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Pulmonary Disease, Chronic ObstructivePRIHSNCT03358771

COPD Discharge Bundle Delivered Alone or Enhanced Through a Care Coordinator

A study testing COPD discharge care bundle and COPD discharge care bundle & coordinator in people with Pulmonary Disease, Chronic Obstructive, run by University of Alberta at 5 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Chronic obstructive pulmonary disease (COPD) is a common, chronic progressive lung disease that is characterized by shortness of breath, activity limitation, and a predisposition to flare-ups resulting in frequent emergency department (ED) visits and hospitalizations. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
COPD discharge care bundle and COPD discharge care bundle & coordinator
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,710 participants
Where
5 sitesCanada
Study dates
1 Mar 2017to 30 Dec 2019
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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Medical diagnosis of COPD;
  • Male or female, 50 years of age and over, admitted to ED or hospital for an exacerbation of COPD. The age limit is imposed to reduce the chances of enrolling patients with asthma.
  • Any stage of severity;
  • Not being treated previously under the COPD care bundle

Who cannot join

  • Patients with a diagnosis other than COPD will be excluded.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Canada5 sites
  • Foothills Medical Centre

    Calgary, Alberta

  • Rockyview General Hospital

    Calgary, Alberta

  • Royal Alexandra Hospital

    Edmonton, Alberta

  • University of Alberta Hospital

    Edmonton, Alberta

  • Red Deer Regional Hospital Centre

    Red Deer, Alberta, T4N 4E7

Other trials in Canada

About this study

Official title: Effectiveness and Cost-effectiveness of a COPD Discharge Bundle Delivered Alone or Enhanced Through a Care Coordinator

Chronic obstructive pulmonary disease (COPD) is a common, chronic progressive lung disease that is characterized by shortness of breath, activity limitation, and a predisposition to flare-ups resulting in frequent emergency department (ED) visits and hospitalizations. COPD flare-ups increase risks of disease progression and mortality and account for the greatest proportion of preventable hospitalizations among major chronic diseases.

Evidence show that timely integrated disease management can prevent future COPD flare-ups and readmissions, but recent data indicate that appropriate follow-up after a COPD hospitalization is limited. To reduce this care gap, the investigators developed a discharge care bundle to help a patient that are being discharged from hospital or ED after COPD flare-up transition to community care.

The aim of this study is to assess how effective and cost-effective is such bundle delivered alone or supported by the dedicated care manager. The investigators will be assessing reduction of ED and hospital readmission.

Read the detailed description

Introduction/Significance

Chronic obstructive pulmonary disease (COPD) is a common, chronic progressive lung disease that is characterized by shortness of breath, activity limitation, and a predisposition to acute exacerbations resulting in frequent emergency department (ED) visits and hospitalizations. COPD exacerbations account for the greatest proportion of preventable hospitalizations among major chronic diseases. In Alberta, a recent report from the COPD Working Group of the Respiratory Health Strategic Clinical Network (RHSCN) found that, with an average length of stay of 12.9 days, COPD hospitalizations result in an estimated total inpatient cost of $112 million annually. In addition to increasing the risk of disease progression and mortality, COPD exacerbations are a major risk factor for subsequent COPD exacerbations, resulting in additional ED visits and hospitalizations. Approximately 35% of COPD patients who are discharged from the ED have a subsequent revisit within 30 days of initial ED discharge. National data indicate that 18% of hospitalized COPD patients are readmitted within one year after the index hospitalization while 14% are admitted twice within the year. Analysis of Alberta Health Services (AHS) administrative data shows that the 30-day hospital readmission rates for COPD in Alberta during 2012 (18.8%) and 2013 (19.5%) were well above the national 30-day readmission rate for all hospital admissions (8.4%).

The Canadian Thoracic Society (CTS) has developed evidence-based management guidelines for optimizing COPD care and preventing exacerbations and has recommended that COPD patients should be seen by their primary care provider within 14 days following an exacerbation. Further, the Global Initiative for Obstructive Lung Disease has proposed a list of items to review with the patient at discharge and recommends follow-up at 4-6 weeks after discharge. Despite evidence from systematic reviews that timely integrated disease management can prevent future COPD exacerbations and readmissions, recent Alberta data indicate that appropriate follow-up after a COPD hospitalization is limited. An audit at the University of Alberta hospital found that only 43% of COPD patients received appropriate medication prescriptions at discharge; only 10% of eligible patients were referred to a rehabilitation program while only 58% of smokers received instructions on smoking cessation interventions. To overcome these care gaps in COPD, previously published work has supported the introduction of clinical bundles and case management for follow-up after discharge, suggesting promising results to reduce readmissions and minimize health care utilization costs. Clinical bundles support the translation of clinical guidelines into local protocols and their subsequent standardization and application to clinical practice, enhance integrated care, and optimize patient outcomes while maximizing clinical efficiency and containing costs.

A recently completed systematic review of the scientific literature on the effectiveness of COPD discharge care bundles showed that COPD discharge care bundles reduced hospital readmission rates (Risk Ratio [RR]=0.8; 95% Confidence Interval [CI] [0.65, 0.99]); they did not, however, significantly reduce long-term mortality (RR=0.74; CI [0.43; 1.28]) nor improved quality of life after acute care discharge (Mean Difference=1.84; CI [-5.23, 5.80])

COPD discharge care bundle

In view of the promising results from systematic reviews that indicate that integrated care bundles can be effective for conditions with relatively predictable trajectories of care such as COPD, the investigators want to assess whether a COPD discharge bundle adapted to local ED and hospital settings is a relevant, feasible and cost-effective alternative within the Alberta health care system, and whether the addition of a care coordinator to the bundle further reduces ED and hospital readmissions while containing health care costs.

To assure that the care bundle is relevant to the local practice and applicable in the Alberta health system, the research team developed a COPD discharge care bundle through an evidence-based consultation-driven process. During this process, the researchers consulted patients and expert clinicians from Alberta and Canada. The development of the bundle has been a part of 3-year PRIHS project titled "Developing and assessing the effectiveness of a post-discharge care pathway to reduce emergency department revisits and hospital re-admission rates for patients with COPD". The process of bundle development involved several steps:

  • Systematic review - to identify evidence-based components incorporated in COPD discharge care bundles in the scientific literature;
  • 2-step Delphi technique with field experts and patients to reach consensus on the evidence-based individual components of discharge care bundles;
  • A face-to-face Consensus Meeting with practitioners and experts from Alberta and to finalize components of the bundle and identify practical issues for bundle implementation;
  • Targeted focus groups with patients and health professionals who work within hospitals, emergency units and/or primary care settings to recognize barriers and facilitators for care bundle implementation.

As a result, the investigators developed the COPD discharge care bundle that includes 7 action items (see Table 2). The list constitutes a single intervention (COPD discharge care bundle). The bundle has subsequently been integrated into the new provincial AHS COPD Order Set by the AHS pathway development team. The current study will specifically examine the efficacy of this new discharge care bundle, and whether the addition of a case manager will improve care. Currently, the research team is conducting the needs and readiness assessments within the five hospitals that are part of the project to determine the best implementation strategies.

Study objectives

This study aims to assess the effectiveness and cost-effectiveness of an evidence-based COPD discharge care bundle, delivered alone or facilitated by a dedicated care coordinator, to reduce ED and hospital readmissions, and improve patient-centered and economic outcomes.

Being tested
COPD discharge care bundle, COPD discharge care bundle & coordinator
Keywords
COPD, AECOPD, Discharge care bundle, Patient Care Bundles
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.

  • COPD discharge care bundleOther

    As a part of RHSCN quality improvement initiative, the elements of the COPD discharge bundle were integrated into a standardized COPD admission order set and are being implemented province-wide. The discharging physician/team will complete the COPD bundle (with reminders facilitated by clinical decision support tools) prior to patient discharge. A copy of the bundle is retained in the patient's medical record, and another copy is sent to the patient's primary care provider detailing the components of the bundle that were completed prior to discharge, and those still needing to be addressed. The patient will also receive a patient-focused discharge checklist detailing discharge bundle items

  • COPD discharge care bundle & coordinatorOther

    The coordinator will be health professional associated with a Primary Care Network, ED or AHS with access to patient information. Patients will be informed that care coordinator may contact them for follow up after discharge. At 48-72 hours after hospital/ED discharge and then at intervals to be determined, the care coordinator will contact the patient by phone. The care coordinator will identify specific needs or problems that patient may have encountered after discharge, which could potentially affect the successful transition from acute to community care setting. Specifically, the care coordinator will seek information on any follow up with family doctor visit, pulmonary rehabilitation and smoking cessation referrals

Study groups in NCT03358771
Study groupRoleWhat they receive
Usual CareNo interventionDuring the initial stepped wedge phase, all sites will receive usual care. There is currently no standardized discharge care bundle for COPD in Alberta. Some electronic patient information sheets do exist; however, their content is general and use is limited. It is expected that a vast majority of patients will transition to the community on a sub-optimal medication regimen, with limited referral to additional outpatient programs and no formal follow-up organized with a primary care provider (e.g., "F/U prn" or "F/U with Fam MD").
COPD discharge care bundleActive comparatorCOPD discharge care bundle: 1. Ensure patient has demonstrated adequate inhaler technique 2. Send discharge summary to family physician office and arrange follow-up 3. Optimize and reconcile prescription of respiratory medications 4. Provide a written discharge management plan, and assess patient's and care giver's comprehension of discharge instructions 5. Refer to pulmonary rehabilitation 6. Screen for frailty and comorbid condition(s) 7. Assess smoking status, provide counseling and refer to smoking cessation program, where appropriate
Receives: Other: COPD discharge care bundle
COPD discharge care bundle & coordinatorExperimentalCOPD discharge care bundle as listed for active comparator arm enhanced with care coordinator support.
Receives: Other: COPD discharge care bundle & coordinator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ED revisits

    Number of revisits

    Measured: 30 days after discharge

  2. Hospital readmissions

    Number of readmissions

    Measured: 30 days after discharge

Secondary outcomes (15)
  1. ED revisits

    Number of revisits

    Measured: 7 days after discharge

  2. ED revisits

    Number of revisits

    Measured: 90 days after discharge

  3. ED revisits

    Number of revisits

    Measured: 1 year after discharge

  4. Hospital readmission

    Number of readmissions

    Measured: 7 days after discharge

  5. Hospital readmission

    Number of readmissions

    Measured: 90 days after discharge

  6. Hospital readmission

    Number of readmissions

    Measured: 1 year after discharge

  7. Time to first physician visit and total visits

    Number of days

    Measured: in the first 30 days after discharge

  8. Time to first physician visit and total visits

    Number of days

    Measured: in the first 90 days after discharge

  9. Mortality

    Number of cases

    Measured: 7 days after discharge

  10. Mortality

    Number of cases

    Measured: 30 days after discharge

  11. Mortality

    Number of cases

    Measured: 90 days after discharge

  12. Mortality

    Number of cases

    Measured: 1 year after discharge

  13. Patient Experience - Inpatient

    For a randomly selected sample of patients, Patient Experience Survey - Inpatient Care

    Measured: 45-60 days after discharge

  14. Patient Experience - ED

    For a randomly selected sample of patients, Patient Experience Survey - Emergency Department

    Measured: 45-60 days after discharge

  15. Economic Evaluation

    Cost per readmission prevented; cost of intervention; cost of healthcare use (MD visits, ED visits, medication use, hospitalizations)

    Measured: 1 year after termination of the trial

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2017
  2. Study start1 Mar 2017
  3. Primary completion30 Dec 2019
  4. Study completion30 Dec 2019

Resources

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
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
3,710 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03358771
Sponsor's protocol ID
Pro00065003
Acronym
PRIHS
Status last verified
May 2021
First submitted
21 Nov 2017
Last updated
5 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Atwood CE, Bhutani M, Ospina MB, Rowe BH, Leigh R, Deuchar L, Faris P, Michas M, Mrklas KJ, Graham J, Aceron R, Damant R, Green L, Hirani N, Longard K, Meyer V, Mitchell P, Tsai W, Walker B, Stickland MK. Optimizing COPD Acute Care Patient Outcomes Using a Standardized Transition Bundle and Care Coordinator: A Randomized Clinical Trial. Chest. 2022 Aug;162(2):321-330. doi: 10.1016/j.chest.2022.03.047. Epub 2022 Apr 9.

    PubMed 35405112

Questions about this trial

What is this clinical trial studying?

A study testing COPD discharge care bundle and COPD discharge care bundle & coordinator in people with Pulmonary Disease, Chronic Obstructive, run by University of Alberta at 5 sites in Canada.

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 4 inclusion and 1 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 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Canada. 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?

ED revisits (time frame: 30 days after discharge). 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?

On the ClinicalTrials.gov record for NCT03358771, 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 5 May 2021.

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