Advancing the Patient Experience in Chronic Obstructive Pulmonary Disease (APEX COPD)

NCT ID: NCT04285047

Last Updated: 2020-02-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 4500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-23
• Study Completion Date: 2022-12-31

Brief Summary

APEX COPD is registry to provide a mechanism to standardize, store and utilize data to enable greater power to answer key research questions, and to improve patient outcomes in COPD primary care.

Detailed Description

In the process of creating of a high-quality longitudinal dataset combining COPD templates and patient reported information and outcome (PRIO) to evaluate outcomes the APEX COPD registry supports changes and improvements in medical practice and deliver high quality research through the following mechanisms:

• Templates integrated into the primary care clinical systems to support standardization of care and data over time.
• Informing doctors at the point of consultation about the status of their patients through data-driven feedback.
• Pre-filled electronic data templates from existing EHR data and questionnaires to reduce administrative burden for Primary Care Clinicians (PCC).
• Engaging primary care clinicians in ongoing quality improvement initiatives directly at the point of care.
• Research publications regarding treatment effectiveness and associated risk in mild to moderate COPD, reason for therapy switch/escalation and hidden undiagnosed and untreated COPD patients in primary care.
• A strong network of primary care clinicians caring for patients with COPD in the US to drive the initiative and ensure impact on clinical practice through educational events, academic organizations and research outputs.

The APEX COPD steering committee (SC) comprise of collective clinical expertise, scientific knowledge and experience in EHR, databases and research, forming an essential element of the APEX COPD registry. The SC plays an essential role in the development and governance of the APEX COPD registry, representing the sites participating, and providing the expertise necessary to implement and drive the initiative. Within this committee a smaller management group guides the operational aspects of the registry.

The research database uses the Observational Medical Outcomes Partnership (OMOP) v5 Common Data Model (CDM) and the OMOP terminology will be updated at least bi-annually. Standardized OMOP Concept IDs will utilize SNOMED, RxNorm and may be adjusted to improve data compatibility with other OPC COPD databases.

Conditions

Chronic Obstructive Pulmonary Disease (13645005)

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: OTHER

Interventions

Advancing Patient Experience (APEX) in COPD

Involves both EMR and PRIO data

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnostic code for COPD or COPD monitoring review code prior to or at consultation
• Aged ≥35 years at COPD diagnosis

Exclusion Criteria

• Patients receiving hospice care
• Patients being actively treated for a cancer diagnosis (not skin)

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: collaborator

DARTNet Institute

OTHER_GOV

Sponsor Role: collaborator

American Academy of Family Physicians National Research Network (AAFP NRN)

UNKNOWN

Sponsor Role: collaborator

Respiratory Effectiveness Group

OTHER

Sponsor Role: collaborator

Optimum Patient Care

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wilson D Pace, MD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

Miramont Family Medicine

Fort Collins, Colorado, United States

Urban Family Practice

Buffalo, New York, United States

MetroHealth System

Cleveland, Ohio, United States

Bandera Family Health Care

San Antonio, Texas, United States

Countries

United States

Other Identifiers

OPCG -1803

Identifier Type: -

Identifier Source: org_study_id