NCT02845583

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

July 29, 2016

Status Verified

July 1, 2016

Enrollment Period

1 year

First QC Date

July 13, 2016

Last Update Submit

July 28, 2016

Conditions

Keywords

NursingDiagnosis Related GroupActivity based costing

Outcome Measures

Primary Outcomes (1)

  • Volume of Nursing Activity

    Count of nusing activities performed to patients in different complexity groups

    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.

    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

    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.

    Through study completion, based on the patients' discharge date. The first outcome assessments are expected in December 2016.

Study Arms (2)

Retrospective cohort

150 oncologic patients belonging to major complexity DRGs

Perspective cohort

150 oncologic patients belonging to major complexity DRGs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università Cattolica del Sacro Cuore

Roma, Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Amelia Palinuro, PhD Student

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd Student

Study Record Dates

First Submitted

July 13, 2016

First Posted

July 27, 2016

Study Start

February 1, 2016

Primary Completion

February 1, 2017

Study Completion

May 1, 2017

Last Updated

July 29, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations