A Study to Evaluate Guideline Adoption Through Quality Improvement Project (QIP) in Pulmonary and Critical Care Medicine (PCCM) Department

NCT ID: NCT06484972

Last Updated: 2025-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1728 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-01

Study Completion Date

2028-03-31

Brief Summary

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This is a cluster randomized controlled trial with PCCM department in each site being the cluster. Fifty-four sites' PCCM departments will be randomized to the QIP arm versus control arm in 2:1 allocation ratio. The QIP arm will perform QIP intervention. The control arm will not receive intervention and continue with usual care.

The primary endpoints of this study are molecular testing rate of non-small cell lung cancer (NSCLC) prior to the first systematic anti-tumor therapy, and adjuvant or first line targeted therapy treatment rate in actionable oncogenic alterations (AGA) NSCLC.

Detailed Description

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Approximately 1728 patients from 54 sites will be enrolled (about 30 NSCLC \[20%-30% squamous cases\] and 2 extensive-stage small-cell lung cancer \[ES-SCLC\] patients in each site). Patients in the QIP arm will be enrolled after about 3-month QIP intervention. Patients in the control arm will be enrolled as soon as the trial starts. Data on lung cancer diagnosis and treatment pattern will be collected.

Conditions

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Lung Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Quality improvement project arm

The Quality improvement project(QIP) arm will perform QIP intervention. Patients in the QIP arm will be enrolled after about 3-month QIP intervention. The QIP interventions include: establish a coaching committee, quality improvement workshop, implementation of quality improvement measures, as well as evaluation periodically and feedback.

No interventions assigned to this group

Control arm

The control arm will not receive intervention and continue with usual care.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1.1.3 PCCM department who want to improve lung cancer healthcare quality and agree to participate in study.

Exclusion Criteria

2.2.2 Participating in another interventional clinical study.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

China-Japan Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wang Chen

Director of the National Center for Respiratory Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Yanhong Ren, M.D

Role: CONTACT

+86 134 6638 0716

Other Identifiers

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ESR-24-22776

Identifier Type: -

Identifier Source: org_study_id

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