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.

Autor:	Chlan LL; Division of Nursing Research, Department of Nursing, Mayo Clinic 200 First St. SW, Rochester, MN, 55905, USA., Ridgeway JL; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, USA., Tofthagen CS; Division of Nursing Research, Department of Nursing, Mayo Clinic 4500 San Pablo Rd., Jacksonville, FL, 32224, USA., Hamann BR; Division of Nursing Research, Department of Nursing, Mayo Clinic 200 First St. SW, Rochester, MN, 55905, USA., Mele KE; Division of Nursing Research, Department of Nursing, Mayo Clinic 200 First St. SW, Rochester, MN, 55905, USA., Dozois D; Division of Nursing Research, Department of Nursing, Mayo Clinic 200 First St. SW, Rochester, MN, 55905, USA., Ness SM; Division of Nursing Research, Department of Nursing, Mayo Clinic 200 First St. SW, Rochester, MN, 55905, USA., Peterson LJ; Division of Nursing Research, Department of Nursing, Mayo Clinic 200 First St. SW, Rochester, MN, 55905, USA.
Jazyk:	angličtina
Zdroj:	Contemporary clinical trials communications [Contemp Clin Trials Commun] 2021 Nov 19; Vol. 24, pp. 100868. Date of Electronic Publication: 2021 Nov 19 (Print Publication: 2021).
DOI:	10.1016/j.conctc.2021.100868
Abstrakt:	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. Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (© 2021 The Authors.)
Databáze:	MEDLINE
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