PATIENT VOICES, a project for the integration of the systematic assessment of patient reported outcomes and experiences within a comprehensive cancer center: a protocol for a mixed method feasibility study

Cinzia Brunelli, Claudia Borreani, Augusto Caraceni, Anna Roli, Marco Bellazzi, Linda Lombi, Emanuela Zito, Chiara Pellegrini, Pierangelo Spada, Stein Kaasa, Anna Maria Foschi, Giovanni Apolone, PATIENT VOICES study group, Giovanni Apolone, Marco Bellazzi, Filiberto Belli, Claudia Borreani, Cinzia Brunelli, Giuseppe Capri, Augusto Caraceni, Paolo Casali, Paolo Corradini, Filippo de Braud, Anna Maria Foschi, Secondo Folli, Marina Garassino, Lisa Licitra, Nicola Nicolai, Chiara Pellegrini, Marco Platania, Giuseppe Procopio, Anna Roli, Roberto Salvioni, Pierangelo Spada, Riccardo Valdagni, Emanuela Zito, Cinzia Brunelli, Claudia Borreani, Augusto Caraceni, Anna Roli, Marco Bellazzi, Linda Lombi, Emanuela Zito, Chiara Pellegrini, Pierangelo Spada, Stein Kaasa, Anna Maria Foschi, Giovanni Apolone, PATIENT VOICES study group, Giovanni Apolone, Marco Bellazzi, Filiberto Belli, Claudia Borreani, Cinzia Brunelli, Giuseppe Capri, Augusto Caraceni, Paolo Casali, Paolo Corradini, Filippo de Braud, Anna Maria Foschi, Secondo Folli, Marina Garassino, Lisa Licitra, Nicola Nicolai, Chiara Pellegrini, Marco Platania, Giuseppe Procopio, Anna Roli, Roberto Salvioni, Pierangelo Spada, Riccardo Valdagni, Emanuela Zito

Abstract

Background: Listening to "patient voices" in terms of symptoms, emotional status and experiences with care, is crucial for patient empowerment in clinical practice. Despite convincing evidence that routine patient reported outcomes and experience measurements (PRMs) with rapid feed-back to oncologists can improve symptom control, patient well-being and cost effectiveness, PRMs are not commonly used in cancer care, due to barriers at various level. Part of these barriers may be overcome through electronic PRMs collection (ePRMs) integrated with the electronic medical record (EMR). The PATIENT VOICES initiative is aimed at achieving a stepwise integration of ePRMs assessment into routine cancer care. The feasibility project presented here is aimed at assessing the knowledge, use and attitudes toward PRMs in a comprehensive cancer centre; developing and assessing feasibility of a flexible system for ePRM assessment; identifying barriers to and developing strategies for implementation and integration of ePRMs clinical practice.

Methods: The project has been organized into four phases: a) pre-development; b) software development and piloting; c) feasibility assessment; d) post-development. A convergent mixed method design, based on concurrent quantitative and qualitative data collection will be applied. A web-survey on health care providers (HCPs), qualitative studies on patients and HCPs (semi-structured interviews and focus groups) as well as longitudinal and cross-sectional quantitative studies will be carried out. The quantitative studies will enroll 600 patients: 200 attending out-patient clinics (physical symptom assessement), 200 attending inpatient wards (psychological distress assessment) and 200 patients followed by multidisciplinary teams (patient experience with care assessment). The Edmonton symptom assessment scale, the Distress Thermometer, and a tool adapted from existing patient reported experience with cancer care questionnaires, will be used in quantitative studies. A multi-disciplinary stakeholder team including researchers, clinicians, health informatics professionals, health system administrators and patients will be involved in the development of potentially effective implementation strategies in the post development phase.

Discussion: The documentation of potential advantages and implementation barriers achieved within this feasibility project, will serve as a starting point for future and more focused interventions aimed at achieving effective ePRMs routine assessment in cancer care.

Trial registration: ClinicalTrials.gov ( NCT03968718 ) May 30th, 2019.

Keywords: Implementation science; Medical informatics; Oncology; Patient participation; Patient reported outcome measures.

Conflict of interest statement

Dr. Caraceni reports personal fees from Kyowa Kirin; Shionogi & Molteni; Angelini; Institute de recherche “Pierre Fabre”; Sandoz International GmbH; Italfarmaco; Pfizer; Molteni & soc. esercizio SpA; Helsin Healthcare; Gruenenthal GmbH, and grants from Molteni & C Soc Esercizio Spa; Prokstrakan; Gruenenthal GmbH; Amgen; Ipsen, outside the submitted work.

All other authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Phases of the PATIENT VOICES feasibility project
Fig. 2
Fig. 2
Patient Voices system diagram. a and b ePROM and ePREM triggers; c patient questionnaire completion; d feedback to patients; e individual level feedback to clinicians; f group level feedback clinicians; g administrator tasks. (ePROMs: electronic Patient Reported Outcome Measurements, ePREMs: electronic Patient Reported Experience Measurements, EMR: Electronic Medical Record)

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