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

Overview

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 Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Other
  • Study Primary Completion Date: December 31, 2022

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.

Interventions

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

Clinical Trial Outcome Measures

Primary Measures

  • Describe and characterize the COPD primary care patient population’s natural history
    • Time Frame: 31 December 2018 to 31 December 2022
    • Baseline data from electronic health record (EHR) and patient reported information and outcomes (PRIO). The EHR data will be updated every three months.
  • 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
    • Time Frame: 31 December 2018 to 31 December 2022
    • Patient reported information and outcomes (PRIO) will be collected annually and before very visit to their doctor

Secondary Measures

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

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 35 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Optimum Patient Care
  • Collaborator
    • Boehringer Ingelheim Pharmaceutical Company (BI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Wilson D Pace, MD, Principal Investigator, Professor

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