Key Performance Indicators for the Assessment of NSCLC Patients Pathway

NCT ID: NCT04676321

Last Updated: 2020-12-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 430 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2020-11-15

Brief Summary

This is a multicenter, observational study involving a retrospective collection of data. A total of potential 16 key performance indicators (KPIs) had been developed from a panel of experts (clinicians, IT experts, etc..) to investigate the appropriateness of care in NSCLC patients, with a special focus on the use of immunotherapy. The eligible population and data will be gathered retrospectively using an algorithm. Administrative databases will be used as unique resource: to identify target population and to collect patient's data with which measure KPIs.

Detailed Description

This is a multi-center, observational study involving retrospective collection of NSCLC patients information. All consecutive patients who had a newly diagnosis of NSCLC in 2017 from healthcare administrative database between January 2017 and December 2017, identified through the proposed algorithm, will be considered. All data needed for KPI calculation, even if they fall outside January-December 2017 period, will be collected. The end of data collection will be defined as patient death or 30 June 2018, whichever came first.

A set of potential KPIs had been developed from a panel of experts (clinicians, IT experts etc..) to investigate the appropriateness of activities within NSCLC care pathway, with a special focus on the use of immunotherapy. The following KPIs will be measured to investigate the appropriateness of NSCLC patient care pathways, with a special focus on the use of immunotherapy:

1. Percentage of patients who performed biopsy within 7 days from the date of examination prescription;

2. Percentage of metastatic NSCLC patients at diagnosis;

3. Percentage of major surgical resections within the year of analysis;

4. Percentage of surgical patients on the total number of patients with exploratory thoracotomy in inpatient setting;

5. Percentage of patients undergoing neoadjuvant therapy ( CT or CT+RT within 6 months prior to the first major resection date;

6. 30-day mortality rate from major surgery;

7. Percentage of patients discussed in the multidisciplinary team (MDT) meeting at least once in the year of incidence;

8. Percentage of patients who performed imaging exams such as MRI, TC and PET within 7 days from MDT meeting;

9. Average and range of length of stay;

10. Average time between biopsy and the first administration of systematic anti-cancer drug;

11. Percentage of patients treated with immunotherapies;

12. Percentage of patients who underwent immunotherapy for more than 6 months after first dose;

13. Percentage of patients who underwent anti-cancer drug treatment in the last 30 days of life;

14. Percentage of patients who underwent the first administration of systematic anticancer drug within 30 days from discussed in MDT meeting;

15. Percentage of patients who underwent RT in the last 30 days of life ( excluded palliative treatments single fraction);

16. Percentage of patients who underwent at least one Integrated Home Care (IHC);

17. Percentage of patients who underwent at least one hospice care;

The eligible population and data will be gathered retrospectively through an algorithm from administrative databases (Hospital discharge cards, pharmaceutical databases as FED and AFT - direct and territorial distribution, the regional register of mortality REM, the regional register of outpatient specialist medical procedure ASA, the integrated home care IHC, and SDHS-hospice). Administrative data will be used as unique resource to identify patients cohort and to measure KPIs along care pathway. An evaluation of the NSCLC patients selection algorithm will be performed on a sub-population using the electronic health record EHR as gold standard.

Conditions

Non Small Cell Lung Cancer

Keywords

lung cancer; NSCLC; Administrative databases; Algorithm

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Patient pathway

Investigation on the appropriateness and quality of NSCLC care among participating sites

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• patients identified from hospital administrative databases of Emilia-Romagna region using a case selection algorithm for identifying Non small cell lung cancer

Exclusion Criteria

• patients not residing in Emilia Romagna region (due to the difficulty in obtaining the medical data).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda USL Reggio Emilia - IRCCS

OTHER_GOV

Sponsor Role: collaborator

Azienda Ospedaliera Universitaria Policlinico

OTHER

Sponsor Role: collaborator

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

OTHER

Sponsor Role: lead

Responsible Party

oriana nanni

Biostatician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mattia Altini, Master

Role: PRINCIPAL_INVESTIGATOR

IRST

Locations

IRST

Meldola, Forlì-Cesena, Italy

IRCCS Arcispedale S.Maria Nuova

Reggio Emilia, RE, Italy

Policlinico of Modena

Modena, , Italy

Countries

Italy

References

Balzi W, Roncadori A, Danesi V, Massa I, Manunta S, Gentili N, Delmonte A, Crino L, Altini M. How to discriminate non-small cell lung cancer (NSCLC) cases from an Italian administrative database? A retrospective, secondary data use study for evaluating a novel algorithm performance. BMJ Open. 2021 Sep 24;11(9):e048188. doi: 10.1136/bmjopen-2020-048188.

Reference Type: DERIVED

PMID: 34561258 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

IRST 162.13

Identifier Type: -

Identifier Source: org_study_id