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

Chronic Obstructive Pulmonary Disease (13645005) Clinical Trial

— APEX COPD  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04285047
• Other study ID #: OPCG -1803
• Status: Enrolling by invitation
• Start date: March 23, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2020
• Source: Optimum Patient Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 4500
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (13645005)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Advancing Patient Experience (APEX) in COPD
Involves both EMR and PRIO data

Locations

Country	Name	City	State
United States	Urban Family Practice	Buffalo	New York
United States	MetroHealth System	Cleveland	Ohio
United States	Miramont Family Medicine	Fort Collins	Colorado
United States	Bandera Family Health Care	San Antonio	Texas

Sponsors (5)

Lead Sponsor	Collaborator
Optimum Patient Care	American Academy of Family Physicians National Research Network (AAFP NRN), Boehringer Ingelheim Pharmaceutical Company (BI), DARTNet Institute, The Respiratory Effectiveness Group (REG)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Describe and characterize the COPD primary care patient population's natural history	Baseline data from electronic health record (EHR) and patient reported information and outcomes (PRIO). The EHR data will be updated every three months.	31 December 2018 to 31 December 2022
Primary	Evaluate the comparative clinical, safety and cost effectiveness of current COPD treatments by class of therapy for COPD overall and in specific patient groups/phenotypes, to understand the predictors of response to available COPD treatment options	Patient reported information and outcomes (PRIO) will be collected annually and before very visit to their doctor	31 December 2018 to 31 December 2022
Secondary	Improve quality of care, and primary care patient outcomes		31 December 2018 to 31 December 2022
Secondary	Understand the clinical phenotypes		31 December 2018 to 31 December 2022
Secondary	Understand the current burden and minimize side effects		31 December 2018 to 31 December 2022
Secondary	Support the development of effective and efficient diagnostic routines		31 December 2018 to 31 December 2022
Secondary	comparing clinician-diagnosed COPD at baseline against established		31 December 2018 to 31 December 2022
Secondary	Describe disease management pattern		31 December 2018 to 31 December 2022
Secondary	Assess impact of inhaler technique		31 December 2018 to 31 December 2022
Secondary	Describe factors associated with treatment choice at baseline		31 December 2018 to 31 December 2022
Secondary	Describe risk factors		31 December 2018 to 31 December 2022
Secondary	Assess the occurrence of exacerbations and other conditions		31 December 2018 to 31 December 2022
Secondary	Assess biomarker data and estimate their predictive value for disease diagnosis		31 December 2018 to 31 December 2022
Secondary	identify patients who may be eligible for participation in future research studies		31 December 2018 to 31 December 2022