Iterative development and pilot testing of an intervention fidelity monitoring plan for the enhanced, electronic health record-facilitated pragmatic clinical trial: Implications for training and protocol integrity

Fidelity monitoring is the degree to which a clinical trial intervention is implemented as intended by a research protocol. Consistent implementation of research protocols supported with extant fidelity monitoring plans contribute rigor and validity of study results. Fidelity monitoring plans should...

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Autores principales:	Linda L. Chlan, PhD, RN, ATSF, FAAN, Jennifer L. Ridgeway, Cindy S. Tofthagen, Brianne R. Hamann, Kendra E. Mele, Donna Dozois, Sheryl M. Ness, Laura J. Peterson
Formato:	article
Lenguaje:	EN
Publicado:	Elsevier 2021
Materias:	Electronic health record Self-management Symptom management Patient-reported outcome measure Intervention fidelity monitoring Nurse Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/49b3ea0d87c541d1a6809d040e866810
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spelling	oai:doaj.org-article:49b3ea0d87c541d1a6809d040e8668102021-11-24T04:32:43ZIterative development and pilot testing of an intervention fidelity monitoring plan for the enhanced, electronic health record-facilitated pragmatic clinical trial: Implications for training and protocol integrity2451-865410.1016/j.conctc.2021.100868https://doaj.org/article/49b3ea0d87c541d1a6809d040e8668102021-12-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S245186542100168Xhttps://doaj.org/toc/2451-8654Fidelity monitoring is the degree to which a clinical trial intervention is implemented as intended by a research protocol. Consistent implementation of research protocols supported with extant fidelity monitoring plans contribute rigor and validity of study results. Fidelity monitoring plans should be comprehensive yet practical to accommodate the realities of conducting research, particularly a pragmatic clinical trial, in dynamic settings with heterogeneous patient populations. The purposes of this paper are to describe the (1) iterative development and implementation of protocols for intervention fidelity monitoring, (2) pilot testing of the fidelity monitoring plan, (3) the identification of interventionist training deficiencies, and (4) opportunities to enhance protocol rigor for a cancer symptom management intervention delivered through the electronic health record patient portal and telephone as part of a complex, multi-component pragmatic clinical trial to uncover training deficits and bolster protocol integrity. The intervention focuses on prominent symptoms reported among medical oncology patients including sleep disturbance, pain, anxiety, depression, low energy (fatigue) and physical function. In this pragmatic trial, the role of interventionist is a registered nurse symptom care manager (RN SCM). A three-part fidelity monitoring plan with checklists audit: Part-1 RN SCM role training activities in research components, clinical training components, and protocol simulation training; Part-2 RN SCM adherence to the intervention core components delivered over the telephone; and Part-3 maintenance of adherence to core intervention components. The goal is ≥ 80% adherence to components of each of the three checklists. An initial pilot test of the fidelity monitoring plan was conducted to evaluate the checklists and the RN SCM adherence to core protocol components. RN SCM skills and training deficits were identified during the pilot phase, as were opportunities to improve protocol integrity. Overall, approximately 50% of the audited RN SCM telephone calls had ≥80% fidelity to the core components. There remains on-going need for RN SCM training and skill building in action planning. The content presented in this paper is intended to begin to fill the gap of fidelity monitoring plans for complex interventions tested in pragmatic clinical trials and delivered remotely in an effort to strengthen protocol integrity.Linda L. Chlan, PhD, RN, ATSF, FAANJennifer L. RidgewayCindy S. TofthagenBrianne R. HamannKendra E. MeleDonna DozoisSheryl M. NessLaura J. PetersonElsevierarticleElectronic health recordSelf-managementSymptom managementPatient-reported outcome measureIntervention fidelity monitoringNurseMedicine (General)R5-920ENContemporary Clinical Trials Communications, Vol 24, Iss , Pp 100868- (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Electronic health record Self-management Symptom management Patient-reported outcome measure Intervention fidelity monitoring Nurse Medicine (General) R5-920
spellingShingle	Electronic health record Self-management Symptom management Patient-reported outcome measure Intervention fidelity monitoring Nurse Medicine (General) R5-920 Linda L. Chlan, PhD, RN, ATSF, FAAN Jennifer L. Ridgeway Cindy S. Tofthagen Brianne R. Hamann Kendra E. Mele Donna Dozois Sheryl M. Ness Laura J. Peterson Iterative development and pilot testing of an intervention fidelity monitoring plan for the enhanced, electronic health record-facilitated pragmatic clinical trial: Implications for training and protocol integrity
description	Fidelity monitoring is the degree to which a clinical trial intervention is implemented as intended by a research protocol. Consistent implementation of research protocols supported with extant fidelity monitoring plans contribute rigor and validity of study results. Fidelity monitoring plans should be comprehensive yet practical to accommodate the realities of conducting research, particularly a pragmatic clinical trial, in dynamic settings with heterogeneous patient populations. The purposes of this paper are to describe the (1) iterative development and implementation of protocols for intervention fidelity monitoring, (2) pilot testing of the fidelity monitoring plan, (3) the identification of interventionist training deficiencies, and (4) opportunities to enhance protocol rigor for a cancer symptom management intervention delivered through the electronic health record patient portal and telephone as part of a complex, multi-component pragmatic clinical trial to uncover training deficits and bolster protocol integrity. The intervention focuses on prominent symptoms reported among medical oncology patients including sleep disturbance, pain, anxiety, depression, low energy (fatigue) and physical function. In this pragmatic trial, the role of interventionist is a registered nurse symptom care manager (RN SCM). A three-part fidelity monitoring plan with checklists audit: Part-1 RN SCM role training activities in research components, clinical training components, and protocol simulation training; Part-2 RN SCM adherence to the intervention core components delivered over the telephone; and Part-3 maintenance of adherence to core intervention components. The goal is ≥ 80% adherence to components of each of the three checklists. An initial pilot test of the fidelity monitoring plan was conducted to evaluate the checklists and the RN SCM adherence to core protocol components. RN SCM skills and training deficits were identified during the pilot phase, as were opportunities to improve protocol integrity. Overall, approximately 50% of the audited RN SCM telephone calls had ≥80% fidelity to the core components. There remains on-going need for RN SCM training and skill building in action planning. The content presented in this paper is intended to begin to fill the gap of fidelity monitoring plans for complex interventions tested in pragmatic clinical trials and delivered remotely in an effort to strengthen protocol integrity.
format	article
author	Linda L. Chlan, PhD, RN, ATSF, FAAN Jennifer L. Ridgeway Cindy S. Tofthagen Brianne R. Hamann Kendra E. Mele Donna Dozois Sheryl M. Ness Laura J. Peterson
author_facet	Linda L. Chlan, PhD, RN, ATSF, FAAN Jennifer L. Ridgeway Cindy S. Tofthagen Brianne R. Hamann Kendra E. Mele Donna Dozois Sheryl M. Ness Laura J. Peterson
author_sort	Linda L. Chlan, PhD, RN, ATSF, FAAN
title	Iterative development and pilot testing of an intervention fidelity monitoring plan for the enhanced, electronic health record-facilitated pragmatic clinical trial: Implications for training and protocol integrity
title_short	Iterative development and pilot testing of an intervention fidelity monitoring plan for the enhanced, electronic health record-facilitated pragmatic clinical trial: Implications for training and protocol integrity
title_full	Iterative development and pilot testing of an intervention fidelity monitoring plan for the enhanced, electronic health record-facilitated pragmatic clinical trial: Implications for training and protocol integrity
title_fullStr	Iterative development and pilot testing of an intervention fidelity monitoring plan for the enhanced, electronic health record-facilitated pragmatic clinical trial: Implications for training and protocol integrity
title_full_unstemmed	Iterative development and pilot testing of an intervention fidelity monitoring plan for the enhanced, electronic health record-facilitated pragmatic clinical trial: Implications for training and protocol integrity
title_sort	iterative development and pilot testing of an intervention fidelity monitoring plan for the enhanced, electronic health record-facilitated pragmatic clinical trial: implications for training and protocol integrity
publisher	Elsevier
publishDate	2021
url	https://doaj.org/article/49b3ea0d87c541d1a6809d040e866810
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Iterative development and pilot testing of an intervention fidelity monitoring plan for the enhanced, electronic health record-facilitated pragmatic clinical trial: Implications for training and protocol integrity

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