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Open Access 01-12-2014 | 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

Authors: Carla Ida Ripamonti, Cesarina Prandi, Massimo Costantini, Elisa Perfetti, Fabio Pellegrini, Marco Visentin, Lorenza Garrino, Anna De Luca, Maria Adelaide Pessi, Carlo Peruselli

Published in: BMC Palliative Care | Issue 1/2014

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

Available only for authorised users

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The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1472-684X/13/15/prepub

Title: The effectiveness of the quality program Pac-IficO to improve pain management in hospitalized cancer patients: a before-after cluster phase II trial
Authors: Carla Ida Ripamonti
Cesarina Prandi
Massimo Costantini
Elisa Perfetti
Fabio Pellegrini
Marco Visentin
Lorenza Garrino
Anna De Luca
Maria Adelaide Pessi
Carlo Peruselli
Publication date: 01-12-2014
Publisher: BioMed Central
Published in: BMC Palliative Care / Issue 1/2014
Electronic ISSN: 1472-684X
DOI: https://doi.org/10.1186/1472-684X-13-15

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

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

Abstract

Background

Methods/design

Discussion

Trial registration

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods/design

Discussion

Trial registration

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