Improving Pain Management in Hospitalized Cancer Patients. A Before-after Cluster Phase II Trial

The Effectiveness of the Quality Program Pac-IficO to Improve Pain Management in Hospitalized Cancer Patients. A Before-after Cluster Phase II Trial

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. This is a before-after cluster phase II study performed in medicine, oncology and respiratory disease hospital wards. The Pac-IFicO programme is a complex interventions with multiple components. The primary end-point of the study is the proportion of cancer patients with severe pain.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: the Pac-IFicO programme

Detailed Description

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 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.

This is a before-after cluster phase II study. After the before assessment, 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 interventions 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 programs 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, quality of pain management. We plan to recruit about 500 cancer patients from ten hospital wards. This sample size should be sufficient, after appropriate statistical adjustments for clustering, to detect an absolute decrease in the proportion of cancer patients with severe pain (the primary end-point) from 20% to 9%.

• Study Type: Interventional
• Enrollment (Actual): 504
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria

WARD LEVEL

1. consent from the head of the ward to participate to the study;
2. ward classified as oncology, medicine, respiratory disease ward according to the regional classification of hospitals;
3. number of beds: ≥20 ;
4. number of ordinary admissions with primary or secondary diagnosis of tumour (ICD-IX 140-239) >180 per year;
5. yearly average stay in hospital between 4 and 19 days;
6. punctual prevalence of patients with primary or secondary diagnosis of tumour (ICD-IX 140-239) ≥ 8 patients.

STAFF LEVEL

1. affiliation to the ward;
2. informed consent to participate to the study.

PATIENT LEVEL

1. ordinarily admitted in the ward for at least 24 hours;
2. age ≥ 18 years
3. able to fill in the questionnaire according the profession judgment;
4. informed consent to participate to the study.

Exclusion criteria

WARD LEVEL

1. the ward had received or is receiving quality improvement programme of staff education for improve pain control.

PATIENT LEVEL

1. patient already assessed in one of the previous assessments.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The Pac-IFicO programme; The Pac-IFicO programme is a complex interventions aimed at improving the quality of pain managementi in hospitalized patients.	Other: the Pac-IFicO programme; The Pac-IFicO programme is a complex interventions 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 programs performed through guides from the wards, and an organisational intervention to the ward.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of hospitalized cancer patients with average severe pain (score 7-10) within the latest 24 hours	All eligible patients will be assessed in the month before (the before sample) and in the month after the implementation of the intervention (the after sample). For both samples the outcomes are composite measures from the five assessments in the month before and from five assessments in the month after. Each outcome results from the sum of patients with severe pain in the five assessments (the numerator) divided the total number of assessed patients in the five assessments (the denominator) x 100.	up to 28±1 days after Pac-IficO completion.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
knowledge of the ward professionals in pain management	Knowledge of the ward professionals in pain management were assessed before and after the implementation of the intervention by administering the Italian version of the Pain Attitudes and Knowledge Scale (PAK)	In the month before and in the month after the completion of the intervention.
quality of pain management in cancer patients	All eligible patients will be assessed in the month before (the before sample) and in the month after the implementation of the intervention (the after sample). For both samples the outcomes are composite measures from the five assessments in the month before and from five assessments in the month after. Each outcome results from the sum of patients with severe pain in the five assessments (the numerator) divided the total number of assessed patients in the five assessments (the denominator) x 100.	up to 28±1 days after Pac-IficO completion

Collaborators and Investigators

• Sponsor: Arcispedale Santa Maria Nuova-IRCCS
• Investigators: Principal Investigator: Carlo Peruselli, MD, ASL Biella (Italy)

Publications and helpful links

General Publications

• Ripamonti CI, Prandi C, Costantini M, Perfetti E, Pellegrini F, Visentin M, Garrino L, De Luca A, Pessi MA, Peruselli C. The effectiveness of the quality program Pac-IficO to improve pain management in hospitalized cancer patients: a before-after cluster phase II trial. BMC Palliat Care. 2014 Mar 29;13(1):15. doi: 10.1186/1472-684X-13-15.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: November 8, 2013
• First Submitted That Met QC Criteria: January 13, 2014
• First Posted (Estimate): January 14, 2014

Study Record Updates

• Last Update Posted (Estimate): January 14, 2014
• Last Update Submitted That Met QC Criteria: January 13, 2014
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: cancer, pain, cluster trial, quality improvement
• Other Study ID Numbers: RFPS-2006-6-341684