Chronic Obstructive Pulmonary DiseaseNCT02135744
Pre-Discharge Bundle for Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease to Reduce Readmissions
A study testing Bundle tool in people with Chronic Obstructive Pulmonary Disease and Exacerbation of Chronic Obstructive Pulmonary Disease, run by Henry Ford Health System at 1 site in United States.
Trial summary
Hospital readmissions for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) pose burdens to the healthcare system and patients. The aim of this study was to determine whether a screening and educational tool, administered prior to discharge, would result in a decrease in the rate of hospital… Read more about this study
- Who is it for?
- Ages 40 to 99 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Exacerbation of Chronic Obstructive Pulmonary Disease
- What is being tested?
- Bundle tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Apr 2013
- Phase
- Interventional
- 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 40 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of COPD with the presence of an AECOPD
- Age > 40
- Current or ex-smoker with history of at least 20 pack-years
Who cannot join
- Past history of asthma, interstitial lung disease, bronchiectasis, presence of airway hardware (e.g. tracheal stents or tracheotomy), lung cancer, any other cancer with a life expectancy of less than 1 year
- Presence of a language barrier
- Residence in a nursing home
- Intensive care unit stay during the current admission
- Delirium or dementia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pre-Discharge Bundle for Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease to Reduce Readmissions and Emergency Department Visits: a Randomized, Controlled Trial.
Hospital readmissions for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) pose burdens to the healthcare system and patients. The aim of this study was to determine whether a screening and educational tool, administered prior to discharge, would result in a decrease in the rate of hospital readmissions.
Read the detailed description
Hospital readmissions for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) pose burdens to the healthcare system and patients. A current gap in knowledge is whether a pre-discharge screening and educational tool, administered to patients with COPD, reduces readmissions and emergency department (ED) visits.
A single center, randomized trial of patients admitted with AECOPD. Patients will be randomized to control (standard care) or "bundle" group in which patients receive smoking cessation counseling, screening for gastroesophageal reflux disease and depression or anxiety, standardized inhaler teaching, and a 48-hour post-discharge phone call.
- Conditions
- Chronic Obstructive Pulmonary Disease, Exacerbation of Chronic Obstructive Pulmonary Disease
- Being tested
- Bundle tool
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Readmissions
- 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.
Bundle toolBehavioural
Tool consists of 1. screening measures to identify the presence of various risk factors for COPD exacerbations and 2. Educational components for the disease of COPD.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Group of patients undergo standard care as determined by the primary inpatient team |
| Bundle | Experimental | Group of patients that receive the screening and educational tool Receives: Behavioral: Bundle tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 day readmission rate
Time until readmission or ER visit, 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study startFeb 2010
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Jennings, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135744
- Sponsor's protocol ID
- 6174
- Status last verified
- Jan 2024
- First submitted
- 8 May 2014
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Jennings JH, Thavarajah K, Mendez MP, Eichenhorn M, Kvale P, Yessayan L. Predischarge bundle for patients with acute exacerbations of COPD to reduce readmissions and ED visits: a randomized controlled trial. Chest. 2015 May;147(5):1227-1234. doi: 10.1378/chest.14-1123.
PubMed 25940250
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Discharge Bundle for Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease to Reduce Readmissions and Emergency Department Visits: a Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT02135744
- Acronym / sponsor ID
- 6174
- Conditions
- Chronic Obstructive Pulmonary Disease, Exacerbation of Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Readmissions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 12 May 2014 (estimated)
- 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.
Hospital readmissions for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) pose burdens to the healthcare system and patients. The aim of this study was to determine whether a screening and educational tool, administered prior to discharge, would result in a decrease in the rate of hospital readmissions.
Detailed description
Hospital readmissions for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) pose burdens to the healthcare system and patients. A current gap in knowledge is whether a pre-discharge screening and educational tool, administered to patients with COPD, reduces readmissions and emergency department (ED) visits.
A single center, randomized trial of patients admitted with AECOPD. Patients will be randomized to control (standard care) or "bundle" group in which patients receive smoking cessation counseling, screening for gastroesophageal reflux disease and depression or anxiety, standardized inhaler teaching, and a 48-hour post-discharge phone call.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Group of patients undergo standard care as determined by the primary inpatient team |
| Bundle | Experimental | Behavioral: Bundle toolGroup of patients that receive the screening and educational tool |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of COPD with the presence of an AECOPD
- Age > 40
- Current or ex-smoker with history of at least 20 pack-years
Key exclusion criteria (5 listed)
- Past history of asthma, interstitial lung disease, bronchiectasis, presence of airway hardware (e.g. tracheal stents or tracheotomy), lung cancer, any other cancer with a life expectancy of less than 1 year
- Presence of a language barrier
- Residence in a nursing home
- Intensive care unit stay during the current admission
- Delirium or dementia.
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 |
|---|---|---|
| Bundle toolTool consists of 1. screening measures to identify the presence of various risk factors for COPD exacerbations and 2. Educational components for the disease of COPD. | Behavioural | Bundle |
Primary outcome
30 day readmission rate
Time frame: 30 days
Time until readmission or ER visit, 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Derived from this study: PubMed 25940250Jennings JH, Thavarajah K, Mendez MP, Eichenhorn M, Kvale P, Yessayan L. Predischarge bundle for patients with acute exacerbations of COPD to reduce readmissions and ED visits: a randomized controlled trial. Chest. 2015 May;147(5):1227-1234. doi: 10.1378/chest.14-1123.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bundle tool in people with Chronic Obstructive Pulmonary Disease and Exacerbation of Chronic Obstructive Pulmonary Disease, run by Henry Ford Health System at 1 site 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 3 inclusion and 5 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 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
30 day readmission rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02135744, which also lists 1 linked publication.
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 18 Jan 2024.