Key Performance Indicators for the Assessment of NSCLC Patients Pathway

Completed

• Conditions: Non Small Cell Lung Cancer

• Registration Number: NCT04676321
• Lead Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

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.

Study Timeline

• Study Start: 2020-10-01
• Primary Completion: 2020-10-15
• Study Completion: 2020-11-15
• Status Verified: 2020-12
• Study First Submitted: 2020-12-15
• Study First Submitted QC: 2020-12-15
• Last Update Submitted: 2020-12-15
• Study First Posted: 2020-12-21
• Last Update Posted: 2020-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 430

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Key Performance indicators	six months	To measure a set of potential indicators (KPIs) derived from administrative database in order to investigate the appropriateness and quality of NSCLC care among participating sites.

Secondary Outcome Measures

Name	Time	Method
Algorithm evaluatation	two month	The secondary outcome is to develop and evaluate an algorithm to identify the eligible population of the study from administrative databases against to a clinical database. Algorithm will be used to identify study eligible patients and measure KPIs from hospital administrative databases.

Trial Locations

Locations (3)

IRCCS Arcispedale S.Maria Nuova; 🇮🇹 Reggio Emilia, RE, Italy

Policlinico of Modena; 🇮🇹 Modena, Italy

IRST; 🇮🇹 Meldola, Forlì-Cesena, Italy