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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease (13645005)
• Intervention / Treatment: Other: Advancing Patient Experience (APEX) in COPD

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.

• Study Type: Observational
• Enrollment (Anticipated): 4500

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Fort Collins, Colorado, United States, 80528
      • Miramont Family Medicine
  • New York
    • Buffalo, New York, United States, 14201
      • Urban Family Practice
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • MetroHealth System
  • Texas
    • San Antonio, Texas, United States, 78249
      • Bandera Family Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Time Frame
Improve quality of care, and primary care patient outcomes	31 December 2018 to 31 December 2022
Understand the clinical phenotypes	31 December 2018 to 31 December 2022
Understand the current burden and minimize side effects	31 December 2018 to 31 December 2022
Support the development of effective and efficient diagnostic routines	31 December 2018 to 31 December 2022
comparing clinician-diagnosed COPD at baseline against established	31 December 2018 to 31 December 2022
Describe disease management pattern	31 December 2018 to 31 December 2022
Assess impact of inhaler technique	31 December 2018 to 31 December 2022
Describe factors associated with treatment choice at baseline	31 December 2018 to 31 December 2022
Describe risk factors	31 December 2018 to 31 December 2022
Assess the occurrence of exacerbations and other conditions	31 December 2018 to 31 December 2022
Assess biomarker data and estimate their predictive value for disease diagnosis	31 December 2018 to 31 December 2022
identify patients who may be eligible for participation in future research studies	31 December 2018 to 31 December 2022

Collaborators and Investigators

• Sponsor: Optimum Patient Care
• Collaborators: Respiratory Effectiveness Group; Boehringer Ingelheim Pharmaceutical Company (BI); DARTNet Institute; American Academy of Family Physicians National Research Network (AAFP NRN)
• Investigators: Principal Investigator: Wilson D Pace, MD, Professor

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2019
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: February 23, 2020
• First Submitted That Met QC Criteria: February 23, 2020
• First Posted (Actual): February 26, 2020

Study Record Updates

• Last Update Posted (Actual): February 26, 2020
• Last Update Submitted That Met QC Criteria: February 23, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Treatment; Electronic Medical Record; Registry; Therapy; Chronic Obstructive Pulmonary Disease; Electronic Health Record; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease; Patient Reported Information and Outcomes
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: OPCG -1803

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No