Background
Methods/Design
Study design
Primary aim
Secondary aims
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quality of communication between the healthcare professionals, patients and families;
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quality of emotional support to family members before and after the patients' death;
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coordination of care;
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provision of care focusing on patient's individual needs;
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patient's physical well-being through a better control of physical symptoms;
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appropriateness of therapeutic and diagnostic procedures performed during the last days of the patient's life;
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quality of communication between hospital staff and General Practitioners (GPs).
General procedures of the cluster trial
End-points
Eligibility criteria
Ward level
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classified in the regional records as "Medical", "General Medical" or "Internal Medical";
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at least 25 cancer deaths on the ward per year. The data can be estimated from a review of deaths occurring on the ward over a minimum 6 month period during the two years preceding the start of the trial
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consent from the Hospital Management to participate to the trial
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consent from the Head of the Medical Ward to participate to the trial
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consent from an expert and skills-trained PCU to implement the LCP-I Program
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if in the same hospital another Medical Ward has already been randomly selected to participate in the research program (regardless of which arm was randomized).
Individual level
Procedures of assessment (Figure 3)
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communication between ward staff and GPs
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confirmation or integration of information regarding the patient's caregiver (name, relationship, address and telephone number).
Randomisation
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verifies the eligibility of the coupled wards
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assigns a numerical code to the two wards
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records the allocation of the wards
The LCP-I Program
Step 1-3: Development of the implementation project on the ward
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Step 1: Establishing the project - preparing the environment
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Identify and describe the characteristics of the ward
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Identify and describe the characteristics of the PCU
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Obtain consent from the subjects involved
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Present the general outlines of the LCP-I Program to the ward staff
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Outline the LCP-I Program on the ward
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Begin the approval procedure for the training program
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Register the Project at the National Center for LCP-I
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Step 2: Developing the Documentation
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Acquire educational materials for training
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Prepare the necessary documentation for the ward
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Step 3: Base review - Retrospective evaluation of variances related to end of life care on the ward
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Review the medical documentation of the patients who died on the ward
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Investigate the variances with the ward staff
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Step 4-8: Implementation of the Program on the ward
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Step 4: Induction of the Program. Intensive Education Program (duration less than a month)
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3 modules of 4 hours (12 hours total) repeated twice to allow the participation of all clinical ward staff (doctors and nurses).
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Step 5: Clinical implementation of the LCP-I documentation. Intensive support to the ward staff (6 weeks)
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the ward staff, closely supported (coaching, telephone and direct guidance, discussion of clinical cases) by the PCU team overseeing the implementation process, starts using the LCP-I documentation for dying patients.
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Step 6: Semi-intensive support to the ward staff (6 weeks)
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the ward staff, accompanied by the PCU team overseeing the implementation process, learns to use the LCP-I documentation as standard procedure for dying patients. Clinical audits are planned for difficult cases.
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Step 7: Evaluation and further Training (end of the 4° month)
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the PCU team evaluates the outcome of the preliminary steps with the aim of developing an appropriate training strategy for the ward staff during the subsequent stages of the implementation process.
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Step 8: Consolidation phase (2 months)
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the LCP-I documentation is established in the ward as an indicator of the quality of end of life care for all dying patients. The PCU team supports the ward staff using the most suitable tools for consolidation of the changes introduced by the LCP-I Program.
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Step 9-10: sustainability of high standards of quality of end of life care on the ward
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Step 9: Initiation of a strategy for sustainability
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the LCP-I is established as routine procedure on the ward and in the hospital
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develop an end-of-life care strategy for the ward.
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Step 10: Regional and national strategy
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use the outcome of the trial study to stimulate discussions at a regional and national level regarding issues linked to the quality of end-of-life care
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Statistical methods
Primary end-point
Sample size
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the intraclass correlation coefficient can be estimated between 0.01 and 0.05 [23]
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according to the review of cancer deaths on the Medical Wards potentially involved, we can expect an average number of cancer deaths in the 6 months of the assessment ranging between 15 and 20.
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it is foreseen that the regions participating will be able to randomize 10 pairs of Medical Wards (20 clusters overall).
Average size of the clusters | ||||
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Intraclass Correlation Coefficient | 10 | 15 | 20 | 25 |
0.01 | 22 |
16
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12
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10
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0.05 | 30 | 24 |
20
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18
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0.10 | 38 | 32 | 30 | 28 |
Statistical analysis
Ethical issues
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the ethics committee is required not only to express an opinion on the study, but also to carry out monitoring activities. More precisely, every 3 months the Scientific Coordinator will send to the Ethical Committee of the National Cancer Research Institute of Genoa and to the Ethical Committees of each trust involved in the trial a detailed progress report highlighting all variances, in particular with regards to the relations with the family. For any further clarification, each Ethical Committee can request the Scientific Coordinator's participation.
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the processing of data included in medical documentation is considered of significant public interest, to that purpose, in agreement with Articles 20 and 21 of the Italian Confidentiality Laws, it is accessible to the National Health Service and other Public Health organizations for the planning, management, monitoring and evaluation of healthcare;
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in theory the evaluation could be subject to informed consent of the terminal cancer patients (patients who might die of cancer). In fact, the patients involved in the Program evaluation, who are nearly always incapable of giving valid consent, are identified after death (as cancer deaths), regardless of whether they were hospitalized in a ward where it LCP-I Program was implemented;
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in all cases, where the patients are competent and aware of their health status (parameters previously assessed independently in the LCP-I Program) and where there is considered no risk to the patient, the clinical ward staff will be trained to deliver information to the patient and to ask them the consent to the use of personal data. This procedure will be recorded in the medical records;
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during the study and in subsequent publications, any personal data will be disaggregated and made anonymous.
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sampling of 2,000 cancer deaths in 30 Italian Local Healthcare Authorities' areas.
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caregiver identification in 95% of cases (N = 1900)
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realization of 1271 valid interviews (64% of the sample).
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reasons for non-completion of the interviews: no caregiver identified (5%), refusal (20%), caregiver not contactable (8%), other (3%).