Condition or disease | Intervention/treatment |
---|---|
Financial Benefit Colorectal Cancer Surgery Auditing Activity | Procedure: all colorectal cancer surgical procedures |
Focus of this project is to evaluate the possible financial benefit resulting from an optimization of surgical outcomes throughout a collaborative and systematic auditing activity.
The primary objective of this analysis is to assess the employed resources by National Health System related to surgical activities for primary colorectal cancer during a collaborative and systematic auditing activity in 8 Surgical Units of Emilia-Romagna. A project team composed by experts in colorectal cancer care will be created with the task of identifying the needed resources to allocate to the project and the set of administrative, economic and performance indicators to be measured during the project. A friendly, time-preserving dataset that includes all the items to be collected to measure established indicators will be developed. An analysis on costs and performance indicators will be conducted on colorectal procedures performed between 1 January 2019 and 31 December 2019 within the participating centers. From the second year auditing activity will be implemented among institutions of Emilia-Romagna. Analysis results obtained from the first year of collecting data will be used as a starting feedback report to implement the auditing activity dedicated to colorectal cancer. During the whole second year monthly feedback reports will be drafted and used for monitoring costs and performances outcomes of colorectal surgery procedures between 1 January 2020 and 31 December 2020.
At the end of the second year a final analysis will be performed to compare resources employed for colorectal cancer surgery between the first and second year. Economical and performance data will be collected.
Focusing on costs, the main sources to be used are administrative databases. Full in-hospital costs will be collected for each patient for the time interval between the day of admission for surgery and the following post-operative 90-days. The Diagnosis Related Groups (DRG) standardized payments will be used to calculate inpatient costs.
Another source for cost and performance information is the clinical chart (paper or electronic) in all its parts. The investigators will focus primarily on set of data, that potentially could contribute to define the cost of care on basis of post-operative pathway. Key performance indicators common to both colon and rectal surgery or specific for one of the two surgical procedure will be considered.
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 1400 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 6 Months |
Official Title: | A Plan for Evaluating Costs and Outcomes of Colorectal Surgery in Emilia-Romagna (Emilia-Romagna Surgical Colorectal Cancer Audit-ESCA) |
Actual Study Start Date : | April 16, 2019 |
Estimated Primary Completion Date : | December 31, 2020 |
Estimated Study Completion Date : | December 31, 2020 |
Group/Cohort | Intervention/treatment |
---|---|
Colon surgery
patients diagnosed with colon cancer, who undergone at least one surgical procedure at one of participating hospitals during the observational period
|
Procedure: all colorectal cancer surgical procedures
colorectal cancer surgical procedures
|
Rectal surgery
patients diagnosed with rectal cancer, who undergone at least one surgical procedure at one of participating hospitals during the observational period
|
Procedure: all colorectal cancer surgical procedures
colorectal cancer surgical procedures
|
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
• multiple synchronous primary tumours;
Contact: Valentina Danesi, engineer | 00390543739264 | valentina.danesi@irst.emr.it |
Italy | |
Istituto Scientifico Romagnolo per lo studio e la cura dei tumori | Recruiting |
Meldola, FC, Italy, 47014 | |
Contact: Valentina Danesi, Biomedical Engineering 00390543739264 valentina.danesi@irst.emr.it | |
Principal Investigator: Mattia Altini, physician | |
AUO Chirurgia Generale e D'Urgenza Ospedale M.Bufalini | Recruiting |
Cesena, Forli-Cesena, Italy, 47521 | |
Contact: Luca Ansaloni, physician luca.ansaloni@auslromagna.it | |
Principal Investigator: Luca Ansaloni, physician | |
AUO CHIRURGIA GENERALE OSPEDALE G. B. Morgagni- Pierantoni | Recruiting |
Forlì, Forli-Cesena, Italy, 47121 | |
Contact: Giorgio Ercolani, physician giorgio.ercolani2@unibo.it | |
Principal Investigator: Giorgio Ercolani, physician | |
Auo Chirurgia Generale Ospedale Degli Infermi | Recruiting |
Faenza, Ravenna, Italy, 48018 | |
Contact: Giampaolo Ugolini, physician giampaolo.ugolini@auslromagna.it | |
Principal Investigator: Giampaolo Ugolini, physician | |
AUO Chirurgia Generale Ospedale Umberto I | Recruiting |
Lugo, Ravenna, Italy | |
Contact: Rosario Mario Tranchino, physician rosariomario.tranchino@auslromagna.it | |
Principal Investigator: Rosario Mario Tranchino, physician | |
AUO Chirurgia Generale Ospedale Ceccarini | Recruiting |
Riccione, Rimini, Italy, 47838 | |
Contact: Andrea Lucchi, physician andrea.lucchi@auslromagna.it | |
Principal Investigator: Andrea Lucchi, physician | |
AOU Chirurgia Generale Ospedale G. Da Saliceto | Not yet recruiting |
Piacenza, Italy, 29121 | |
Contact: Patrizio Capelli, physician p.capelli@ausl.pc.it | |
Principal Investigator: Patrizio Capelli, physician | |
AUO Chirurgia Generale ed Urgenza Ospedale S. Maria delle Croci | Recruiting |
Ravenna, Italy, 48121 | |
Contact: Paolo Soliani, physician paolo.soliani@auslromagna.it | |
Principal Investigator: Paolo Soliani, physician | |
Auo Chirurgia Generale Ospedale Degli Infermi | Recruiting |
Rimini, Italy, 47923 | |
Contact: Gianluca Garulli, physician gianluca.garulli@auslromagna.it | |
Principal Investigator: Gianluca Garulli, physician |
Principal Investigator: | Mattia Altini, physician | IRST |
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date | May 28, 2019 | ||||
First Posted Date | June 11, 2019 | ||||
Last Update Posted Date | June 11, 2019 | ||||
Actual Study Start Date | April 16, 2019 | ||||
Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
|
||||
Original Primary Outcome Measures | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures |
|
||||
Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Emilia-Romagna Surgical Colorectal Cancer Audit- ESCA | ||||
Official Title | A Plan for Evaluating Costs and Outcomes of Colorectal Surgery in Emilia-Romagna (Emilia-Romagna Surgical Colorectal Cancer Audit-ESCA) | ||||
Brief Summary | Focus of this project is to evaluate the possible financial benefit resulting from an optimization of surgical outcomes throughout a collaborative and systematic auditing activity.The primary objective of this analysis is to assess the employed resources by National Health System related to surgical activities for primary colorectal cancer during a collaborative and systematic auditing activity in 8 Surgical Units of Emilia-Romagna | ||||
Detailed Description |
Focus of this project is to evaluate the possible financial benefit resulting from an optimization of surgical outcomes throughout a collaborative and systematic auditing activity. The primary objective of this analysis is to assess the employed resources by National Health System related to surgical activities for primary colorectal cancer during a collaborative and systematic auditing activity in 8 Surgical Units of Emilia-Romagna. A project team composed by experts in colorectal cancer care will be created with the task of identifying the needed resources to allocate to the project and the set of administrative, economic and performance indicators to be measured during the project. A friendly, time-preserving dataset that includes all the items to be collected to measure established indicators will be developed. An analysis on costs and performance indicators will be conducted on colorectal procedures performed between 1 January 2019 and 31 December 2019 within the participating centers. From the second year auditing activity will be implemented among institutions of Emilia-Romagna. Analysis results obtained from the first year of collecting data will be used as a starting feedback report to implement the auditing activity dedicated to colorectal cancer. During the whole second year monthly feedback reports will be drafted and used for monitoring costs and performances outcomes of colorectal surgery procedures between 1 January 2020 and 31 December 2020. At the end of the second year a final analysis will be performed to compare resources employed for colorectal cancer surgery between the first and second year. Economical and performance data will be collected. Focusing on costs, the main sources to be used are administrative databases. Full in-hospital costs will be collected for each patient for the time interval between the day of admission for surgery and the following post-operative 90-days. The Diagnosis Related Groups (DRG) standardized payments will be used to calculate inpatient costs. Another source for cost and performance information is the clinical chart (paper or electronic) in all its parts. The investigators will focus primarily on set of data, that potentially could contribute to define the cost of care on basis of post-operative pathway. Key performance indicators common to both colon and rectal surgery or specific for one of the two surgical procedure will be considered. |
||||
Study Type | Observational [Patient Registry] | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||
Target Follow-Up Duration | 6 Months | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | All consecutive patients diagnosed with malignant colorectal cancer, who undergone at least one surgical procedure at one of participating hospitals during the observational period will be collected | ||||
Condition |
|
||||
Intervention | Procedure: all colorectal cancer surgical procedures
colorectal cancer surgical procedures
|
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Study Groups/Cohorts |
|
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Unknown status | ||||
Estimated Enrollment |
1400 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | December 31, 2020 | ||||
Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria: • multiple synchronous primary tumours; |
||||
Sex/Gender |
|
||||
Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Italy | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03982641 | ||||
Other Study ID Numbers | IRST153.07 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
|
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IPD Sharing Statement |
|
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Responsible Party | Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori | ||||
Study Sponsor | Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori | ||||
Collaborators | Not Provided | ||||
Investigators |
|
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PRS Account | Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori | ||||
Verification Date | June 2019 |