treatment fidelity refers to the degree to which the treatment was administered as intended. It directly impacts the internal validity of research. Assessment of treatment fidelity must be built into study design. Methods (Design, Sample, Setting, Measures, Analysis): In a pilot study, an adult-health NP was trained to deliver manual-based CBT to five osteoarthritis patients with chronic pain. Efficacy of this intervention when administered by research-based psychologists has been demonstrated. In order to improve access to this care, we hypothesize that a trained non-mental health NP can effectively deliver CBT in a community setting. Steps to enhance treatment fidelity were built into the study design: (1) an expert in CBT provided training, (2) the NP followed a 10-session manual-based treatment protocol, (3) weekly supervision, (4) treatment sessions were audiotaped. Analysis included coding audiotapes to assess adherence to treatment curriculum, assessment of patients' completion of assignments, patients' reported use of acquired skills, and patient satisfaction with treatment. Results: Outcome data from this study were similar, but yielded some differences from psychologist-administered treatment in published efficacy trials. Analysis of treatment fidelity provided objective information regarding actual treatment dosing. Specifically, there was evidence of omissions in treatment curriculum and communication of the importance of home practice and self-efficacy. Conclusions and Implications: Assessment of treatment fidelity has provided valuable, objective information to evaluate trial outcomes and to inform improved treatment administration strategies for a larger, multi-site randomized controlled study. When treatment fidelity is enhanced and monitored, evaluation of trial outcomes and directions for future research are improved.
Repository Posting Date:
27-Oct-2011
Date of Publication:
27-Oct-2011
Conference Date:
2006
Conference Name:
18th Annual Scientific Sessions
Conference Host:
Eastern Nursing Research Society
Conference Location:
Cherry Hill, New Jersey
Description:
�New Momentum for Nursing Research: Multidisciplinary Alliances�, held on April 20th -22nd at the Hilton in Cherry Hill, New Jersey
Note:
This is an abstract-only submission. If the author has submitted a full-text item based on this abstract, you may find it by browsing the Virginia Henderson Global Nursing e-Repository by author. If author contact information is available in this abstract, please feel free to contact him or her with your queries regarding this submission. Alternatively, please contact the conference host, journal, or publisher (according to the circumstance) for further details regarding this item. If a citation is listed in this record, the item has been published and is available via open-access avenues or a journal/database subscription. Contact your library for assistance in obtaining the as-published article.

Full metadata record

DC FieldValue Language
dc.type.categoryAbstracten_US
dc.typePresentationen_GB
dc.titleAssessing Treatment Fidelity in Clinical Trials: An Example from a Nurse-Practitioner, Community-based Cognitive -Behavioral Intervention for Pain (CBT)en_GB
dc.contributor.authorBruckenthal, Patriciaen_US
dc.contributor.authorBroderick, Joan E.en_US
dc.contributor.authorKeefe, Francis J.en_US
dc.author.detailsPatricia Bruckenthal, PhD, RN, ANP, Clinical Associate Professor, Stony Brook University Adult Health Nursing, Stony Brook, New York, USA, email: patricia.bruckenthal@stonybrook.edu; Joan E. Broderick, PhD; Francis J. Keefe, PhDen_US
dc.identifier.urihttp://hdl.handle.net/10755/163381-
dc.description.abstractPurpose: To demonstrate the value of assessing treatment fidelity in the context of clinical trials Theoretical Framework: A key element to interpreting behavior change research is measurement of actual treatment dosing. Treatment fidelity refers to the degree to which the treatment was administered as intended. It directly impacts the internal validity of research. Assessment of treatment fidelity must be built into study design. Methods (Design, Sample, Setting, Measures, Analysis): In a pilot study, an adult-health NP was trained to deliver manual-based CBT to five osteoarthritis patients with chronic pain. Efficacy of this intervention when administered by research-based psychologists has been demonstrated. In order to improve access to this care, we hypothesize that a trained non-mental health NP can effectively deliver CBT in a community setting. Steps to enhance treatment fidelity were built into the study design: (1) an expert in CBT provided training, (2) the NP followed a 10-session manual-based treatment protocol, (3) weekly supervision, (4) treatment sessions were audiotaped. Analysis included coding audiotapes to assess adherence to treatment curriculum, assessment of patients' completion of assignments, patients' reported use of acquired skills, and patient satisfaction with treatment. Results: Outcome data from this study were similar, but yielded some differences from psychologist-administered treatment in published efficacy trials. Analysis of treatment fidelity provided objective information regarding actual treatment dosing. Specifically, there was evidence of omissions in treatment curriculum and communication of the importance of home practice and self-efficacy. Conclusions and Implications: Assessment of treatment fidelity has provided valuable, objective information to evaluate trial outcomes and to inform improved treatment administration strategies for a larger, multi-site randomized controlled study. When treatment fidelity is enhanced and monitored, evaluation of trial outcomes and directions for future research are improved.en_GB
dc.date.available2011-10-27T11:06:33Z-
dc.date.issued2011-10-27en_GB
dc.date.accessioned2011-10-27T11:06:33Z-
dc.conference.date2006en_US
dc.conference.name18th Annual Scientific Sessionsen_US
dc.conference.hostEastern Nursing Research Societyen_US
dc.conference.locationCherry Hill, New Jerseyen_US
dc.description�New Momentum for Nursing Research: Multidisciplinary Alliances�, held on April 20th -22nd at the Hilton in Cherry Hill, New Jerseyen_US
dc.description.noteThis is an abstract-only submission. If the author has submitted a full-text item based on this abstract, you may find it by browsing the Virginia Henderson Global Nursing e-Repository by author. If author contact information is available in this abstract, please feel free to contact him or her with your queries regarding this submission. Alternatively, please contact the conference host, journal, or publisher (according to the circumstance) for further details regarding this item. If a citation is listed in this record, the item has been published and is available via open-access avenues or a journal/database subscription. Contact your library for assistance in obtaining the as-published article.-
All Items in this repository are protected by copyright, with all rights reserved, unless otherwise indicated.