CancerNCT02845583
Nursing Activities for High Complexity Oncologic Care Patients
An observational study of Cancer, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
the study consists of an observational study aimed at quantifying the economic burden of the nursing activities on the overall cost of hospitalizations funded through DRG tariffs for Major complexity oncology patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2016to May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The sample has been chosen considering the prevalence of hospitalizations per year in medical oncology U.O.C. related to certain DRG and characterized by greater complexity of care, so as to provide a useful information base for study. For the retrospective study the survey will be conducted on a sample of 150 patients. Patients will be enrolled at high, medium and low complexity of care, hospitalized for chemotherapy and for biliary obstructive urinary tract and in the first half of 2016.
Who may be able to join
- CHT with a duration of hospital stay of 2-3 days (microcitomi and NHL),
- CHT with a length of hospital stay of 4-5 days (sarcomas),
- CHT with a length of hospital stay > 5 days (in case of high doses: testicle cancer, Ewing's sarcoma and bone sarcoma)
- Oncologic patients with higher complexity care.
Who cannot join
- Patients of 18 years of age or less
- Patients transferred to other units while inpatient
- Patients transferred in U.O.C. of Oncology after major surgery procedures in other departments
- Outlier admissions
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Università Cattolica del Sacro Cuore
Roma, Roma, 00168
Maurizio Zega, PhD, +390630154796, maurizio.zega@policlinicogemelli.it
Amelia Palinuro, PhD Student, +393468599660, amelia.stop@hotmail.it
About this study
Official title: Quantifying and Measuring the Economic Impact of Nursing Activities During the Hospital Stay of High Complexity Oncologic Care Patients
the study consists of an observational study aimed at quantifying the economic burden of the nursing activities on the overall cost of hospitalizations funded through DRG tariffs for Major complexity oncology patients.
Read the detailed description
Study design
The methodological approach used to achieve the objective of this research is quantitative. A mixed study design is being adopted:
- Retrospective study to determine the nature and volume of activity provided at nursing classes of patients whose admission is attributed to a specific DRG
- Longitudinal prospective study to determine the variability of costs of nurses with regard to DRG refund, comparatively to distribution of patients for every single section (high, medium, low complexity).
Study population The sample has been chosen considering the prevalence of hospitalizations per year in medical oncology U.O.C. related to certain DRG and characterized by greater complexity of care, so as to provide a useful information base for study. For the retrospective study the survey will be conducted on a sample of 150 patients. Patients will be enrolled at high, medium and low complexity of care, hospitalized for chemotherapy and for biliary obstructive urinary tract and in the first half of 2016. It is estimated that the sample represents 30% of the total number of admissions made in 2016. A prospective longitudinal study will take into consideration a sample of 150 patients with the same characteristics considered for enrollment in the retrospective study.
The study will include patients who under go: CHT with a duration of hospital stay of 2-3 days (microcitomi and NHL), CHT with a length of hospital stay of 4-5 days (sarcomas), CHT with a length of hospital stay > 5 days or at high doses (testicle cancer, Ewing's sarcoma and bone sarcoma) and patients with higher complexity care.
Patients of 18 years of age or less will be excluded, as well as patients that were transferred to other units while inpatient, patients transferred in U.O.C. of Oncology after major surgery procedures in other departments, and admissions that are outliers.
The duration for the monitoring phase on the allocation and the distribution of patients among the different sections of hospital care intensity (Intensità di cure, IC) and care complexity (Complessità Assistenziale, CA), based on the results obtained by the Triage of corridor (TriCO), is estimated for 3 months up to a maximum of six months starting from March 2016. For the collection of data relating to the amount and types of activities provided in the first half of 2016 is estimated to have a maximum of 30 days and others 30 days for the detection the relative DRG reimbursed for hospitalizations considered.
Survey instruments
- Professional Assessment Instrument (PAI). It is a tool that documents nursing processes implemented in a computerized way using nursing language according to the North American Nursing Diagnosis Association International (NANDA-I).
- Hospital discharge card (Scheda di dimissione ospedaliera, SDO). It is a tool that contains information about each patient discharged, that are necessary for the attribution to DRG and for finding the rate payable for each episode of hospitalization
- Scheda di mobilità interna dei pazienti. It is a card that contains data of Tri-CO at the entrance of the patient and any variations of that index during hospitalization.
Interventions The study will be presented to the manager and coordinator of the U.O.C. Medical Oncology through a moment of training/information.
In order to collect data on the variation of Tri-CO during hospitalization, and consequently the different allocation to U.O.C. of Oncology of patients in sections of low, medium and high complexity of care, a point of contact (nurse) will be identified who will deal with the collection and retention of such information in the manner set out in the research protocol.
Outcome measures
The primary outcome expected by the survey is the quantification of the volume of nursing activities provided to patients and its cost. In addition, we expect to realize economic indicators which make it possible to ascertain:
- Cost weight of the nursing staff on the DRG rate reimbursed in relation to the complexity care of the patient;
- Cost weight of the nursing staff on the reimbursement for hospitalization in connection with the DRG of patient discharge.
- Gap between theoretical and actual cost of nurses in relation to the care delivered for a specific patient; Knowledge of actual costs for each distinct and specific episode of hospitalization would enhance its "uniqueness". An economic analysis of labor nursing costs for individual patient could provide input for the determination of the costs of all the professionals of the Foundation, contributing to the improvement of corporate strategic management for resource allocation.
Statistical analysis Statistical analyses will be performed using methods of descriptive statistics and inferential statistics appropriate to the sample size and study variables. Prospective longitudinal study will be used to determine the frequency distribution and the variance on the stay of the patients in each individual section of hospital in-patient treatment which is attributed to a specific DRG. Then a factorial analysis and regression techniques will be used to measure the type of bond that exists between the dependent variable Y (nursing) and independent variables X1, X2, X3 ... (DRG, age, days of hospitalization, complications, etc). Then the analysis will continue by studying which variables will affect the distribution of patients for IC and CA level and how it can change this assignment during a single in-patient episode, creating a variability in costs of services paid.
- Conditions
- Cancer
- Keywords
- Nursing, Diagnosis Related Group, Activity based costing
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective cohort | 150 oncologic patients belonging to major complexity DRGs | |
| Perspective cohort | 150 oncologic patients belonging to major complexity DRGs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of Nursing Activity
Count of nusing activities performed to patients in different complexity groups
Measured: Through study completion, based on the patients' discharge date. The first outcome assessments are expected in December 2016.
Secondary outcomes (3)
Cost weight of the nursing staff on the DRG rate reimbursed in relation to the complexity care (Complessità Assistenziale, CA) of the patient.
Cost weight of the nursing staff on the DRG rate reimbursed in relation to the complexity care of the patient
Measured: Through study completion, based on the patients' discharge date. The first outcome assessments are expected in December 2016.
Cost weight of the nursing staff on the reimbursement for hospitalization in connection with the DRG of patient discharge
Cost weight of the nursing staff on the reimbursement for hospitalization in connection with the DRG of patient discharge.
Measured: Through study completion, based on the patients' discharge date. The first outcome assessments are expected in December 2016.
Mean difference between theoretical and actual cost of nurses in relation to the care delivered for a specific patient.
Difference between theoretical and actual cost of nurses in relation to the care delivered for a specific patient. The nursing time cost expressed in minutes results from the standard cost for each nursing hour worked by a nurse. The time in minutes of the performance is detected by the time indicated on standard nursing protocols considered for the study. The time in minutes of a benefit provided to specific types of patients considered comes from the average execution time of nursing care.
Measured: Through study completion, based on the patients' discharge date. The first outcome assessments are expected in December 2016.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amelia Palinuro, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845583
- Sponsor's protocol ID
- FAG14
- Status last verified
- Jul 2016
- First submitted
- 13 Jul 2016
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying and Measuring the Economic Impact of Nursing Activities During the Hospital Stay of High Complexity Oncologic Care Patients
- ClinicalTrials.gov ID
- NCT02845583
- Acronym / sponsor ID
- FAG14
- Conditions
- Cancer
- Keywords
- Nursing, Diagnosis Related Group, Activity based costing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 27 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
the study consists of an observational study aimed at quantifying the economic burden of the nursing activities on the overall cost of hospitalizations funded through DRG tariffs for Major complexity oncology patients.
Detailed description
Study design
The methodological approach used to achieve the objective of this research is quantitative. A mixed study design is being adopted:
- Retrospective study to determine the nature and volume of activity provided at nursing classes of patients whose admission is attributed to a specific DRG
- Longitudinal prospective study to determine the variability of costs of nurses with regard to DRG refund, comparatively to distribution of patients for every single section (high, medium, low complexity).
Study population The sample has been chosen considering the prevalence of hospitalizations per year in medical oncology U.O.C. related to certain DRG and characterized by greater complexity of care, so as to provide a useful information base for study. For the retrospective study the survey will be conducted on a sample of 150 patients. Patients will be enrolled at high, medium and low complexity of care, hospitalized for chemotherapy and for biliary obstructive urinary tract and in the first half of 2016. It is estimated that the sample represents 30% of the total number of admissions made in 2016. A prospective longitudinal study will take into consideration a sample of 150 patients with the same characteristics considered for enrollment in the retrospective study.
The study will include patients who under go: CHT with a duration of hospital stay of 2-3 days (microcitomi and NHL), CHT with a length of hospital stay of 4-5 days (sarcomas), CHT with a length of hospital stay > 5 days or at high doses (testicle cancer, Ewing's sarcoma and bone sarcoma) and patients with higher complexity care.
Patients of 18 years of age or less will be excluded, as well as patients that were transferred to other units while inpatient, patients transferred in U.O.C. of Oncology after major surgery procedures in other departments, and admissions that are outliers.
The duration for the monitoring phase on the allocation and the distribution of patients among the different sections of hospital care intensity (Intensità di cure, IC) and care complexity (Complessità Assistenziale, CA), based on the results obtained by the Triage of corridor (TriCO), is estimated for 3 months up to a maximum of six months starting from March 2016. For the collection of data relating to the amount and types of activities provided in the first half of 2016 is estimated to have a maximum of 30 days and others 30 days for the detection the relative DRG reimbursed for hospitalizations considered.
Survey instruments
- Professional Assessment Instrument (PAI). It is a tool that documents nursing processes implemented in a computerized way using nursing language according to the North American Nursing Diagnosis Association International (NANDA-I).
- Hospital discharge card (Scheda di dimissione ospedaliera, SDO). It is a tool that contains information about each patient discharged, that are necessary for the attribution to DRG and for finding the rate payable for each episode of hospitalization
- Scheda di mobilità interna dei pazienti. It is a card that contains data of Tri-CO at the entrance of the patient and any variations of that index during hospitalization.
Interventions The study will be presented to the manager and coordinator of the U.O.C. Medical Oncology through a moment of training/information.
In order to collect data on the variation of Tri-CO during hospitalization, and consequently the different allocation to U.O.C. of Oncology of patients in sections of low, medium and high complexity of care, a point of contact (nurse) will be identified who will deal with the collection and retention of such information in the manner set out in the research protocol.
Outcome measures
The primary outcome expected by the survey is the quantification of the volume of nursing activities provided to patients and its cost. In addition, we expect to realize economic indicators which make it possible to ascertain:
- Cost weight of the nursing staff on the DRG rate reimbursed in relation to the complexity care of the patient;
- Cost weight of the nursing staff on the reimbursement for hospitalization in connection with the DRG of patient discharge.
- Gap between theoretical and actual cost of nurses in relation to the care delivered for a specific patient; Knowledge of actual costs for each distinct and specific episode of hospitalization would enhance its "uniqueness". An economic analysis of labor nursing costs for individual patient could provide input for the determination of the costs of all the professionals of the Foundation, contributing to the improvement of corporate strategic management for resource allocation.
Statistical analysis Statistical analyses will be performed using methods of descriptive statistics and inferential statistics appropriate to the sample size and study variables. Prospective longitudinal study will be used to determine the frequency distribution and the variance on the stay of the patients in each individual section of hospital in-patient treatment which is attributed to a specific DRG. Then a factorial analysis and regression techniques will be used to measure the type of bond that exists between the dependent variable Y (nursing) and independent variables X1, X2, X3 ... (DRG, age, days of hospitalization, complications, etc). Then the analysis will continue by studying which variables will affect the distribution of patients for IC and CA level and how it can change this assignment during a single in-patient episode, creating a variability in costs of services paid.
Study design
- Observational model
- Cohort
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective cohort | – | –150 oncologic patients belonging to major complexity DRGs |
| Perspective cohort | – | –150 oncologic patients belonging to major complexity DRGs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The sample has been chosen considering the prevalence of hospitalizations per year in medical oncology U.O.C. related to certain DRG and characterized by greater complexity of care, so as to provide a useful information base for study. For the retrospective study the survey will be conducted on a sample of 150 patients. Patients will be enrolled at high, medium and low complexity of care, hospitalized for chemotherapy and for biliary obstructive urinary tract and in the first half of 2016.
Key inclusion criteria (4 listed)
- CHT with a duration of hospital stay of 2-3 days (microcitomi and NHL),
- CHT with a length of hospital stay of 4-5 days (sarcomas),
- CHT with a length of hospital stay > 5 days (in case of high doses: testicle cancer, Ewing's sarcoma and bone sarcoma)
- Oncologic patients with higher complexity care.
Key exclusion criteria (4 listed)
- Patients of 18 years of age or less
- Patients transferred to other units while inpatient
- Patients transferred in U.O.C. of Oncology after major surgery procedures in other departments
- Outlier admissions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Volume of Nursing Activity
Time frame: Through study completion, based on the patients' discharge date. The first outcome assessments are expected in December 2016.
Count of nusing activities performed to patients in different complexity groups
3 secondary outcomes
Cost weight of the nursing staff on the DRG rate reimbursed in relation to the complexity care (Complessità Assistenziale, CA) of the patient.
Time frame: Through study completion, based on the patients' discharge date. The first outcome assessments are expected in December 2016.
Cost weight of the nursing staff on the reimbursement for hospitalization in connection with the DRG of patient discharge
Time frame: Through study completion, based on the patients' discharge date. The first outcome assessments are expected in December 2016.
Mean difference between theoretical and actual cost of nurses in relation to the care delivered for a specific patient.
Time frame: Through study completion, based on the patients' discharge date. The first outcome assessments are expected in December 2016.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Catholic University of the Sacred Heart at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amelia Palinuro, PhD Student (+393468599660, amelia.stop@hotmail.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of Nursing Activity (time frame: Through study completion, based on the patients' discharge date. The first outcome assessments are expected in December 2016.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2016.