Open Access Study protocol

The effectiveness of the quality program Pac-IficO to improve pain management in hospitalized cancer patients: a before-after cluster phase II trial

Carla Ida Ripamonti1*, Cesarina Prandi2, Massimo Costantini3, Elisa Perfetti4, Fabio Pellegrini5, Marco Visentin6, Lorenza Garrino7, Anna De Luca8, Maria Adelaide Pessi1 and Carlo Peruselli2

Author Affiliations

1 Supportive Care in Cancer Unit, Department of Hematology and Pediatric Onco-Hematology, Fondazione IRCCS, Istituto Nazionale dei Tumori, Milano, Italy

2 Palliative Care Unit Biella Hospital Italy, Biella, Italy

3 Palliative Care Unit, IRCCS Arcispedale Santa Maria Nuova, Reggio Emilia, Italy

4 Unit of Oncology Biella Hospital Italy, Biella, Italy

5 Unit of Biostatistic, Fondazione Mario Negri Sud, Santa Maria Imbaro, Chieti, Italy

6 Palliative Care Unit Vicenza Hospital, Vicenza, Italy

7 Department of Public Health and Pediatrics Sciences, University of Turin, Turin, Italy

8 Palliative Care Unit, Cittadella della Salute Torino, Torino, Italy

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BMC Palliative Care 2014, 13:15  doi:10.1186/1472-684X-13-15

Published: 29 March 2014

Abstract

Background

Cancer-related pain continues to be a major healthcare issue worldwide. Despite the availability of effective analgesic drugs, published guidelines and educational programs for Health Care Professionals (HCPs) the symptom is still under-diagnosed and its treatment is not appropriate in many patients. The objective of the study is to evaluate the efficacy of the Pac-IFicO programme in improving the quality of pain management in hospitalised cancer patients.

Methods/design

This is a before-after cluster phase II study. After the before assessment, the experimental intervention – the Pac-IFicO programme – will be implemented in ten medicine, oncology and respiratory disease hospital wards. The same assessment will be repeated after the completion of the intervention. The Pac-IFicO programme is a complex intervention with multiple components. It includes focus group with ward professionals for identifying possible local obstacles to optimal pain control, informative material for the patients, an educational program performed through guides from the wards, and an organisational intervention to the ward. The primary end-point of the study is the proportion of cancer patients with severe pain. Secondary end-points include opioids administered in the wards, knowledge in pain management, and quality of pain management. We plan to recruit about 500 cancer patients. This sample size should be sufficient, after appropriate statistical adjustments for clustering, to detect an absolute decrease in the primary end-point from 20% to 9%.

Discussion

This trial is aimed at exploring with an experimental approach the efficacy of a new quality improvement educational intervention.

Trial registration

ClinicalTrials.gov: NCT02035098

Keywords:
Cancer; Pain; Educational program; Information of the patients; Pac-IFicO program