Chronic Obstructive Pulmonary Disease (13645005)APEX COPDNCT04285047
Advancing the Patient Experience in Chronic Obstructive Pulmonary Disease (APEX COPD)
An observational study of Chronic Obstructive Pulmonary Disease (13645005), run by Optimum Patient Care at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (13645005)
- What is being tested?
- Advancing Patient Experience (APEX) in COPD
- How many people
- 4,500 participants
- Where
- 4 sitesUnited States
- Study dates
- 23 Mar 2019to 31 Dec 2022
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Diagnostic code for COPD or COPD monitoring review code prior to or at consultation
- Aged ≥35 years at COPD diagnosis
Who cannot join
- Patients receiving hospice care
- Patients being actively treated for a cancer diagnosis (not skin)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Urban Family Practice
Buffalo, New York, 14201
MetroHealth System
Cleveland, Ohio, 44109
Miramont Family Medicine
Fort Collins, Colorado, 80528
Bandera Family Health Care
San Antonio, Texas, 78249
About this study
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.
Read the 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.
- Being tested
- Advancing Patient Experience (APEX) in COPD
- 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
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advancing Patient Experience (APEX) in COPDOther
Involves both EMR and PRIO data
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 31 December 2018 to 31 December 2022
Secondary outcomes (12)
Improve quality of care, and primary care patient outcomes
Measured: 31 December 2018 to 31 December 2022
Understand the clinical phenotypes
Measured: 31 December 2018 to 31 December 2022
Understand the current burden and minimize side effects
Measured: 31 December 2018 to 31 December 2022
Support the development of effective and efficient diagnostic routines
Measured: 31 December 2018 to 31 December 2022
comparing clinician-diagnosed COPD at baseline against established
Measured: 31 December 2018 to 31 December 2022
Describe disease management pattern
Measured: 31 December 2018 to 31 December 2022
Assess impact of inhaler technique
Measured: 31 December 2018 to 31 December 2022
Describe factors associated with treatment choice at baseline
Measured: 31 December 2018 to 31 December 2022
Describe risk factors
Measured: 31 December 2018 to 31 December 2022
Assess the occurrence of exacerbations and other conditions
Measured: 31 December 2018 to 31 December 2022
Assess biomarker data and estimate their predictive value for disease diagnosis
Measured: 31 December 2018 to 31 December 2022
identify patients who may be eligible for participation in future research studies
Measured: 31 December 2018 to 31 December 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start23 Mar 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (13645005)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 4,500 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Optimum Patient Care
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim, DARTNet Institute, American Academy of Family Physicians National Research Network, Respiratory Effectiveness Group
- Responsible party
- Sponsor
- Investigators
- Wilson D Pace, MD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285047
- Sponsor's protocol ID
- OPCG -1803
- Acronym
- APEX COPD
- Status last verified
- Feb 2020
- First submitted
- 23 Feb 2020
- Last updated
- 26 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing the Patient Experience in Chronic Obstructive Pulmonary Disease (APEX COPD)
- ClinicalTrials.gov ID
- NCT04285047
- Acronym / sponsor ID
- APEX COPD / OPCG -1803
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- Optimum Patient CareUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim, DARTNet Institute, American Academy of Family Physicians National Research Network, Respiratory Effectiveness Group
- Study start
- 23 Mar 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 4 Years
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Diagnostic code for COPD or COPD monitoring review code prior to or at consultation
- Aged ≥35 years at COPD diagnosis
Key exclusion criteria (2 listed)
- Patients receiving hospice care
- Patients being actively treated for a cancer diagnosis (not skin)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advancing Patient Experience (APEX) in COPDInvolves both EMR and PRIO data | Other | – |
Primary outcome
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
12 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilson D Pace, MD principal investigator
Professor
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (13645005), run by Optimum Patient Care at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe and characterize the COPD primary care patient population's natural history (time frame: 31 December 2018 to 31 December 2022). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020.