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

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ClinicalTrials.gov Identifier: NCT02035098
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : January 14, 2014
Sponsor:
Information provided by (Responsible Party):
Arcispedale Santa Maria Nuova-IRCCS

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cancer Other: the Pac-IFicO programme Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 504 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : March 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. percentage of hospitalized cancer patients with average severe pain (score 7-10) within the latest 24 hours [ Time Frame: up to 28±1 days after Pac-IficO completion. ]
    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.


Secondary Outcome Measures :
  1. knowledge of the ward professionals in pain management [ Time Frame: In the month before and in the month after the completion of the intervention. ]
    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)

  2. quality of pain management in cancer patients [ Time Frame: up to 28±1 days after Pac-IficO completion ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035098


Sponsors and Collaborators
Arcispedale Santa Maria Nuova-IRCCS
Investigators
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Principal Investigator: Carlo Peruselli, MD ASL Biella (Italy)
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Arcispedale Santa Maria Nuova-IRCCS
ClinicalTrials.gov Identifier: NCT02035098    
Other Study ID Numbers: RFPS-2006-6-341684
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: January 14, 2014
Last Verified: November 2013
Keywords provided by Arcispedale Santa Maria Nuova-IRCCS:
cancer, pain, cluster trial, quality improvement