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: | Kendra E. Mele, Laura J. Peterson, Cindy Tofthagen, Jennifer L. Ridgeway, Donna Dozois, Sheryl M. Ness, Linda L. Chlan, Brianne R. Hamann |
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| Rok vydání: | 2021 |
| Předmět: |
Medicine (General)
Computer science Electronic health record media_common.quotation_subject EHR Electronic health record SCM Symptom Care Manager Fidelity E2C2 Enhanced Electronic Health Record-facilitated Cancer Symptom Control Audit RN Registered Nurse Article R5-920 SPADE Sleep disturbance Pain Anxiety Depression Energy (fatigue) Intervention (counseling) Self-management medicine media_common Pharmacology Protocol (science) Medical education Nurse Patient portal SMART Specific-Measurable-Achievable-Relevant-Time limited Symptom management General Medicine Patient-reported outcome measure Intervention fidelity monitoring Clinical trial Identification (information) Anxiety medicine.symptom |
| Zdroj: | Contemporary Clinical Trials Communications Contemporary Clinical Trials Communications, Vol 24, Iss, Pp 100868-(2021) |
| ISSN: | 2451-8654 |
| DOI: | 10.1016/j.conctc.2021.100868 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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