Chronic Obstructive Pulmonary DiseaseNCT03207776
An Evaluation of Post Discharge Utilization Among Patients With an Acute Exacerbation of COPD
A study testing COPD Clinical Pathway in people with Chronic Obstructive Pulmonary Disease, run by Wake Forest University Health Sciences at 8 sites in United States.
Trial summary
Patients who are hospitalized at select Carolinas Healthcare System (CHS) sites with Chronic Obstructive Pulmonary Disorder (COPD) acute exacerbation symptoms will be treated per the CHS COPD Clinical Pathway. Patient outcomes will be followed, including but not limited to readmission. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- COPD Clinical Pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,832 participants
- Where
- 8 sitesUnited States
- Study dates
- 12 Jun 2017to 13 Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Identified as having an acute exacerbation of COPD within 24 hours of admission
Who cannot join
- Death during the index encounter
- No initial discharge as of the end of the study period
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Carolinas Medical Center
Charlotte, North Carolina, 28203
Carolinas Healthcare System - Pineville
Charlotte, North Carolina, 28210
Carolinas Healthcare System - University
Charlotte, North Carolina, 28262
Carolinas Healthcare System - NorthEast
Concord, North Carolina, 28025
Carolinas Healthcare System - Kings Mountain
Kings Mountain, North Carolina, 28086
Carolinas Healthcare System Lincoln
Lincolnton, North Carolina, 28092
Carolinas Healthcare System - Union
Monroe, North Carolina, 28112
Carolinas Healthcare System - Cleveland
Shelby, North Carolina, 28150
About this study
Official title: A Cluster Randomized, Stepped-Wedge Evaluation of Post Discharge Utilization Among Patients With an Acute Exacerbation of Chronic Obstructive Pulmonary Disorder (COPD)
Patients who are hospitalized at select Carolinas Healthcare System (CHS) sites with Chronic Obstructive Pulmonary Disorder (COPD) acute exacerbation symptoms will be treated per the CHS COPD Clinical Pathway. Patient outcomes will be followed, including but not limited to readmission. Patients on the pathway will also have access to navigator services.
Read the detailed description
Patients hospitalized at participating CHS sites with COPD acute exacerbation symptoms, will be treated per the CHS COPD clinical pathway. The COPD clinical pathway will include four components: (i) discrete, evidence-based care steps (ii) patient navigation, (iii) daily data driven care gap identification, (iv) monthly leadership huddles. These components are all part of usual care for patients in this population, but each component is not applied to patients consistently across the System. For this reason, the pathway will be applied consistently and completely in patients meeting COPD acute exacerbation criteria at participating sites. Patients will be followed for 60 days in total after discharge from their COPD acute exacerbation symptoms to determine the potential effectiveness of complete implementation of all 4 components in the care of COPD patients. Patients on the pathway will also have access to navigator services.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Usual Care, COPD Clinical Pathway
- 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.
Usual CareOther
Treatment of patients in the usual manner based on their diagnosis and resources available at that site.
COPD Clinical PathwayOther
A group of 4 Usual Care components that are applied consistently and completely amongst all patients who present with COPD acute exacerbation symptoms, plus access to navigator services.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Treatment of patients in the usual manner based on their diagnosis and resources available at that site (Usual Care). Receives: Other: Usual Care |
| Intervention | Other | A group of 4 Usual Care components that are applied consistently and completely amongst all patients who present with COPD acute exacerbation symptoms, plus access to navigator services (COPD Clinical Pathway). Receives: Other: COPD Clinical Pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthcare Utilization
Occurrence of Emergency Department, inpatient, or observation encounters after the initial encounter at accrual
Measured: 60 days
Secondary outcomes (3)
Quality, Comfort, and Care (QCC) Defined Readmission Rate
Readmission to the same facility
Measured: 30 days
Patient-centric (Protocol Defined) Readmission Rate
Readmission to any facility within Carolinas HealthCare System
Measured: 30 days
30-day COPD Specific, Acute Care Utilization to Any Hospital Within the System
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start12 Jun 2017
- Primary completion12 Feb 2018
- Study completion13 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 4,832 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Howard, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03207776
- Sponsor's protocol ID
- 00021790
- Status last verified
- Jul 2020
- First submitted
- 28 Jun 2017
- Last updated
- 22 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomized, Stepped-Wedge Evaluation of Post Discharge Utilization Among Patients With an Acute Exacerbation of Chronic Obstructive Pulmonary Disorder (COPD)
- ClinicalTrials.gov ID
- NCT03207776
- Acronym / sponsor ID
- 00021790
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,832 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 12 Feb 2018 (actual)
- Study completion
- 13 Aug 2018 (actual)
- First posted
- 5 Jul 2017 (actual)
- Results
- Posted 14 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients who are hospitalized at select Carolinas Healthcare System (CHS) sites with Chronic Obstructive Pulmonary Disorder (COPD) acute exacerbation symptoms will be treated per the CHS COPD Clinical Pathway. Patient outcomes will be followed, including but not limited to readmission. Patients on the pathway will also have access to navigator services.
Detailed description
Patients hospitalized at participating CHS sites with COPD acute exacerbation symptoms, will be treated per the CHS COPD clinical pathway. The COPD clinical pathway will include four components: (i) discrete, evidence-based care steps (ii) patient navigation, (iii) daily data driven care gap identification, (iv) monthly leadership huddles. These components are all part of usual care for patients in this population, but each component is not applied to patients consistently across the System. For this reason, the pathway will be applied consistently and completely in patients meeting COPD acute exacerbation criteria at participating sites. Patients will be followed for 60 days in total after discharge from their COPD acute exacerbation symptoms to determine the potential effectiveness of complete implementation of all 4 components in the care of COPD patients. Patients on the pathway will also have access to navigator services.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: Usual CareTreatment of patients in the usual manner based on their diagnosis and resources available at that site (Usual Care). |
| Intervention | Other | Other: COPD Clinical PathwayA group of 4 Usual Care components that are applied consistently and completely amongst all patients who present with COPD acute exacerbation symptoms, plus access to navigator services (COPD Clinical Pathway). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Identified as having an acute exacerbation of COPD within 24 hours of admission
Key exclusion criteria (2 listed)
- Death during the index encounter
- No initial discharge as of the end of the study period
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 |
|---|---|---|
| Usual CareTreatment of patients in the usual manner based on their diagnosis and resources available at that site. | Other | Control |
| COPD Clinical PathwayA group of 4 Usual Care components that are applied consistently and completely amongst all patients who present with COPD acute exacerbation symptoms, plus access to navigator services. | Other | Intervention |
Primary outcome
Healthcare Utilization
Time frame: 60 days
Occurrence of Emergency Department, inpatient, or observation encounters after the initial encounter at accrual
3 secondary outcomes
Quality, Comfort, and Care (QCC) Defined Readmission Rate
Time frame: 30 days
Patient-centric (Protocol Defined) Readmission Rate
Time frame: 30 days
30-day COPD Specific, Acute Care Utilization to Any Hospital Within the System
Time frame: 30 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Daniel Howard, MD principal investigator
Wake Forest University Health Sciences
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COPD Clinical Pathway in people with Chronic Obstructive Pulmonary Disease, run by Wake Forest University Health Sciences at 8 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 1 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: finished, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Yes. Results are posted in the registry (first posted 14 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Healthcare Utilization (time frame: 60 days). 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 22 Apr 2022.