Clinical trial NCT02035098: Improving Pain Management in Hospitalized Cancer Patients. A Before-after Cluster Phase II Trial
Official title: The Effectiveness of the Quality Program Pac-IficO to Improve Pain Management in Hospitalized Cancer Patients. A Before-after Cluster Phase II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cancer
Keywords: cancer, pain, cluster trial, quality improvement
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
First posted: 2014-01-14
Enrollment: 504
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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%.

Eligibility criteria: 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.

Primary outcomes:
measure: percentage of hospitalized cancer patients with average severe pain (score 7-10) within the latest 24 hours
timeFrame: up to 28±1 days after Pac-IficO completion.
Secondary outcomes:
measure: knowledge of the ward professionals in pain management
timeFrame: In the month before and in the month after the completion of the intervention.
measure: quality of pain management in cancer patients
timeFrame: up to 28±1 days after Pac-IficO completion
Other outcomes:
Locations:
Study officials:
affiliation: ASL Biella (Italy)
name: Carlo Peruselli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.