Clinical trial NCT04285047: Advancing the Patient Experience in Chronic Obstructive Pulmonary Disease (APEX COPD)
Official title: Advancing the Patient Experience in Chronic Obstructive Pulmonary Disease (APEX COPD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease (13645005)
Keywords: Chronic Obstructive Pulmonary Disease
Chronic Obstructive Lung Disease
Chronic Obstructive Airway Disease
Registry
Electronic Health Record
Electronic Medical Record
Patient Reported Information and Outcomes
Treatment
Therapy
Lead sponsor: Optimum Patient Care
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
name: DARTNet Institute
name: American Academy of Family Physicians National Research Network (AAFP NRN)
name: Respiratory Effectiveness Group
First posted: 2020-02-26
Enrollment: 4500
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study populations comprise of patients aged over 35 years and receiving care for COPD at participating primary care sites across the US in accordance with local regulatory/ethical requirements.

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.

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)

Primary outcomes:
measure: Describe and characterize the COPD primary care patient population's natural history
timeFrame: 31 December 2018 to 31 December 2022
measure: 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
timeFrame: 31 December 2018 to 31 December 2022
Secondary outcomes:
measure: Improve quality of care, and primary care patient outcomes
timeFrame: 31 December 2018 to 31 December 2022
measure: Understand the clinical phenotypes
timeFrame: 31 December 2018 to 31 December 2022
measure: Understand the current burden and minimize side effects
timeFrame: 31 December 2018 to 31 December 2022
measure: Support the development of effective and efficient diagnostic routines
timeFrame: 31 December 2018 to 31 December 2022
measure: comparing clinician-diagnosed COPD at baseline against established
timeFrame: 31 December 2018 to 31 December 2022
measure: Describe disease management pattern
timeFrame: 31 December 2018 to 31 December 2022
measure: Assess impact of inhaler technique
timeFrame: 31 December 2018 to 31 December 2022
measure: Describe factors associated with treatment choice at baseline
timeFrame: 31 December 2018 to 31 December 2022
measure: Describe risk factors
timeFrame: 31 December 2018 to 31 December 2022
measure: Assess the occurrence of exacerbations and other conditions
timeFrame: 31 December 2018 to 31 December 2022
measure: Assess biomarker data and estimate their predictive value for disease diagnosis
timeFrame: 31 December 2018 to 31 December 2022
measure: identify patients who may be eligible for participation in future research studies
timeFrame: 31 December 2018 to 31 December 2022
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Miramont Family Medicine
state: Colorado
city: Buffalo
country: United States
facility: Urban Family Practice
state: New York
city: Cleveland
country: United States
facility: MetroHealth System
state: Ohio
city: San Antonio
country: United States
facility: Bandera Family Health Care
state: Texas
Study officials:
affiliation: Professor
name: Wilson D Pace, MD
role: PRINCIPAL_INVESTIGATOR
References: