NCT03358771

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,710

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 2, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

May 5, 2021

Status Verified

May 1, 2021

Enrollment Period

2.8 years

First QC Date

November 21, 2017

Last Update Submit

May 3, 2021

Conditions

Keywords

COPDAECOPDDischarge care bundlePatient Care Bundles

Outcome Measures

Primary Outcomes (2)

  • ED revisits

    Number of revisits

    30 days after discharge

  • Hospital readmissions

    Number of readmissions

    30 days after discharge

Secondary Outcomes (15)

  • ED revisits

    7 days after discharge

  • ED revisits

    90 days after discharge

  • ED revisits

    1 year after discharge

  • Hospital readmission

    7 days after discharge

  • Hospital readmission

    90 days after discharge

  • +10 more secondary outcomes

Study Arms (3)

Usual Care

NO INTERVENTION

During 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 bundle

ACTIVE COMPARATOR

COPD 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

Other: COPD discharge care bundle

COPD discharge care bundle & coordinator

EXPERIMENTAL

COPD discharge care bundle as listed for active comparator arm enhanced with care coordinator support.

Other: COPD discharge care bundle & coordinator

Interventions

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

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

COPD discharge care bundle & coordinator

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Foothills Medical Centre

Calgary, Alberta, Canada

Location

Rockyview General Hospital

Calgary, Alberta, Canada

Location

Royal Alexandra Hospital

Edmonton, Alberta, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, Canada

Location

Red Deer Regional Hospital Centre

Red Deer, Alberta, T4N 4E7, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael K Stickland, PhD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 21, 2017

First Posted

December 2, 2017

Study Start

March 1, 2017

Primary Completion

December 30, 2019

Study Completion

December 30, 2019

Last Updated

May 5, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations